CN115518122A - Application of traditional Chinese medicine composition in preparation of medicine for treating sicca syndrome - Google Patents
Application of traditional Chinese medicine composition in preparation of medicine for treating sicca syndrome Download PDFInfo
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- CN115518122A CN115518122A CN202011447386.2A CN202011447386A CN115518122A CN 115518122 A CN115518122 A CN 115518122A CN 202011447386 A CN202011447386 A CN 202011447386A CN 115518122 A CN115518122 A CN 115518122A
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Abstract
The invention provides application of a traditional Chinese medicine composition in preparing a medicine for treating sicca syndrome, the traditional Chinese medicine composition is composed of traditional Chinese medicines such as ginseng, radix ophiopogonis, dogwood, salvia miltiorrhiza, fried spina date seeds, loranthus parasiticus, red paeony roots, ground beeltles, nardostachys roots and the like, and clinical experiments prove that the traditional Chinese medicine composition has a remarkable clinical curative effect on the sicca syndrome.
Description
Technical Field
The invention relates to application of a traditional Chinese medicine composition in preparing a medicine for treating sicca syndrome, belonging to the field of application of Chinese herbal medicines.
Background
Sjogren Syndrome (SS), also known as autoimmune exocrine gland epithelioitis, is a chronic autoimmune disease that involves the exocrine glands of the body. The disease is characterized by the damage of immune cells to external secretory glands such as salivary glands, lacrimal glands and the like, often causes dryness of eyes, nose, skin and vagina, and may affect other organs of the body such as liver, pancreas, kidney and the like and even involve the central nervous system.
The cause of sjogren's syndrome is not clear, but numerous studies have shown that it is associated with factors such as genetic, sex hormone, viral infection and immunological dysfunction. The traditional Chinese medicine considers that: the cause of sicca syndrome is the disturbance of the production and transportation of body fluids, which is caused by heat generating dryness and by dryness generating toxicity, and serious ones can involve various organ glands, resulting in the collapse of immune system. Therefore, the traditional Chinese medicine mainly adopts the functions of supplementing qi, nourishing yin and strengthening the spleen to promote the production of body fluid, clearing heat, activating blood circulation and removing blood stasis to promote the secretion of saliva.
The Beijing coordination hospital finds that the prevalence rate of the disease is 0.77% -0.29% in the investigation of thousands of people. The disease mostly occurs in women over 40 years old, and the incidence rate of men is less than 10%. The etiology and pathogenesis of the disease are complex, and are one of the subjects discussed in the academic world of traditional Chinese medicine, and the focus of the disease at the early stage of the disease course is considered to be related to age and environment, so diagnosis is often confirmed after the disease condition is aggravated. At present, no method for radically treating the sicca syndrome exists internationally, but western medicine treatment mainly aims at relieving immune injury, and other effective measures are not available temporarily, so that the traditional Chinese medicine has wide prospects and application values in prevention and treatment of the sicca syndrome.
Patent ZL02146572.X discloses a pharmaceutical composition for treating coronary heart disease and ventricular premature beat and a preparation method thereof, and the content recorded in patent ZL02146572.X is cited in the entire patent application. The patent does not disclose the application of the pharmaceutical composition in the preparation of a medicament for treating sjogren's syndrome.
Disclosure of Invention
The invention aims to provide application of a traditional Chinese medicine composition in preparing a medicine for treating sicca syndrome, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
45-180 parts of ginseng, 50-200 parts of dwarf lilyturf tuber, 125-450 parts of dogwood, 125-450 parts of salvia miltiorrhiza, 95-400 parts of fried spina date seed, 95-400 parts of Chinese taxillus twig, 45-200 parts of red paeony root, 35-150 parts of ground beeltle, 45-200 parts of nardostachyos root and rhizome, 25-90 parts of coptis chinensis, 35-150 parts of kadsura longepedunculata and 75-300 parts of dragon bone.
The weight ratio of the raw materials in the traditional Chinese medicine composition is preferably as follows:
89 parts of ginseng, 112 parts of dwarf lilyturf tuber, 224 parts of dogwood, 224 parts of salvia miltiorrhiza, 186 parts of fried spina date seed, 186 parts of Chinese taxillus twig, 89 parts of red paeony root, 75 parts of ground beeltle, 89 parts of nardostachyos root and rhizome, 45 parts of coptis chinensis, 67 parts of kadsura longepedunculata and 149 parts of dragon bone.
The weight ratio of the raw materials of the traditional Chinese medicine composition is also preferably as follows:
45 parts of ginseng, 112 parts of dwarf lilyturf tuber, 224 parts of dogwood, 225 parts of salvia miltiorrhiza, 186 parts of fried spina date seed, 186 parts of Chinese taxillus twig, 89 parts of red paeony root, 45 parts of nardostachys root, 35 parts of ground beetle, 45 parts of coptis chinensis, 67 parts of kadsura longepedunculata and 149 parts of keel.
The weight ratio of the raw materials of the traditional Chinese medicine composition is also preferably as follows:
90 parts of ginseng, 135 parts of dwarf lilyturf tuber, 270 parts of dogwood, 200 parts of salvia miltiorrhiza, 150 parts of fried spina date seed, 150 parts of Chinese taxillus twig, 100 parts of red paeony root, 100 parts of ground beeltle, 95 parts of nardostachyos root and rhizome, 60 parts of coptis chinensis, 75 parts of kadsura longepedunculata and 150 parts of dragon bone.
In the application of the invention, the active ingredients of the traditional Chinese medicine composition are prepared by the following steps:
a) Reflux-extracting radix Ginseng with 70% ethanol for three times, mixing extractive solutions, filtering, concentrating, oven drying, and pulverizing into fine powder;
b) Reflux-extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and radix Et rhizoma Nardostachyos with 70% ethanol for 3 times, mixing extractive solutions, filtering, and concentrating to obtain extract;
c) Pulverizing Eupolyphaga Seu Steleophaga into fine powder;
d) Decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis in water for 2 times, mixing extractive solutions, and concentrating to obtain extract.
e) Mixing the extracts obtained in the steps b) and d), adding the fine medicine powder obtained in the step c), drying, crushing into fine powder, adding the fine medicine powder obtained in the step a), and uniformly mixing to obtain the active ingredient of the traditional Chinese medicine composition.
Preferably, the preparation method of the capsule of the invention comprises the following steps:
(1) Reflux-extracting Ginseng radix with 8 times of 70% ethanol for three times, 3 hr for the first time, and 2 hr for each time, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into 80 mesh powder;
(2) Reflux-extracting fructus Schisandrae chinensis, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma, and radix Et rhizoma Nardostachyos with 8 times of 70% ethanol for 3 times, mixing extractive solutions, filtering, and recovering ethanol;
(3) The terrapin is crushed into 80-mesh powder;
(4) Decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis with 9 times of water for 2 times, mixing extractive solutions, filtering, mixing with the extractive solution of step (2), concentrating, mixing with the powders of steps (1) and (3), oven drying, pulverizing into 80 mesh powder, and making into capsule.
The traditional Chinese medicine composition is a traditional Chinese medicine compound preparation researched and developed according to the theory of collateral diseases of traditional Chinese medicine. Mainly comprises ginseng, dwarf lilyturf tuber, salvia miltiorrhiza, nardostachys root and schisandra chinensis, and has the functions of tonifying qi and yin, promoting blood circulation and removing obstruction in channels, and nourishing yin and moistening lung. The medicine treats the pathogenesis of pathogenic factors of vital qi deficiency, yin deficiency and fluid deficiency, blood stasis blocking collaterals and excessive dryness and toxicity of sicca syndrome. The medicine composition has stable property, controllable quality, obvious curative effect, extremely low toxicity and good clinical curative effect. Has no drug dependence and tolerance, has no adverse reaction and is easy to be accepted by patients.
The Chinese medicinal composition has Latin name of active ingredient as raw material medicine and its preparation method from Chinese medicinal dictionary (7 months 1977, first edition, shanghai science and technology Press) and Chinese pharmacopoeia (2005 edition, chemical industry Press).
The traditional Chinese medicine composition can be prepared into any pharmaceutically acceptable conventional dosage forms, such as capsules, tablets, granules, powder, oral liquid or pills and the like, according to the conventional preparation process, for example, the preparation process recorded in Vanbitin traditional Chinese medicine pharmacy (1 st 12 months in 1997 of Shanghai science publishers).
In the application of the invention, the preparation formulation of the traditional Chinese medicine composition is capsules, tablets, granules, powder, oral liquid or pills, and in order to realize the above formulation, pharmaceutically acceptable auxiliary materials are added when the formulations are prepared, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, cross-linked sodium carboxymethylcellulose, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the adhesive comprises starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; the sweetener comprises: saccharin sodium, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, and the like; the flavoring agent comprises: sweeteners and various essences; the preservative comprises: nipagin, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroacetidine acetate, eucalyptus oil, etc.; the matrix comprises: PEG6000, PEG4000, insect wax, etc. In order to realize the traditional Chinese medicine pharmacy, other pharmaceutically acceptable auxiliary materials (auxiliary materials recorded in each dosage form in the 12 th month and 1 st edition of Shanghai science Press 1997) are required to be added when preparing the dosage forms.
Test examples
In order to confirm the efficacy of the drug of the present invention in treating sjogren's syndrome, the following clinical trial studies were conducted using the capsules prepared in example 1 (hereinafter referred to as drug of the present invention) and the capsules prepared in experimental example 1 composed of the same crude drug in excess of parts by weight and experimental example 2 composed of different crude drugs having similar efficacy in replacement of part (hereinafter referred to as drug 1, drug 2):
1. data and method
1.1 General data
80 female patients with sjogren syndrome who were admitted to Ling Hospital from 2018, 1 month to 2019, 12 months in Hebei were selected as study subjects, and were randomly divided into 20 cases, each of which was a control group, a treatment group, an experimental group 1 and an experimental group 2.
(1) The age of the control group is 30 to 70 years, the average age (50 +/-7.54) years, the course of disease is 0.2 to 10 years, and the average course of disease (5 +/-4.48) years;
(2) the age of the treatment group is 29 to 69 years, the average age (51 +/-0.33) years, the course of disease is 0.3 to 9.8 years, and the average course of disease (4 +/-9.56) years;
(3) experiment 1, the age is 30 to 69 years, the average age (50 +/-7.74) is 0.3 to 10.2 years, and the average course (5 +/-0.08) is 5 years;
(4) experiment 2 groups are 31 to 69 years old, the average age (49 +/-9.95 years old), the course of disease is 0.3 to 10 years old, and the average course of disease (5 +/-5.29) years old;
the general data of four groups of patients were not significantly different (P > 0.05). The study was approved by the ethical committee of our hospital, and patients and family members gave informed consent to the study.
1.2 Inclusion case criteria
The diagnosis standard is that the primary sicca syndrome can be diagnosed when at least one of the following six items is included and other connective tissue diseases, lymphoma and sarcoidosis are excluded. (1) The eye symptoms include at least one of persistent dry eye for more than 3 months, and repeated glistening feeling by using artificial tear more than 3 times per day. (2) The oral symptom is at least one of the following symptoms, namely continuous dry mouth for more than 3 months, repeated or continuous parotid gland swelling after adults, and water is needed to be fed when dry food is eaten. (3) Schvers test < 5 mm/5 min. (4) Slow drainage of parotid gland contrast medium, dilated main duct, irregular edge, punctate, spherical and luminal tail catheter. (5) Lip mucosa biopsy lymphocytes > 1 foci, with 50 lymphocytes being 1 foci. (6) Serum ANA, RF, anti-SSA, anti-SSB were positive for at least 1.
1.3 exclusion criteria
(1) The medicine composition can not be matched with a traditional Chinese medicine therapist, (2) a person who is not seriously affected by the disease and has serious organ diseases such as the gravity, the liver, the kidney, the brain and the like, (3) a pregnant woman or a lactating woman, (4) a person who has a history of medicine allergy, and (5) a patient who has received treatment of an immunosuppressant, chloroquine and adrenal glucocorticoid within 3 weeks before the test.
1.4 methods of treatment
Prednisone was administered at 10 mg/day for the control group; the treatment group was given the oral drug of the present invention 4 granules/time, 3 times/day; experiment group 1 was given oral medication 1,2-4 doses/time, 3 times/day; the experimental group 2 is given with the oral drug 2,2-4 granules/time, 3 times/day; a treatment course comprises 30 days and 2 treatment courses.
1.5 therapeutic efficacy criteria
Refer to the clinical research guidance of new traditional Chinese medicines:
(1) the clinical cure is realized; the symptoms disappear completely, and the physical and chemical examination result is normal;
(2) the effect is shown: the main symptoms disappear, and the physical and chemical inspection results are obviously improved;
(3) the method has the following advantages: the main symptoms disappear partially, and the physical and chemical examination result is improved to some extent;
(4) and (4) invalidation: the main symptoms and the results of physical and chemical examinations did not improve.
Total effective rate of clinical treatment = [ (number of cure cases + number of significant cases + number of effective cases)/number of total cases ] × 100%.
1.6 statistical methods
Statistical analysis of the data was performed using SPSS20.0 statistical software. Adopting x shape for counting 2 Checking; comparing the mean between multiple groups of the measurement data by using variance analysis; p <0.05 is significant.
Therapeutic results
2.1 clinical efficacy
The total effective rate of the treatment effect of the patients in the treatment group is 90 percent, which is obviously higher than 55 percent of that in the control group, 60 percent of that in the experimental group 1 and 50 percent of that in the experimental group 2; the cure rate of the treatment effect of the patients in the treatment group is 55 percent, which is obviously higher than that of the control group by 15 percent, the total effective rate of the experimental group 1 is 20 percent, and the difference of the total effective rate of the experimental group 1 and the total effective rate of the experimental group 2 is 25 percent, which have statistical significance (P is less than 0.05), and the difference is shown in the table 1.
Adverse reactions
No adverse reaction was observed in the control group, the treatment group, the experimental group 1 and the experimental group 2.
Conclusion
The study proves that after four groups of patients with confirmed sjogren's syndrome are respectively treated by taking the contrast drug, the drug of the invention and the drugs 1 and 2, the total effective rate of the treatment effect of the treatment group is obviously higher than that of the contrast group, the experiment group 1 and the experiment group 2, the cure rate is obviously higher than that of the contrast group, the experiment group 1 and the experiment group 2, and the drug of the invention with the weight part ratio in a specific range and the formula with specific drug flavor is fully proved to have obvious curative effect on the treatment of the sjogren's syndrome.
Detailed Description
The following examples illustrate the preparation of the Chinese medicinal composition of the present invention, but are not intended to limit the scope of the invention in any way.
Example 1
In order to facilitate the application of the Chinese medicinal composition in treating sicca syndrome, the Chinese medicinal composition is prepared into capsules
Prescription:
89g of ginseng, 112g of dwarf lilyturf tuber, 224g of dogwood fruit, 224g of salvia miltiorrhiza bunge
Parched semen Ziziphi Spinosae 186g herba Taxilli 186g radix Paeoniae Rubra 89g Eupolyphaga Seu Steleophaga 75g
89g of rhizoma nardostachyos, 45g of coptis chinensis, 67g of kadsura longepedunculata, 149g of dragon bone
The preparation method comprises the following steps:
a) In the above formula, ginseng radix is extracted with 70% ethanol under reflux for three times, the first time is 3 hr, and each time is 2 hr, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into fine powder;
b) In the above formula, extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 70% ethanol under reflux for three times, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract;
c) In the above formula, the ground beetle is pulverized into fine powder for standby;
d) In the above formula, radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra, and Os Draconis are decocted in water twice, the extractive solutions are combined, filtered, the filtrate is combined with the extractive solution of fructus Schisandrae Sphenantherae, etc., and concentrated to obtain extract for use;
e) Mixing the extracts obtained in the steps b) and d), adding the fine medicine powder obtained in the step c), drying, crushing into fine powder, adding the fine medicine powder obtained in the step a), uniformly mixing, and filling into 1000 capsules.
Example 2
In order to facilitate the application of the traditional Chinese medicine composition in treating sicca syndrome, the traditional Chinese medicine composition is prepared into tablets
Prescription:
45g of ginseng, 112g of dwarf lilyturf tuber, 224g of dogwood, 224g of salvia miltiorrhiza, 225g of fried spina date seed and 186g of wild jujube
Chinese taxillus twig 186g red peony root 89g nardostachys root 45g ground beetle 35g coptis root 45g
Kadsura longepedunculata 67g and dragon bone 149g.
The preparation method comprises the following steps:
a) In the above formula, ginseng radix is extracted with 70% ethanol under reflux for three times, the first time for 3 hr, and each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into fine powder;
b) In the above formula, extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 70% ethanol under reflux for three times, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract;
c) In the above formula, the ground beetle is pulverized into fine powder for standby;
d) In the above formula, decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis in water twice, mixing extractive solutions, filtering, mixing filtrate with extractive solution of fructus Schisandrae Sphenantherae, etc., and concentrating to obtain extract;
e) Mixing the extracts obtained in the steps b) and d), adding the fine powder of the medicine obtained in the step c), drying, crushing into fine powder, adding the fine powder of the medicine obtained in the step a), mixing uniformly, and pressing into 1000 tablets according to a conventional preparation process.
Example 3
In order to facilitate the application of the traditional Chinese medicine composition in treating sicca syndrome, the traditional Chinese medicine composition is prepared into granules
Prescription:
175g of ginseng, 192g of dwarf lilyturf tuber, 421g of dogwood, 440g of salvia miltiorrhiza, 440g of fried spina date seed and 395g of wild jujube seed
396g of parasitic loranthus, 188g of red paeony root, 98g of ground beetle, 188g of nard and 85g of coptis chinensis
Kadsura longepedunculata 147g and dragon bone 278g.
The preparation method comprises the following steps:
a) In the above formula, ginseng radix is extracted with 70% ethanol under reflux for three times, the first time for 3 hr, and each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into fine powder;
b) In the above formula, extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 70% ethanol under reflux for three times, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract;
c) In the above formula, the ground beetle is pulverized into fine powder for standby;
d) In the above formula, radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra, and Os Draconis are decocted in water twice, the extractive solutions are combined, filtered, the filtrate is combined with the extractive solution of fructus Schisandrae Sphenantherae, etc., and concentrated to obtain extract for use;
e) Mixing the extracts obtained in step b) and d), adding the fine powder obtained in step c), drying, pulverizing into fine powder, adding the fine powder obtained in step a), mixing, and making into 1000 bags of granules according to conventional preparation.
Experimental group 1
In order to facilitate the application of the Chinese medicinal composition in treating sicca syndrome, the Chinese medicinal composition is prepared into capsules
Prescription:
200g of ginseng, 40g of dwarf lilyturf tuber, 500g of dogwood, 500g of danshen root and 100g
500g of fried spina date seed, 80g of parasitic loranthus, 250g of red paeony root, 20g of ground beetle
Rhizoma nardostachyos 220g coptis chinensis 20g kadsura longepedunculata 170g keel 50g
The preparation method comprises the following steps:
a) In the above formula, ginseng radix is extracted with 70% ethanol under reflux for three times, the first time is 3 hr, and each time is 2 hr, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into fine powder;
b) In the above formula, extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 70% ethanol under reflux for three times, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract;
c) In the above formula, the ground beetle is pulverized into fine powder for standby;
d) In the above formula, decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis in water twice, mixing extractive solutions, filtering, mixing filtrate with extractive solution of fructus Schisandrae Sphenantherae, etc., and concentrating to obtain extract;
e) Mixing the extracts obtained in the steps b) and d), adding the fine medicine powder obtained in the step c), drying, crushing into fine powder, adding the fine medicine powder obtained in the step a), uniformly mixing, and filling into 1000 capsules.
Experimental group 2
In order to facilitate the application of the Chinese medicinal composition in treating sicca syndrome, the Chinese medicinal composition is prepared into capsules
Prescription:
american ginseng 89g asparagus 112g gordon euryale seed 224g red sage root 224g
Baizi kernel 186g mistletoe 186g white peony root 89g drynaria 75g
Poria cocos 89g phellodendron bark 45g schisandra fruit 67g oyster 149g
The preparation method comprises the following steps:
a) In the above formula, radix Panacis Quinquefolii is extracted with 70% ethanol under reflux for three times, 3 hr for the first time, and 2 hr for each time thereafter, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into fine powder;
b) In the above formula, extracting fructus Schisandrae Bicoloris, semen euryales, saviae Miltiorrhizae radix, cortex Phellodendri, and Poria with 70% ethanol under reflux for three times, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract;
c) In the above formula, rhizoma drynariae is pulverized into fine powder for later use;
d) In the above formula, decocting radix asparagi, semen Platycladi, herba Visci, radix Paeoniae alba, and Concha Ostreae in water twice, mixing extractive solutions, filtering, mixing filtrate with extractive solution of radix Schisandrae Bicoloris, etc., and concentrating to obtain extract;
e) Mixing the extracts obtained in the steps b) and d), adding the fine medicine powder obtained in the step c), drying, crushing into fine powder, adding the fine medicine powder obtained in the step a), uniformly mixing, and filling into 1000 capsules.
Claims (7)
1. The application of a traditional Chinese medicine composition in preparing a medicine for treating sicca syndrome is characterized in that the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
45-180 parts of ginseng, 50-200 parts of dwarf lilyturf tuber, 125-450 parts of dogwood, 125-450 parts of salvia miltiorrhiza, 95-400 parts of fried spina date seed, 95-400 parts of Chinese taxillus twig, 45-200 parts of red paeony root, 35-150 parts of ground beeltle, 45-200 parts of nardostachyos root and rhizome, 25-90 parts of coptis chinensis, 35-150 parts of kadsura longepedunculata and 75-300 parts of keel.
2. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
89 parts of ginseng, 112 parts of dwarf lilyturf tuber, 224 parts of dogwood, 224 parts of salvia miltiorrhiza, 186 parts of fried spina date seed, 186 parts of Chinese taxillus twig, 89 parts of red paeony root, 75 parts of ground beeltle, 89 parts of nardostachyos root and rhizome, 45 parts of coptis chinensis, 67 parts of kadsura longepedunculata and 149 parts of dragon bone.
3. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
45 parts of ginseng, 112 parts of dwarf lilyturf tuber, 224 parts of dogwood, 225 parts of salvia miltiorrhiza, 186 parts of fried spina date seed, 186 parts of Chinese taxillus twig, 89 parts of red paeony root, 45 parts of nardostachys root, 35 parts of ground beetle, 45 parts of coptis chinensis, 67 parts of kadsura longepedunculata and 149 parts of keel.
4. The application of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:
90 parts of ginseng, 135 parts of dwarf lilyturf tuber, 270 parts of dogwood, 200 parts of salvia miltiorrhiza, 150 parts of fried spina date seed, 150 parts of Chinese taxillus twig, 100 parts of red paeony root, 100 parts of ground beeltle, 95 parts of nardostachyos root and rhizome, 60 parts of coptis chinensis, 75 parts of kadsura longepedunculata and 150 parts of dragon bone.
5. The use of any one of claims 1 to 4, wherein the active ingredients of the Chinese medicinal composition are prepared by the steps of:
a) Reflux-extracting radix Ginseng with 70% ethanol for three times, mixing extractive solutions, filtering, concentrating, oven drying, and pulverizing into fine powder;
b) Reflux-extracting fructus Schisandrae Sphenantherae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 70% ethanol for 3 times, mixing extractive solutions, filtering, and concentrating to obtain extract;
c) Pulverizing Eupolyphaga Seu Steleophaga into fine powder;
d) Decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis in water for 2 times, mixing extractive solutions, and concentrating to obtain extract;
e) Mixing the extracts obtained in the steps b) and d), adding the fine medicine powder obtained in the step c), drying, crushing into fine powder, adding the fine medicine powder obtained in the step a), and uniformly mixing to obtain the active ingredient of the traditional Chinese medicine composition.
6. The use of any one of claims 1-4, wherein the formulation of the Chinese medicinal composition is one of a capsule, a tablet, a granule, a powder, or an oral liquid.
7. The preparation method of the traditional Chinese medicine composition capsule as claimed in claim 6, wherein the medicine is prepared by the following steps:
(1) Reflux-extracting Ginseng radix with 8 times of 70% ethanol for three times, 3 hr for the first time, and 2 hr for each time, mixing extractive solutions, filtering, recovering ethanol, concentrating, oven drying, and pulverizing into 80 mesh powder;
(2) Reflux-extracting fructus Schisandrae, corni fructus, saviae Miltiorrhizae radix, coptidis rhizoma and rhizoma et radix Valerianae with 8 times of 70% ethanol for 3 times, mixing extractive solutions, filtering, and recovering ethanol;
(3) Pulverizing the soil beetles into 80-mesh powder;
(4) Decocting radix Ophiopogonis, parched semen Ziziphi Spinosae, herba Taxilli, radix Paeoniae Rubra and Os Draconis with 9 times of water for 2 times, mixing extractive solutions, filtering, mixing with the extractive solution of step (2), concentrating, mixing with the powders of steps (1) and (3), oven drying, pulverizing into 80 mesh powder, and making into capsule.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101632781A (en) * | 2008-07-21 | 2010-01-27 | 河北以岭医药研究院有限公司 | Application of Chinese medicinal composition in preparing medicament for treating xerophthalmia |
CN102210807A (en) * | 2010-04-08 | 2011-10-12 | 北京以岭药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicaments for treating angina pectoris |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN101632781A (en) * | 2008-07-21 | 2010-01-27 | 河北以岭医药研究院有限公司 | Application of Chinese medicinal composition in preparing medicament for treating xerophthalmia |
CN102210807A (en) * | 2010-04-08 | 2011-10-12 | 北京以岭药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicaments for treating angina pectoris |
Non-Patent Citations (1)
Title |
---|
徐红书: "参松养心胶囊联合胺碘酮治疗心房纤颤的疗效观察", 中国医药指南, vol. 11, no. 01, 10 January 2013 (2013-01-10), pages 263 - 264 * |
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