PHARMACEUTICAL COMPOSITION TREATING SNORING, PREPARATION METHOD THEREFOR AND USE THEREOF

Abstract

The present invention relates to a pharmaceutical composition for snoring treatment which comprising 15-25 doses of Gambir and 5-15 doses of Cassia. Fabrication of the composition is also described. The present invention relates to Gambir and Cassia and their compositions with Trichosanthes, Turmeric and Phragmites, which has remarkable effects on improving or inhibiting snoring and has no side-effects. It can be a new choice for clinical treatment of snoring since it has no surgery risks.

Claims

1. A pharmaceutical composition for snoring treatment features that its crude drugs contain components proportioned by weight as follows: 15-25 doses of Gambir and 5-15 doses of Cassia.

2. The pharmaceutical composition mentioned above in claim 1 features that its crude drugs contain components proportioned by weight as follows: 15 doses of Gambir and 5 doses of Cassia; 20 doses of Gambir and 10 doses of Cassia; 25 doses of Gambir and 15 doses of Cassia.

3. The pharmaceutical composition mentioned above in claim 1 features that its crude drugs contain components proportioned by weight as follows: 12-18 doses of Trichosanthes, 12-20 doses of Phragmites and 6-12 doses of Turmeric.

4. The pharmaceutical composition mentioned above in claim 3 features that its crude drugs contain components proportioned by weight as follows: 15 doses of Gambir, 5 doses of Cassia, 12 doses of Trichosanthes, 12 doses of Phragmites and 6 doses of Turmeric; 20 doses of Gambir, 10 doses of Cassia, 15 doses of Trichosanthes, 17 doses of Phragmites and 9 doses of Turmeric; 25 doses of Gambir, 15 doses of Cassia, 18 doses of Trichosanthes, 20 doses of Phragmites and 12 doses of Turmeric;

5. The pharmaceutical composition mentioned above in claim 1 features that it is a dosage form of drug fabricated by combing the active ingredients such as power, aqueous extract and alcohol extract of the crude drugs with common pharmaceutical auxiliaries or auxiliary materials.

6. The dosage form of drug mentioned above in claim 5 features that it is a gastrointestinal absorption form of drug.

7. Fabrication of pharmaceutical compositions mentioned in claims 1-4 features that it includes the following steps: (1) The crude drugs are taken in certain proportions; (2) Take the crude drugs and mix them up for aqueous extraction, or extract the crude drugs respectively. Then take the aqueous extractives out for use in next step. (3) Add common pharmaceutical auxiliaries or auxiliary materials into the aqueous extractives and the composition is made.

8. Fabrication mentioned above in claim 7 features that the extraction is made by decoction or ultrasound.

9. Any of the pharmaceutical compositions mentioned in claims 1-4 are useful for fabricating drugs for snoring treatment.

10. The pharmaceutical composition mentioned above in claim 2 features that it is a dosage form of drug fabricated by combing the active ingredients such as power, aqueous extract and alcohol extract of the crude drugs with common pharmaceutical auxiliaries or auxiliary materials.

11. The pharmaceutical composition mentioned above in claim 3 features that it is a dosage form of drug fabricated by combing the active ingredients such as power, aqueous extract and alcohol extract of the crude drugs with common pharmaceutical auxiliaries or auxiliary materials.

12. The pharmaceutical composition mentioned above in claim 4 features that it is a dosage form of drug fabricated by combing the active ingredients such as power, aqueous extract and alcohol extract of the crude drugs with common pharmaceutical auxiliaries or auxiliary materials.

13. The dosage form of drug mentioned above in claim 10 features that it is a gastrointestinal absorption form of drug.

14. The dosage form of drug mentioned above in claim 11 features that it is a gastrointestinal absorption form of drug.

15. The dosage form of drug mentioned above in claim 12 features that it is a gastrointestinal absorption form of drug.

Description

DETAILED FABRICATION

Example 1 Fabrication of Pharmaceutical Composition of the Present Invention

[0042] Formula: 15 doses of Gambir and 5 doses of Cassia

[0043] The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0044] 1. Take Gambir and Cassia, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.;

[0045] 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0046] 3. According to extraction ratio of Gambir and Cassia, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary troches.

Example 2 Fabrication of the Pharmaceutical Composition of the Present Invention

[0047] Formula: 20 doses of Gambir and 10 doses of Cassia

[0048] The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0049] 1. Take Gambir and Cassia, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.;

[0050] 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0051] 3. According to extraction ratio of Gambir and Cassia, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary capsules.

Example 3 Fabrication of the Pharmaceutical Composition of the Present Invention

[0052] Formula: 25 doses of Gambir and 15 doses of Cassia The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0053] 1. Take Gambir and Cassia, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.; 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0054] 3. According to extraction ratio of Gambir and Cassia, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary granules.

Example 4

[0055] Formula: 15 doses of Gambir, 5 doses of Cassia, 12 doses of Trichosanthes, 12 doses of Phragmites and 6 doses of Turmeric

[0056] The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0057] 1. Take Gambir, Cassia, Trichosanthes, Phragmites and Turmeric, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.;

[0058] 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0059] 3. According to extraction ratio of Gambir and Cassia Trichosanthes, Phragmites and Turmeric, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary troches.

Example 5

[0060] Formula: 20 doses of Gambir, 10 doses of Cassia, 15 doses of Trichosanthes, 17 doses of Phragmites and 9 doses of Turmeric

[0061] The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0062] 1. Take Gambir, Cassia, Trichosanthes, Phragmites and Turmeric, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.;

[0063] 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0064] 3. According to extraction ratio of Gambir and Cassia Trichosanthes, Phragmites and Turmeric, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary capsules.

Example 6

[0065] Formula: 25 doses of Gambir, 15 doses of Cassia, 18 doses of Trichosanthes, 20 doses of Phragmites and 12 doses of Turmeric

[0066] The present invention provides fabrication of the composition of medicine material and plant extractives mentioned above. The main steps are:

[0067] 1. Take Gambir, Cassia, Trichosanthes, Phragmites and Turmeric, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.;

[0068] 2. Dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder;

[0069] 3. According to extraction ratio of Gambir and Cassia Trichosanthes, Phragmites and Turmeric, mix the dry extract powder of the two evenly at the proportion prescribed in the formula, add appropriate auxiliaries and make them into ordinary granules.

[0070] Experiments are listed below to demonstrate the benefits and effects of the present invention:

[0071] Dosages of the test drugs, are calculated by its proportion of corresponding extracted materials in g/kg.

Experiment 1 Safety and Efficacy Evaluation of Composition of Gambir and Cassia

I. Safety Evaluation

[0072] Products fabricated with composition of the present invention in Example 3 are used in the following experiment.

1. Acute Toxicity Test

[0073] Give intragastric administration of 50 g test product (crude drug)/kg to lab mouse at one time. The mouse didn't die during the experiment period. Thus it can be concluded that maximum tolerance dose to mouse at one time is 50 g (crude drug)/kg which equals 125 times of clinical daily dosage to human (2 capsules, which contains 12 g of crude drug, one time for man of 60 kg. Daily dosage for man is 24 g which is 0.4 g/kg).

2. Long Term Toxicity Test

[0074] Give lab mouse intragastric administration of dosage of 20 g/kg for 14 consecutive weeks.

[0075] Compared with the control group that are given with distilled water, no clinical symptoms, weight gaining or changes in indicators in hematology and blood biochemical examination, toxicity in organs, system and pathological tissue have been noticed. Four weeks after drug withdrawal, no chronic toxicity has been noticed in the same examination items in the tested animal, which shows that consecutive oral administration of composition of the present invention has no apparent toxic or side-effects.

[0076] This experiment shows that the pharmaceutical composition of the present invention has high safety.

II. Clinical Statistical Analysis

[0077] Products fabricated with composition of the present invention in Example 1 are taken as test products.

[0078] Take Gambir and Cassia, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.; dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder; according to extraction ratio of Gambir and Cassia, mix the dry extract powder of the two evenly at the proportion of 15:5, add appropriate auxiliaries and make them into ordinary troches. Test product of composition of Gambir and Cassia has been made.

[0079] Mix the dry extract powder evenly at the proportion of 15 doses of Gambir, add appropriate auxiliaries and make them into ordinary troches. Test product of Gambir has been made.

[0080] Compare effects of taking composition of the present invention, composition of Gambir and Cassia and just Gambir. Dosage is 2 troches, 0.25 g in each troche (equals to 12 g of crude drug), before going to bed; analyze statistics of effects on 200 sleep apnea patients.

[0081] Symptoms of Sleep Apnea are Mainly:

[0082] Daytime: clinical symptoms are sleepiness, fatigue, hypomnesis, dyspnea chest discomfort, irritability, headache in the morning, dizziness and thirsty and throat ache. Standard symptoms shall be diagnosed by the pause times and duration of sleep apnea.

[0083] Nighttime: clinical symptoms are snoring, frequent pause of breathing, abnormal sleep actions; insomnia, dreaminess, labored breathing, polyuria and enuresis.

[0084] Degrees are mild, moderate and severe.

[0085] Mild patients suffer 30-50 times of apnea/seven hours, pause duration 10-30 seconds;

[0086] Moderate patients suffer 50-100 times of apnea/seven hours, pause duration 30-60 seconds;

[0087] Severe patients suffer 100-200 times of apnea/seven hours, pause duration 60+seconds;

[0088] Among the 240 patients, 180 are male and 60 are female, aging from 36-82. 120 of them are mild patients, 90 are moderate and 30 are severe. In the experiment, there are 3 groups: composition group of the present invention, group of Gambir+Cassia and group of Gambir. Each group has 80 patients, 60 of which are male, 20 are female, 40 are mild patients, 30 are moderate and 10 are severe.

[0089] Treatment: take the medicines with warm water every night before going to bed. 7 days are a therapy.

[0090] Evaluation standard for efficacy: effective: snoring sound lowered, times of awakening by labored breathing reduced, fatigue and restlessness during sleep disappeared, energetic during daytime, dizziness and tiredness disappeared.

[0091] Obvious efficacy: snoring sound lowered, thirstiness disappeared, never awakened by labored breathing, no sleepiness during daytime.

[0092] Cured: sleep well, snoring disappeared, complications caused by snoring disappeared, headache, dizziness, fatigue and sleepiness totally disappeared, energetic during daytime, clear thinking, memory enhanced. Totally recovered.

[0093] Effects Comparing:

TABLE-US-00001 1 therapy 2 therapies Obvious Cured Obvious Cured Degree Medicine Effective efficacy Cured ratio Effective efficacy Cured ratio Mild Composition 2 6 32 80% 0 4 36 .sup.90% patients of the present invention Gambir + 9 5 26 65% 3 6 31 77.5% Cassia Gambir 15 4 21 52.5%.sup. 7 8 25 62.5% Moderate Composition 3 9 18 60% 1 4 25 83.3% patients of the present invention Gambir + 12 7 11 36.7%.sup. 5 6 19 63.3% Cassia Gambir 15 6 9 30% 7 7 16 53.3% Severe Composition 2 5 3 30% 1 3 6 .sup.60% patients of the present invention Gambir + 5 4 1 10% 2 5 3 .sup.30% Cassia Gambir 6 4 0 0 4 4 2 .sup.20%

[0094] No side-effects have been noticed during the therapy.

[0095] Compared with the group of Gambir+Cassia and Gambir, composition of the present invention has better efficacy. It takes effect faster, has no side-effects and is remarkably effective for snoring treatment.

Experiment 2 Safety and Efficacy Evaluation of Composition of Gambir and Cassia

I. Safety Evaluation

[0096] Products fabricated with composition of the present invention in Example 1 and 2 are used in the following experiment.

1. Acute Toxicity Test

[0097] Give intragastric administration of 50 g test product (crude drug)/kg to lab mouse at one time. The mouse didn't die during the experiment period. Thus it can be concluded that maximum tolerance dose to mouse at one time is 50 g (crude drug)/kg which equals 125 times of clinical daily dosage to human (2 capsules, which contains 12 g of crude drug, one time for man of 60 kg. Daily dosage for man is 24 g which is 0.4 g/kg).

2. Long Term Toxicity Test

[0098] Give lab mouse intragastric administration of dosage of 20 g/kg test product for 14 consecutive weeks. Compared with the control group that are given with distilled water, no clinical symptoms, weight gaining or changes in indicators in hematology and blood biochemical examination, toxicity in organs, system and pathological tissue have been noticed. Four weeks after drug withdrawal, no chronic toxicity has been noticed in the same examination items in the tested animal, which shows that consecutive oral administration of composition of the present invention has no apparent toxic or side-effects.

[0099] This experiment shows that the pharmaceutical composition of the present invention in Example 1 and 2 has high safety.

II. Clinical Statistical Analysis

[0100] Products fabricated with composition of the present invention in Example 2 and 3 are taken as test products.

[0101] Take Gambir and Cassia, decoct respectively with water for three times. For the first time, add water amounting 6 times of the drugs and soak them for 1 hour, then decoct for 2 hours; for the second time, add water amounting 5 times of the drugs and decoct for 1 hours; for the third time, add water amounting 4 times of the drug, decoct for 1 hour, filter and put the filtrate together, heat and condense it to density ratio of 1.10-1.12 at the temperature of 60-65 C.; dry the concentrated solution with high-speed centrifuging and spraying drier and make 80-120 meshes of dry extract powder; according to extraction ratio of Gambir and Cassia, mix the dry extract powder of the two evenly at the proportion of 15:5, add appropriate auxiliaries and make them into ordinary troches. Test product of composition of Gambir and Cassia has been made.

[0102] Mix the dry extract powder evenly at the proportion of 15 doses of Gambir, add appropriate auxiliaries and make them into ordinary troches. Test product of Gambir has been made.

[0103] Compare effects of taking composition of the present invention, composition of Gambir and Cassia and drug of just Gambir. Dosage is 2 troches, 0.25 g in each troche (equals to 12 g of crude drug), before going to bed; analyze statistics of effects on 320 sleep apnea patients.

Symptoms of Sleep Apnea are Mainly:

[0104] Daytime: clinical symptoms are sleepiness, fatigue, hypomnesis, dyspnea chest discomfort, irritability, headache in the morning, dizziness and thirsty and throat ache. Standard symptoms shall be diagnosed by the pause times and duration of sleep apnea.

[0105] Nighttime: clinical symptoms are snoring, frequent pause of breathing, abnormal sleep actions; insomnia, dreaminess, labored breathing, polyuria and enuresis.

[0106] Degrees are mild, moderate and severe.

[0107] Mild patients suffer 30-50 times of apnea/seven hours, pause duration 10-30 seconds;

[0108] Moderate patients suffer 50-100 times of apnea/seven hours, pause duration 30-60 seconds;

[0109] Severe patients suffer 100-200 times of apnea/seven hours, pause duration 60+seconds;

[0110] Among the 320 patients, 240 are male and 80 are female, aging from 36-82. 160 of them are mild patients, 1200 are moderate and 40 are severe. In the experiment, there are 4 groups: group given composition of the present invention in example 2, group given composition of the present invention in example 3, group of Gambir+Cassia and group of Gambir. Each group has 80 patients, 60 of which are male, 20 are female, 40 are mild patients, 30 are moderate and 10 are severe.

[0111] Treatment: take the medicines with warm water every night before going to bed. 7 days are a therapy.

[0112] Evaluation Standard for Efficacy:

[0113] Effective: snoring sound lowered, times of awakening by labored breathing reduced, fatigue and restlessness during sleep disappeared, energetic during daytime, dizziness and tiredness disappeared.

[0114] Obvious efficacy: snoring sound lowered, thirstiness disappeared, never awakened by labored breathing, no sleepiness during daytime.

[0115] Cured: sleep well, snoring disappeared, complications caused by snoring disappeared, headache, dizziness, fatigue and sleepiness totally disappeared, energetic during daytime, clear thinking, memory enhanced. Totally recovered.

[0116] Effects Comparing:

TABLE-US-00002 1 therapy 2 therapies Obvious Cured Obvious Cured Degree Medicine Effective efficacy Cured ratio Effective efficacy Cured ratio Mild Composition 3 5 32 80% 1 2 37 92.5% patients fabricate in example 2 Composition 2 5 33 82.5%.sup. 0 3 37 92.5% fabricate in example 3 Gambir + 9 5 26 65% 3 6 31 77.5% Cassia Gambir 15 4 21 52.5%.sup. 7 8 25 62.5% Moderate Composition 6 6 18 60% 2 3 25 83.3% patients of the present invention Composition 4 7 19 63.3%.sup. 1 3 26 86.6% fabricate in example 3 Gambir + 12 7 11 36.7%.sup. 5 6 19 63.3% Cassia Gambir 15 6 9 30% 7 7 16 53.3% Severe Composition 3 4 3 30% 2 2 6 .sup.60% patients of the present invention Composition 2 4 4 40% 1 3 6 .sup.60% fabricate in example 3 Gambir + 5 4 1 10% 2 5 3 .sup.30% Cassia Gambir 6 4 0 0 4 4 2 .sup.20%

[0117] No side-effects have been noticed during the therapy.

[0118] Compared with the group of Gambir+Cassia and Gambir, compositions of the present invention in example 2 and 3 have better efficacy. They take effect faster, have no side-effects and are remarkably effective for snoring treatment.

Experiment 3 Safety and Efficacy Evaluation of Composition of Gambir, Cassia Trichosanthes, Phragmites and Turmeric

I. Safety Evaluation

[0119] Products fabricated with composition of the present invention in Example 6 are used in the following experiment.

1. Acute Toxicity Test

[0120] Give intragastric administration of 50 g test product (crude drug)/kg to lab mouse at one time. The mouse didn't die during the experiment period. Thus it can be concluded that maximum tolerance dose to mouse at one time is 50 g (crude drug)/kg which equals 125 times of clinical daily dosage to human (2 capsules, which contains 12 g of crude drug, one time for man of 60 kg. Daily dosage for man is 24 g which is 0.4 g/kg).

2. Long Term Toxicity Test

[0121] Give lab mouse intragastric administration of dosage of 20 g/kg for 14 consecutive weeks. Compared with the control group that are given with distilled water, no clinical symptoms, weight gaining or changes in indicators in hematology and blood biochemical examination, toxicity in organs, system and pathological tissue have been noticed. Four weeks after drug withdrawal, no chronic toxicity has been noticed in the same examination items in the tested animal, which shows that consecutive oral administration of composition of the present invention has no apparent toxic or side-effects.

II. Clinical Statistical Analysis

[0122] Take products fabricated with composition of the present invention in Example 4. Dosage is 2 troches, 0.25 g in each troche (equals to 12 g of crude drug), before going to bed; analyze statistics of effects on 120 sleep apnea patients.

[0123] Symptoms of Sleep Apnea are Mainly:

[0124] Daytime: clinical symptoms are sleepiness, fatigue, hypomnesis, dyspnea chest discomfort, irritability, headache in the morning, dizziness and thirsty and throat ache. Standard symptoms shall be diagnosed by the pause times and duration of sleep apnea.

[0125] Nighttime: clinical symptoms are snoring, frequent pause of breathing, abnormal sleep actions; insomnia, dreaminess, labored breathing, polyuria and enuresis.

[0126] Degrees are mild, moderate and severe.

[0127] Mild patients suffer 30-50 times of apnea/seven hours, pause duration 10-30 seconds;

[0128] Moderate patients suffer 50-100 times of apnea/seven hours, pause duration 30-60 seconds;

[0129] Severe patients suffer 100-200 times of apnea/seven hours, pause duration 60+seconds;

[0130] Among the 120 patients, 80 are male and 40 are female, aging from 36-82. 60 of them are mild patients, 40 are moderate and 20 are severe.

[0131] Treatment: take the medicines with warm water every night before going to bed. 7 days are a therapy.

[0132] Evaluation standard for efficacy: effective: snoring sound lowered, times of awakening by labored breathing reduced, fatigue and restlessness during sleep disappeared, energetic during daytime, dizziness and tiredness disappeared.

[0133] Obvious efficacy: snoring sound lowered, thirstiness disappeared, never awakened by labored breathing, no sleepiness during daytime.

[0134] Cured: sleep well, snoring disappeared, complications caused by snoring disappeared, headache, dizziness, fatigue and sleepiness totally disappeared, energetic during daytime, clear thinking, memory enhanced. Totally recovered.

[0135] Treatment Effects

TABLE-US-00003 1 therapy 2 therapies Obvious Cured Obvious Cured Degree Medicine Effective efficacy Cured ratio Effective efficacy Cured ratio Mild Composition 3 4 53 88.3%.sup. 0 3 57 95% patients of the present invention Moderate Composition 5 7 28 70% 1 3 36 87.5%.sup. patients of the present invention Severe Composition 4 7 9 45% 1 5 14 70% patients of the present invention

[0136] No side-effects have been noticed during the therapy.

[0137] Treatment effects show that composition of the present invention has good efficacy. It takes effect fast, has no side-effects, has no side-effects and is remarkably effective for snoring treatment. Cured ratios of mild, moderate and severe patients are respectively 88.3%, 70%, 45% after 1 therapy of the composition, and 95%, 87.5%, 70% after 1 therapies, while cured ratios mild, moderate and severe patients are respectively 80%, 60%, 30% after 1 therapy of composition of Gambir+Cassia and 90%, 83.3%, 60% after 2 therapies. Therefore, treatment effects of composition of the five drugs are better than that of composition of just two.

Experiment 4 Safety and Efficacy Evaluation of Composition of Gambir, Cassia, Trichosanthes, Phragmites and Turmeric

I. Safety Evaluation

[0138] Products fabricated with composition of the present invention in Example 4 and 5 are used in the following experiment.

1. Acute Toxicity Test

[0139] Give intragastric administration of 50 g test product (crude drug)/kg to lab mouse at one time. The mouse didn't die during the experiment period. Thus it can be concluded that maximum tolerance dose to mouse at one time is 50 g (crude drug)/kg which equals 125 times of clinical daily dosage to human (2 capsules, which contains 12 g of crude drug, one time for man of 60 kg. Daily dosage for man is 24 g which is 0.4 g/kg).

2. Long Term Toxicity Test

[0140] Give lab mouse intragastric administration of dosage of 20 g/kg test product for 14 consecutive weeks. Compared with the control group that are given with distilled water, no clinical symptoms, weight gaining or changes in indicators in hematology and blood biochemical examination, toxicity in organs, system and pathological tissue have been noticed. Four weeks after drug withdrawal, no chronic toxicity has been noticed in the same examination items in the tested animal, which shows that consecutive oral administration of composition of the present invention has no apparent toxic or side-effects.

[0141] This experiment shows that the pharmaceutical composition of the present invention in Example 4 and 5 has high safety.

II. Clinical Statistical Analysis

[0142] Take composition of the present invention (fabricated in Example 4 and 5) as test products.

[0143] Dosage is 2 troches, 0.25 g in each troche (equals to 12 g of crude drug), before going to bed; analyze statistics of effects on 240 sleep apnea patients.

[0144] Symptoms of Sleep Apnea are Mainly:

[0145] Daytime: clinical symptoms are sleepiness, fatigue, hypomnesis, dyspnea chest discomfort, irritability, headache in the morning, dizziness and thirsty and throat ache. Standard symptoms shall be diagnosed by the pause times and duration of sleep apnea.

[0146] Nighttime: clinical symptoms are snoring, frequent pause of breathing, abnormal sleep actions; insomnia, dreaminess, labored breathing, polyuria and enuresis.

[0147] Degrees are mild, moderate and severe.

[0148] Mild patients suffer 30-50 times of apnea/seven hours, pause duration 10-30 seconds;

[0149] Moderate patients suffer 50-100 times of apnea/seven hours, pause duration 30-60 seconds; Severe patients suffer 100-200 times of apnea/seven hours, pause duration 60+seconds;

[0150] Among the 240 patients, 160 are male and 80 are female, aging from 36-82. 120 of them are mild patients, 80 are moderate and 40 are severe. In the experiment, there are 2 groups: group given composition of the present invention in example 5 and group given composition of the present invention in example 6. Each group has 120 patients, 80 of which are male, 40 are female, 60 are mild patients, 40 are moderate and 20 are severe.

[0151] Treatment: take the medicines with warm water every night before going to bed. 7 days are a therapy.

[0152] Evaluation Standard for Efficacy:

[0153] Effective: snoring sound lowered, times of awakening by labored breathing reduced, fatigue and restlessness during sleep disappeared, energetic during daytime, dizziness and tiredness disappeared.

[0154] Obvious efficacy: snoring sound lowered, thirstiness disappeared, never awakened by labored breathing, no sleepiness during daytime.

[0155] Cured: sleep well, snoring disappeared, complications caused by snoring disappeared, headache, dizziness, fatigue and sleepiness totally disappeared, energetic during daytime, clear thinking, memory enhanced. Totally recovered.

[0156] Effects Comparing:

TABLE-US-00004 1 therapy 2 therapies Obvious Cured Obvious Cured Degree Medicine Effective efficacy Cured ratio Effective efficacy Cured ratio Mild Composition 2 4 54 91.6% 1 2 57 95% patients fabricated in example 5 Composition 1 5 54 91.6% 0 2 58 96.7%.sup. fabricated in example 6 Moderate Composition 5 7 28 .sup.70% 2 2 36 90% patients fabricated in example 5 Composition 3 8 29 72.5% 2 2 36 90% fabricated in example 6 Severe Composition 5 5 10 .sup.50% 2 4 14 70% patients fabricated in example 5 Composition 3 7 10 .sup.50% 1 5 14 70% fabricated in example 6

[0157] No side-effects have been noticed during the therapy.

[0158] Treatment effects show that compositions of the present invention in example 5 and 6 have good efficacy. They take effect fast, have no side-effects, and are remarkably effective for snoring treatment. Cured ratios of mild, moderate and severe patients are respectively 91.6%, 70%, 50% after 1 therapy of composition in example 5, and 95%, 90%, 70% after 2 therapies; 91.6%, 72.5%, 50% after 1 therapy of composition in example 6 and 96.7%, 90%, 70% after 2 therapies; 80%, 60% and 30% after 1 therapy of composition of Gambir and Cassia and 90%, 83.3% and 60% after 2 therapies. Therefore, treatment effects of composition of the five drugs in example 5 and 6 are better than that of composition of just two of Gambir and Cassia.