CN1323690C

CN1323690C - Prescription of Huanyuan Injection and its preparation process and usage

Info

Publication number: CN1323690C
Application number: CNB2003101090134A
Authority: CN
Inventors: 王左; 玄振玉; 刘继勇
Original assignee: SHANGHAI YOUSEEN NEW DRUG DEVELOPMENT Co Ltd
Current assignee: Shanghai Youseen New Drug Development Co., Ltd.
Priority date: 2003-12-02
Filing date: 2003-12-02
Publication date: 2007-07-04
Anticipated expiration: 2023-12-02
Also published as: CN1546089A

Abstract

The present invention belongs to the technical field of medicine, and more especially, a prescription, a preparation technology and applications of a reduction injection which is a traditional Chinese medicine injection preparation and is used for curing acute hemorrhagic stroke. The reduction injection comprises Chinese medicinal herbs, such as astragalus root, etc., and adjuvant materials, and the prescription is composed of astragalus root, rehmannia root, achyranthes bidentata, F68, medicinal charcoal, 95% of alcohol, injection water, etc. The present invention provides a rational effective prescription and a preparation method which lower the expensive expense and the large risk of operative therapy in the cure of hemorrhagic stroke and overcome large side effects brought by general pharmacotherapy. The reduction injection is easy to accept by patients, can be used for curing hemorrhagic stroke diseases on clinic, and obtains a satisfactory curative effect.

Description

Injection of treatment acute hemorrhagic apoplexy and preparation method thereof

[technical field]

The invention belongs to medical technical field, specifically a kind of Chinese medicine for the treatment of the acute hemorrhagic apoplexy.

[background technology]

Hemorrhagic apoplexy is a kind of emergency case of nervous system disease, belongs to a class commonly encountered diseases, frequently-occurring disease, and is occurred frequently in 50～60 years old crowd.In China, the sickness rate of hemorrhagic apoplexy has the trend that rises year by year.According to statistics, the existing number of patients in the whole nation is about 6,000,000, and annual kainogenesis hemorrhagic apoplexy patient has 130～1,500,000, and wherein 70% has DB heavy disabled person in various degree to account for more than 40%.About 1,000,000 people of person that die from the hemorrhagic apoplexy every year.The hemorrhagic apoplexy onset is hurried, and disease progression is fast, is seriously threatening human beings'health and life.To the treatment of hemorrhagic cerebral apoplexy, the operative therapy expense is expensive and have a big risk; The conventional medicine therapy mainly is some first aid class medicines, as mannitol (be mainly used in and fall intracranial pressure), anticoagulant (reduction platelet aggregation rate) etc., but in the treatment disease, these medicines have also brought very big side effect, be prone to dehydration as mannitol, electrolyte disturbance etc.

[summary of the invention]

The purpose of this invention is to provide a kind of Chinese medicine for the treatment of the acute hemorrhagic apoplexy and preparation method thereof.

A kind of Chinese medicine injection for the treatment of the acute hemorrhagic apoplexy is formed by feedstock production such as the Radix Astragali, the Radix Rehmanniae, Radix Achyranthis Bidentatae, F68, medicinal charcoal, 95% ethanol, injection waters; Implement prescription by 4.5 kilograms of the Radixs Astragali, 3.5 kilograms in the Radix Rehmanniae, 2 kilograms of Radix Achyranthis Bidentataes, 5 liters of herbal extracts, 0.2%, 5% sodium hydroxide solution that F68 accounts for said ratio content can add in right amount, and medicinal charcoal is that pin accounts for 0.2% of said ratio content with 767 and is prepared from.Preparation technology may further comprise the steps: extract (1): the Radix Astragali, the Radix Rehmanniae, Radix Achyranthis Bidentatae pharmaceutical decocting piece, extracting in water, for the first time add 12 times of amounts of water, extracted 1 hour, add 8 times of amounts of water for the second time, extracted 1 hour, add 4 times of amounts of water for the third time, extracted 1 hour, filter respectively with 16 layers of gauze, merging filtrate is concentrated into every milliliter and is equivalent to crude drug 1g; (2) alcohol is handled: add ethanol again and make content reach 75%, left standstill cold preservation 24 hours, and sucking filtration, filtrate recycling ethanol concentrates, and adds ethanol again and makes and contain the alcohol amount and reach 85%, leaves standstill cold preservation 24 hours, sucking filtration, filtrate recycling ethanol, and be concentrated into every milliliter and be equivalent to crude drug 1g; (3) water treatment: get its concentrated solution and add 10 times of amount distilled water, stir evenly, left standstill cold preservation 4 hours, 0.8 μ m microporous filter membrane sucking filtration, filtrate cold preservation, the intermediate concentrated solution of using as preparation; (4) preparation: A is measured the intermediate concentrated solution by formula proportion, adds an amount of injection and blunges; B takes by weighing F68 by formula proportion, and an amount of water for injection dissolving adds among the A and stirs; The C5% sodium hydroxide solution is an amount of, regulates the medicinal liquid pH value between 7.5～8.5; D adds water for injection more than 80 ℃ to configuration amount in C; E takes by weighing medicinal charcoal (pin is with 767) by formula proportion, adds D; (5) filtrate: configuration liquid keeps the temperature water-bath more than 80 ℃, under certain mixing speed, and 30～60 minutes; After the medicinal charcoal decolouring, sucking filtration coarse filtration while hot; Use respectively on 0.8,0.45, the 0.22 μ m microporous filter membrane and do not have medicinal charcoal; (6) feed liquid fill, loading amount are the 10ml/ bottle; (7) sealing by fusing; (8) pressure sterilizing: 115 ℃, 30 minutes; (9) injection that gets product.

Compared with prior art, the invention provides a kind of rational and effective prescription and manufacture method, in the treatment hemorrhagic apoplexy, it is expensive and have a big risk to have reduced the expense of operative therapy, has overcome the very big side effect that the conventional medicine therapy is brought.Make the patient be easy to accept, and in clinical, be used for the treatment of the hemorrhagic apoplexy disease, obtain gratifying curative effect.

[description of drawings]

Accompanying drawing 1 is a process chart of the present invention.

Referring to accompanying drawing, 1 for extracting; 2 is that alcohol is handled; 3 are water treatment; 4 for making up a prescription; 5 for filtering; 6 are fill; 7 is sealing by fusing; 8 are sterilization; 9 be finished product.

The production technology of this technology is clearly to this professional people.

[specific embodiment]

The invention will be further described below in conjunction with accompanying drawing.

Prescription and proportioning:

Radix Astragali 4.5kg, Radix Rehmanniae 3.5kg, Radix Achyranthis Bidentatae 2kg pharmaceutical decocting piece

Herbal extract 5L

F68 0.2％

5% sodium hydroxide solution is an amount of

Medicinal charcoal (pin is with 767) 0.2%

Water for injection adds to 10L

Be mixed with 1000

Its preparation method is:

At first get the formula ratio Radix Astragali, the Radix Rehmanniae, Radix Achyranthis Bidentatae pharmaceutical decocting piece, extracting in water.For the first time add 12 times of amounts of water, extracted 1 hour, add 8 times of amounts of water for the second time, extracted 1 hour, add 4 times of amounts of water for the third time, extracted 1 hour, filter respectively with 16 layers of gauze, merging filtrate is concentrated into 5L.Carry out two kinds of purification process then: (1) alcohol is handled.In concentrated solution, add ethanol and make content reach 75%, left standstill cold preservation 24 hours, sucking filtration, filtrate recycling ethanol concentrates, and adds ethanol again and makes and contain the alcohol amount and reach 85%, leaves standstill cold preservation 24 hours, sucking filtration, filtrate recycling ethanol, and be concentrated into 5L.(2) water treatment.Get above-mentioned concentrated solution and add 10 times of amount distilled water, stir evenly, left standstill cold preservation 24 hours, 0.8 μ m membrane filtration, put cold, once more with 0.8 μ m filter membrane sucking filtration, filtrate cold preservation, the concentrated solution of using as preparation.Then prepare injection: (1) prepares the washing and the drying of ampoule: washing, and ultrasound wave is more than 25 seconds; Drying, 180 ℃, 2 hours; (2) measure the intermediate concentrated solution by formula proportion, add an amount of water for injection and stir; (3) take by weighing F68 by formula proportion, an amount of water for injection dissolving adds in (2) and stirs; (4) 5% sodium hydroxide solutions are an amount of, regulate the medicinal liquid pH value between 7.5～8.5; (5) in (4), add water for injection more than 80 ℃ to amount of preparation; (6) take by weighing medicinal charcoal (pin is with 767) by formula proportion, add (5); (7) preparation liquid keeps the temperature (water-bath) more than 80 ℃, under certain mixing speed, and 30～60 minutes; (8) after the medicinal charcoal decolouring, sucking filtration (coarse filtration) while hot; (9) use 0.8,0.45,0.22 μ m microporous filter membrane vacuum filtration to 0.22 μ m microporous filter membrane, not have medicinal charcoal 2～3 times respectively; (10) feed liquid fill, loading amount 10ml/ props up.(11) after the fill, sealing by fusing; (12) pressure sterilizing is 115 ℃, and 30 minutes, the injection that gets product made 1000 altogether.

Claims

1, a kind of Chinese medicine injection for the treatment of the acute hemorrhagic apoplexy, it is characterized in that, this Chinese medicine injection is made by following raw material of Chinese medicine and adjuvant: 4.5 kilograms of the Radixs Astragali, 3.5 kilograms in the Radix Rehmanniae, 2 kilograms of Radix Achyranthis Bidentataes, F68, medicinal charcoal pin are with 767,95% ethanol, water for injection.

2, the preparation method of the Chinese medicine injection of the described treatment acute hemorrhagic of claim 1 apoplexy is characterized in that, may further comprise the steps:

(1) extract: the Radix Astragali, the Radix Rehmanniae, Radix Achyranthis Bidentatae pharmaceutical decocting piece, extracting in water adds 12 times of amounts of water for the first time, extracts 1 hour, for the second time add 8 times of amounts of water, extracted 1 hour, add 4 times of amounts of water for the third time, extracted 1 hour, filter respectively with 16 layers of gauze, merging filtrate is concentrated into every milliliter and is equivalent to crude drug 1 gram;

(2) alcohol is handled: add ethanol again and make content reach 75%, left standstill cold preservation 24 hours, and sucking filtration, filtrate recycling ethanol concentrates, and adds ethanol again and makes and contain the alcohol amount and reach 85%, leaves standstill cold preservation 24 hours, sucking filtration, filtrate recycling ethanol, and be concentrated into every milliliter and be equivalent to crude drug 1g;

(3) water treatment: get its concentrated solution and add 10 times of amount distilled water, stir evenly, left standstill cold preservation 4 hours, 0.8 μ m microporous filter membrane sucking filtration, filtrate cold preservation, the intermediate concentrated solution of using as preparation;

(4) preparation: A is measured the intermediate concentrated solution by formula proportion, adds an amount of injection and blunges; B takes by weighing F68 by formula proportion, and an amount of water for injection dissolving adds among the A and stirs; The C5% sodium hydroxide solution is an amount of, regulates the medicinal liquid pH value between 7.5～8.5; D adds water for injection more than 80 ℃ to configuration amount in C; E takes by weighing medicinal charcoal by formula proportion, adds D;

(5) filtrate: configuration liquid keeps the temperature water-bath more than 80 ℃, under certain mixing speed, and 30～60 minutes; After the medicinal charcoal decolouring, sucking filtration coarse filtration while hot; Use respectively on 0.8,0.45, the 0.22 μ m microporous filter membrane and do not have medicinal charcoal;

(6) feed liquid fill, loading amount are the 10ml/ bottle;

(7) sealing by fusing;

(8) pressure sterilizing: 115 ℃, 30 minutes;

(9) injection that gets product.