CN1537571A

CN1537571A - Strong Rhizoma Gastrodiae and eucommia bark granule, and its prepn. method

Info

Publication number: CN1537571A
Application number: CNA031182763A
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-04-15
Filing date: 2003-04-15
Publication date: 2004-10-20

Abstract

A Chinese medicine 'Strong gastrodia tuber-eucommia bark pills' for treating limbs numbness, inconvenience for walking, lumbocrural pain, headache and dizziness is an improvement to existing same medicine in the form of pills. Its advantages are quickly taking its effect, high curative effect, high safety, and high stability.

Description

Powerful gastrodia tuber eucommia granule and preparation method

Technical field

This invention relates to the particulate processing technology technical field of Chinese patent medicine, relates in particular to powerful gastrodia tuber eucommia granule and preparation method.

Background technology

Granule is the pharmaceutical formulation of using always, according to the relevant drug act of China, change dosage form as a kind of new drug research, the particulate original dosage form of powerful gastrodia tuber eucommia is powerful gastrodia tuber eucommia ball, has listed in national Bureau of Drugs Supervision's country's standard for traditional Chinese medicines compilation (terrestrial reference rises the GB tentative standard).The technology characteristics of former dosage form is: make water-honeyed pill after 12 flavor medicines are all beaten powder in the prescription.This pill dose is big, a 3g (12 balls), dysphagia, especially to old person, secondly, the pill prolonged disintegration, and this pharmaceutically dosage form is single, and application forms still has only pill, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, and based on this, we use the modern pharmaceutical technology this product technology is done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit the common people.

Summary of the invention

The purpose of this invention is to provide a kind of powerful gastrodia tuber eucommia granule and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.

1, the particulate preparation method of powerful gastrodia tuber eucommia comprises the steps:

1.1 the particulate prescription of powerful gastrodia tuber eucommia is formed

The Rhizoma Gastrodiae 146-292g Cortex Eucommiae (processed with salt) 155-310g Radix Aconiti Kusnezoffii Preparata 18-36g Radix Aconiti Lateralis Preparata (system) 18-36g

Radix Angelicae Pubescentis 91-182g Rhizoma Ligustici 108-216g Radix Scrophulariae 108-216g Radix Angelicae Sinensis 183-366g

Radix Rehmanniae 292-584g Radix Cyathulae 108-216g Herba Visci 108-216g Rhizoma Et Radix Notopterygii 183-366g

Right amount of auxiliary materials is made 1000 bags altogether.

Its optimum formula is:

The Rhizoma Gastrodiae 219.2g Cortex Eucommiae (processed with salt) 233g Radix Aconiti Kusnezoffii Preparata 27.4g Radix Aconiti Lateralis Preparata (system) 27.4g

Radix Angelicae Pubescentis 136.7g Rhizoma Ligustici 161.6g Radix Scrophulariae 161.6g Radix Angelicae Sinensis 274.1g

Radix Rehmanniae 438.2g Radix Cyathulae 161.6g Herba Visci 161.6g Rhizoma Et Radix Notopterygii 274.1g

Right amount of auxiliary materials is made 1000 bags altogether

1.2 the particulate preparation technology of powerful gastrodia tuber eucommia

Technology one, will write out a prescription in 12 the flavor medicines be up to the standards standby respectively; Whole pulverizing medicinal materials become fine powder in will writing out a prescription, and add appropriate amount of auxiliary materials, mix mixing, make granule, 60 ℃ of dryings, and granulate, quality inspection, packing is promptly.

Technology two, will write out a prescription in 12 the flavor medicines be up to the standards standby respectively; Get Rhizoma Gastrodiae, Radix Aconiti Kusnezoffii Preparata, Radix Aconiti Lateralis Preparata, Rhizoma Ligustici, Radix Cyathulae mixed powder and be broken into fine powder; Eight flavors such as all the other Radix Angelicae Pubescentiss are ground into coarse powder, add water steaming and decocting 2-3 time, and each 2-3 hour, it was standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil adds an amount of cyclodextrin, and enclose becomes the cyclodextrin of volatile oil clathrate or add an amount of dissolve with ethanol that to make the volatile oil alcoholic solution standby; Water boiling liquid filters, and filtrate is condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃), spray drying, collecting dried cream powder/be condensed into relative density is the thick paste of 1.20-1.40 (60 ℃), add the appropriate amount of auxiliary materials mixing, granulate drying, add the cyclodextrin of volatile oil clathrate, add an amount of dissolve with ethanol and make volatile oil alcoholic solution mixing, packing, quality inspection, packing, promptly.

1.3 by the technology gained is granule

The added adjuvant of powerful gastrodia tuber eucommia granule can be: 30 POVIDONE K 30 BP/USP ₃₀, any or multiple mixing in the micropowder silica gel, starch, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.

Ground spice such as Rhizoma Gastrodiae was broken into 80-160 purpose fine powder in the technology, was preferably superfine powder and was broken into 200-300 purpose fine powder.

Eight flavors such as all the other Radix Angelicae Pubescentiss were broken into 5-40 purpose coarse powder in the technology, were preferably 10-20 order coarse powder.

The condition that five tastes decocting such as Herba Leonuri boils in the technology is: amount of water is doubly measured for 6-12 for the first time, and second and third time doubly measured for 4-10, decocts 1-3 hour at every turn 2-3 time.Best amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time, each 2 hours.

The relative density that is condensed into thick paste in the technology is 1.20-1.40 (60 ℃), and best relative density is 1.32-1.35 (60 ℃).

The relative density that is condensed into concentrated solution in the technology is 1.05-1.15 (60 ℃), and best relative density is 1.08-1.10 (60 ℃).

The spray drying inlet temperature is 100-200 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.

The temperature of particle drying is controlled at 50-80 ℃ in the technology, is preferably 60 ℃.

Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).

The quality control of this product mainly is discriminating, inspection, three aspects of assay, and existing having increased differentiated the thin layer of the Cortex Eucommiae, Radix Angelicae Pubescentis, Radix Angelicae Sinensis; Heavy metal, arsenic salt are carried out limit examine; Increased on the assay to aconitine quantitatively.

This invention its superiority compared with the prior art is: production technology more becomes fully rationally, quality standard has had further raising, makes product that the qualitative, quantitative control method of more comprehensive science be arranged, and makes the quality of product that better guarantee arranged.

The specific embodiment

The optimum implementation of this invention is: 12 flavor medicines are up to the standards standby respectively in will writing out a prescription; Get Rhizoma Gastrodiae, Radix Aconiti Kusnezoffii Preparata, Radix Aconiti Lateralis Preparata, Rhizoma Ligustici, Radix Cyathulae mixed powder and be broken into fine powder; Eight flavors such as all the other Radix Angelicae Pubescentiss are ground into coarse powder, add water steaming and decocting 2-3 time, and each 2-3 hour, it was standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil adds an amount of cyclodextrin, and enclose becomes the cyclodextrin of volatile oil clathrate or add an amount of dissolve with ethanol that to make the volatile oil alcoholic solution standby; Water boiling liquid filters, and filtrate is condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃), spray drying, collecting dried cream powder/be condensed into relative density is the thick paste of 1.20-1.40 (60 ℃), add the appropriate amount of auxiliary materials mixing, granulate drying, add the cyclodextrin of volatile oil clathrate, add an amount of dissolve with ethanol and make volatile oil alcoholic solution mixing, packing, quality inspection, packing, promptly.

The present invention is dosage form technological innovation on the basis of existing pill, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, satisfies and ensured people's medication demand.

Claims

1, a kind of powerful gastrodia tuber eucommia granule and preparation method is characterized in that:

(1) Rhizoma Gastrodiae, Radix Aconiti Kusnezoffii Preparata, Radix Aconiti Lateralis Preparata, Rhizoma Ligustici, Radix Cyathulae ground spice were broken into 80-160 purpose fine powder in the technology, were preferably superfine powder and were broken into 200-300 purpose fine powder.

(2) all the other Radix Angelicae Pubescentiss, the Cortex Eucommiae, Radix Scrophulariae, Radix Angelicae Sinensis, Radix Rehmanniae, Herba Visci, Rhizoma Et Radix Notopterygii seven flavors were broken into 5-40 purpose coarse powder in the technology, were preferably 10-20 order coarse powder, and water decocts, and collects volatile oil.

(3) condition that decocting boils in the technology is: amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts 2-3 time, and each 1-3 hour, best amount of water was 10 times of amounts for the first time, is 8 times of amounts for the second time, each 2 hours.

(4) relative density that is condensed into thick paste in the technology is 1.20-1.40 (60 ℃), and best relative density is 1.32-1.35 (60 ℃).

(5) relative density that is condensed into concentrated solution in the technology is 1.05-1.15 (60 ℃), and best relative density is 1.08-1.10 (60 ℃).

(6) the spray drying inlet temperature is 100-200 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.

(7) temperature of particle drying is controlled at 50-80 ℃ in the technology, is preferably 60 ℃.

(8) cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).

(9) added adjuvant can be in the technology: any/multiple mixing in 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, starch, beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, the essence etc. is used.

(10) (1), (2), (3), (4), (5), (6), (7), (8), (9) are fed intake by the requirement of national standard prescription, make powerful gastrodia tuber eucommia granule.

2, powerful gastrodia tuber eucommia granule according to claim 1 and preparation method is characterized in that: whole pulverizing medicinal materials become fine powder in the prescription, add appropriate amount of auxiliary materials, mix mixing, make granule, 60 ℃ of dryings, granulate, quality inspection, packing makes powerful gastrodia tuber eucommia granule.

3, powerful gastrodia tuber eucommia granule according to claim 1 and preparation method is characterized in that: have the thin layer of the Cortex Eucommiae, Radix Angelicae Pubescentis, Radix Angelicae Sinensis to differentiate on the quality control examination criteria; Have heavy metal only 10/1000000ths, arsenic salt 2/1000000ths limit examines only; The detection by quantitative that aconitine is arranged.