CN101543580A - Traditional Chinese medicine micro pills for treating sciatica and preparation method thereof - Google Patents

Abstract

The invention relates to traditional Chinese medicine micro pills for treating sciatica and a preparation method thereof. The micro pills comprise dry extract powder and microcrystalline cellulose of the aqueous extract of effective ingredients based on the weight ratio. The invention also provides a preparation method of the traditional Chinese medicine micro pills. The invention renews the medicament form, thereby improving the conditions of high cost and high safety risk existing in the prior process, satisfying the requirements of enterprises for convenience and safety, and providing new medicament formulations which are more convenient and cheaper for patients.

Description

A kind of Chinese medicine pellet formulation preparation method for the treatment of sciatica

Technical field

The invention belongs to the preparation technique field of Chinese patent medicine, relate in particular to a kind of Chinese medicine pellet preparation for the treatment of sciatica and preparation method thereof.

Background technology

Sciatica is a kind of commonly encountered diseases, frequently-occurring disease.The sciatica pathogenic factor belongs to the arthromyodynia category due to motherland's medical science more except that wound.Doctor trained in Western medicine expectant treatment curative effect is limited, and the treatment that undergos surgery has a big risk, and sufferer is painful big, and the doctor trained in Western medicine operative therapy only removes compressing, the factor of blocking-up damage, and can not prevent secondary injury and repair damaged portion.Thereby, the domestic Chinese medicines that adopt more.

With Fructus Chaenomelis, Rhizoma Polygonati Odorati, Cortex Acanthopancis, Rhizoma Et Radix Notopterygii, Radix Angelicae Pubescentis, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Homalomenae, Radix Cyathulae, Herba Taxilli.The Chinese medicine of making have invigorate blood circulation, collateral dredging, analgesic effect, can be used for sciatic nerve pain, limitation of activity and numb limbs and tense tendons etc.Concrete weight portion prescription is as follows:

Fructus Chaenomelis 70-85, Rhizoma Polygonati Odorati 75-85, Cortex Acanthopancis 45-60, Rhizoma Et Radix Notopterygii 40-60, Radix Angelicae Pubescentis 45-60, Radix Angelicae Sinensis 45-60, Pericarpium Citri Reticulatae 90-120, Rhizoma Chuanxiong 45-60, Flos Carthami 45-60, Rhizoma Homalomenae 20-30, Radix Cyathulae 45-60, Herba Taxilli 20-30.

Prepare and have the existing granule sale of preparation of identical curative effect on the market with above-mentioned Chinese medicine effective ingredient prescription.Because the semi-finished product viscosity higher difficult shaping of the Chinese medicine in this prescription after extracting, concentrating, therefore when manufacturing granule, need the adjuvant amount of adding bigger, supplementary product consumption is about 2 times of extract weight, medication dose is big, and one time oral dose can reach 6 grams.Simultaneously, need in the particle manufacture to use ethanol as wetting agent, ethanol is inflammable and can cause environmental pollution, and has increased the danger of producing, and by pharmaceutical production GMP management expectancy, must just can produce in meeting the workshop of explosion-proof condition.

Summary of the invention

The purpose of this invention is to provide that a kind of production cost is low, technology is simple, the treatment neck of being convenient to take, the pellet preparations and the preparation method of lumbar spondylosis Chinese medicine.

The technical solution used in the present invention is as follows:

A kind of Chinese medicine pellet preparation for the treatment of sciatica is made up of the effective ingredient of following weight portion: Fructus Chaenomelis 70-85, Rhizoma Polygonati Odorati 75-85, Cortex Acanthopancis 45-60, Rhizoma Et Radix Notopterygii 40-60, Radix Angelicae Pubescentis 45-60, Radix Angelicae Sinensis 45-60, Pericarpium Citri Reticulatae 90-120, Rhizoma Chuanxiong 45-60, Flos Carthami 45-60, Rhizoma Homalomenae 20-30, Radix Cyathulae 45-60, Herba Taxilli 20-30.This pellet preparations by the dried cream powder of described effective ingredient water extract and microcrystalline Cellulose by weight the micropill of the particle diameter of forming less than 2.1mm,, and effective ingredient dried cream powder: microcrystalline Cellulose is 1:1.0～1.5.

The preparation method of the pellet preparations of the Chinese medicine of this treatment sciatica comprises the steps:

(1) get it filled by the parts by weight of effective ingredient, decoct with water, decocting liquid filters, and concentrated and drying under reduced pressure obtains the dried cream powder of effective ingredient water extract;

(2) dried cream powder and the microcrystalline Cellulose that step (1) is obtained sieves respectively, mix by weight effective ingredient dried cream powder, microcrystalline Cellulose, and by weight effective ingredient dried cream powder, distilled water, add distilled water and make the mixing soft material, extrude at last, round as a ball, dry, obtain the pellet preparations of particle diameter less than 2.1mm.

The concrete preparation method step of the Chinese medicine pellet preparation of this treatment sciatica is as follows:

(1) get it filled by the parts by weight of effective ingredient, the decocting that adds 10～12 times of weight boils three times, and 1.5 hours for the first time, 1 hour for the second time, 1 hour for the third time, decocting liquid filtered and merges, and concentrating under reduced pressure, drying under reduced pressure make the dried cream powder of effective ingredient water extract;

(2) dried cream powder that step (1) is obtained and microcrystalline Cellulose are crossed 100 mesh sieves, effective ingredient dried cream powder by weight respectively: microcrystalline Cellulose is that mix 1:1.0～1.5, and makes the mixing soft material by weight effective ingredient dried cream powder adding distilled water;

(3) with extrude round as a ball comminutor with the mixing soft material that step (2) obtains extrude, round as a ball, obtain the micropill of particle diameter less than 2.1mm, micropill places 80 ℃ of dryings of baking oven, crosses sieve classification, the pellet preparations of the neck that obtains medical treatment, lumbar spondylosis Chinese medicine at last.

Mostly be compound medicines in the present Chinese medicine patent medicine, flavour of a drug are many, dose is big, and serve as main to be not easy to take with big honeyed pills, granule, though there is the sub-fraction Chinese patent medicine to find the method for effective site by separation and Extraction through research, change into new dosage form, but the clinical efficacy of most of Chinese patent medicines malleable dosage form not; In theory Chinese medicine is made the components unchanged that the micropill dosage form can guarantee former Chinese patent medicine, can reduce the dose of medicine again by the adjuvant that reduces medicament, and greatly facilitate taking of patient, can become a kind of very popular new formulation in the Chinese medicine preparation.But, also have only the Chinese medicine of seldom counting to carry out the transformation of this kind dosage form in recent years because production technology and production equipment are had relatively high expectations.Microcrystalline Cellulose is to remove wherein amorphous fiber by wood fibre or cotton fiber after the strong acid hydrolysis, the remaining lower needle-like crystallite of the degree of polymerization, its compressibility is good, have effects such as bonding, fluidizer, disintegrate concurrently, be applicable to direct compression technology especially, the tablet hardness traitor who neutralizes, easy disintegrating again, microcrystalline Cellulose is retrospective distortion in pressure process, capillarity is in addition destroyed adhesion between the particle, impelled the preparation disintegrate in very easily diversion is gone into.

The specific embodiment

The present invention also provides a kind of and has extracted preferably, the method for preparations shaping, and this method is to get Fructus Chaenomelis 70-85, Rhizoma Polygonati Odorati 75-85, Cortex Acanthopancis 45-60, Rhizoma Et Radix Notopterygii 40-60, Radix Angelicae Pubescentis 45-60, Radix Angelicae Sinensis 45-60, Pericarpium Citri Reticulatae 90-120, Rhizoma Chuanxiong 45-60, Flos Carthami 45-60, Rhizoma Homalomenae 20-30, Radix Cyathulae 45-60, Herba Taxilli 20-30.The decocting that adds 10～12 times of weight boils secondary, obtains micropill.The pellet preparations that makes is carried out stability test: after the micropill that makes is packed with two aluminum composite membranes, put constant temperature and humidity mutually in, at 37 ℃, placed one month under relative humidity 75% condition, observe micropill outward appearance and character and do not have obvious change, do not find moisture absorption phenomenon yet, can think that this pellet preparations has very high stability.

Beneficial effect of the present invention is, the screening of the research of inventor by production technology, supplementary product kind and The experiment of quantity of solvent ratio makes this traditional Chinese medicine pellet auxiliary material input amount reduce half, thereby has reduced medicine of the present invention The cost of thing pellet preparations, reduced the pharmaceutical production workload, formed that the patient medications taking dose reduces by half and The advantages such as taking convenience. By the renewal of formulation, the expensive and security risks of the existing production technology of improvement, Satisfy facilitation, the safe of enterprise's production technology, provide more convenient, the valency taken for the patient again The new pharmaceutical formulation that lattice are more cheap.

Claims (4)

1, a kind of Chinese medicine pellet preparation of sciatica, it is characterized in that, form: Fructus Chaenomelis 70-85, Rhizoma Polygonati Odorati 75-85, Cortex Acanthopancis 45-60, Rhizoma Et Radix Notopterygii 40-60, Radix Angelicae Pubescentis 45-60, Radix Angelicae Sinensis 45-60, Pericarpium Citri Reticulatae 90-120, Rhizoma Chuanxiong 45-60, Flos Carthami 45-60, Rhizoma Homalomenae 20-30, Radix Cyathulae 45-60, Herba Taxilli 20-30 by the effective ingredient of following weight portion.

2, the pellet preparations of treatment neck according to claim 1, lumbar spondylosis Chinese medicine, it is characterized in that, the particle diameter that described pellet preparations is made up of by following weight ratio the dried cream powder of described effective ingredient water extract and microcrystalline Cellulose is less than the micropill of 2.5mm, and the effective ingredient dried cream powder: microcrystalline Cellulose is 1: 1.0～1.5.

3, the preparation method of the Chinese medicine pellet preparation of claim 1 or 2 described treatment sciatica is characterized in that, comprises the steps:

(1) get it filled by the parts by weight of effective ingredient, decoct with water, decocting liquid filters, and concentrated and drying under reduced pressure obtains the dried cream powder of effective ingredient water extract;

(2) dried cream powder and the microcrystalline Cellulose that step (1) is obtained sieves respectively, mix by weight effective ingredient dried cream powder, microcrystalline Cellulose, and by weight effective ingredient dried cream powder, distilled water, add distilled water and make the mixing soft material, extrude at last, round as a ball, dry, obtain the pellet preparations of particle diameter less than 2.1mm.

4, the Chinese medicine pellet formulation preparation method of treatment sciatica according to claim 1 and 2 is characterized in that preparation process is as follows:

(1) get it filled by the parts by weight of effective ingredient, the decocting that adds 10～12 times of weight boils three times, and 1.5 hours for the first time, 1 hour for the second time, 1 hour for the third time, decocting liquid filtered and merges, and concentrating under reduced pressure, drying under reduced pressure make the dried cream powder of effective ingredient water extract;

(2) dried cream powder that step (1) is obtained and microcrystalline Cellulose are crossed 100 mesh sieves, effective ingredient dried cream powder by weight respectively: microcrystalline Cellulose is that mix 1:1.0～1.5, and makes the mixing soft material by weight effective ingredient dried cream powder adding distilled water;

(3) with extrude round as a ball comminutor with the mixing soft material that step (2) obtains extrude, round as a ball, obtain the micropill of particle diameter less than 2.1mm, micropill places 80 ℃ of dryings of baking oven, crosses sieve classification, the pellet preparations of the neck that obtains medical treatment, lumbar spondylosis Chinese medicine at last.