CN101780227A - Traditional Chinese medicine composition for treating acute stroke and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating acute stroke and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating acute stroke and a preparation method thereof. The traditional Chinese medicine composition mainly comprises the following raw medicines: senna leaf, giant knotweed rhizome, artificial bovine calculus powder, concretio silicea bambusae and trichosanthes fruit seed. The traditional Chinese medicine composition provided by the invention has the efficacy of dredging intestines and inducing resuscitation, is suitable for the symptoms of viscera and phlegm retention and viscera qi obstruction caused by the acute stroke, and is used for treating phlegm retention and viscera qi obstruction of yang and yin shutting syndromes of viscera caused by the stroke. The traditional Chinese medicine composition for treating patients suffering from acute stroke can improve clinical curative effect, reduce mortality and improve the life quality of patients; and the clinical application is safe without side effects.
Description
Technical field
The invention belongs to technical field of Chinese medicines, specifically, the present invention relates to a kind of Chinese medicine composition for the treatment of suffering from acute stroke, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Its sickness rate of apoplexy, disability rate, case fatality rate, relapse rate are all very high, serious harm human life and health.Go through the clinical practice in thousands of years, the traditional Chinese medical science has definite curative effect and special advantages having accumulated rich experience aspect prevention, treatment and the rehabilitation of primary disease.
Disturbance of consciousness is the critical clinical symptoms of apoplexy, clinical with cerebral hemorrhage for seeing more, should actively take measures to suffering from acute stroke disturbance of consciousness patient, promote consciously, help reducing case fatality rate.Clinical treatment to apoplectic coma, to fall the cranium pressing be clinical first-selection for evacuation of hematoma and dehydration, to hyperosmotic dehydration agent commonly used of cerebral edema medical treatment such as mannitol etc., extensively is used in a large number in clinical, its side effect and untoward reaction also obtain paying attention to.A large amount of clinical datas show that the patient of suffering from acute stroke disturbance of consciousness has constipation mostly, and excess syndrome of YANG MING FU-organ such as abdominal distention, halitosis cards is for the utilization of purging FU-organs method provides objective basis.Clinical observation confirms that all excess syndrome of YANG MING FU-organ is that more syndrome appears in the apoplexy coma, provides strong evidence thereby treat this disease for the purging FU-organs method.
Shen Jinlin; old commenting; (Chinese tcm emergency such as Zhao Anmin; 1998; 7 (4): 151) report adopts from intending " ice yellow liquor " (Rhizoma Coptidis, Radix Et Rhizoma Rhei, Calculus Bovis, Rhizoma Acori Graminei, Borneolum Syntheticum; the used dosage of every flavor medicine is not described) rectum instils and to add routine of western medicine and treat 21 routine acute cerebral hemorrhage patients; and with 20 routine western medical treatment patients relatively; the result shows that be 28h the average time that treatment group disturbance of consciousness improves; matched group 32h; treatment group total effective rate is 85.71%, and matched group is 65.6%, and learning by statistics to handle has significant difference.
Surplus perseverance just waits (the practical clinical emergency treatment of the combination of Chinese and Western medicine, 1999,6 (1): 33) the report utilization changes with the card plus-minus in conjunction with clinical pattern of syndrome from intending " purging FU-organs brain refreshing liquid " (Radix Curcumae, Radix Salviae Miltiorrhizae, Radix Notoginseng, Radix Et Rhizoma Rhei, Hirudo, Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis, Poria, Rhizoma Acori Graminei, Fructus Crataegi, Herba Leonuri), rectum instils and treats hypertensive cerebral hemorrhage 32 examples, 13 examples (40.6%) as a result are almost recovered in 32 examples, marked improvement 16 examples (50%), progressive 2 examples (6.3%), total effective rate is 96.9%, and patient's disturbance of consciousness improves time average 24h.
(the Henan traditional Chinese medical science such as Hao Yuhong, 2003,23 (9): 23-24) report adopt have that purging FU-organs rushes down turbid, function of promoting blood circulation to disperse blood clots hold acute courageous and upright apoplexy 130 examples of gas purging FU-organs capsule (Radix Et Rhizoma Rhei, Arisaema Cum Bile, Fructus Trichosanthis, Fructus Aurantii Immaturus, Radix Salviae Miltiorrhizae etc.) treatment for a short time, 34 examples are almost recovered, marked improvement 56 examples, progressive 27 examples, no change 9 examples, worsen 4 examples, effective percentage 90.0%.
Yang Qingrong, Li Baohua, Chen Xuan equality (the Shaanxi traditional Chinese medical science, 2000,21 (2): 50) report adopts purging FU-organs to rush down soup (Fructus Trichosanthis, Arisaema Cum Bile, Radix Et Rhizoma Rhei, Natrii Sulfas, Fructus Aurantii Immaturus, Radix Salviae Miltiorrhizae) treatment apoplexy (middle internal organs) acute stages 40 example down, total effective rate 97.5%, and get effect rapidly.
(Anhui tcm clinical practice magazine, 1996,8 (5): 206) report adopts from plan side's treatment suffering from acute stroke internal organs excess syndrome Zhang Shourong etc., has obtained better curative effect.Shared 9 flavor medicines in the side: Radix Et Rhizoma Rhei (back down) 10-15g, Matrii Sulfas Exsiccatus (dashing) 6-10g, Arisaema Cum Bile 9g, Concretio silicea Bambusae seu schizostachyi 15g, Scorpio 6g, Bombyx Batryticatus 5g, Ramulus Uncariae Cum Uncis (back down) 20g, Rhizoma Acori Graminei 9g, Radix Rehmanniae 15g.
Wang Jingning, (the Jiangxi Chinese medicine, 1995,26 (5): 12) report is treated the 50 routine clinical observations of suffering from acute stroke excess syndrome with purging FU-organs blood stasis dispelling ruling by law to Wang Dongfang etc., obtains satisfactory effect clinically.Shared 12 flavor medicines in the side: Radix Et Rhizoma Rhei (back down) 12g-20g, Natrii Sulfas (dashing), Fructus Aurantii, each 10g of Rhizoma Arisaematis (processed), Rhizoma Acori Graminei 10g-15g, Fructus Trichosanthis 15g-20g, Radix Salviae Miltiorrhizae 20g, Rhizoma Chuanxiong, Semen Persicae, Radix Paeoniae Rubra, each 12g of Radix Angelicae Sinensis, Radix Glycyrrhizae 10g.
Lan Gongzhou etc. (journal of shanghai Chinese medicine, 1996,4:10) report purging FU-organs clearing away heat method treatment acute apoplexy 120 examples obtain obvious curative effects clinically.The side selects the white tiger CHENGQI TANG, totally 5 flavor medicines: Gypsum Fibrosum 30 grams, the Rhizoma Anemarrhenae 10 grams, Radix Glycyrrhizae 6 grams, Radix Et Rhizoma Rhei 10 grams, Natrii Sulfas 10 grams.
At present to apoplexy at acute stage particularly the treatment of anxious Cavity in Critical Patients be still a weak link, lack effective preparation and means, the development onset rapidly, new drug safely and effectively, be still the task of top priority of rescuing the suffering from acute stroke comatose patient to adapt to clinical treatment needs.
Summary of the invention
The object of the present invention is to provide a kind of new Chinese medicine composition that is used for the treatment of suffering from acute stroke.
For achieving the above object, the present invention has taked following technical scheme:
A kind of Chinese medicine composition for the treatment of suffering from acute stroke, this Chinese medicine composition is made up of following crude drug: Folium Sennae, Rhizoma Polygoni Cuspidati, artificial bezoar powder, Concretio Silicea Bambusae, Fructus Trichosanthis core.
Preferably, this Chinese medicine composition is made up of following bulk drugs: Folium Sennae 1-10 part, Rhizoma Polygoni Cuspidati 3-100 part, artificial bezoar powder 1-10 part, Concretio Silicea Bambusae 3-30 part, Fructus Trichosanthis core 3-100 part.
More preferably, this Chinese medicine composition is made up of following bulk drugs: Folium Sennae 2-8 part, Rhizoma Polygoni Cuspidati 5-50 part, artificial bezoar powder 1-3 part, Concretio Silicea Bambusae 5-15 part, Fructus Trichosanthis core 6-30 part.
More preferably, this Chinese medicine composition is made up of following bulk drugs: 3 parts of Folium Sennae, 10 parts of Rhizoma Polygoni Cuspidati, 1.5 parts of artificial bezoar powders, 6 parts of Concretio Silicea Bambusaes, 9 parts of Fructus Trichosanthis core.
Another object of the present invention provides the preparation method of above-mentioned Chinese medicine composition.
A kind of preparation method for the treatment of the Chinese medicine composition of suffering from acute stroke may further comprise the steps:
(1) get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core and decoct with water 2-3 time, each 0.5-1.5 hour, filter, merges three times filtrate, room temperature is put cold, adds 95% ethanol and makes and contain the alcohol amount and reach 60%-75%, stirs evenly, and leaves standstill, and filtration is concentrated into thick extractum behind the filtrate recycling ethanol;
(2) get Folium Sennae and clean fast, the oven dry pulverizing is crossed the 80-120 mesh sieve, and it is standby to sterilize;
(3) Folium Sennae that artificial bezoar powder and step (2) are obtained adds in the thick extractum that step (1) obtains, and stirs evenly, and filtration sterilization promptly.
Preferably, decocting 3 times in the described step (1), is 1 hour for the first time, is 45 minutes for the second time, is 45 minutes for the third time.
Get Chinese medicine composition, add conventional adjuvant (starch, plant wet goods), make acceptable tablet, powder, capsule or granule clinically according to a conventional method; Be preferably capsule.
Apoplexy at acute stage is how real to mark, and accounts for critical role by FU QI being obstructed due to the knot in wind-fire, expectorant, the stasis of blood in the apoplexy pathogenesis changes.It is one of the basic method of treatment of apoplexy at acute stage that purging FU-organs is let out turbid, and Chinese medicine composition of the present invention promptly is at the apoplexy at acute stage patient is many establishes with the card of FU QI being obstructed, is monarch drug with Folium Sennae, Rhizoma Polygoni Cuspidati, and purging FU-organs rushes down down, the blood circulation promoting and blood stasis dispelling detoxifcation of reducing phlegm; Relieve dizziness, high fever, infantile convulsions, epilepsy, etc. eliminating phlegm, the refreshment of having one's ideas straightened out of artificial Calculus Bovis is ministerial drug; The Concretio Silicea Bambusae eliminating phlegm and calming wind, Semen Trichosanthis intestine moistening expectorant is adjuvant altogether.All medicines share, and make the stagnant expectorant heresy of heap soil or fertilizer over and around the roots be able to let out clearly rapidly, and to correct the disorderly contrary of QI and blood, QI and blood is failed cloth, and the numbness collateral dredging is lived; It is logical that internal organs is so incensed that, foul smell descends, can not upper punch, upset gods, and reach the purpose of " purging FU-organs refreshment ".
The medical material that is used for Chinese medicine composition of the present invention is as follows:
Folium Sennae: be the dry lobule of leguminous plant cassia angustifolia Vahl Cassia ang μ stifolia Vahl..Rhizoma Polygoni Cuspidati: be dry rhizome and the root of polygonaceae plant Rhizoma Polygoni Cuspidati Polygon μ m c μ spidat μ m Sieb.et Z μ cc..Artificial bezoar powder: for second biochemical-pharmaceutical factory, Wuhan produces.Semen Trichosanthis: be the dry mature seed of cucurbitaceous plant Chinese juniper beach wormwood Trichosanthes kirilowii Maxim..Concretio Silicea Bambusae: be the dry block of the juice in the grass Chinese textile bamboo Bamb μ sa textilis Mecl μ re cane.
Different with disclosed Chinese patent medicine in the prior art, the present invention is a brand-new Chinese patent medicine formula.Raw material components of the present invention and prior art relatively see table 1 for details.
Table 1 Chinese medicine composition composition of the present invention and prior art Chinese patent medicine ratio of components are
| The Chinese medicine title | The present invention | The ice yellow liquor | Purging FU-organs is waken up | For a short time hold the gas purging FU-organs | Purging FU-organs rushes down | Zhang Shi certainly | White tiger is held |
| Brain liquid | Capsule | Following soup | Plan side | Gas soup | |||
| Folium Sennae | ** | Do not have | Do not have | Do not have | |||
| Rhizoma Polygoni Cuspidati | ** | ||||||
| The artificial Calculus Bovis | ** | ?** | |||||
| Concretio Silicea Bambusae | ** | ** | |||||
| Semen Trichosanthis | ** | ** | ** | ||||
| Radix Et Rhizoma Rhei | ?** | ** | ** | ** | ** | ** | |
| Rhizoma Acori Graminei | ?** | ** | ** | ||||
| Borneolum Syntheticum | |||||||
| Radix Salviae Miltiorrhizae | ?** | ** | ** | ** | ** | ||
| Rhizoma Gastrodiae | ** | ||||||
| Natrii Sulfas | ** | ** | ** | ||||
| Do not announce Chinese medicine | ?** | ** | ** | ** | |||
| Amount to flavour of a drug | 5 | ?＞5 | 11 | ＞5 | 6 | 9 | 5 |
| The announcement of Chinese medicine ratio | Have | Do not have | Do not have | Do not have | Do not have | Have | Have |
Annotate:
*Contain this medicine in the expression prescription, the space person represents not have this medicine in the prescription.
Dosage form
Chinese medicine composition of the present invention can be peroral dosage form or injection type.Peroral dosage form comprises powder, liquid, capsule or tablet.In addition, Chinese medicine composition of the present invention also can comprise pharmaceutical carrier.
The dosage form of Chinese medicine composition of the present invention comprises injection, oral liquid, tablet, pill, capsule, suppository, Emulsion, suspension etc.
In the Chinese medicine composition of the present invention except comprising effective ingredient, also should comprise the carrier such as excipient and the adjuvant that allow use on the galenic pharmacy, the effect of these carriers is the preparations that are processed into that help effective ingredient, and the delivery effective ingredient is to the interior site of action of body.
Chinese medicine composition of the present invention can be used with the form of pharmaceutical preparation, for example use with the pharmaceutical preparation of solid, semisolid or liquid form, the pharmaceutical preparation of these forms contains Chinese medicine composition of the present invention as effective ingredient, also be mixed with the excipient and the adjuvant of organic or inorganic, be applicable to external, intestinal and gastrointestinal medicine for external use.For example, this effective ingredient can be compound with nontoxic pharmaceutical excipient commonly used, makes tablet, pill, capsule, suppository, solution, Emulsion, suspension and any operable dosage form.Excipient of the present invention or adjuvant comprise Talcum, water, glucose, lactose, arabic gum, gelatin, mannitol, starch, magnesium trisilicate, corn starch, keratin, colloid silicon, potato starch and any carrier for preparing solid, semisolid or liquid form preparation, auxiliary agents such as auxiliary, stable, thickening in addition,, painted, flavoring also can use.
Be preparation Chinese medicine composition of the present invention such as tablet or capsule, Chinese medicine composition of the present invention mixes with pharmaceutical carrier, this carrier is film-making agent component commonly used, as corn starch, dicalcium phosphate, sucrose, sorbitol, Talcum, fatty acid, magnesium stearate, natural gum and other medicinal diluent, or compound recipe contains the mixture of basic Chinese medicine composition of the present invention uniformly or its nontoxic pharmaceutical salts.Compound recipe is meant that effective ingredient disperses uniformly before the basic prescription uniformly in this compound recipe, and like this, this compound recipe can be divided into the dosage form that equates effective unit dosage at any time, as tablet, pill and capsule.Compound recipe is divided into the above-mentioned dosage form of unit dose before this solid prescription, contains the compound recipe of the present invention of effective dose, preferred capsule.
Containing the tablet of Chinese medicine composition of the present invention or pill can coating or compound, reaches the dosage form that prolongs drug action to provide.For example, dosage component and external dose component in this tablet or pill can comprise, the latter coats the former fully.This two component can be separated with enteric layer, and this enteric layer is used for stoping and decomposes under one's belt and to allow and should interior component enter duodenum insusceptibly or delay release.Multiple medical material can be used as this class enteric layer or coating, comprises the mixture of multiple polymeric acid or polymeric acid, as Lac, hexadecanol and cellulose acetate.
Chinese medicine composition of the present invention can also be made liquid preparation, as oral liquid or injection, comprise syrup, water or the oil suspension of aqueous solution, suitable taste, the Emulsion of band taste (containing edible oil such as Oleum Gossypii semen, Oleum sesami, Oleum Cocois, Oleum Arachidis hypogaeae semen and other excipient).The adjuvant of aqueous suspension or excipient comprise synthetic nature natural gum, as tragacanth, acacia gum, alginate, dextran, sodium carboxymethyl cellulose (CMC), and methylcellulose, polyvinyl pyrrolidone (PVP), gelatin.
The dosage form of oral liquid preparation has solution, syrup or suspension, also can be dried and make solid, and the liquid dosage form use is used as in the dissolving of water or other excipient again before taking.In the preparation method of these liquid preparations, the additives that allow to use on the pharmaceutics comprise dispersion medium such as sorbitol, hydrogenated edible oil, methylcellulose; Also comprise antiseptic such as methyl or propyl group P-phenol; Emulsifying agent such as lecithin, acacia gum: non-water-soluble excipient such as almond oil, oils and fats, ethyl hexanol; Artificial color or sweeting agent.
The dosage form of the oral cavity medicine of Chinese medicine composition of the present invention is tablet and rhombus sheet normally.
Chinese medicine composition of the present invention can be made parenteral dosage form, as using injection with conventional microcatheter technology or transfusion.Injection can use the peace of the unit dose of adding preservative agent to flow the container package of vial or other multiple dose.Chinese medicine composition of the present invention can make water or butyrous excipient make suspension, solution and Emulsion, and excipient comprises dispersion medium, stabilizing agent and/or suspending agent.In addition, the effective ingredient in the compound recipe also can be made dry powder, and dry powder is dissolved again by suitable excipient (as sterile water for injection) before taking.The outer dosage form of the gastrointestinal tract that Chinese medicine composition of the present invention is suitable comprises the aqueous solution of this reactive compound, and this reactive compound is a water solublity, as water soluble salt.The suspension of this reactive compound can be with the suspension administration of suitable oily injection.Suitable lipophilic solution or excipient comprise fatty oil such as Oleum sesami, synthetic fatty acid cheese such as ethyl oleate and triglyceride.Preparation water-soluble injection suspension needs suspending agent to increase the viscosity of disperse medium, as sodium carboxymethyl cellulose, sorbitol and/or dextran.Can also comprise stabilizing agent in the suspension.The outside that liposome can surround drug molecule helps medicine to enter in the cell.
Route of administration
According to the present invention, the pharmaceutical formulation that is used to be administered systemically can be prepared by enterally administer, non-enterally administer and local application.In fact, all prescriptions of three types can use simultaneously, to reach being administered systemically of this effective ingredient.Route of administration comprises the parenteral approach, as subcutaneous, vein, intramuscular injection, intraperitoneal administration, mucosa delivery; Gastrointestinal administration comprises oral and approach such as coloclysis.
Dosage
The dosage of administration should be decided according to patient's age, body weight, health status, the course of treatment, individual variation and dosage form and the different of route of administration.Those skilled in the art can determine the optimum range of each component effective dose according to individual need.
Chinese medicine composition of the present invention according to clinical practical situation, can use or unite use separately, also can unite use with other medicine or diagnostic agent.In some preferred schemes, Chinese medicine composition of the present invention can be taken jointly with other chemical compound, and these other chemical compounds according to the conventional therapy practice, are usually used in treating these diseases.
The invention provides the certain methods of treatment suffering from acute stroke, these methods are to take this Chinese medicine composition of treatment effective dose to mammal to be controlled.This treatment can take place to carry out in 72 hours at cerebrovascular disease.These methods be preferred for treating suffer from acute cerebral hemorrhage, mammal that cerebral infarction or hemorrhagic apoplexy disease belong to the internal organs excess syndrome.These methods of the present invention more preferably are used for the treatment of by diagnosis and suffer from the human patients that cerebral hemorrhage, focal ischemia apoplexy or hemorrhagic apoplexy belong to the internal organs excess syndrome.
Method of the present invention also comprises the improvement situation of estimating the mammal state of an illness with the standard of quality of life.These indexes comprise the minimizing of getting back to the ability of living on one's own life, the ability of getting back to work and neurologic impairment integration.In addition, method of the present invention also comprises the improvement situation of estimating the mammal state of an illness with case fatality rate.
Chinese medicine composition of the present invention normally is used in the mammalian body and uses, as the mankind, sheep, horse, camel, pig, Canis familiaris L., cat, rat or mice etc., and also can be in external application.
Compared with prior art, the present invention has following beneficial effect:
Chinese medicine composition provided by the invention has the effect of purging FU-organs refreshment, is applicable to the card of internal organs in the suffering from acute stroke, stagnating phlem and pathogen, FU QI being obstructed, for stagnating phlem and pathogen, the FU QI being obstructed of the coma with heat excess nature of internal organs in apoplexy card or coma with cold excess nature card are established.Animal experiment shows; Chinese medicine composition of the present invention can obviously improve rat neurosigns and the hot internal organs excess syndrome performance of expectorant such as feces is dry and hard, irritated, nasal discharge is many, gurgling with sputum behind the cerebral hemorrhage; and can improve the brain capillary permeability and alleviate cerebral edema; promote absorption of hematoma; alleviate the cerebral tissue pressurized, microcirculation improvement and cerebral tissue blood supply oxygen supply and reach the protection cerebral tissue, improve the purpose of function of nervous system.Clinical studies show, traditional Chinese medicine composition for treating patients suffering from acute stroke of the present invention can improve clinical efficacy, reduces case fatality rate, improves patient's quality of life; Traditional Chinese medicine composition for treating suffering from acute stroke obnubilation of the present invention belongs to the hot internal organs of expectorant reality person and can impel consciously as early as possible, alleviates the degree of stupor.Clinical practice safety has no side effect.
The specific embodiment
The capsule preparation of embodiment 1 Chinese medicine composition of the present invention
Chinese medicine composition is made up of following bulk drugs among this embodiment: 3 parts of Folium Sennae, 10 parts of Rhizoma Polygoni Cuspidati, 6 parts of Concretio Silicea Bambusaes, 9 parts of Fructus Trichosanthis core, 1.5 parts of artificial bezoar powders, and preparation method may further comprise the steps:
1. get Folium Sennae and clean (avoiding immersion) fast, oven dry (60 ℃) pulverizing is crossed 100 mesh sieves, and it is standby to sterilize;
2. get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core cleaning and chopping, decoct (the back 1h that boils, 45min three times after soaking half an hour with an amount of ordinary water, 45min), filter, merge three times filtrate, be concentrated to 80,000 milliliters, room temperature is put cold, adds 95% ethanol and makes and contain alcohol amount and reach 60%, stirs evenly, leave standstill 24h, filter, filtrate recycling ethanol is concentrated to 12000 milliliters and gets extractum to the greatest extent.
3. add Folium Sennae and artificial bezoar powder in extractum, stir evenly the system soft material, granulate, cross 12 mesh sieves, 55～60 ℃ of oven dry are pulverized, and are encapsulated, every dress 0.4g.
The preparation tablets of embodiment 2 Chinese medicine compositions of the present invention
Chinese medicine composition is made up of following bulk drugs among this embodiment: 1 part of Folium Sennae, 3 parts of Rhizoma Polygoni Cuspidati, 3 parts of Concretio Silicea Bambusaes, 3 parts of Fructus Trichosanthis core, 1 part of artificial bezoar powder, and preparation method may further comprise the steps:
1. get Folium Sennae and clean (avoiding immersion) fast, oven dry (60 ℃) pulverizing is crossed 100 mesh sieves, and it is standby to sterilize;
2. get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core cleaning and chopping, decoct (the back 1h that boils, 45min three times after soaking half an hour with an amount of ordinary water, 45min), filter, merge three times filtrate, be concentrated to 80,000 milliliters, room temperature is put cold, adds 95% ethanol and makes and contain alcohol amount and reach 60%, stirs evenly, leave standstill 24h, filter, filtrate recycling ethanol is concentrated to 12000 milliliters and gets extractum to the greatest extent.
3. in extractum, add Folium Sennae and artificial bezoar powder, add the conventional tablet adjuvant, be prepared into tablet according to a conventional method.
The granule preparation of embodiment 3 Chinese medicine compositions of the present invention
Chinese medicine composition is made up of following bulk drugs among this embodiment: 9.6 parts of Folium Sennae, 96 parts of Rhizoma Polygoni Cuspidati, 27.6 parts of Concretio Silicea Bambusaes, 86.4 parts of Fructus Trichosanthis core, 9.4 parts of artificial bezoar powders, and preparation method may further comprise the steps:
1. get Folium Sennae and clean (avoiding immersion) fast, oven dry (60 ℃) pulverizing is crossed 100 mesh sieves, and it is standby to sterilize;
2. get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core cleaning and chopping, decoct (the back 1h that boils, 45min three times after soaking half an hour with an amount of ordinary water, 45min), filter, merge three times filtrate, be concentrated to 80,000 milliliters, room temperature is put cold, adds 95% ethanol and makes and contain alcohol amount and reach 60%, stirs evenly, leave standstill 24h, filter, filtrate recycling ethanol is concentrated to 12000 milliliters and gets extractum to the greatest extent.
3. in extractum, add Folium Sennae and artificial bezoar powder, add conventional granulates agent adjuvant, be prepared into granule according to a conventional method.
The oral liquid preparation of embodiment 4 Chinese medicine compositions of the present invention
Chinese medicine composition is made up of following bulk drugs among this embodiment: 8 parts of Folium Sennae, 50 parts of Rhizoma Polygoni Cuspidati, 15 parts of Concretio Silicea Bambusaes, 29 parts of Fructus Trichosanthis core, 2.7 parts of artificial bezoar powders, and preparation method may further comprise the steps:
1. get Folium Sennae and clean (avoiding immersion) fast, oven dry (60 ℃) pulverizing is crossed 100 mesh sieves, and it is standby to sterilize;
2. get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core cleaning and chopping, decoct (the back 1h that boils, 45min three times after soaking half an hour with an amount of ordinary water, 45min), filter, merge three times filtrate, be concentrated to 80,000 milliliters, room temperature is put cold, adds 95% ethanol and makes and contain alcohol amount and reach 60%, stirs evenly, leave standstill 24h, filter, filtrate recycling ethanol is concentrated to 12000 milliliters and gets extractum to the greatest extent.
3. in extractum, add Folium Sennae and artificial bezoar powder, add conventional oral liquid adjuvant, be prepared into oral liquid according to a conventional method.The pharmaceutical research of test example 1 Chinese medicine composition of the present invention
1. materials and methods
1.1 laboratory animal
240 of regular grade SD rats, body weight 200-250g, male and female half and half.
1.2 medicine
The medicine of embodiment 1 is produced the 0.4g/ grain by the Guangdong Provincial TCM Hospital Drug Manufacturing Room; The content 6.0g of the medicine of embodiment 1 is dissolved in the 200ml distilled water, pH7.8, the 200ml/ bottle makes medicinal liquid; The rat dosage is tried to achieve (1.0g/kg/ day) by people and rat body surface area ratio scaling method during experiment.(during oral administration medicinal liquid being made into concentration is 0.1g/ml, every each administration 2ml of rat 200g body weight, 1 time/day; Concentration is 0.1g/ml during coloclysis, each administration 2ml, 1 time/day)
1.3 cerebral hemorrhage rats modelling
Rat prepares with reference to the molding method of appointing damp light report with 10% chloral hydrate intraperitoneal injection of anesthesia (3.0ml/kg body weight) back, postanesthetic rat ventricumbent position is fixed on the brain solid positioner, shave hair, routine disinfection, the about 0.8cm of median incision under the scalp, expose skull, 0.2mm behind skull dorsal part bregma, center line is opened 2.9mm place skull surface to the right and is holed with dental drill, the microsyringe (the about 0.7mm of syringe needle diameter) that is fixed on the stereotactic apparatus is vertically inserted cerebral tissue, the degree of depth is 5mm (herein for caudatum position), with automatic propeller to the right caudatum push and contain 0.5 μ/μ l collagenase VII (TypeVII, every μ l contain 1 μ, U.S. sigma company produces) and the normal saline 1.2 μ l of 7 μ/μ l heparin (commercially available), sew up scalp after the withdraw of the needle,, cause brain essence hemorrhage by destroying the basement membrane of blood vessel in the tail shell nuclear.
1.4 grouping and administration
240 rats are divided into three batches at random experimentize, every batch of rat is divided into four groups at random, and 20 every group, male and female half and half.
(1) sham operated rats: inject right side tail shell nuclear with 1.2 μ l physiologic saline for substitute collagenases, postoperative gavaged distilled water 2ml in 6 hours, and day once, with self-designed rat clysmata, slowly inject distilled water with syringe simultaneously, do not make to spill by 2ml/200g/ time amount, kept 20 minutes, day once.
(2) model control group: cerebral hemorrhage mold is set up after 6 hours and is gavaged distilled water 2ml, and day, once rectum was injected distilled water 2ml/200g/ time, does not make to spill, and kept 20 minutes, and day once.
(3) irritate the stomach group: cerebral hemorrhage mold was set up back 6 hours, by the amount of 1.0g/kg the medicine of embodiment 1 was dissolved in the distilled water gavaging, and each 2ml day, once rectum injected distilled water 2ml/200g/ time, does not make to spill, and kept 20 minutes, and day once.
(4) the medicinal liquid rectally group of the medicine of embodiment 1: cerebral hemorrhage mold is set up and was gavaged distilled water 2ml in back 6 hours, day once, rectum injects medicinal liquid 2ml/200g/ time, day once, do not make to spill, kept 20 minutes, (note: adopt the enema method of design voluntarily to give the rat medication, guarantee that medicine keeps more than 20 minutes at intestinal, does not make medicine liquid leakage when injecting).
2 results
2.1 rat model carries out the nervous symptoms scoring
Treat after 3 days, 5 days, irritate stomach group, rectally group and the scoring zero difference P of model group function of nervous system＞0.05; Treat after 7 days, irritating stomach group, rectally group and the scoring of model group function of nervous system has significant difference P＜0.05; And be improved as excellent with the scoring of rectally group function of nervous system.Illustrate that the treatment of medicinal liquid rectally can significantly improve rat neurologic impairment symptom (seeing Table 2) after 7 days.
The variation of table 2 rat neurologic impairment integration (x ± s)
*Compare P＜0.05 with while segment model matched group
*Compare P＜0.01 with while segment model matched group
2.2. hematoma changes
Perusal model group rat, postoperative saw the swelling of operation side on the 3rd day, and hematoma is obvious, and the about 4-5mm of hemorrhage diameter illustrates the modeling success; Hematoma absorbed to some extent in the 5th day; The 7th day still visible little hematoma.Sham operated rats rat cerebral tissue no change.Rectally group, filling stomach group are compared with model group, and the day part hematoma all reduces to some extent.
2.3 influence to cerebral hemorrhage rats brain coefficient
The no significant change of each day of sham operated rats rat brain coefficient, model control group brain coefficient significantly raises (P＜0.01) than sham operated rats, especially with the 5th day significantly.The treatment of medicine liquid irrigation stomach and rectally all can make the brain coefficient significantly descend, and is excellent (seeing Table 3) with the rectally group.
Table 3 medicinal liquid is to the influence (% of cerebral hemorrhage rats brain coefficient; X ± s)
*Compare P＜0.05 with while segment model matched group
*Compare P＜0.01 with while segment model matched group
Zero with the period sham operated rats relatively P＜0.05 00 with period sham operated rats P＜0.01 relatively
2.4 influence to the cerebral hemorrhage rats brain water content
The no significant change of each day of sham operated rats rat cerebral tissue water content, the model control group brain water content promptly had rising on the 3rd day, reached the peak on the 5th day, and the 7th day still than sham operated rats significantly high (P＜0.01).Behind the medicinal liquid enema treatment, brain water content obviously descends (P＜0.01) than model control group, irritates stomach group good effect (seeing Table 4).
Table 4 medicinal liquid is to the influence (% of cerebral hemorrhage rats brain water content; X ± s)
*Compare P＜0.05 with while segment model matched group
*Compare P＜0.01 with while segment model matched group
Zero with the period sham operated rats relatively P＜0.05 00 with period sham operated rats P＜0.01 relatively
2.5 influence to cerebral hemorrhage rats cerebral tissue EB content
Each time point of the EB of sham operated rats rat cerebral tissue content does not have significant change, and model control group cerebral tissue EB contains flow control and reached the peak in 3 days, gradually descends, but still significantly increases (P＜0.01) than sham operated rats in the 5th, 7 day.The medicinal liquid enema treatment can significantly reduce cerebral tissue EB content, improves cerebrovascular permeability, and curative effect is irritated stomach and treated (seeing Table 5).
Table 5 medicinal liquid is to influence (the μ g/g of the hemorrhage side cerebral tissue of cerebral hemorrhage rats EB content; X ± s)
*Compare P＜0.05 with while segment model matched group
*Compare P＜0.01 with while segment model matched group
Zero with the period sham operated rats relatively P＜0.05 00 with period sham operated rats P＜0.01 relatively
The toxicologic study of test example 2 Chinese medicine compositions of the present invention
1. carry out acute toxicity test with mice
The LD of the medicine of embodiment 1
50Be 223.92 ± 20.89 gram/kilograms.This dosage is bigger 134 times than the dosage of giving human.Mice does not have 1 death as a result.
2. carry out long term toxicity test with the SD rat
The medicine of embodiment 1 is delivered medicine to SD rat three months with the oral dose of 83.5 gram/kg/day.This dosage is bigger 50 times than the dosage of giving human.Find that Chinese medicine composition of the present invention is safe.In rodentine acute and long term toxicity test, do not find that Chinese medicine composition of the present invention has tangible toxicity and side effect.
The clinical research of test example 3 Chinese medicine compositions of the present invention
1. case is selected
With reference to the Evaluation of Diagnostic Criteria of Hypertension of WHO formulation in 1987, " the cerebral hemorrhage diagnostic point " that second national cerebrovascular academic conference of Chinese Medical Association in 1986 worked out all made a definite diagnosis with image analysis CT or MR; Diagnostic criteria in " tcm internal medicine emergent treatment standard " " apoplexy emergency case diagnosis and treatment standard " that apoplexy diagnostic criteria reference 1994 Department of Medical Administration of State Administration of Traditional Chinese Medicine issue.The case that this research is included in all meets the Western medicine diagnose standard, and Chinese medical discrimination belongs to internal organs coma with heat excess nature card or coma with cold excess nature card in the apoplexy, and the age is below 80 years old; Course of disease t＜7d; The bleeding part is in basal ganglia region, and amount of bleeding V＜30ml belongs to II, III, IV level person according to Wang Zhongcheng chief editor " cerebrovascular and surgical intervention thereof " state of consciousness classification, without the severe complication of organs such as the heart, liver, kidney.
2. comparability detects before the treatment
Treat preceding two groups sex, age, the course of disease, amount of bleeding, GCS scoring, state of consciousness, cerebral hernia generation, centerline construction skew, the broken people's ventricles of the brain of hematoma, hemorrhage CT typing, modus operandi, Chinese medical discrimination typing and temperature pulse respiration, blood pressure, picture of the tongue, pulse condition, tcm symptom etc. relatively, there are no significant for difference (P＞0.05).Prompting is treated preceding two groups of baseline unanimities, is had comparability.
3. therapeutic scheme
The case grouping: be divided into two groups (i.e. treatment group and matched groups) by the simple randomization contrast method, every group is no less than 30 examples.
3.1 matched group
3.1.1 Primary Care
Patient admission is kept quite, strict bed rest; Keep respiratory passage unblocked, remove oral foreign body, inhale expectorant, low discharge oxygen supply, head cold compress; Take the circumstances into consideration dehydrations such as quiet mannitol, furosemide, dexamethasone and fall the cranium pressure; Controlling blood pressure; Nourishing brain cell is kept water, electrolyte balance; There is the infected in time to use antibiotic; Companion's digestive tract hemorrhage person gives H2 antagonist and hemorrhage etc.According to the dialectical use Chinese patent medicine of the state of an illness, Chinese medicine, used Chinese patent medicine, Chinese medicine can not contain and the identical or similar medicine of Chinese medicine composition effect of the present invention.
3.1.2 surgical operation therapy: select modus operandi according to conditions of patients.
3.1.3 western medicine: use 20% mannitol 125ml according to the state of an illness, intravenous drip every 6-12h 1 time, stops to subtract gradually; ATP60mg, coenzyme A 100 μ add quiet of 5% glucose 500ml (diabetics changes normal saline into), and 1 time/d, logotype 28d.
3.2 treatment group
3.2.1 Primary Care: same 3.1.1.
3.2.2 surgical operation therapy: select modus operandi according to conditions of patients.
3.2.3 in Primary Care, with 4 oral or nasal feedings of medicine of embodiment 1, or the medicinal liquid 200ml rectum of the medicine of embodiment 1 instils, greater than 4-6 time/day person, dosage reduces by half as times of defecation, adjusts consumption according to this, to guarantee internal organs gas unobstructed (defecate 1-3 every day) degree of being, logotype 7 days.
4. result
4.1 ordinary circumstance
All the patient obvious ANOMALOUS VARIATIONS do not occur at treatment bleeding from anus, urine, stool routine and the heart, liver, kidney function test, and untoward reaction appears in none example in the therapeutic process.
4.2 mind is changeed clear time ratio
The patient after treatment, treatment group safe consciousness time average out to 4.94 days, matched group safe consciousness time average out to 6.9 days learn to be handled by statistics, and significant difference (P＜0.05) is arranged between two groups.It is conscious to show that TF208 can impel, and two groups of recovery times have significant difference: P＜0.05 (seeing Table 6) through the t check.
Table 6 liang group patient safe consciousness time relatively
4.3 the 8th day the Glasgow-Pittsb μ rgh stupor scoring of before the treatment and treatment back relatively
Glasgow-Pittsb μ rgh stupor score value zero difference (P＞0.05) before two groups of treatments, the treatment back was pressed the scoring of Glasgow-Pittsb μ rgh stupor marking scales on the 8th day, then treat the component value and improve greater than irritating the stomach group, learning by statistics to handle has utmost point significant difference (P＜0.01).Illustrate that TF208 can obviously improve patient's stupor degree (seeing Table 7).
Reach the 8th day the Glasgow-Pittsb μ rgh stupor scoring of treatment back before the table 7 liang group patient treatment
*Relatively compare P＜0.01 before P＜0.01 00 and this group treatment with matched group
4.4 treat back 28 days clinical efficacies relatively for two groups
It is 54.84% that total produce effects is organized in treatment, and total effective rate is 80.65%, and the total produce effects of matched group is 43.33%, and total effective rate is 66.67%, and learning by statistics to handle has significant difference, treatment group curative effect to be better than matched group, and two groups of data are checked P＜0.05 through X2; Show that two groups of curative effects have significant difference (seeing Table 8).
Back 28 days clinical efficacies [example (%)] of table 8 liang group treatment
Test routine 1-3 presentation of results, Chinese medicine composition of the present invention can obviously improve rat neurosigns and the hot internal organs excess syndrome performance of expectorant such as feces is dry and hard, irritated, nasal discharge is many, gurgling with sputum behind the cerebral hemorrhage, clinical studies show, traditional Chinese medicine composition for treating patients suffering from acute stroke of the present invention can improve clinical efficacy, reduce case fatality rate, improve patient's quality of life; Clinical practice safety has no side effect.
Claims (8)
1. Chinese medicine composition for the treatment of suffering from acute stroke, it is characterized in that: this Chinese medicine composition is made up of following crude drug: Folium Sennae, Rhizoma Polygoni Cuspidati, artificial bezoar powder, Concretio Silicea Bambusae, Fructus Trichosanthis core.
2. the Chinese medicine composition of treatment suffering from acute stroke according to claim 1 is characterized in that: this Chinese medicine composition is made up of following bulk drugs: Folium Sennae 1-10 part, Rhizoma Polygoni Cuspidati 3-100 part, artificial bezoar powder 1-10 part, Concretio Silicea Bambusae 3-30 part, Fructus Trichosanthis core 3-100 part.
3. the Chinese medicine composition of treatment suffering from acute stroke according to claim 2 is characterized in that: this Chinese medicine composition is made up of following bulk drugs: Folium Sennae 2-8 part, Rhizoma Polygoni Cuspidati 5-50 part, artificial bezoar powder 1-3 part, Concretio Silicea Bambusae 5-15 part, Fructus Trichosanthis core 6-30 part.
4. the Chinese medicine composition of treatment suffering from acute stroke according to claim 3 is characterized in that: this Chinese medicine composition is made up of following bulk drugs: 3 parts of Folium Sennae, 10 parts of Rhizoma Polygoni Cuspidati, 1.5 parts of artificial bezoar powders, 6 parts of Concretio Silicea Bambusaes, 9 parts of Fructus Trichosanthis core.
5. the preparation method of the Chinese medicine composition of each described treatment suffering from acute stroke of claim 1-4 is characterized in that: may further comprise the steps:
(1) get Rhizoma Polygoni Cuspidati, Concretio Silicea Bambusae, Fructus Trichosanthis core and decoct with water 2-3 time, each 0.5-1.5 hour, filter, merges three times filtrate, room temperature is put cold, adds 95% ethanol and makes and contain the alcohol amount and reach 60%-75%, stirs evenly, and leaves standstill, and filtration is concentrated into thick extractum behind the filtrate recycling ethanol;
(2) get Folium Sennae and clean fast, the oven dry pulverizing is crossed the 80-120 mesh sieve, and it is standby to sterilize;
(3) Folium Sennae that artificial bezoar powder and step (2) are obtained adds in the thick extractum that step (1) obtains, and stirs evenly, and filtration sterilization promptly.
6. the preparation method of the Chinese medicine composition of treatment suffering from acute stroke according to claim 5 is characterized in that: decocting 3 times in the described step (1), is 1 hour for the first time, is 45 minutes for the second time, is 45 minutes for the third time.
7. the preparation method of the Chinese medicine composition of treatment suffering from acute stroke according to claim 5 is characterized in that: the weighting profit requires 5 Chinese medicine compositions that make, and adds conventional adjuvant, makes tablet, powder, capsule or granule.
8. the preparation method of the Chinese medicine composition of treatment suffering from acute stroke according to claim 7 is characterized in that: the weighting profit requires 5 Chinese medicine compositions that make, and adds conventional adjuvant, makes capsule.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104491743A (en) * | 2015-01-04 | 2015-04-08 | 霍山县中医院 | Traditional Chinese medicine for treating cerebral hemorrhage |
| CN105727129A (en) * | 2014-12-09 | 2016-07-06 | 山东阿如拉药物研究开发有限公司 | Tibetan medicine composition for treating stroke caused by stagnation of phlegm and blood |
| CN109938870A (en) * | 2019-03-20 | 2019-06-28 | 复旦大学附属华山医院 | A kind of rat intracerebral hemorrhage patients merge method for building up and its application of pyemia composite model |
| CN111329942A (en) * | 2020-05-15 | 2020-06-26 | 肖宗平 | Liver-protecting traditional Chinese medicine composition and pharmaceutical composition thereof |
| CN111821365A (en) * | 2019-04-22 | 2020-10-27 | 英成楼 | Composition for treating apoplexy sequela and preparation method thereof |
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| CN100522227C (en) * | 2004-07-05 | 2009-08-05 | 北京华夏医胜创新科技有限责任公司 | Medicine composition for treating acute ischemic apoplexia ,and preparation method therefor |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100522227C (en) * | 2004-07-05 | 2009-08-05 | 北京华夏医胜创新科技有限责任公司 | Medicine composition for treating acute ischemic apoplexia ,and preparation method therefor |
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| 《新中医》 20090831 朱磊等 刘茂才教授分期治疗中风经验介绍 第9-10页 1-8 第41卷, 第8期 * |
| 《新中医》 20090831 朱磊等 刘茂才教授分期治疗中风经验介绍 第9-10页 1-8 第41卷, 第8期 2 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105727129A (en) * | 2014-12-09 | 2016-07-06 | 山东阿如拉药物研究开发有限公司 | Tibetan medicine composition for treating stroke caused by stagnation of phlegm and blood |
| CN105727129B (en) * | 2014-12-09 | 2019-06-04 | 金诃藏药（山东）健康产业有限公司 | A kind of Tibetan medicinal composition for treating apoplexy caused by phlegm stagnation in collateral |
| CN104491743A (en) * | 2015-01-04 | 2015-04-08 | 霍山县中医院 | Traditional Chinese medicine for treating cerebral hemorrhage |
| CN109938870A (en) * | 2019-03-20 | 2019-06-28 | 复旦大学附属华山医院 | A kind of rat intracerebral hemorrhage patients merge method for building up and its application of pyemia composite model |
| CN111821365A (en) * | 2019-04-22 | 2020-10-27 | 英成楼 | Composition for treating apoplexy sequela and preparation method thereof |
| CN111329942A (en) * | 2020-05-15 | 2020-06-26 | 肖宗平 | Liver-protecting traditional Chinese medicine composition and pharmaceutical composition thereof |
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