CN101732513B - Shoumingshan capsules for treating hyperlipidemia and method for preparing same - Google Patents

Shoumingshan capsules for treating hyperlipidemia and method for preparing same Download PDF

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CN101732513B
CN101732513B CN2010101212146A CN201010121214A CN101732513B CN 101732513 B CN101732513 B CN 101732513B CN 2010101212146 A CN2010101212146 A CN 2010101212146A CN 201010121214 A CN201010121214 A CN 201010121214A CN 101732513 B CN101732513 B CN 101732513B
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capsules
shoumingshan
vinegar
oletum trogopterori
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CN101732513A (en
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马全龙
宫瑞萍
王长清
孙相民
高华荣
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SHANDONG HUAYANG PHARMACEUTICAL CO Ltd
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马兆臣
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Abstract

The invention relates to Shoumingshan capsules for treating hyperlipidemia. The capsules are prepared from the following raw materials in percentage by weight: 15 to 25 percent of tuber fleeceflower root, 15 to 25 percent of hawthorn fruit, 15 to 25 percent of cassia seed, 5 to 15 percent of vinegar fried trogopterus dung, fried cattail pollen, and 15 to 30 percent of oriental waterplantain rhizome. The preparation method comprises the following steps of: preparing the vinegar fried trogopterus dung and the fried cattail pollen; and weighing the tuber fleeceflower root, the hawthorn fruit, the cassia seed, the vinegar fried trogopterus dung, the fried cattail pollen and the oriental waterplantain rhizome in a weight ratio and mixing, adding water into the mixture, decocting the mixture for three times, filtering and mixing the filtrate, condensing the filtrate, adding ethanol, standing the mixture, and then condensing and drying the mixture to obtain the Shoumingshan capsules. The Shoumingshan capsules have the functions of nourishing the liver and kidney, activating blood circulation to dissipate blood stasis and eliminating phlegm and reducing turbidity, and can be used for treating deficiency of liver-yin and kidney-yin and phlegm-stasis blockade type essential hyperlipidemia, such as dizziness, blurred vision, chest pain, mental weariness, soreness of the waist and knees, dry pharynx and thirsty mouth, tongue ecchymosis and slimy tongue fur.

Description

Be used for the treatment of Shoumingshan capsules of hyperlipemia and preparation method thereof
Technical field
The present invention relates to a kind of Shoumingshan capsules that is used for the treatment of hyperlipemia, also relate to the preparation method of this medicine.
Background technology
Hyperlipemia is commonly called as hyperlipidemia, is meant the class disease that cholesterol in the blood plasma that is caused by a variety of causes or triglyceride levels raise or the both raises.Hyperlipidemia is the arch-criminal who causes cardiovascular and cerebrovascular disease, and sickness rate is more than 7%, and China has 9,000 ten thousand people to suffer from hyperlipidemia approximately.Cholesterol, triglyceride levels raise in the hyperlipidemia blood plasma, often show as a certain class and the rising of a few class lipoprotein levels in the blood plasma, hyperlipidemia is with simple hypercholesterolemia or simple hypertriglyceridemia or both double metabolism disorder of blood lipid diseases of seeing.
Blood lipid-lowering medicine commonly used at present has following a few class:
1. the special class of shellfish: as fenofibrate, bezafibrate etc., this type of medicine effect for reducing blood fat is strong, and is rapid-action, and the effect of triglyceride reducing is stronger than the effect of cholesterol reducing, but easily causes digestive tract reaction, anaphylaxis.
2. Statins: this type of medicine has lovastatin, simvastatin etc., and this type of medicine is based on cholesterol reducing, and effect for reducing fat is strong, and is rapid-action, but easily causes gastrointestinal symptom and erythra.
3. nicotinic acid class: this type of drug dose is excessive untoward reaction such as liver poisoning, hyperglycemia.
4. polyene unsaturated fatty acid class: this class medicine has blood fat reducing and reduces the effect of blood viscosity, but effect is relatively gentleer, and easily is oxidized to atherogenic material.
Summary of the invention
Purpose of the present invention just provides a kind of Shoumingshan capsules of treatment hyperlipemia of determined curative effect.
Another object of the present invention provides the preparation method of Shoumingshan capsules.
Each component pharmacological action that the present invention is selected:
Radix Polygoni Multiflori is the root piece of Polygonaceae herbaceos perennial Radix Polygoni Multiflori, the abnormal smells from the patient bitter cold, contain anthraquinones such as chrysophanic acid, emodin, chrysophanol, aloe-emodin, can promote intestinal peristalsis promoting, reduce cholesterol absorption, increased excretions of cholesterol is drained, thereby plays blood fat reducing, antiatherogenic effect.
Fructus Crataegi is the fruit of Rosaceae machaka or dungarunga plant Crataegi cuneatae, the sweet tepor of nature and flavor acid, contain class materials such as Crataegolic acid, tartaric acid, citric acid, contain a large amount of vitamin Cs and trace element, have the effect of blood circulation promoting and blood stasis dispelling, promoting digestion and invigorating the stomach, hypertension and hyperlipemia and expansion coronary vasodilator, blood vessel dilating is arranged, bring high blood pressure down, cholesterol reducing increases effects such as gastric juice digestive enzyme.
Semen Cassiae is the mature seed of blunt leaf Semen Cassiae of pulse family annual plant or Semen Cassiae, be the Chinese medicine that a kind of sweet-bitter flavor is slightly cold, mainly contain phytosterol and anthraquinones, have and suppress the effect that serum cholesterol raises and atheromatous plaque forms, lipid-lowering effect is remarkable.
The Oletum Trogopterori bitter in the mouth, sweet, warm in nature, promoting blood circulation and stopping pain, removing stasis to stop bleeding, the removing food stagnancy detoxifcation, Oletum Trogopterori is joined Pollen Typhae, promoting blood circulation, promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain strength strengthens, with controlling qi depression to blood stasis, all diseases of trusted subordinate's pain (comprising the angina pectoris that coronary heart disease causes).
Pollen Typhae is the pollen of Typhaceae aquatic herbaceous plant raupo Pollen Typhae, and nature and flavor are sweet flat, contain plant sterols such as sitosterol, stigmasterol, campesterol, can suppress the exogenous cholesterol of intestinal absorption, thereby play the effect of blood fat reducing.But have only Pollen Tyjphae that effect is arranged, Pollen Typhae oil and residue do not have this drug effect.
Rhizoma Alismatis is the tuber of the perennial limnocryptophyte Rhizoma Alismatis of Alismataceae, and slightly sweet flavor is cold in nature, contains triterpenoid compound, can influence steatolysis, the raw material of synthetic cholesterol is reduced, thereby have blood fat reducing, prevents and treats the effect of atherosclerosis and fatty liver.
Each component of Shoumingshan capsules of the present invention all has certain inhibition cholesterol, the effect of blood fat reducing, thus the collaborative pharmacological action that the present invention is based on its various components can more effective treatment hyperlipemia.
Shoumingshan capsules of the present invention is made by the raw material of following weight ratio:
Radix Polygoni Multiflori 15%-25% Fructus Crataegi 15%-25% Semen Cassiae 15%-25%
Processed with vinegar Oletum Trogopterori 5%-15% Pollen Tyjphae (parched) 5%-15% Rhizoma Alismatis 15%-30%
Shoumingshan capsules of the present invention, most preferred raw material weight is composed as follows:
Radix Polygoni Multiflori 19% Fructus Crataegi 19% Semen Cassiae 19%
Processed with vinegar Oletum Trogopterori 9.5% Pollen Tyjphae (parched) 9.5% Rhizoma Alismatis 24%
The preparation method of Shoumingshan capsules of the present invention comprises the steps:
(1) clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori; Clean Pollen Typhae is put pot interior slow fire fry to yellowish-brown, taking-up cools and promptly gets Pollen Tyjphae (parched);
(2) take by weighing Six-element such as Radix Polygoni Multiflori, Fructus Crataegi, Semen Cassiae, processed with vinegar Oletum Trogopterori, Pollen Tyjphae (parched), Rhizoma Alismatis and this Six-element medicine decocted with water three times by weight, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, filter decocting liquid, merging filtrate;
(3) concentrate above-mentioned filtrate to extractum (d=1.10~1.12,70 ℃), adding ethanol, to make pure weight fraction be 50-70%, leaves standstill 24h;
(4) reclaim ethanol and be concentrated into extractum (d=1.25~1.30,90 ℃), be drying to obtain the active component of medicine of the present invention;
(5) active component with medicine of the present invention mixes with medical starch, granulate, and granulate, encapsulated, promptly get Shoumingshan capsules agent of the present invention.
In addition, for ease of taking, the active component of Shoumingshan capsules agent medicine of the present invention can also be prepared into various pharmaceutically acceptable dosage forms with pharmaceutically acceptable carrier, comprises decoction, powder, tablet, granule.
Shoumingshan capsules function tonification Liver and kidney of the present invention, blood circulation promoting and blood stasis dispelling, the turbid descending that eliminates the phlegm is used for the hepatic and renal YIN deficiency, expectorant stasis of blood accumulation type Primary hyperlipemia, disease is seen dizziness, and is dizzy, chest pain, Mental fatigue, soreness of the waist and knees, parched throat xerostomia, tongue with ecchymosis, greasy fur.
The specific embodiment
One. the test example
1. clinical research
Research material: the treatment group is taken medicine Shoumingshan capsules of the present invention (every contains medicated powder 0.22 gram, is equivalent to 3.6 gram crude drugs); Matched group is taken MAIAN KELI (every bag 20 gram).
Research method: observe 437 routine hyperlipidemia patients altogether, be divided into 2 groups at random, wherein 326 examples are organized in treatment, matched group 111 examples.Male's 231 examples, women's 206 examples are the married.Minimum 1 example of treatment group age 5 years old, maximum age 1 example 79 years old, 55.88 ± 7.16 years old mean age; Minimum 1 example of matched group age 2 years old, maximum age 1 example 79 years old, 56.47 ± 11.26 years old mean age.Treatment group average course of disease is 2.94 ± 1.25 years, and matched group is 3.01 ± 0.92 years, and two groups of contrast differences are significantly (P>0.05) not.
Method of administration is taken Shoumingshan capsules for the treatment group, and each 4, every day three times; Matched group is taken MAIAN KELI, and each one bag (every bag 20 gram) is a course of treatment every day 3 times all around, serve on two courses of treatment.
Warp is to the hyperlipemia clinical trial, and observed result is as follows:
Table 1 Shoumingshan capsules is to the influence of blood fat (x ± s)
Figure GSA00000029112000031
Self contrasts: *: p<0.05, *P<0.01, * *Contrast between P<0.01 group: ▲ ▲P<0.001
Table 2 liang group patient symptom curative effect (example/%)
Group n Produce effects Effectively Invalid Total effective rate
The treatment group 326 36.80 48.78 14.42 85.58
Matched group 111 22.52 40.54 36.94 63.06
Compare P<0.01 with matched group
Table 3 Shoumingshan capsules accent fat curative effect situation (example/%)
Group n Produce effects Effectively Invalid Worsen Total effective rate
The treatment group TC?n=150 51(34.0) 68(45.3) 28(18.7) 3(2.0) 79.3
Matched group TC?n=44 15(34.1) 10(22.7) 14(31.8) 5(11.4) 56.8
The treatment group TG?n=240 82(34.2) 95(39.6) 45(18.7) 18(7.5) 73.8
Matched group TG?n=78 21(26.9) 31(39.8) 16(20.5) 10(12.8) 66.7
The treatment group HDL-C?n=194 91(46.9) 65(33.5) 31(15.9) 7(3.7) 80.4
Matched group HDL-C?n71= 23(32.4) 18(25.4) 20(28.1) 10(14.1) 57.8
The treatment group AI?n=269 169(62.8) 57(21.2) 32(11.9) 11(4.1) 84.0
Matched group AI?n=90 30(33.3) 28(31.1) 20(22.2) 12(13.4) 64.4
Contrast between group: through X 2Check, blood fat curative effect TC, HDL, the equal highly significant P of AI differences<0.01
Observed result shows: symptom curative effect treatment group total effective rate is 85.58%, the matched group total effective rate is 63.06%, two groups of contrasts are learned by statistics and are handled, difference highly significant (P<0.01), reducing TG (triglyceride) total effective rate treatment group is 73.8%, matched group is 66.7%, two groups of contrast differences are significantly (P>0.05%) not, (high density lipoprotein total effective rate treatment group is 80.4% to rising HDL-C, matched group is 57.8%, two groups of contrast difference's highly significants (P<0.01), reducing AI (atherogenic index) total effective rate treatment group is that 84% matched group is 64.4%, two group of contrast difference's highly significant (P<0.01).
2. pharmacological toxicology research
Acute toxicity test: select 20 of the white mice of healthy purebred LACA20g body weight, twice on the half and half, one gastric infusion of male and female, 330 times of being equivalent to be grown up of dosage, observed seven days, none animal dead and abnormal phenomena take place, and illustrate that heavy dose of Shoumingshan capsules does not have acute toxic reaction.
Long term toxicity test: through purebred SD rat oral gavage, every day was by 80 times, 40 times, 10 times administrations of adult's dose, totally 90 days.The result shows that Shoumingshan capsules toxicity is less, and by 3.34 grams of taking medicine every day, 5 weeks of the course of treatment are safe.
Two. preparation example
Preparation example 1
Clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori is standby; Clean Pollen Typhae is put pot interior slow fire fry, take out and to cool that promptly to get Pollen Tyjphae (parched) standby to yellowish-brown; Take by weighing following raw materials in weight: Radix Polygoni Multiflori 1200 grams, Fructus Crataegi 1200 grams, Semen Cassiae 1200 grams, processed with vinegar Oletum Trogopterori 600 grams, Pollen Tyjphae (parched) 600 grams, Rhizoma Alismatis 1500 grams, above Six-element, decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, decocting liquid filtered, filtrate merges, being concentrated into the extractum relative density is 1.10 (70 ℃), adds ethanol and makes and contain alcohol amount and reach 60%, leaves standstill 24h, reclaim ethanol and be concentrated into extractum relative density 1.25 (90 ℃), mix with medical starch dry back, granulates granulate, encapsulated, promptly get Shoumingshan capsules of the present invention.
Preparation example 2
Clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori is standby; Clean Pollen Typhae is put pot interior slow fire fry, take out and to cool that promptly to get Pollen Tyjphae (parched) standby to yellowish-brown; Take by weighing following raw materials in weight: Radix Polygoni Multiflori 2400 grams, Fructus Crataegi 2400 grams, Semen Cassiae 2400 grams, processed with vinegar Oletum Trogopterori 600 grams, Pollen Tyjphae (parched) 600 grams, Rhizoma Alismatis 1600 grams, above Six-element, decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, decocting liquid filtered, filtrate merges, being concentrated into the extractum relative density is 1.12 (70 ℃), adds ethanol and makes and contain alcohol amount and reach 55%, leaves standstill 24h, reclaim ethanol and be concentrated into extractum relative density 1.25 (90 ℃), mix with medical starch dry back, granulates granulate, encapsulated, promptly get Shoumingshan capsules of the present invention.
Preparation example 3
Clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori is standby; Clean Pollen Typhae is put pot interior slow fire fry, take out and to cool that promptly to get Pollen Tyjphae (parched) standby to yellowish-brown; Take by weighing following raw materials in weight: Radix Polygoni Multiflori 1600 grams, Fructus Crataegi 1600 grams, Semen Cassiae 1600 grams, processed with vinegar Oletum Trogopterori 1200 grams, Pollen Tyjphae (parched) 1200 grams, Rhizoma Alismatis 2800 grams, above Six-element, decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, decocting liquid filtered, filtrate merges, being concentrated into the extractum relative density is 1.10 (70 ℃), adds ethanol and makes and contain alcohol amount and reach 70%, leaves standstill 24h, reclaim ethanol and be concentrated into extractum relative density 1.30 (90 ℃), mix with medical starch dry back, granulates granulate, encapsulated, promptly get Shoumingshan capsules of the present invention.
Preparation example 4 (preparation of medicinal tablet of the present invention)
Clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori is standby; Clean Pollen Typhae is put pot interior slow fire fry, take out and to cool that promptly to get Pollen Tyjphae (parched) standby to yellowish-brown; Take by weighing following raw materials in weight: Radix Polygoni Multiflori 1000 grams, Fructus Crataegi 1000 grams, Semen Cassiae 1000 grams, processed with vinegar Oletum Trogopterori 500 grams, Pollen Tyjphae (parched) 500 grams, Rhizoma Alismatis 1250 grams, above Six-element decocts with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, decocting liquid filters, filtrate merges, and being concentrated into the extractum relative density is 1.12 (70 ℃), adds ethanol and makes and contain the alcohol amount and reach 50%, leave standstill 24h, reclaim ethanol and be concentrated into extractum relative density 1.25 (90 ℃), drying is ground into fine powder, with the right amount of auxiliary materials mixing, granulate, drying adds an amount of magnesium stearate, mix, tabletting, coating promptly gets the medicinal tablet of treatment hyperlipemia of the present invention.
Preparation example 5 (preparation of medicinal granule of the present invention)
Clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori is standby; Clean Pollen Typhae is put pot interior slow fire fry, take out and to cool that promptly to get Pollen Tyjphae (parched) standby to yellowish-brown; Take by weighing following raw materials in weight: Radix Polygoni Multiflori 1800 grams, Fructus Crataegi 1800 grams, Semen Cassiae 1800 grams, processed with vinegar Oletum Trogopterori 900 grams, Pollen Tyjphae (parched) 900 grams, Rhizoma Alismatis 2250 grams, above Six-element decocts with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, decocting liquid filtered, and filtrate merges, being concentrated into the extractum relative density is 1.10 (70 ℃), add ethanol and make and contain alcohol amount and reach 70%, leave standstill 24h, reclaim ethanol and also be concentrated into extractum relative density 1.30 (90 ℃), dry, be ground into fine powder,, granulate with the appropriate amount of auxiliary materials mixing, dry, granulate is packed, and promptly gets the medicinal granule of treatment hyperlipemia of the present invention.

Claims (3)

1. Shoumingshan capsules that is used for the treatment of hyperlipemia is characterized in that being made by the raw material of following weight ratio:
Radix Polygoni Multiflori 15%-25% Fructus Crataegi 15%-25% Semen Cassiae 15%-25%
Processed with vinegar Oletum Trogopterori 5%-15% Pollen Tyjphae (parched) 5%-15% Rhizoma Alismatis 15%-30%.
2. Shoumingshan capsules according to claim 1 is characterized in that the weight of each raw material is composed as follows:
Radix Polygoni Multiflori 19% Fructus Crataegi 19% Semen Cassiae 19%
Processed with vinegar Oletum Trogopterori 9.5% Pollen Tyjphae (parched) 9.5% Rhizoma Alismatis 24%.
3. the preparation method of claim 1 or 2 described Shoumingshan capsules is characterized in that comprising the steps:
(1) clean Oletum Trogopterori is put in the pot, after slow fire is made popular, evenly sprayed rice vinegar, it is little when glossy to the surface to stir-fry again, and taking-up is dried, the processed with vinegar Oletum Trogopterori; Clean Pollen Typhae is put pot interior slow fire fry to yellowish-brown, taking-up cools and promptly gets Pollen Tyjphae (parched);
(2) take by weighing Six-element such as Radix Polygoni Multiflori, Fructus Crataegi, Semen Cassiae, processed with vinegar Oletum Trogopterori, Pollen Tyjphae (parched), Rhizoma Alismatis and this Six-element medicine decocted with water three times by weight, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, filter decocting liquid, merging filtrate;
Relative density is 1.10~1.12 extractum when (3) concentrating above-mentioned filtrate to 70 ℃, and adding ethanol, to make pure weight fraction be 50-70%, leaves standstill 24h;
(4) reclaim ethanol and when being concentrated into 90 ℃ relative density be 1.25~1.30 extractum, be drying to obtain the active component of medicine;
(5) active component with medicine mixes with medical starch, granulate, and granulate, encapsulated, promptly get the Shoumingshan capsules agent.
CN2010101212146A 2009-09-16 2010-02-07 Shoumingshan capsules for treating hyperlipidemia and method for preparing same Active CN101732513B (en)

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CN200910018747A CN101653522A (en) 2009-09-16 2009-09-16 Medicine for curing hyperlipemia and preparation method thereof
CN2010101212146A CN101732513B (en) 2009-09-16 2010-02-07 Shoumingshan capsules for treating hyperlipidemia and method for preparing same

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101069737A (en) * 2007-06-08 2007-11-14 郭永德 Chinese herbal medicine oral liquor for reducing humanbody cholesterin and regulating blood-fat and clearing intestines and relaxing the bowels
CN101337057A (en) * 2008-08-12 2009-01-07 浙江省医学科学院 Zhiqing granule and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101069737A (en) * 2007-06-08 2007-11-14 郭永德 Chinese herbal medicine oral liquor for reducing humanbody cholesterin and regulating blood-fat and clearing intestines and relaxing the bowels
CN101337057A (en) * 2008-08-12 2009-01-07 浙江省医学科学院 Zhiqing granule and preparation method thereof

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