CN1520871A

CN1520871A - Effervescence granulas for treating gynecologic inflammations and preparing process thereof

Info

Publication number: CN1520871A
Application number: CNA031186149A
Authority: CN
Inventors: 毛友昌; 毛晓敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-02-12
Filing date: 2003-02-12
Publication date: 2004-08-18

Abstract

The Fuyankang effervescent granule is prepared through grinding zedoary and Chinese yam as fine powder; crushing other 11 kinds of Chinese medicinal materials including burreed rhizome, etc. and decocting or steaming to extract volatile oil; concentrating the decoction or steamed liquid into paste and spray drying; drying the selected supplementary material and effervescence agent; and finally mixing based on the recipe to form the effervescent granule. The present invention is one improvement to available medicine preparation form with increased six kinds of Chinese medicinal materials, perfect preparation process and quality standard and raised product quality.

Description

The preparation method of FUYANKANG effervescent granule

Technical field

This invention relates to the processing technology technical field of Chinese patent medicine effervescent granule, relates in particular to the preparation method of FUYANKANG effervescent granule.

Background technology

Effervescent granule is a kind of new 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 FUYANKANG tablet, capsule, granule and pill, tablet has been listed in the 10th of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ", granule and capsule see among the bulletin of National Drug Administration's approved clinical research, and pill records in national standard for traditional Chinese medicines compilation surgery, gynecological's fascicle, is made up of 13 flavor Chinese medicines.The technology of former tablet, capsule, three kinds of dosage forms of granule is: Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder, all the other ten simply decocting liquid be condensed into thick paste, fine powder and thick paste mixed pelletization, drying, tabletting are made tablet then, perhaps fine powder and thick paste mixing, granulation, drying, be filled into capsule, perhaps fine powder and thick paste and Icing Sugar, dextrin granulate, dry granule.Former pill is that whole medical materials are beaten powder and become honeyed pill and water-honeyed pill with honey and water processed with honey.Tablet carries, produces all convenient, but the tablets amount is bigger, dysphagia, especially Ms, and pill is taken inconvenience especially.Have simultaneously the loss of volatile ingredient in the production process jointly, the quality standard of control product quality is lower, only has two flavor thin layers to differentiate in the 13 flavor medicines, is difficult to control product quality.The shortcoming of the quality aspect that exists based on former tablet, capsule, granule and pill, we use the modern pharmaceutical technology this product technology are made significant improvement, form new preparation, guarantee the quality monitoring of product, and the raising drug effect is benefited the common people.

Summary of the invention

The preparation method that the purpose of this invention is to provide a kind of FUYANKANG effervescent granule is improved the quality of products and curative effect, increases the stability of product, and a kind of Ms is more pleased to take, to satisfy needs of medical treatment better.

The objective of the invention is such realization:

The preparation method of FUYANKANG effervescent granule comprises the steps:

One, the prescription of FUYANKANG effervescent granule is formed

Radix Paeoniae Rubra 360g Rhizoma Smilacis Glabrae 600g rhizoma sparganic (processed with vinegar) 360g

Fructus Toosendan (stir-fry) 360g Rhizoma Curcumae (processed with vinegar) 360g Rhizoma Corydalis (processed with vinegar) 360g

Semen Euryales (stir-fry) 600g Radix Angelicae Sinensis 600g Radix Sophorae Flavescentis 360g

Rhizoma Cyperi (processed with vinegar) 240g Cortex Phellodendri 360g Radix Salviae Miltiorrhizae 600g

Rhizoma Dioscoreae 720g

Right amount of auxiliary materials is made 1000 bags altogether.

Two, FUYANKANG effervescent granule preparation technology

Technology one cleans 13 flavor medicines respectively, removes impurity, and it is standby to be up to the standards; More than 13 the flavor, Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder, sieve.All the other rhizoma sparganic etc. ten decoct with water three times simply, 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, filtrate is condensed into the thick paste that relative density is 1.18-1.22 (85 ℃), with above-mentioned powder mixing, drying, be ground into fine powder, add an amount of sweeting agent and appropriate amount of auxiliary materials mixing drying, pulverizing adds effervescent and reaches the appropriate amount of auxiliary materials mixing in right amount, granulate drying, packing, quality inspection, packing, promptly.

Technology two cleans 13 flavor medicines respectively, removes impurity, and it is standby to be up to the standards; More than 13 the flavor, Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder, sieve.All the other rhizoma sparganic etc. ten decoct with water three times simply, and 2 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is condensed into the concentrated solution that relative density is ten Herba indigoferae Pseudotinctoriae of 1.05-1.15 (60 ℃), and it is standby to be spray dried to dried cream powder; Get dried cream powder and add Rhizoma Curcumae fine powder, Rhizoma Dioscoreae fine powder, effervescent and reach the appropriate amount of auxiliary materials mixing in right amount, granulate, drying, packing, quality inspection, packing, promptly.

Technology three cleans 13 flavor medicines respectively, removes impurity, and it is standby to be up to the standards; More than 13 the flavor, Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder, sieve.All the other rhizoma sparganic etc. ten mixed powder simply are broken into coarse powder and add the water steaming and decocting three times, collect volatile oil and water boiling liquid, merge three times water boiling liquid, filter, left standstill 24 hours, get the concentrated solution that supernatant concentration to relative density is 1.05-1.15 (60 ℃), spray drying, it is standby to collect dried cream powder; Said extracted volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby; Get dried cream powder and add Rhizoma Curcumae fine powder, Rhizoma Dioscoreae fine powder, volatile oil cyclodextrin clathrate and an amount of effervescent and adjuvant, mixing is granulated, drying, and packing, quality inspection, packing, promptly.

Three, prepared by technology one, two, three is effervescent 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.

Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder and were generally 80-160 purpose fine powder in the technology, and the best is that superfine powder is broken into 200-300 purpose fine powder.

Ten Herba indigoferae Pseudotinctoriae such as all the other rhizoma sparganic are ground into coarse powder and were generally 5-20 purpose coarse powder in the technology, are preferably 10 order coarse powder.

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

The relative density that is condensed into thick paste in the technology is 1.15-1.30 (80 ℃), and best relative density is the clear paste of 1.18-1.22 (80 ℃).

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 (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 ℃, and leaving air temp is 100 ℃.

The temperature of particle drying is controlled at 50-90 ℃ 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 acid source of effervescent is a kind of or two kinds in citric acid, tartaric acid, the fumaric acid in the prescription, and carbon dioxide source is a kind of in sodium carbonate, sodium bicarbonate, the potassium carbonate or two kinds; Be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8-1.1: 1.2-1.5, and getting is 1.0: 1.3, and consumption is that sodium bicarbonate is 3-10%, and citric acid is 5-15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.

This product quality control mainly is discriminating, inspection, three aspects of assay, and 13 flavor medicines are former in the prescription has only Rhizoma Curcumae, Cortex Phellodendri two flavor thin layers to differentiate that existing having increased differentiated the thin layer of Radix Paeoniae Rubra, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, the Rhizoma Corydalis five tastes; Heavy metal, arsenic salt are carried out limit examine, and be controlled at dispersing and dissolving in 5 minutes; Rhizoma Corydalis is carried out quantitatively.

This invention its superiority compared with the prior art is: production technology more becomes rationally, and quality standard has new raising again, 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 13 flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; More than 13 the flavor, Rhizoma Curcumae, Rhizoma Dioscoreae powder are broken into fine powder, sieve.All the other rhizoma sparganic etc. ten mixed powder simply are broken into coarse powder and add the water steaming and decocting three times, collect volatile oil and water boiling liquid, merge three times water boiling liquid, filter, left standstill 24 hours, get the concentrated solution that supernatant concentration to relative density is 1.05-1.15 (60 ℃), spray drying, it is standby to collect dried cream powder; Said extracted volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby; Get dried cream powder and add Rhizoma Curcumae fine powder, Rhizoma Dioscoreae fine powder, volatile oil cyclodextrin clathrate and an amount of effervescent and adjuvant, mixing is granulated, drying, and packing, quality inspection, packing, promptly.

Claims

1, the preparation method of FUYANKANG effervescent granule is characterized in that it may further comprise the steps:

(1) Rhizoma Curcumae that is ground into fine powder in the technology, Rhizoma Dioscoreae be for being ground into 80-160 purpose fine powder, and it is standby that the best is that superfine powder is broken into 200-300 purpose fine powder.

(2) rhizoma sparganic, Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, Fructus Toosendan (stir-fry), Rhizoma Corydalis (processed with vinegar), Semen Euryales (stir-fry), Radix Angelicae Sinensis, Radix Sophorae Flavescentis, Rhizoma Cyperi (processed with vinegar), Cortex Phellodendri, Radix Salviae Miltiorrhizae ten Herba indigoferae Pseudotinctoriae are ground into coarse powder and were generally 5-20 purpose coarse powder in the technology, are preferably 10 order coarse powder.

(3) rhizoma sparganic, Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, Fructus Toosendan (stir-fry), Rhizoma Corydalis (processed with vinegar), Semen Euryales (stir-fry), Radix Angelicae Sinensis, Radix Sophorae Flavescentis, Rhizoma Cyperi (processed with vinegar), Cortex Phellodendri, Radix Salviae Miltiorrhizae ten Herba indigoferae Pseudotinctoriae decoctings boil/water steaming and decocting collection volatile oil and water boiling liquid in the technology.Decocting boils/and the condition of water steaming and decocting is: and amount of water is doubly measured for 6-12 for the first time, and second and third time doubly measured for 4-10, and the 2-6 hour first time of time of decoction/steaming and decocting, second and third time is 1-3 hour.Best second and third time respectively is 8 times of amounts for amount of water is 10 times of amounts for the first time, and best decoction/digestion time is for being 4 hours for the first time, and second and third time respectively is 2 hours.

(4) relative density of the concentrated solution of ten Herba indigoferae Pseudotinctoriae such as rhizoma sparganic, Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, Fructus Toosendan (stir-fry), Rhizoma Corydalis (processed with vinegar), Semen Euryales (stir-fry), Radix Angelicae Sinensis, Radix Sophorae Flavescentis, Rhizoma Cyperi (processed with vinegar), Cortex Phellodendri, Radix Salviae Miltiorrhizae is 1.05-1.15 (60 ℃) in the technology, 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) temperature of particle drying is controlled at 50-90 ℃ in the technology, is preferably 60 ℃.

(7) 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).

(8) used adjuvant is in the technology: any/multiple mixing in 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, Aspartane, starch, dextrin, magnesium stearate, the essence is used.

(9) added effervescent in the technology, its acid source are a kind of in citric acid, tartaric acid, the fumaric acid/two kind, and carbon dioxide source is a kind of/two kind in sodium carbonate, sodium bicarbonate, the potassium carbonate; Be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8-1.1: 1.2-1.5, and getting is 1.0: 1.3, and consumption is that sodium bicarbonate is 3-10%, and citric acid is 5-15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.

2, the preparation method of FUYANKANG effervescent granule according to claim 1, it is characterized in that volatile oil standby material, Rhizoma Curcumae, Rhizoma Dioscoreae fine powder standby material, rhizoma sparganic, Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, Fructus Toosendan (stir-fry), Rhizoma Corydalis (processed with vinegar), Semen Euryales (stir-fry), Radix Angelicae Sinensis, Radix Sophorae Flavescentis, Rhizoma Cyperi (processed with vinegar), Cortex Phellodendri, Radix Salviae Miltiorrhizae ten standby material, adjuvant, effervescent simply, granulate on request, dry, packing, quality inspection, the packing and must invention product FUYANKANG effervescent granule.