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 is used as the substance for treatment and/or prevention of diseases associated with the substance. The essence of disease is the imbalance of the biological structure system. Different structural imbalances 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 as the substance for treatment and/or prevention of diseases associated with the substance, or diseases caused by the substance; wherein the stable structure corresponding to the substance refers to a structure of the substance that is present in a solid state under a high temperature of 500° C. or more.

2. The method of claim 1, wherein the diseases associated with the substance include a disease caused by some materials in the substance and/or a disease caused by changes in some materials in the substance.

3.-7. (canceled)

8. The method of claim 1, wherein the disease is a lactose intolerance, and the method, comprising: using a stable structure corresponding to lactose or to a lactose-containing substance as the substance for treatment and/or prevention of lactose intolerance; wherein the stable structure corresponding to the substance refers to a structure of the substance that is present in a solid state under a high temperature of 500° C. or more.

9.-10. (canceled)

11. The method of claim 1, comprising: using a stable structure corresponding to a pathologically changed substance as the substance for treatment and/or prevention of diseases caused by a pathologically changed substance identical or similar to the pathologically changed substance.

12.-13. (canceled)

14. The method of claim 1, comprising: using a stable structure corresponding to a pathologically unchanged substance as the substance for treatment and/or prevention of diseases caused by a pathological change in a substance identical or similar to the pathologically unchanged substance.

15.-16. (canceled)

17. The method of claim 1, comprising, using a stable structure corresponding to substance C or a substance containing substance C as the substance for treatment and/or prevention of disease A caused by a certain substance, wherein disease A is a disease caused directly by the certain substance or caused by a pathological change in the certain substance; substance B is a substance associated with disease A; substance C is similar to or of the same type as substance B, and the certain substance does not induce disease A in an organism containing substance C; the stable structure corresponding to the substance refers to a structure of the substance that is present in a solid state under a high temperature of 500° C. or more.

18. The method of claim 1, comprising: using a stable structure corresponding to substance C or a substance containing substance C as the substance for treatment and/or prevention of disease A, wherein disease A is the disease to be treated or prevented; substance B is a substance associated with disease A; substance C is similar to or of the same type as substance B, and an organism containing substance C would not have disease A; the stable structure corresponding to the substance refers to a structure of the substance that is present in a solid state under a high temperature of 500° C. or more.

19.-20. (canceled)

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

22. The method of claim 21, wherein the stable structure corresponding to the substance associated with rhinitis is one or more selected from: (1) a stable structure corresponding to a substance causing rhinitis in an organism; (2) a stable structure corresponding to a rhinitis-associated substance of an organism itself; (3) a stable structure corresponding to a substance containing a rhinitis-inhibiting structure; and (4) a stable structure corresponding to a substance containing the substance according to any one of (1) to (3) above.

23.-24. (canceled)

25. The substance for treatment and/or prevention of diseases of claim 29, which is usable for manufacture of medicaments, health products, food, and food additives.

26. A culturing method for preparing a substance for treatment and/or prevention of diseases, comprising: using a substance associated with the diseases to be treated and/or prevented to culture a substance for treatment and/or prevention of diseases.

27. The method of claim 26, wherein the using a substance associated with the diseases to be treated and/or prevented to culture a substance for treatment and/or prevention of diseases comprises: developing the tolerance of an organism with the substance that directly causes the disease, until the disease-causing substance does not cause the disease in the organism; and using a substance of the organism or of an offspring of the organism as the substance for treatment and/or prevention of diseases; wherein the organism is preferably swine, bovine, Caprinae, or primate.

28. The method of claim 26, wherein the using a substance associated with the diseases to be treated and/or prevented to culture a substance for treatment and/or prevention of diseases comprises: cultivating an organism with the stable structure corresponding to the substance associated with the diseases, until the organism will not have the disease; and using a substance of the organism or an offspring of the organism as the substance for treatment and/or prevention of diseases; wherein the organism is preferably swine, bovine, Caprinae, or primate; wherein the stable structure corresponding to the substance refers to a structure of the substance that is present in a solid state under a high temperature of 500° C. or more.

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

30. The substance for treatment and/or prevention of diseases of claim 29, wherein the stable structure corresponding to the substance or a substance comprising the substance is prepared by high-temperature carbonization.

Description

DETAILED DESCRIPTION OF INVENTION

[0121] 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.

[0122] 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.

[0123] The embodiments are as follows.

Example 1 Substance for Treatment and/or Prevention of Lactose Intolerance, Method for Designing the Substance, and Method for Preparing the Substance

[0124] Lactose intolerance in an organism is due to imbalance between the biological structure system and the structure of lactose. The stable structure corresponding to lactose was used as the external structure to act on a lactose intolerant organism, and the biological structure system established a balance between the biological structure system and the structure of lactose under the action of the external structure. Therefore, using the stable structure corresponding to lactose as the substance for treating and/or preventing lactose intolerance represents the method for designing and preparing the substance for treatment and/or prevention of diseases in an organism directly caused by foreign objects.

[0125] The stable structure corresponding to the substance is characterized by the structure of the substance that is present in a solid state under a high temperature of 500° C. or more. Therefore, in the method for preparing the substance for treatment and/or prevention of lactose intolerance, the stable structure corresponding to lactose or a lactose-containing substance can be prepared by high-temperature carbonization. Because milk is easier to obtain than pure lactose, the stable structure corresponding to milk powder containing lactose was prepared by high-temperature carbonization.

Example 2 Clinical Study with the Substance Prepared in Example 1 in Patients with Lactose Intolerance

[0126] This example used the substance prepared in Example 1 for efficacy verification, as specifically shown below.

[0127] 1. Clinical data: A total of 38 cases of outpatients and inpatients with lactose intolerant were enrolled, including 18 males and 20 females, aged from 2 to 13 years old. The symptoms were mainly gastrointestinal discomfort (including various degrees of abdominal pain, constipation or diarrhea, distended tummy, fetid breath, etc.).

[0128] 2. Diagnosis criteria: According to the patients' medical history, a double-blind placebo-controlled food provocation test was conducted as the diagnostic criteria for testing food intolerance to diagnose lactose intolerance.

[0129] 3. Treatment method: The patients orally took the substance prepared in Example 1, 3 g per time, once a day, for 3 consecutive days.

[0130] 4. Efficacy evaluation criteria: “cured” means regression of clinical symptoms, formed stools, and normal microscopy; “effective” means substantial regression of clinical symptoms, changed stool components, reduced frequency of stools, and a small number of red blood cells or white blood cells detectable in microscopy of stools; “ineffective” means no apparent improvement in clinical symptoms or even aggravated symptoms, unchanged stool components, and watery stools. Total effective rate=cured rate+effective rate.

[0131] 5. Efficacy results: After treatment, 35 patients were cured, 2 patients showed “effective”, and one patient showed “ineffective”, with a total effective rate of 97.37%. After treatment, these patients consumed different dairy products such as cow milk several times and did not have any symptoms. And during the efficacy observation period, no side effect or drug dependence was observed.

Example 3 Substance for Treatment and/or Prevention of Ankylosing Spondylitis, Method for Designing the Substance, and Method for Preparing the Substance

[0132] 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. Therefore, from the structural point of view, needed is use of the stable structure corresponding to the connective tissue as an external structure to act on the organism suffering from ankylosing spondylitis to restore the balance of the structure system. Therefore, using the stable structure corresponding to the connective tissue as a substance for treatment and/or prevention of ankylosing spondylitis represents the designing and preparation methods in which the stable structure corresponding to a pathologically unchanged substance is used as the substance for treatment and/or prevention of diseases caused by a pathological change in a substance identical or similar to the pathologically unchanged substance, i.e. supporting “the positive” with “the positive”. Because the connective tissue of bovine is easily available, in this example, the connective tissue of healthy bovine was subjected to high-temperature carbonization to obtain the substance for treatment or prevention of ankylosing spondylitis.

Example 4: Clinical Study with the Substance Prepared in Example 3 in Patients with Ankylosing Spondylitis

[0133] 1. Clinical data: This example enrolled totally 54 patients with ankylosing spondylitis, who were randomly divided into the treatment group of 28 patients and a control group of 26 patients according to the order of visit. The treatment group comprised 23 males and 5 females, aged from 31 to 52 years old, with an average course of disease of 10.3 years. The control group comprised 22 males and 4 females, aged from 33 to 51 years old, with an average course of disease of 10.1 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.

[0134] 2. Diagnosis criteria: (1) Unexplained lumbago and leg pain/discomfort 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 Patrick sign test (Fabere 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).

[0135] 3. Treatment method: All patients were given diet and functional exercise guidance. Patients in the treatment group orally took the substance prepared in Example 3, 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.

[0136] 4. Efficacy evaluation criteria: The total effective rate=markedly effective rate+effective rate. “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.

[0137] 5. Treatment results: Both groups were treated for 1 month and observed for efficacy. Among the 28 patients in the treatment group, 24 showed “markedly effective”, 3 showed “effective”, and one showed “ineffective”, with a total effective rate of 96.42%. Among the 26 patients in the control group, 4 cases showed “markedly effective”, 10 showed “effective”, and 12 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 1). During the treatment, patients in the treatment group did not show adverse drug reaction or drug dependence.

TABLE-US-00001 TABLE 1 Comparison of the effective rates between the two groups after treatment (Example) Total Number of Markedly effective Group patients effective Effective Ineffective rate (%) Treatment 28 24 3 1 96.42% Control 26 4 10 12 53.85%

Example 5 Substance for Treatment and/or Prevention of Frequent Urination, Method for Designing the Substance, and Method for Preparing the Substance

[0138] When there is inflammation, an injury or a disease in the bladder, its elasticity decreases, the urine storage capacity is reduced, the nerve perception threshold is lowered, and the urinary central nerve is in an excited state, then frequent urination is caused. The structural imbalance of the bladder causes functional imbalance and frequent urination. A bladder with a balanced structure is described as “the positive” in the present disclosure. Each structure is in interaction with another structure. If “the positive” is used as an external structure to act on the biological structure system, due to the self-adapting, self-organizing and self-stabilizing function of the biological structure system, the biological structure system will regulate the expression of genes of structures that interact with the external structure to a normal level according to the structural information from each structure in the external structure, so that the imbalanced structure restores the balance. Therefore, the stable structure corresponding to the bladder of an animal like swine, bovine, or Caprinae can be used to treat frequent urination in a human, which represents the designing and preparation methods in which the stable structure corresponding to a pathologically unchanged substance is used as a substance for treatment and/or prevention of diseases caused by a pathological change in a substance identical or similar to the pathologically unchanged substance, i.e. supporting the “positive” by the “positive”.

[0139] In this example, a bladder of healthy swine was selected and subjected to high-temperature carbonization to obtain the substance for treatment or prevention of frequent urination.

Example 6: Clinical Study with the Substance Prepared in Example 5 in Patients with Frequent Urination

[0140] 1. Clinical data: 33 cases (a total number) of outpatients and inpatients with frequent urination were enrolled, and a before-and-after study was conducted.

[0141] 2. Diagnosis criteria: for urinating 4-6 times during the day and 0-2 times at night, significantly increased frequency is regarded as frequent urination. Patients with frequent urination due to a non-bladder disorder were excluded.

[0142] 3. Treatment method: The patients orally took the substance for treating frequent urination prepared in Example 5, 3 g per time, once a day, for 14 consecutive days.

[0143] 4. Efficacy evaluation criteria: “cured” means that the frequency of urination returns to normal; “effective” means that the frequency of urination is significantly reduced; “ineffective” means that the frequency of urination is not significantly reduced or even increased.

[0144] 5. Treatment results: The effectiveness was observed after treatment. Among 33 patients, 15 showed markedly effective, 16 showed effective, and 2 showed ineffective, with a total effective rate of 93.94%.

Example 7 Substance for Treatment and/or Prevention of Allergic Rhinitis, Method for Designing the Substance, and Method for Preparing the Substance

[0145] 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.

[0146] 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 8 Clinical Application Trial with the Substance Prepared in Example 7 for Treatment of Allergic Rhinitis

[0147] This example used the substance prepared in Example 7 above for efficacy verification, as specifically shown below.

[0148] 1. Clinical data: 60 cases (a total number) of 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.

[0149] 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.

[0150] 3. Treatment method: the patients in the treatment group orally took the substance associated with treatment of allergic rhinitis prepared in Example 7, 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.

[0151] 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.

[0152] 5. Efficacy results: Table 2 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 the control group and allergic symptoms appeared after contact with allergens after drug discontinuance.

TABLE-US-00002 TABLE 2 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%