CN1456256A

CN1456256A - Compound pseudo-ginseng preparing method

Info

Publication number: CN1456256A
Application number: CN 03118655
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-02-20
Filing date: 2003-02-20
Publication date: 2003-11-19

Abstract

A process for preparing Chinese medicine "Compound notoginseng tablet" for treating bone fracture, injury, contusion, sprain, etc includes such steps as pulverizing part of its raw materials, crushing the rest and decocting to collect volatile oil, mixing all together, tabletting and coating. Its advantage is high curative effect and safety.

Description

The preparation method of FUFANG SANQI PIAN

Technical field

This invention relates to the processing technology technical field of Chinese patent medicine tablet, relates in particular to the preparation method of FUFANG SANQI PIAN.

Background technology

Tablet is a kind of pharmaceutical formulation commonly used, according to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of FUFANG SANQI PIAN is: the compound recipe Radix Notoginseng looses and FUFANG SANQI JIAONANG, the compound recipe Radix Notoginseng looses and has taken in the 19th of China's the Sanitation Ministry medicine standard " Chinese traditional patent formulation preparation ", and FUFANG SANQI PIAN is taken in " national standard for traditional Chinese medicines compilation " (terrestrial reference rises the GB part) orthopedics department fascicle.The technology features of former two kinds of dosage forms is that whole medical materials in the prescription (eight flavors) form through directly pulverizing packing.Though powder has clothes backs performance to make fast advantage, its divided dose is inaccurate, takes that to be inconvenient to be the big defective of one; Though capsule has solved the divided dose problem, there is the big shortcoming of dose equally.Simultaneously powder, capsule all exist in the processing technology quality standard controlling index lower, detect the less shortcoming that influences quality that waits of data.Have the shortcoming that influences quality based on powder, capsule, we use the modern pharmaceutical technology this product technology are done necessary the improvement, form new preparation, guarantee the quality monitoring of product, improve drug effect, benefit the common people.

Summary of the invention

The preparation method that the purpose of this invention is to provide a kind of FUFANG SANQI PIAN is improved the quality of products and curative effect, increases the stability of product, satisfies needs of medical treatment better.

The objective of the invention is such realization:

The preparation method of FUFANG SANQI PIAN comprises the steps:

One, the prescription of FUFANG SANQI PIAN is formed

Radix Notoginseng 125-250g Radix Angelicae Dahuricae 25-65g Eupolyphaga Seu Steleophaga 25-65g

Rhizoma Chuanxiong 25-65g Radix Angelicae Sinensis 25-65g Flos Carthami 25-65g

Olibanum (system) 25-65g Myrrha (processed) 25-65g

Right amount of auxiliary materials is made 1000 altogether.

Its optimum formula is:

Radix Notoginseng 190g Radix Angelicae Dahuricae 44g Eupolyphaga Seu Steleophaga 44g

Rhizoma Chuanxiong 44g Radix Angelicae Sinensis 44g Flos Carthami 44g

Olibanum (system) 44g Myrrha (processed) 44g

Right amount of auxiliary materials is made 1000 altogether.

Two, FUFANG SANQI PIAN preparation technology

Technology one cleans eight flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Eight flavor medicines are ground into fine powder in will writing out a prescription, and add the appropriate amount of auxiliary materials mixing, granulate, and cold drying, tabletting, coating, quality inspection, packing, promptly.

Technology two cleans eight flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Eight flavor medicines are ground into fine powder in will writing out a prescription, and add the appropriate amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Technology three cleans eight flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get Radix Notoginseng (recipe quantity 1/2), Eupolyphaga Seu Steleophaga, Olibanum, that Myrrha is ground into fine powder is standby; Radix Notoginseng (recipe quantity 1/2), Radix Angelicae Sinensis, the Radix Angelicae Dahuricae, Rhizoma Chuanxiong, Flos Carthami powder are broken into coarse powder, add the water steaming and decocting, and gained volatile oil and water boiling liquid are standby; Water boiling liquid filters, it is 1.05～1.15 (50 ℃) that the filtrate thin film concentration becomes relative density, best relative density is the concentrated solution of 1.05 (50 ℃), spray drying, collecting dried cream powder or being condensed into relative density is 1.20～1.35 (50 ℃), the best is the thick paste of 1.25 (50 ℃), and drying gets dry extract, and it is standby to be ground into fine powder; Said extracted volatile oil becomes the volatile oil alcoholic solution or becomes the cyclodextrin of volatile oil clathrate standby with cyclodextrin inclusion compound with an amount of dissolve with ethanol solution; Get fine powders such as above-mentioned dried cream powder, Radix Notoginseng and add appropriate amount of auxiliary materials, mixing is granulated, and drying adds volatile oil alcoholic solution or cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Three, be Film coated tablets by technology one, two, three prepared tablets, its film-coat material all adopts stomach dissolution type film-coat pre-mixing agent (Opadry).

The medical material that is ground into coarse powder in the technology was preferably 10 order coarse powder for being ground into 5-30 purpose coarse powder.

Need be ground into the medical material/dried cream of fine powder in the technology, can routine be ground into 80-160 purpose fine powder or superfine powder is broken into 200-300 purpose fine powder.

Added adjuvant is in the technology: any or multiple mixing in beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, low-substituted hydroxypropyl cellulose, starch, dextrin, the magnesium stearate is used.

Granulate in the technology and adopt alcohol granulation.

The dry drying under reduced pressure that adopts in the technology, temperature is 50-80 ℃, is preferably 60 ℃.

Water boiling liquid is condensed into the concentrated solution that relative density is 1.05～1.15 (50 ℃) in the technology, and the spray drying inlet temperature is 100-200 ℃, and leaving air temp is 50-150 ℃; Best relative density is 1.05 (50 ℃), and inlet temperature is 150 ℃, and leaving air temp is 100 ℃.

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: 7 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 2-10 (ml/g), optimal proportion is: 1: 5 (ml/g).

The relative density of thick paste is 1.20～1.35 (50 ℃) in the technology, and the best is 1.25 (50 ℃).

Former powder quality standard is low, has only a microscopical identification in the discriminating, and does not have quantitative target; The original capsule quality standard is existing to be improved, and has increased Radix Notoginseng, the thin layer discriminating of the Radix Angelicae Dahuricae and the limit examine of arsenic salt, and Radix Notoginseng has been carried out quantitatively.Further improve on the basis of present original standard and improve, the thin layer that has increased Radix Angelicae Sinensis, Rhizoma Chuanxiong on differentiating is differentiated, has increased the limit examine of heavy metal on checking.

This invention its superiority compared with the prior art is: production technology more becomes fully rationally, can better protect and stable volatile ingredient, and quality standard improves greatly simultaneously, makes product that the qualitative, quantitative control method of science be arranged, and quality and curative effect have had assurance.

The specific embodiment

The optimum implementation of this invention is that eight flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Radix Notoginseng (recipe quantity 1/2), Eupolyphaga Seu Steleophaga, Olibanum, that Myrrha is ground into fine powder is standby; Radix Notoginseng (recipe quantity 1/2), Radix Angelicae Sinensis, the Radix Angelicae Dahuricae, Rhizoma Chuanxiong, Flos Carthami powder are broken into coarse powder, add the water steaming and decocting, and gained volatile oil and water boiling liquid are standby; Water boiling liquid filters, it is 1.05～1.15 (50 ℃) that the filtrate thin film concentration becomes relative density, best relative density is the concentrated solution of 1.05 (50 ℃), spray drying, collecting dried cream powder or being condensed into relative density is 1.20～1.35 (50 ℃), the best is the thick paste of 1.25 (50 ℃), and drying gets dry extract, and it is standby to be ground into fine powder; Said extracted volatile oil becomes the volatile oil alcoholic solution or becomes the cyclodextrin of volatile oil clathrate standby with cyclodextrin inclusion compound with an amount of dissolve with ethanol solution; Get fine powders such as above-mentioned dried cream powder, Radix Notoginseng and add appropriate amount of auxiliary materials, mixing is granulated, and drying adds volatile oil alcoholic solution or cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, tabletting, and coating, quality inspection, packing, promptly.

Claims

1, the preparation method of FUFANG SANQI PIAN is characterized in that it may further comprise the steps:

What (1) Radix Notoginseng, the Radix Angelicae Dahuricae, Eupolyphaga Seu Steleophaga, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Olibanum, Myrrha were required to be coarse powder in the technology was ground into 5-30 purpose coarse powder, was preferably 10 order coarse powder, added the water steaming and decocting and collected volatile oil.

(2) Radix Notoginseng in the technology, the Radix Angelicae Dahuricae, Eupolyphaga Seu Steleophaga, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami, Olibanum, Myrrha and concentrate that the dried cream in back is required to be fine powder be ground into 80-160 purpose fine powder, best superfine powder is broken into 200-300 purpose fine powder.

(3) alcohol granulation is adopted in granulation in the technology.

(4) the dry drying under reduced pressure that adopts in the technology, temperature is 50-80 ℃, is preferably 60 ℃.

(5) water boiling liquid is condensed into the concentrated solution that relative density is 1.05～1.15 (50 ℃) in the technology, and the spray drying inlet temperature is 100-200 ℃, and leaving air temp is 50-150 ℃; Best relative density is 1.05 (50 ℃), and inlet temperature is 150 ℃, and leaving air temp is 100 ℃.

(6) 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: 7 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 2-10 (ml/g), optimal proportion is: 1: 5 (ml/g).

(7) relative density of thick paste is 1.20～1.35 (50 ℃) in the technology, and the best is 1.25 (50 ℃).

(8) added adjuvant is in the technology: any/multiple mixing in beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, low-substituted hydroxypropyl cellulose, starch, dextrin, the magnesium stearate is used.

(9) coating material of tablet adopts stomach dissolution type film-coat pre-mixing agent Opadry.

(10) feed intake after the standby material of (1), (2), (3), (4), (5), (6), (7), (8), (9) is converted by the requirement of national standard prescription, mix, pulverizing, tabletting, coating, make FUFANG SANQI PIAN.

2, the preparation method of FUFANG SANQI PIAN according to claim 1, it is characterized in that on the quality monitoring standard, Radix Notoginseng, the Radix Angelicae Dahuricae having been carried out the limit examine of thin layer discriminating and arsenic salt, and Radix Notoginseng carried out quantitatively, in the discriminating Radix Angelicae Sinensis, Rhizoma Chuanxiong are carried out the thin layer discriminating, on checking, heavy metal has been carried out limit examine.