CN105687261A

CN105687261A - Compound preparation for treating cerebral infarction and preparation method of compound preparation

Info

Publication number: CN105687261A
Application number: CN201410703345.3A
Authority: CN
Inventors: 张昕
Original assignee: Heilongjiang Zhicheng Medicine Technology Co Ltd
Current assignee: Heilongjiang Zhicheng Medicine Technology Co Ltd
Priority date: 2014-11-26
Filing date: 2014-11-26
Publication date: 2016-06-22

Abstract

The invention discloses a compound preparation for treating cerebral infarction and a preparation method of the compound preparation. The compound preparation consists of the following raw materials: major ingredients: clopidogrel hydrogen sulfate, vitamin E niacinate and a ginkgo biloba extract, and adjuvant materials: a filling agent, a disintegrating agent, a binding agent and a lubricating agent, wherein adjuvant materials include the following components in percentage: the filling agent, the disintegrating agent, the binding agent, the lubricating agent and a flow aid. The prepared compound preparation disclosed by the invention is convenient to take and is capable of improving the compliance of patient; and in addition, the preparation method is simple and easy to implement and is applicable to industrial production.

Description

A kind of for compound preparation treating cerebral infarction and preparation method thereof

Technical field

The invention belongs to pharmaceutical field, be specifically related to a kind of for compound preparation treating cerebral infarction and preparation method thereof。

Background technology

Cerebral infarction (cerebral infarction, cerebral infarction) refers to ischemic necrosis or the cerebral malacia of the limitation cerebral tissue owing to brain blood supplies obstacle, ischemia, anoxia cause, the clinical common type of cerebral infarction has cerebral thrombosis, lacunar infarct and cerebral embolism etc., and cerebral infarction accounts for the 80% of whole apoplexy。Several diseases that property associated therewith is bigger are: diabetes, obesity, hypertension, rheumatic heart disease, arrhythmia, the dehydration of a variety of causes, various arteritis, shock, blood pressure drops are too fast excessive etc.。

The invention belongs to the compound preparation of Chinese medicine and western medicine, wherein bisulfate clopidogrel is a kind of anticoagulant, clopidogrel selectivity also suppresses the activation of the Glycoprotein G Plllb/llla complex of the combination of adenosine diphosphate (ADP) (ADP) and its platelet receptor and the ADP mediation of secondary, it is adaptable to myocardial infarction, Ischemic Stroke or make a definite diagnosis the patient of Peripheral arteral disease and the patient of acute coronary syndrome。Folium Ginkgo extract and vitamin E Nicotinate play nourishing brain cell, improve the effect of brain cell metabolism, definite effect, good。Make compound preparation and be applicable to the patient of cerebral infarction。

At present, the existing product on market is made compound preparation and is applicable to lighter cerebral infarction, i.e. Cerebral Infarction Patients, because there is no effective Therapeutic Method at present。Clinically frequently with the mode of Chinese and western drugs administering drug combinations, the medication amount taken is many, patient's therapeutic scheme determined against medical advice, often has the phenomenon missing or taking wrong dosage, causes curative effect bad。

Summary of the invention

It is an object of the invention to provide a kind of taking convenience, improve the compliance of patient, and simple a kind of for compound preparation treating cerebral infarction and preparation method thereof of preparation method。

In order to realize the purpose of the present invention, the present invention is achieved by the following technical solutions: a kind of compound preparation for treating cerebral infarction, it is characterised in that: it is made up of following raw materials according: bisulfate clopidogrel 11%～15%；Vitamin E Nicotinate 24%～28%；Folium Ginkgo extract 10%～12% forms；Filler 10～50%, disintegrating agent 5～40%, binding agent 0.1～20%, lubricant 0.01～5%。

Described filler is one or more the mixing therein of microcrystalline Cellulose, starch, pregelatinized Starch, lactose, dextrin。

Described disintegrating agent is one or more the mixing therein of low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose。

Described binding agent is 5～10% starch slurries, 3～10% polyvidone k30 alcoholic solution, 0.5～5% hypromellose alcoholic solution。

Described lubricant is one or more the mixing therein of magnesium stearate, silicon dioxide, Pulvis Talci, sodium lauryl sulphate。

Concretely comprising the following steps of its preparation method:

1, sorting: by weight percentage, choose bisulfate clopidogrel, vitamin E Nicotinate, Folium Ginkgo extract, filler, disintegrating agent, binding agent, lubricant, crosses supplementary material 80 mesh sieves respectively, sub-elects passing material, standby；

2, mixing granulation: the bisulfate clopidogrel sieved, vitamin E Nicotinate, Folium Ginkgo extract are mixed homogeneously with filler, disintegrating agent; mixed supplementary material is entered in wet granulator; binding agent is put in feed tank; open machine, adjust parameter, open and shear fly cutter; 2-5 minute; discharging, uses oscillating granulator, granulates with 14-18 order nylon screen；

3, dry: to be placed in fluidized-bed coating machine by above-mentioned granule of making, inlet temperature less than 50 DEG C dries, and is dried to moisture below 4%, crosses 16-20 mesh sieve, prepares granulate；

4, always mix: above-mentioned prepared granulate will add lubricant, fluidizer, be placed in three-dimensional motion mixer and mix 30 minutes；

5、Finished product: use rotary tablet machine tabletting, tabletting speed controlling 15-20r/min, prepare finished product；Or directly subtract granulate and load the prepared finished product of capsule。

Beneficial effects of the present invention: the compound preparation for treating cerebral infarction of the present invention, bisulfate clopidogrel is a kind of anticoagulant, the property of can select that also suppresses the activation of the Glycoprotein G Plllb/llla complex of the combination of adenosine diphosphate (ADP) (ADP) and its platelet receptor and the ADP mediation of secondary, it is adaptable to myocardial infarction, Ischemic Stroke or make a definite diagnosis the patient of Peripheral arteral disease and the patient of acute coronary syndrome。Folium Ginkgo extract and vitamin E Nicotinate play nourishing brain cell, improve the effect of brain cell metabolism, definite effect, good。The present invention is prepared into compound preparation, taking convenience, improves the compliance of patient, and preparation method is simple, it is adaptable to commercial production。

Patient to 82 example patient diagnosis lacunar infarction standards, is randomly divided into treatment group 43 example, matched group 39 example。Matched group adopts XUESAITONG PIAN treatment, treatment group adds on matched group basis treats with the compound preparation of the present invention, 2 groups equal 4 weeks is 1 course for the treatment of. during treatment, all patients all give to observe vital sign, if desired oxygen uptake, drop cranium pressure, use brain cell nutrient, smoking cessation is given up alcohol, less salt low fat, does not eat pungent stimulation food, carry out the treatments such as blood pressure lowering, blood fat reducing, blood sugar lowering for complication, under physician guidance, carry out adequate rehabilitation exercise。

Group	Number of cases	Cure	Effective	Effectively	Invalid	Cure rate	Total effective rate
								Treatment group	43	30	7	2	4	69.77	86.05
Matched group	39	15	4	7	13	38.46	48.72

Result: matched group total effective rate is 48.72%, treatment group total effective rate is 86.05%。Two groups of total effective rates compare, and have significant difference, and treatment group is better than matched group。

Conclusion: the compound preparation treatment lacunar of the present invention is plugged with satisfied clinical efficacy。

The process characteristic of the present invention: 1, selecting raw material science, production technology is advanced, and its product is conveniently deposited and uses；2, product Chinese medicine composition is easily absorbed by the body；3, raw material sources are extensive, add process line short, the easy processing and manufacturing of product。

Detailed description of the invention:

Embodiment 1

A kind of compound preparation for treating cerebral infarction, it is characterised in that: it is made up of following raw materials according: bisulfate clopidogrel 11%～15%；Vitamin E Nicotinate 24%～28%；Folium Ginkgo extract 10%～12% forms；Filler 10～50%, disintegrating agent 5～40%, binding agent 0.1～20%, lubricant 0.01～5%。

Concretely comprising the following steps of its preparation method:

Claims

1. the compound preparation being used for treating cerebral infarction, it is characterised in that: it is made up of following raw materials according: bisulfate clopidogrel 11%～15%；Vitamin E Nicotinate 24%～28%；Folium Ginkgo extract 10%～12% forms；Filler 10～50%, disintegrating agent 5～40%, binding agent 0.1～20%, lubricant 0.01～5%。

2. a kind of compound preparation for treating cerebral infarction according to claim 1, it is characterised in that: described filler is one or more the mixing therein of microcrystalline Cellulose, starch, pregelatinized Starch, lactose, dextrin。

3. a kind of compound preparation for treating cerebral infarction according to claim 1, it is characterised in that: described disintegrating agent is one or more the mixing therein of low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose。

4. a kind of compound preparation for treating cerebral infarction according to claim 1, it is characterised in that: described binding agent is 5～10% starch slurries, 3～10% polyvidone k30 alcoholic solution, 0.5～5% hypromellose alcoholic solution。

5. a kind of compound preparation for treating cerebral infarction according to claim 1, it is characterised in that: described lubricant is one or more the mixing therein of magnesium stearate, silicon dioxide, Pulvis Talci, sodium lauryl sulphate。

6. the preparation method of a kind of compound preparation for treating cerebral infarction according to claim 1, it is characterised in that: concretely comprising the following steps of its preparation method:

Sorting: by weight percentage, choose bisulfate clopidogrel, vitamin E Nicotinate, Folium Ginkgo extract, filler, disintegrating agent, binding agent, lubricant, crosses supplementary material 80 mesh sieves respectively, sub-elects passing material, standby；

Mixing granulation: the bisulfate clopidogrel sieved, vitamin E Nicotinate, Folium Ginkgo extract are mixed homogeneously with filler, disintegrating agent; mixed supplementary material is entered in wet granulator; binding agent is put in feed tank; open machine, adjust parameter, open and shear fly cutter; 2-5 minute; discharging, uses oscillating granulator, granulates with 14-18 order nylon screen；

Dry: to be placed in fluidized-bed coating machine by above-mentioned granule of making, inlet temperature less than 50 DEG C dries, and is dried to moisture below 4%, crosses 16-20 mesh sieve, prepares granulate；

Total mixed: above-mentioned prepared granulate will to add lubricant, fluidizer, be placed in three-dimensional motion mixer and mix 30 minutes；

Finished product: use rotary tablet machine tabletting, tabletting speed controlling 15-20r/min, prepare finished product；Or directly subtract granulate and load the prepared finished product of capsule。