CN1522728A

CN1522728A - Female health granule preparation method

Info

Publication number: CN1522728A
Application number: CNA031186424A
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-02-18
Filing date: 2003-02-18
Publication date: 2004-08-25

Abstract

The present invention relates to a preparation method of Chinese medicine Fukangning granule preparation in treating deficiency of both qi and blood and dysmenorrhea of woman. Said Chinese medicine Fukangning is prepared by making 8 Chinese medicinal materials of white peony root, cyperus root and others go through the processes of decocting to obtain volatile oil and decoction, concentrating, spray-drying, adding auxiliary material, granulating, screening and filling so as to obtain the invented product. Said medicine is safe, stable and effective.

Description

The particulate preparation method of FUKANGNING

Technical field

This invention relates to the processing technology technical field of Chinese patent medical granule, relates in particular to the particulate preparation method of FUKANGNING.

Background technology

Granule is a kind of form of Chinese drug, according to the relevant drug act of China, change dosage form as a kind of new drug research, former dosage form has tablet for women's health and tranquilness, and listed in first of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ", form by eight flavor Chinese medicines.The technology of former dosage form is: the Radix Paeoniae Alba (recipe quantity 4/10), Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, Folium Artemisiae Argyi powder are broken into fine powder, and the residue medical material decocts with water, and decocting liquid is condensed into cream, adds above-mentioned fine powder and adjuvant, and mixing is granulated, drying, and tabletting, sugar coating forms.Though containing the medical material of volatile ingredient in the technology, to beat fine powder standby, but in granulation, add, in the dry run loss must be arranged, tablet manufacturing, easy to carry, but this tablets amount is big, and ampoule is 8, the Ms is difficult to be accepted, and the quality standard of control product quality is too low, a few indefiniteness quantitative targets, uncontrollable product quality.Have the shortcoming that influences quality based on tablet, 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 purpose of this invention is to provide the particulate preparation method of a kind of FUKANGNING, improve the quality of products and curative effect, increase the stability of product, the Ms is more pleased to take to satisfy needs of medical treatment better.

The objective of the invention is such realization:

The particulate preparation method of FUKANGNING comprises the steps:

One, the particulate prescription of FUKANGNING is formed

Radix Paeoniae Alba 1572g Rhizoma Cyperi 236g Radix Angelicae Sinensis 196g

Radix Notoginseng 157g Folium Artemisiae Argyi (charcoal) 31g 393g Radix Ophiopogonis

Radix Codonopsis 236g Herba Leonuri 1179g

Right amount of auxiliary materials is made 1000 bags altogether.

Two, FUKANGNING granule preparing process

Technology one cleans eight flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get the Radix Paeoniae Alba (recipe quantity 4/10), Rhizoma Cyperi, Radix Angelicae Sinensis, that Folium Artemisiae Argyi powder is broken into fine powder is standby; The residue Radix Paeoniae Alba, Radix Ophiopogonis, Radix Codonopsis, Herba Leonuri decoct with water 2 times, and collecting decoction filters, and filtrate is condensed into thick paste, adds above-mentioned powder and auxiliary materials and mixing, granulate, and drying, packing, quality inspection, packing, promptly.

Technology two cleans eight flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get in the prescription eight flavor medicated powder and be broken into coarse powder, add the water steaming and decocting and extract 2-3 time, collection volatile oil and water boiling liquid are standby; Above-mentioned volatile oil adds an amount of cyclodextrin inclusion compound and becomes the cyclodextrin of volatile oil clathrate standby; It is 1.05-1.15 (60 ℃) that water boiling liquid is condensed into relative density, and best relative density is the concentrated solution of 1.08 (60 ℃), spray drying, collecting dried cream powder/be condensed into relative density is 1.16-1.40 (80 ℃), and best relative density is the thick paste of 1.25 (80 ℃), is dried to dried cream, be ground into fine powder, add the appropriate amount of auxiliary materials mixing, granulate, drying adds the cyclodextrin of volatile oil clathrate, mixing, packing, quality inspection, packing, promptly.

Three, prepared by technology one, two is granule.

Added adjuvant can be in the technology: any or multiple mixing in 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, starch, dextrin, Aspartane, magnesium stearate, the essence is used.

Whole pulverizing medicinal materials become coarse powder to be generally 5-30 purpose coarse powder in the technology preparation, are preferably 10 order coarse powder.

The dried cream powder of gained is broken into fine powder and was generally 80-160 purpose fine powder in the technology, is preferably 100 order fine powders.

In the technology decocting boil/condition of water steaming and decocting is: decoction/steaming and decocting 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, second and third time doubly measured each 1-3 of the time of decoction/steaming and decocting hour for the 4-10 of dose; The best is: decoction/steaming and decocting 2 times, amount of water are 10 times of amounts of dose for the first time, are 8 times of amounts of dose for the second time, each 2 hours.

The spray drying inlet temperature is 100-200 ℃ in the technology, and leaving air temp is 50-150 ℃, and best inlet temperature is 160 ℃, and leaving air temp is 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, Radix Angelicae Sinensis, Radix Notoginseng, Radix Codonopsis, the Radix Paeoniae Alba in the prescription is carried out thin layer differentiate; Heavy metal, arsenic salt are carried out limit examine; On the assay Radix Paeoniae Alba is carried out quantitatively.

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

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 in the prescription eight flavor medicated powder and be broken into coarse powder, add the water steaming and decocting and extract 2-3 time, collection volatile oil and water boiling liquid are standby; Above-mentioned volatile oil adds an amount of cyclodextrin inclusion compound and becomes the cyclodextrin of volatile oil clathrate standby; It is 1.05-1.15 (60 ℃) that water boiling liquid is condensed into relative density, and best relative density is the concentrated solution of 1.08 (60 ℃), spray drying, collecting dried cream powder/be condensed into relative density is 1.16-1.40 (80 ℃), and best relative density is the thick paste of 1.25 (80 ℃), is dried to dried cream, be ground into fine powder, add the appropriate amount of auxiliary materials mixing, granulate, drying adds the cyclodextrin of volatile oil clathrate, mixing, packing, quality inspection, packing, promptly.

Claims

1, the particulate preparation method of a kind of FUKANGNING is characterized in that it may further comprise the steps:

(1) in the prescription all the medical material Radix Paeoniae Albas (recipe quantity 4/10), Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, Folium Artemisiae Argyi, Radix Ophiopogonis, Radix Codonopsis, motherwort powder be broken into coarse powder and be generally 5-30 purpose coarse powder, be preferably 10 order coarse powder.

(2) Radix Paeoniae Alba in the technology (recipe quantity 4/10), Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, Folium Artemisiae Argyi, Radix Ophiopogonis, Radix Codonopsis, Herba Leonuri, decocting boils/water steaming and decocting and to collect volatile oil standby, decocting boils/and the condition of water steaming and decocting is: decoction/steaming and decocting 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, second and third time doubly measured each 1-3 of the time of decoction/steaming and decocting hour for the 4-10 of dose; The best is: decoction/steaming and decocting 2 times, amount of water are 10 times of amounts of dose for the first time, are 8 times of amounts of dose for the second time, each 2 hours.

(3) relative density that is condensed into thick paste in the technology is 1.16-1.40 (80 ℃), and best relative density is 1.25 (80 ℃).

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

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

(6) dried cream powder of gained is broken into fine powder and was generally 80-160 purpose fine powder in the Radix Paeoniae Alba in the technology (recipe quantity 4/10), Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Notoginseng, Folium Artemisiae Argyi, Radix Ophiopogonis, Radix Codonopsis, the Herba Leonuri technology, is preferably 100 order fine powders.

(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: 30 POVIDONE K 30 BP/USP ₃₀, any/multiple mixing in the micropowder silica gel, starch, dextrin, Aspartane, magnesium stearate, essence uses.

(10) the standby composition with (1), (2), (3), (4), (5), (6), (7), (8), (9) feeds intake by national standard prescription consumption, adds auxiliary materials and mixing, granulates, and the FUKANGNING granule is made in packing.