SUBSTANCE FOR TREATMENT OR PREVENTION OF DISEASES, METHOD FOR DESIGNING THE SAME, AND METHOD FOR PREPARING THE SAME

Abstract

The present disclosure provides a substance for treatment and/or prevention of diseases, the method for designing the substance, and the method for preparing the substance. A stable structure corresponding to a substance associated with diseases is used as the substance for treatment or prevention of the diseases. The essence of disease is the imbalance of the biological structure system. The structural imbalance of different substances will cause different diseases. The present invention discloses that the biological body recognizes the stable structure corresponding to the substance, adjusts its gene or gene expression by the self-adaptation and self-organization functions of its own structural system, and restores the biological structure system to be related to the substance. The balance of structure, treatment and/or prevention of diseases related to the substance.

Claims

1. A method for designing a substance for treatment and/or prevention of diseases, comprising: using a stable structure corresponding to a substance associated with disease as the substance for treatment and/or prevention of the diseases; wherein the stable structure corresponding to the substance refers to the structure of the substance that is present in a solid state at a high temperature of 500° C. or more.

2. The method of claim 1, wherein the stable structure corresponding to a substance associated with disease is one or more selected from: (1) a stable structure corresponding to a substance causing the disease in an organism; (2) a stable structure corresponding to a substance associated with the disease from an organism itself; (3) a stable structure corresponding to a substance containing a disease-inhibiting structure; (4) a stable structure corresponding to a substance containing the substance according to any one of (1) to (3) above.

3. A substance for treatment and/or prevention of diseases, designed according to the method of claim 1.

4. The substance for treatment and/or prevention of diseases of claim 3, wherein the stable structure corresponding to the substance is prepared by high-temperature carbonization.

5.-6. (canceled)

7. The substance for treatment and/or prevention of diseases of claim 4, wherein when the disease is depression, anxiety, mania, bulimia, insomnia, or tension headache, the disease-associated substance is selected from one or more of: substances in the nervous system, and substances in the endocrine system; when the disease is anorexia, the disease-associated substance is selected from one or more of: substances in the nervous system, substances in the endocrine system, the ovary, and the intestinal tract of an organism; when the disease is diabetes, the disease-associated substance is derived from a secreting gland of an organism; when the disease is hypertension, the disease-associated substance is selected from one or more of: substances in the nervous system, substances in the endocrine system, viscera, and blood vessels of an organism; when the disease is menoxenia, amenorrhea, or dysmenorrhea, the disease-associated substance is selected from one or more of: substances in the nervous system, substances in the endocrine system, and the ovary; when the disease is stroke sequelae, the disease-associated substance is derived from substances in the cranial cavity of an organism; when the disease is lacrimation, or xerophthalmia, the disease-associated substance is selected from one or more of: eyes of an organism, immune organs of an organism, and the liver; when the disease is sexual dysfunction, the disease-associated substance is selected from one or more of: substances in the nervous system, substances in the endocrine system, and the reproductive organ of an organism; when the disease is degenerative bone disease, the disease-associated substance is derived from the locomotor system; when the disease is infectious disease, the disease-associated substance is one or more selected from: bacteria, fungi, viruses, viroids, and parasite.

8.-114. (canceled)

115. The substance for treatment and/or prevention of diseases of claim 4, which is usable for manufacture of medicaments, health products, food, and food additives.

116. The method of claim 1, wherein the disease is at least one selected from depression, anxiety, mania, bulimia, anorexia, insomnia, tension headache, diabetes, hypertension, menoxenia, amenorrhea, dysmenorrhea, stroke sequelae, lacrimation, xerophthalmia, sexual dysfunction, degenerative bone disease, urticaria, infectious disease, conjunctivitis, asthma, constipation, and ankylosing spondylitis.

Description

DETAILED DESCRIPTION OF INVENTION

[0400] The present disclosure relates to a substance for treatment and/or prevention of diseases, the method for designing the substance, and the method for preparing the substance. Those skilled in the art can learn from the content of the specification to use different materials or improve the process or use other similar process for preparation, which are all considered to be included in the scope of the present disclosure. It is particularly noteworthy that all similar replacements and modifications are obvious to those skilled in the art, and they are all deemed to be included in the scope of the present disclosure. The method and product of the present disclosure have been described with reference to preferred examples, and it is obvious that those skilled in the art can make modifications or appropriate changes and combinations to the methods described herein without departing from the content, spirit and scope of the present disclosure to carry out and apply the technique of the present disclosure.

[0401] In order to provide further understanding of the present disclosure, the technical solutions in examples of the present disclosure will be clearly and completely described below in conjunction with the examples of the present disclosure. Apparently, the examples described below are only a part of examples of the present invention rather than all of them. Based on the examples of the present disclosure, all other examples obtained by those of ordinary skill in the art without paying creative work shall fall within the protection scope of the present invention.

[0402] The embodiments are as follows.

EXAMPLE 1

Substance for Treatment of Depression and Method for Preparing the Substance

[0403] Depression is a chronic recurrent disease having both affective and physical symptoms. The neurotransmitter serotonin in patients' brain is disordered or deficient, resulting in significant and lasting depressed mood. Therefore, depression mainly involves the nervous system and endocrine system. The content in the cranial cavity of an organism contain depression-associated substances, and are easy to obtain. Therefore, in this example, the substance for treatment or prevention of depression was prepared by high-temperature carbonization of the content in the cranial cavity of Caprinae. If other organs or tissue, such as the adrenal glands, also contains depression-associated pathologically changed substances, it is also preferable to use these depression-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of depression by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of depression can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity.

[0404] In this example, content in the cranial cavity of Caprinae were selected to prepare the substance for treatment and/or prevention of depression by high-temperature carbonization.

Example 2

Clinical Study with the Substance Prepared in Example 1 Against Depression

[0405] This example used the substance prepared in Example 1 for efficacy verification, as specifically shown below.

[0406] 1. Clinical data: 60 cases (in total) of outpatients and inpatients with depression were enrolled, and randomly divided into a treatment group of 30 patients and a control group of 30 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0407] 2. Diagnosis criteria: The diagnosis criteria for depression from The Diagnostic and Statistical Manual of Mental Disorders.

[0408] 3. Treatment method: Patients in the treatment group orally took the substance for treatment of depression prepared in Example 1, 3 g per time, once a day, for 7 consecutive days. Patients in the control group were treated with fluoxetine, the initial and treatment doses both being 20 mg/day, for a course of 4 weeks.

[0409] 4. Efficacy evaluation criteria: After 4 weeks of treatment, the patients were scored by a psychiatrist based on the Hamilton Depression Rating Scale HAMD-17. “Cured” means a HAMD-17 total score <7; “effective” means a HAMD-17 total score of 8-17; and “ineffective” means a HAMD-17 total score>17.

Total effective rate=cured rate+effective rate.

[0410] 5. Efficacy results: After treatment, 27 patients in the treatment group were “cured” or showed “effective”, with a total effective rate of 90.00%, which is significantly (P<0.05) higher than that (76.67%) of the control group.

TABLE-US-00001 TABLE 1 Comparison of the effectiveness in patients with depression after treatment (as Examples) Total Number of effective Group patients Cured Effective Ineffective rate (%) Treatment 30 20 7 3 90.00% Control 30 9 14 7 76.67%

Example 3

Substance for Treatment of Menoxenia and Method for Preparing the Substance

[0411] Menstruation is formed after the hormones secreted by the ovary act on the endometrium. The secretion of hormones by the ovary is controlled by the hormones released by the pituitary gland and hypothalamus. Therefore, abnormalities in the function of any of the ovary, pituitary gland, and hypothalamus will affect menstruation. Therefore, menoxenia mainly involves the endocrine system. The content in the cranial cavity of an organism contain the pituitary gland and hypothalamus, and are easy to obtain. Therefore, in this example, the substance for treatment and/or prevention of menoxenia was prepared by high-temperature carbonization of the content in the cranial cavity of Caprinae. If other organs or tissue, such as the ovary or spleen, also contains menoxenia-associated pathologically changed substances, it is also preferable to use these menoxenia-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of menoxenia by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of menoxenia can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity.

[0412] In this example, content in the cranial cavity of Caprinae were selected to prepare the substance for treatment or prevention of menoxenia by high-temperature carbonization.

Example 4

Clinical Study with the Substance Prepared in Example 3 Against Menoxenia

[0413] 1. Clinical data: 60 cases (in total) of outpatients and inpatients with menoxenia were enrolled, and randomly divided into a treatment group of 30 patients and a control group of 30 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, course of disease, and complication (P>0.05), and they were comparable.

[0414] 2. Diagnosis criteria: Symptoms include disorders in the menstrual cycle and menstrual period, excessive or insufficient bleeding during menstruation, and abdominal pain before and after menstruation.

[0415] 3. Treatment method: Patients in the treatment group orally took the substance for treatment of menoxenia prepared in Example 3, at a dose of 3 g, once a day, started on day 5 since menstruation, for 7 consecutive days. Patients in the control group were orally given clomifene citrate capsules (NMPA Approval No. H31021107), 50 mg/day, started on day 5 since menstruation, for 2 consecutive months.

[0416] 4. Efficacy evaluation criteria: The efficacy evaluation is based on the relevant standards in Guiding Principles for Clinical Research of New Chinese Medicines. “Cured” means that clinical symptoms have disappeared, the menstrual cycle returns to 28±4 days after treatment, and does not recur after stopping the drug; “markedly effective” means that clinical symptoms have been significantly alleviated, and the menstrual cycle returns to 28±8 days after treatment, and does not recur after stopping the drug; “effective” means that clinical symptoms have been alleviated, the menstrual cycle has been improved after treatment, and recurs after stopping the drug; “ineffective” means that clinical symptoms have not been improved, and the menstrual cycle has not been improved after treatment, and recurs after stopping the drug.

Total effective rate=cured rate+effective rate.

[0417] 5. Treatment results: The total effective rates of the treatment group and the control group were 86.67% and 66.67%, respectively, with a significant difference (P<0.05), indicating that the treatment group showed a better result than the control group.

TABLE-US-00002 TABLE 2 Comparison of the effective rates between the two groups after treatment (as Examples) Total Number of Markedly effective Group patients Cured effective Effective Ineffective rate (%) Treatment 30 8 10 8 4 86.67% Control 30 0 10 10 0 66.67%

Example 5

Substance for Treatment of Stroke Sequelae and Method for Preparing the Substance

[0418] “Stroke” is also called “apoplexy” or “cerebrovascular accident”. It is an acute cerebrovascular disease, which is a group of diseases with brain tissue damage due to sudden rupture of blood vessels in the brain or block of blood from flowing into the brain. The stroke sequelae refer to the conditions left after the onset of the acute cerebrovascular disease, mainly manifested in hemiplegia, numbness, crooked mouth and eyes, and aphasia. Therefore, the stroke sequelae mainly involve the nerve system. The content in the cranial cavity of an organism contain stroke sequelae-associated substances, and are easy to obtain. Therefore, in this example, the substance for treatment or prevention of stroke sequelae was prepared by high-temperature carbonization of the content in the cranial cavity of Caprinae. If other organs or tissue also contains stroke sequelae-associated pathologically changed substances, it is also preferable to use these stroke sequelae-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of stroke sequelae by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of stroke sequelae can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity.

[0419] In this example, content in the cranial cavity of Caprinae were used to prepare the substance for treatment or prevention of stroke sequelae by high-temperature carbonization.

Example 6

Clinical Study with the Substance Prepared in Example 5 Against Stroke Sequelae

[0420] This example used the substance prepared in Example 5 for clinical studies, as specifically shown below.

[0421] 1. Clinical data: 32 cases (in total) of outpatients and inpatients with stroke sequelae were enrolled, and randomly divided into a treatment group of 16 patients and a control group of 16 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0422] 2. Diagnosis criteria: The diagnosis criteria for stroke from the Western medicine reference Key points in diagnosis of various cerebrovascular diseases.

[0423] 3. Treatment method: Patients in the treatment group orally took the substance for treatment of stroke sequelae prepared in Example 5, at a dose of 3 g, once a day, for 7 consecutive days. Patients in the control group were treated with a Western medicine regime: the aspirin enteric-coated tablets from Shijiazhuang KANGLI pharmaceuticals, orally taken, 100 mg per time, once per day, methycobal from Eisai China, orally taken, 0.5 mg per time, 3 times per day, and the isosorbide mononitrate tablets from Lunan Better pharmaceutical Co., Ltd., orally taken, 20 mg per time, once per day, for 2 consecutive months.

[0424] 4. Efficacy evaluation criteria: “Markedly effective” means complete or substantial improvement in symptoms after treatment, and recovery of limb function, language function, and living ability; “effective” means relief of symptoms after treatment, and improvement in limb function, language function, and living ability; “ineffective” means failure to achieve the above standards after treatment.

Total effective rate=markedly effective rate+effective rate.

[0425] 5. Efficacy results: As shown in Table 3, after treatment, 15 patients in the treatment group were “cured” or showed “effective”, with a total effective rate of 93.75%, which is significantly (P <0.05) higher than the total effective rate 68.75% of the control group.

TABLE-US-00003 TABLE 3 Comparison of the effectiveness in patients with stroke sequelae after treatment Total Number of Markedly effective Group patients effective Effective Ineffective rate (%) Treatment 16 9 6 1 93.75% Control 16 4 7 5 68.75%

Example 7

Substance for Treatment of Degenerative Osteoarthropathy and Method for Preparing the Substance

[0426] Degenerative osteoarthropathy, also known as osteoarthritis, degenerative arthritis, senile arthritis, or hypertrophic arthritis, is a degenerative disease with degenerative damage to articular cartilage and reactive hyperplasia at joint edges and subchondral bone caused by various factors such as aging, obesity, strain, trauma, joint congenital abnormalities, and joints deformity. Therefore, degenerative osteoarthropathy mainly involves the locomotor system. Joints of an organism contain substances associated with degenerative osteoarthropathy, and are easy to obtain. Therefore, in this example, joints of swine were used to prepare the substance for treatment or prevention of degenerative osteoarthropathy by high-temperature carbonization.

Example 8

Clinical Study with the Substance Prepared in Example 7 Against Degenerative Osteoarthropathy

[0427] This example used the substance prepared in Example 7 for clinical studies, as specifically shown below.

[0428] 1. Clinical data: 17 cases (in total) of patients with degenerative osteoarthropathy were enrolled, 4 males and 13 females, aged from 42 to 59.

[0429] 2. Diagnosis criteria: The diagnosis criteria from Diagnosis standards for bone damage diseases in traditional Chinese medicine.

[0430] 3. Treatment method: Patients orally took the substance for treatment of degenerative osteoarthropathy prepared in Example 7, 3 g per time, once a day, for 14 consecutive days.

[0431] 4. Efficacy evaluation criteria: “Markedly effective” means that the patients' joint activities are not restricted in any way after treatment, and the clinical symptoms such as pain and discomfort have all disappeared. “Effective” means that after treatment the patients' pain has been relived, the restriction to join activity is reduced, and the discomfort and pain are lessened. “Ineffective” means that after treatment the patients' clinical symptoms have not been improved or even worsened, posing a serious impact on daily life.

Total effective rate=markedly effective rate+effective rate.

[0432] 5. Efficacy results: Two months after the treatment the patients were observed for efficacy. Among the 17 patients in total, 12 showed “markedly effective”, 4 showed “effective”, and one showed “ineffective”, with a total effective rate of 94.12%.

Example 9

Substance for Treatment or Prevention of Asthma and Method for Preparing the Substance

[0433] The main symptoms of asthma are wheezing and gasping, and the main pathogenesis of asthma is abnormal inhalation and exhalation of the lung caused by retained phlegm in the lung. The disease is located in the lung and mainly involves the lung meridian and the stomach meridian. Asthma is caused by the internal negatives and induced by external factors such that the lung qi is reversed upwards and the dispersing and descending function of the lung is impaired. People with pyretic pulmonary diseases feel unconscious first, then show vellus hair, aversion to wind and cold, yellow tongue, body fever, and heat conflicting which causes dyspnea with cough. From the perspective of traditional Chinese medicine, the cause of asthma lies in the lung. The lung of an organism contains substances associated with asthma, and is easy to obtain. Therefore, in this example, the lung of swine was used to prepare the substance for treatment or prevention of asthma by high-temperature carbonization. If other organs or tissue also contains asthma-associated pathologically changed substances, it is also preferable to use these asthma-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of asthma by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of asthma can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity.

[0434] In this example, the lung of swine were used to prepare the substance for treatment or prevention of asthma by high-temperature carbonization.

Example 10

Clinical Study with the Substance Prepared in Example 9 Against Asthma

[0435] This example used the substance prepared in Example 9 for efficacy evaluation, as specifically shown below.

[0436] 1. Clinical data: 38 cases (in total) of outpatients and inpatients with asthma were enrolled, and randomly divided into a treatment group of 19 patients and a control group of 19 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, course of disease, and complication (P>0.05), and they were comparable.

[0437] 2. Diagnosis criteria: The diagnosis criteria for asthma from Guidance for prevention and treatment of asthma in China (fundamental edition).

[0438] 3. Treatment method: Patients in the treatment group orally took the substance for treatment of asthma prepared in Example 9, 3 g per time, once a day, for 3 consecutive days. Patients in the control group inhaled the Salmeterol Xinafoate and Fluticasone Propionate powdery inhalant, 1 pack per time, twice a day, for 15 consecutive days.

[0439] 4. Efficacy evaluation criteria: “Cured” means that after treatment, the clinical symptoms of asthma in the patients have disappeared completely without more onsets, and meanwhile the forced expiratory volume (FEV1) in the first second has increased by more than 35% as compared to that before the treatment or FEV1 is greater than 80% of the predicted value, and the peak expiratory flow (PEF) has a diurnal and nocturnal fluctuation rate less than 20%; “markedly effective” means that the clinical symptoms of asthma in patients after treatment have been significantly reduced as compared to those before treatment, but bronchodilators or glucocorticoids are still needed for controlling, and meanwhile FEV1 has increased by 25% to 35% as compared to that before treatment or FEV1 reaches 60%˜79% of the predicted value, and PEF has a diurnal and nocturnal fluctuation rate greater than 20%; “effective” means that the clinical symptoms of asthma in patients after treatment have been reduced as compared to those before treatment, but bronchodilators or glucocorticoids are still needed for controlling, and meanwhile FEV1 has increased by 15% to 24% as compared to that before treatment; “ineffective” means that the clinical symptoms of asthma or the FEV1 value of patients have not been improved or even worsened after treatment.

Total effective rate=cured rate+markedly effective rate+effective rate.

[0440] 5. Efficacy results: As shown in Table 4, after treatment, in the control group 2 patients were “cured”, 4 showed “markedly effective”, 6 showed “effective”, and 7 showed “ineffective”, with a total effective rate of 63.16%, while in the treatment group 11 patients were “cured”, 5 showed “markedly effective”, 2 showed “effective”, and 1 showed “ineffective”, with a total effective rate as high as 94.74%. There was a statistically significant (P <0.05) difference between the two groups. During the treatment, no patient in the treatment group showed adverse effects or drug dependence, while 5 patients in the control group experienced adverse effects.

TABLE-US-00004 TABLE 4 Comparison of the effectiveness in patients with asthma after treatment Total Number of Markedly effective Group patients Cured effective Effective Ineffective rate (%) Treatment 19 11 5 2 1 94.74% Control 19 2 4 6 7 63.16%

Example 11

Substance for Treatment or Prevention of Allergic Rhinitis and Method for Preparing the Substance

[0441] Rhinitis is an inflammatory disease in the nasal cavity, which is an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. Rhinitis caused by allergens is also called allergic rhinitis. As the course of the disease progresses, nasal mucosa congestion, swelling, exudation, hyperplasia, atrophy or necrosis can develop into chronic rhinitis. Therefore, from the perspective of Western medicine, the allergen that causes rhinitis includes substances associated with the disease. From the structural point of view, the root cause is the imbalance due to interactions between the biological structure system and the structure of the allergen. From the perspective of traditional Chinese medicine, “the lung opens up at the nose”, and the lung communicates with the nature through the skin and hair in the nose and the mouth, and easily senses the invasion of foreign cold wind and air. In spring, there are many external winds that easily invade the head, face and skin surface. If the lung is weak at this time, the lung defense is compromised and the striae of the skin and muscle is loose, the wind often penetrates through the mouth and nose or the skin and hair to impede vascular circulation and cause blockage feelings, and the nasal orifices lose their patency and nourishment and become ill. If the lung is weak, the cold wind and “external negatives” can invade and cause nasal congestion, sneezing, and runny nose. If the wind enters from the nose and mouth, it will cause nasal congestion, runny nose and sticky nose. Therefore, according to the theory of traditional Chinese medicine, the cause of rhinitis is ascribed to the lungs. From a structural point of view, the root cause is the imbalance of some structures in the structure system of the lung of an organism, which leads to the structural imbalance between the biological structure system and the structure of the allergen. The balance of the biological structure system is dynamic and is associated with the external structural environment. For example, for humans, some substances, such as Artemisia desertorum, easily cause universal allergic rhinitis in humans, which means that the structural imbalance of the lung is a relative concept. For example, organisms such as swine, bovine, and Caprinae are not allergic to Artemisia desertorum and will not have allergic rhinitis. That is, the lung of swine, bovine and Caprinae contain structures that interact with Artemisia desertorum to avoid allergic rhinitis, i.e., structures that inhibit rhinitis.

[0442] The lung of an organism contains substances associated with allergic rhinitis and is readily available. Therefore, in this example, the lung of swine was selected and subjected to high-temperature carbonization to obtain the substance for treatment or prevention of allergic rhinitis.

Example 12

Clinical Application Trial with the Substance Prepared in Example 11 for Treatment of Allergic Rhinitis

[0443] This example used the substance prepared in Example 11 above for efficacy verification, as specifically shown below.

[0444] 1. Clinical data: 60 cases (a total number) of 60 outpatients and inpatients with allergic rhinitis were enrolled, and were randomly divided into a treatment group with 30 patients and a control group with 30 patients. There was no significant difference between the two groups in clinical data and conditions. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0445] 2. Diagnosis criteria: 2 or more clinical symptoms such as sneezing, clear water-like nasal discharge, nasal congestion, and nasal itching, appearing continuously or continually for 1 hour or more every day. It may be accompanied by eye symptoms such as eye itching and conjunctival hyperemia. Common signs often include pale nasal mucosa, edema, and watery nasal discharge. Positive in the allergen skin prick test.

[0446] 3. Treatment method: the patients in the treatment group orally took the substance associated with treatment of allergic rhinitis prepared in Example 11, 3 g per time, once a day, for 3 consecutive days. The patients in the control group orally took loratadine 10 mg per time, once day, for 30 days.

[0447] 4. Efficacy evaluation criteria: “cured” means that symptoms and signs disappear for 60 days without recurrence; “effective” means that symptoms and signs are alleviated, and the number of onsets is reduced; “ineffective” means that the effective standard is not met. Total effective rate=cured rate+effective rate.

[0448] 5. Efficacy results: Table 5 shows that there were totally 28 patients in the treatment group showing “cured” and “effective” after treatment, with a total effective rate of 93.33%. In contrast, the control group showed a total effective rate of 66.67% after treatment, which is significantly lower (P<0.05). During the treatment, patients in the treatment group experienced no drug adverse reaction or drug dependence, and no recurrence during the 6-month follow-up, while adverse reactions occurred in 5 cases from in the control group and allergic symptoms appeared after contact with allergens after drug discontinuance.

TABLE-US-00005 TABLE 5 Comparison of effectiveness of treatment of patients with allergic rhinitis (as Examples) Total Number of effective Group patients Cured Effective Ineffective rate (%) Treatment 30 22 6 2 93.33% Control 30 0 20 10 66.67%

Example 13

Substance for Treatment of Conjunctivitis and Method for Preparing the Substance

[0449] Conjunctivitis is redness or inflammation on the transparent membrane covering the eyeball and a part the membrane inside the inner eyelid. Allergens, chemical agents, and underlying diseases can cause redness of eyes. Therefore, from the perspective of Western medicine, the allergens that cause conjunctivitis are substances associated with conjunctivitis. From the structure point of view, the root cause is the imbalance between the biological structure system and the structure of the allergens upon interactions. From the perspective of traditional Chinese medicine, the Neijing says that “the liver is physiologically connected to the eyes” via the foot Jueyin channel, so the eyes are most closely associated with the liver meridian. Although “all meridians relate to the eyes” and “the essence of the five ZANG-organs and six FU-organs are all upwards converged on the eyes” indicating that the eyes have extensive connections with the meridians and viscera, it is most closely related to the foot Jueyin channel, and thus reference to “eyes” is always intimated with the foot Jueyin. If the liver blood is sufficient, the eyes will be bright, and the vision will be clear; if the liver blood is insufficient, the eyes will be short of nutrition, dry and dim, and the vision will be unclear or night blind; if the liver meridian is invaded by wind heat, the eyes will be red and itchy; if the liver has inflammation, the eyes are red and produce cataract; if the liver Yang is hyperactive, dizziness is felt in the head and eyes; if the liver wind is stirred, the eyes have squint and an upward vision. Therefore, from the perspective of traditional Chinese medicine, the cause of conjunctivitis lies in the liver. From a structural perspective, the root cause is imbalance of certain structures in the structure system of the liver of an organism, which leads to structural imbalance between the biological structure system and the allergen structure, resulting in conjunctivitis, especially allergic conjunctivitis. The balance of the biological structure system is dynamic and is related to the external structural environment. For example, for humans, some substances easily generally cause allergic conjunctivitis in humans, such as Artemisia desertorum, but not in organisms such as swine, bovine and Caprinae which are not allergic to Artemisia desertorum, which means that the structural imbalance of the liver is relative, and the liver structure of swine, bovine and Caprinae contains a structure that interacts with the structure of Artemisia desertorum to prevent allergic conjunctivitis in these organisms, i.e. a structure that inhibits the cause of conjunctivitis.

[0450] The liver of an organism contains conjunctivitis-associated substances, and is easy to obtain. Therefore, in this example, the liver of healthy swine was used to prepare the substance for treatment or prevention of conjunctivitis by high-temperature carbonization.

Example 14

Clinical Study with the Substance Prepared in Example 13 Against Conjunctivitis

[0451] This example used the substance prepared in Example 13 for clinical studies, as specifically shown below.

[0452] 1. Clinical data: 32 cases (in total) of outpatients and inpatients with conjunctivitis were enrolled. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0453] 2. Diagnosis criteria: Foreign body sensation, burning sensation, a feel of heavy eyelids, and increased secretions in the affected eye; when the disease involves the cornea, photophobia, tearing, and varying degrees of vision loss may occur; conjunctival hyperemia; conjunctival edema; subconjunctival hemorrhage.

[0454] 3. Treatment method: Patients orally took the substance for treatment of conjunctivitis prepared in Example 13, 3 g per time, once a day, for 2 consecutive days.

[0455] 4. Efficacy evaluation criteria: “Cured” means complete disappearance of clinical symptoms without recurrence; “effective” means improvement of clinical symptoms; “ineffective” means no change in clinical symptoms or aggravation of clinical symptoms.

Total effective rate=cured rate+effective rate.

[0456] 5. Efficacy results: After the treatment the patients were observed for efficacy. Among the 32 patients in total, 27 were “cured”, 4 showed “effective”, and one showed “ineffective”, with a total effective rate of 96.88%.

Example 15

Substance for Treatment or Prevention of Chronic Urticaria and Method for Preparing the Substance

[0457] Urticaria is a skin disease characterized by wheal and angioedema, with various and complex causes. The foreign substances that cause urticaria such as castor beans, drugs and other substances are substance associated with diseases. Urticaria is a symptom, that is, an external manifestation of structural imbalance. Different substances can cause the same or similar structural imbalance, and the possible structures in these substances causing urticaria in an organism are the same or similar. Therefore, using only the stable structure corresponding to a known substance therein to act on the biological structure system can accomplish the supporting of “the positive” with “the external negative” according to the present application, thanks to the self-adapting, self-organizing, and structural stability-maintaining function of the biological structure system. According to the method for designing a substance for treatment and/or prevention of urticaria of the present disclosure, the stable structure corresponding to castor bean is preferably used in the present disclosure as the substance for treatment and/or prevention of urticaria. Because substances like ricin, ricinine, castor allergen and hemagglutinin in castor bean can cause urticaria with typical symptoms of disease, can be used as representative urticaria-associated substances and are also easy to obtain, in this example castor bean was selected and subjected to high-temperature carbonization to obtain the substance for treatment or prevention of urticaria.

Example 16

Clinical Study with the Substance Prepared in Example 15 Against Urticaria

[0458] This example used the substance prepared in Example 15 above for clinical studies, as specifically shown below.

[0459] 1. Clinical data: A total of 56 outpatients and inpatients with urticaria were enrolled, and were randomly divided into a treatment group with 28 patients and a control group with 28 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0460] 2. Diagnosis criteria: The diagnosis criteria for urticaria from Guidelines for diagnosis and treatment of urticaria in China (2014), intermittent seizures, a course of disease >6 weeks.

[0461] 3. Treatment method: the patients in the treatment group orally took the substance associated with treatment of urticaria prepared in Example 15, 3 g per time, once a day, for 3 consecutive days. The patients in the control group orally took loratadine 5 mg per time, once day, for 30 days.

[0462] 4. Efficacy evaluation criteria: “Cured” means that wheal and pruritus have subsided, other accompanying symptoms and signs have disappeared, and re-exposure to the allergens will not produce allergic symptoms; “markedly effective” means that the pruritus has been significantly relieved, the wheal has subsided by 80% or more, and other accompanying symptoms and signs have been improved; “effective” means that the pruritus has been relieved, the wheal has subsided by 50% to 80%, and other accompanying symptoms and signs have been reduced; “ineffective” means that the clinical symptoms and signs have not changed significantly, or even worsened. Total effective rate=cured rate+markedly effective rate+effective rate.

[0463] 5. Efficacy results: Table 6 shows that there were totally 26 patients in the treatment group showing “cured”, “markedly effective” or “effective” after treatment, with a total effective rate of 92.86%. In contrast, the control group showed a total effective rate of 53.57% after treatment, which is significantly lower (P<0.05). During the treatment, patients experienced no adverse reaction or drug dependence, and no recurrence during the 6-month follow-up.

TABLE-US-00006 TABLE 6 Comparison of effectiveness of treatment of patients with chronic urticaria Total Number of Markedly effective Group patients Cured effective Effective Ineffective rate (%) Treatment 28 13 7 6 2 92.86% Control 28 0 9 6 13 53.57%

Example 17

Substance for Treatment and/or Prevention of Ankylosing Spondylitis and Methods for Designing and Preparing the Substance

[0464] Ankylosing spondylitis is a chronic inflammatory disease whose main symptoms are sacroiliitis and spinal enthesitis, characterized by fibrosis and ossification of the large joints of the limbs, the annulus fibrosus disci intervertebralis and its nearby connective tissue, as well as ankylosis. The stable structure corresponding to the connective tissue is needed as an external structure to act on the organism suffering from ankylosing spondylitis to restore the balance of the structure system. Therefore, uthe stable structure corresponding to the connective tissue is used as a substance for treatment and/or prevention of ankylosing spondylitis. Because the connective tissue of an organism is easily available, in this example, the connective tissue of healthy bovine was selected and subjected to high-temperature carbonization to obtain the substance for treatment or prevention of ankylosing spondylitis.

Example 18

Clinical Study with the Substance Prepared in Example 17 in Patients with Ankylosing Spondylitis

[0465] 1. Clinical data: This example enrolled totally 27 patients with ankylosing spondylitis, who were randomly divided into a treatment group of 14 patients and a control group of 13 patients according to the order of visit. The treatment group comprised 7 males and 7 females, 31-52 years old, with an average course of disease of 10.3 years. The control group comprised 6 males and 7 females, 33 to 51 years old, with an average course of disease of 10.8 years. There was no statistically significant difference between the two groups of patients in gender, age, condition and other clinical data (P>0.05), and they were comparable.

[0466] 2. Diagnosis criteria: (1) lumbago and leg pain/discomfort of undetermined origin that occurred before the age of 40; (2) Insidious onset; (3) The course of disease >1 week; (4) Morning stiffness, static, or night pain, alleviated after exercise; (5) Positive for Gaenslen's test, percussion pain in sacroiliac joints and sacrum; (6) Inflammatory changes in the imaging examination of sacroiliac joints. Ankylosing spondylitis can be considered if one of the clinical criteria (1) to (4) is met on the basis of (5); and ankylosing spondylitis can be diagnosed if one of the clinical criteria is met on the basis of (6).

[0467] 3. Treatment method: All patients were given diet and functional exercise guidance. Patients in the treatment group orally took the substance prepared in Example 17, 3 g per time, once a day, for 7 days. Patients in the control group orally took sulfasalazine enteric tablets, 3 tablets per time, 2 times a day, for 1 month.

[0468] 4. Efficacy evaluation criteria: The total effective rate=(markedly effective+effective)/total number of patients*100%. “Markedly effective” means that the patient's clinical symptoms and signs are significantly alleviated after treatment; “effective” means that the patient's clinical symptoms and signs are improved after treatment, but not to the standard level of “markedly effective”; “ineffective” means that the patient's clinical symptoms or signs are not improved after treatment or even become severe.

[0469] 5. Treatment results: Both groups were treated for 1 month and observed for efficacy. Among the 14 patients in the treatment group, 12 showed “markedly effective”, 1 showed “effective”, and 1 showed “ineffective”, with a total effective rate of 92.86%. Among the 13 patients in the control group, 2 cases showed “markedly effective”, 5 showed “effective”, and 6 showed “ineffective”, with a total effective rate of 53.85%. The difference in the total effective rate between the treatment group and the control group was statistically significant (P<0.001), that is, the treatment group showed significantly better efficacy than the control group (see Table 7). During the treatment, patients in the treatment group did not show adverse drug reaction or drug dependence.

TABLE-US-00007 TABLE 7 Comparison of the effective rates between the two groups after treatment (as Examples) Total Number of Markedly effective Group patients effective Effective Ineffective rate (%) Treatment 14 12 1 1 92.86% Control 13 2 5 6 53.85%

Example 19

Substance for Treatment or Prevention of Hypertension and Methods for Designing and Preparing the Substance

[0470] Most hypertensive patients, especially in the early stage of hypertension, show signs of increased sympathetic nerve activity: the release of catecholamines, epinephrine, and norepinephrine in the adrenal medulla increases, and the level of adrenaline in the blood continues to increase. Catecholamines act on the central nervous system, increase its excitability, enhance the release of norepinephrine from sympathetic nerve endings, increase cardiac output, and elevate the blood pressure. The content in the cranial cavity and the adrenal glands of an organism contain hypertension-associated pathologically changed substances, and are easy to obtain. Therefore, it is preferable to prepare the substance for treatment and/or prevention of hypertension by high-temperature carbonization of the content in the cranial cavity of an organism and/or the adrenal glands. If other organs or tissue also contains hypertension-associated pathologically changed substances, it is also preferable to use these hypertension-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of hypertension by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of hypertension can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity. Therefore, in this example, content in the cranial cavity of Caprinae and the adrenal glands of swine were selected to prepare the substance for treatment or prevention of hypertension by high-temperature carbonization.

Example 20

Clinical Study with the Substance Prepared in Example 19 Against Hypertension

[0471] This example used the substance prepared in Example 19 above for clinical studies, as specifically shown below.

[0472] 1. Clinical data: In this example, totally 46 hypertensive patients were treated and observed clinically, including 25 males and 21 females, 18-75 years old, with a course of disease of 0.5 to 30 years, who were randomly divided into a treatment group of 23 patients and a control group of 23 patients. There was no significant difference between the two groups in clinical data. There was no statistically significant difference between the two groups in age, gender, course of disease, and complication (P>0.05), and they were comparable.

[0473] 2. Diagnosis criteria: According to the Guidelines for Diagnosis of Hypertension in China (2010), hypertension can be diagnosed if the systolic pressure≥140 mmHg and/or the diastolic pressure≥90 mmHg. Grade 1 hypertension: systolic pressure 140 to 159 mmHg and/or diastolic pressure 90 to 99 mmHg; Grade 2 hypertension: systolic pressure 160 to 179 mmHg and/or diastolic pressure 100 to 109 mmHg; Grade 3 hypertension: systolic pressure≥180 mmHg and/or diastolic pressure≥110 mmHg.

[0474] 3. Treatment method: Patients in the treatment group orally took the substance for treatment of hypertension prepared in Example 19, at a dose of 3 g, once a day, for 10 consecutive days. Patients in the control group orally took Levamlodipine Beslate and losartan potassium tablets, 3 times a day under supervision of a physician, and the dose was maintained for 3 months or more.

[0475] 4. Efficacy evaluation criteria: “Cured” means that after stopping the drug the diastolic pressure is normal without recurrence; “markedly effective” means that the diastolic pressure drops by 10 mmHg or more and returns to normal, or the diastolic blood pressure does not return to normal but drops by 20 mmHg or more; “effective” means that the diastolic pressure drops by 10 mmHg or more, or the diastolic pressure drops by less than 10 mmHg and returns to normal, and the systolic pressure drops by 30 mmHg or more; “ineffective” means that the above standards are not met. Total effective rate=cured rate+markedly effective rate+effective rate.

[0476] 5. Treatment results: After treatment, 23 hypertensive patients in the treatment group were tested for 3 months. As for the efficacy, 12 cases met the criteria for “cured”, and 7 cases met the criteria for “markedly effective”, see Table 8 below for details. The total effective rates of the treatment group and the control group were 95.65% and 56.52%, respectively, with a significant difference in efficacy between the two groups, indicating that the treatment group showed better results than the control group. During the treatment, in the control group there were 6 cases showing adverse drug reactions and 4 cases showing drug dependence. After administration, patients in the treatment group showing “effective” and “markedly effective” had their blood pressure well controlled, without drug dependence and adverse drug reactions.

TABLE-US-00008 TABLE 8 Comparison of the effective rates between the two groups after treatment (as Examples) Total Number of Markedly effective Group patients Cured effective Effective Ineffective rate (%) Treatment 23 12 7 3 1 95.65% Control 23 0 9 4 10 56.52%

Example 21

Substance for Treatment or Prevention of Diabetes and Method for Preparing the Substance

[0477] Diabetes is a syndrome of a series of metabolic disorders of proteins, fats, electrolytes, and the like caused by absolute or relative insufficient secretion of insulin and decreased sensitivity of target tissue cells to insulin. A variety of hormones secreted by the adrenal medulla affect glucose metabolism, antagonize the effect of insulin, and increase the blood sugar level. The substances in the islets of pancreas and/or adrenal glands of an organism contain diabetes-associated pathologically changed substances, and are easy to obtain. Therefore, it is preferable to prepare the substance for treatment and/or prevention of diabetes by high-temperature carbonization of the substances in the islets of pancreas and/or adrenal glands of an organism. If other organs or tissue also contains diabetes-associated pathologically changed substances, it is also preferable to use these diabetes-associated pathologically changed organs or tissue to prepare the substance for treatment and/or prevention of diabetes by high-temperature carbonization. In doing so, complex problems are simplified, and substances for treatment and/or prevention of diabetes can be designed and prepared without knowing the specific pathologically changed structure or the mechanism of pathogenicity. Therefore, in this example, the islets of pancreas and adrenal glands of swine were selected to prepare the substance for treatment or prevention of diabetes by high-temperature carbonization.

Example 22

Clinical Study with the Substance Prepared in Example 21 Against Diabetes

[0478] This example used the substance prepared in Example 21 above for clinical studies, as specifically shown below.

[0479] 1. Clinical data: In this example, 15 diabetic patients were treated and observed clinically, including 7 males and 8 females, 45-75 years old, with a course of disease of 0.5 to 10 years.

[0480] 2. Diagnosis criteria: All patients met the 1999 WHO diagnostic criteria for diabetes: fasting blood glucose≥7.0 mmol/L, 2 hours postprandial or random blood glucose≥11.1 mmol/L.

[0481] 3. Treatment method: Patients orally took the substance for treatment of diabetes prepared in Example 21, at a dose of 3 g, once a day, for 7 consecutive days.

[0482] 4. Efficacy evaluation criteria: The criteria were established with reference to the evaluation methods of efficacy against diabetes in the Guiding Principles of Clinical Research on New Chinese Medicines for Treatment of Diabetes. “Cured” means complete recovery of clinical symptoms and signs, with the fasting blood glucose and the 2 hours postprandial or random blood glucose returning to normal; “markedly effective” means that clinical symptoms and signs have been improved, with the fasting blood glucose≤7.0 mmol/L, and the 2 h postprandial or random blood glucose≤11.1 mmol/L; “effective” means that the clinical symptoms are better than those before treatment, and the blood glucose drops by more than 20% of the pre-treatment level, but does not reach the standard for “markedly effective”; “ineffective” means that the clinical symptoms and signs have not been improved or have been worsened, and the blood glucose indicators have not changed or have increased. Total effective rate=cured rate+markedly effective rate+effective rate.

[0483] 5. Treatment results: After treatment, 15 diabetic patients were tested for 3 months. As for the efficacy, 4 cases met the criteria for “cured” with the blood glucose controlled at a normal level, 9 cases met the criteria for “markedly effective”, and 2 cases showed “ineffective”, with a total effective rate of 86.67%. After taking the medicine one time, the “cured”, “markedly effective” and “effective” patients' blood glucose were well controlled during the follow-up of half a year, and there was no drug dependence and adverse drug reactions.