CN100500200C

CN100500200C - Fuyankang pills against gynecologic inflammation and their preparation

Info

Publication number: CN100500200C
Application number: CNB031245064A
Authority: CN
Inventors: 毛友昌; 毛小敏
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-06-03
Filing date: 2003-06-03
Publication date: 2009-06-17
Anticipated expiration: 2023-06-03
Also published as: CN1552368A

Abstract

A Chinese medicine 'Fuyankang pill' for treating chronic amexitis, pelvic inflammation, veginitis, cystitis, chronic appendicitis, etc is an improvement to existing relative medicine. Its preparing process is also disclosed. Its advantages are high curative effect, high release speed, and high biologic utilization rate.

Description

Fuyankang pill and preparation method

Technical field

This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to Fuyankang pill and preparation method.

Background technology

Pill is a kind of conventional dosage forms, because quick development of modern science and technology, pharmaceutical machine equipment is brought in constant renewal in and is regenerated, the extensive use of the appearance of novel pellet processing machine and new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed people to the traditional prejudice of traditional pill " black, big, thick ", advantages such as the pill that makes it to produce has that drug release rate is fast, bioavailability is high, divided dose is accurate, takes, easy to carry, good looking appearance.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, 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.Disintegration of tablet is slow, and volatile ingredient easily loses in process of production, and dose is bigger, dysphagia, especially Ms; The pill dose is bigger, especially inconvenience.The common simultaneously quality standard of control product quality that exists is lower, is difficult to control the deficiency of product quality.We use the modern pharmaceutical technology this product technology are made significant improvement based on this, form new preparation, improve the quality standard of product simultaneously, guarantee the quality monitoring of product, improve drug effect, benefit the common people, this is significant to inheriting and develop motherland's medicine legacy.

Summary of the invention

The purpose of this invention is to provide a kind of Fuyankang pill and preparation method, improve the quality of products and curative effect, increase the stability of product, a kind of Ms is more pleased to take, to satisfy needs of medical treatment better.

The objective of the invention is such realization:

1. Fuyankang pill and preparation method comprise the steps:

1.1 the prescription of Fuyankang pill is formed

Radix Paeoniae Rubra 120-240g Rhizoma Smilacis Glabrae 200-400g rhizoma sparganic (processed with vinegar) 120-240g

Fructus Toosendan (stir-fry) 120-240g Rhizoma Curcumae (processed with vinegar) 120-240g Rhizoma Corydalis (processed with vinegar) 120-240g

Semen Euryales (stir-fry) 200-400g Radix Angelicae Sinensis 200-400g Radix Sophorae Flavescentis 120-240g

Rhizoma Cyperi (processed with vinegar) 80-160g Cortex Phellodendri 120-240g Radix Salviae Miltiorrhizae 200-400g

Rhizoma Dioscoreae 240-480g right amount of auxiliary materials is made 1000g altogether.

Optimum formula is:

Radix Paeoniae Rubra 180g Rhizoma Smilacis Glabrae 300g rhizoma sparganic (processed with vinegar) 180g

Fructus Toosendan (stir-fry) 180g Rhizoma Curcumae (processed with vinegar) 180g Rhizoma Corydalis (processed with vinegar) 180g

Semen Euryales (stir-fry) 300g Radix Angelicae Sinensis 300g Radix Sophorae Flavescentis 180g

Rhizoma Cyperi (processed with vinegar) 120g Cortex Phellodendri 180g Radix Salviae Miltiorrhizae 300g

Rhizoma Dioscoreae 360g right amount of auxiliary materials is made 1000g altogether.

1.2 Fuyankang pill preparation technology

Technology one cleans 13 flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get Rhizoma Curcumae, that Rhizoma Dioscoreae powder is broken into fine powder is standby; All the other rhizoma sparganic etc. ten are ground into coarse powder/be cut into decoction pieces simply, decoct with water 2-4 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, and pill, drying, promptly.

Technology two cleans 13 flavor medicines respectively, removes impurity, and it is standby to be up to the standards; 13 flavor medicated powder are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, collection volatile oil and water boiling liquid are standby; Water boiling liquid merges, and filters, and filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; Above-mentioned volatile oil cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Get above-mentioned thick paste/dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.

1.3 by technology one, two prepared balls is Fuyankang pill.

The ball of gained can wrap film-coat in the technology, and the film-coat material adopts stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, one or more mixing of methylcellulose to use.

Used adjuvant can be that one or more mixing such as sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 are used in the technology.

The particle diameter of the ball of gained is 0.5-6mm in the technology, is preferably 1-4mm.

In the technology ball of gained can directly use or the capsulae vacuus of packing in use.

The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.

The technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.

The technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces, is generally 5-30 purpose coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.

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

The relative density of thick paste is 1.15-1.45 (60 ℃) in the technology, and best relative density is 1.30-1.35 (60 ℃).

The drying of extract can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.

Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.

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

2. this product quality control mainly is discriminating, inspection, three aspects of assay.

The former dosage form of 13 flavor medicines 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 in the prescription; Increased in the inspection that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; Increased the quantitative of Rhizoma Corydalis on the assay.

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

Embodiment 1: 13 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; 13 flavors of writing out a prescription are ground into coarse powder and add the water steaming and decocting three times, and 2 hours for the first time, second and third time each 1 hour, it is standby to collect volatile oil and water boiling liquid; Water boiling liquid merges, and filters, and it is 1.08-1.10 (60 ℃) that filtrate is concentrated into relative density, spray drying, and it is standby to collect dried cream powder; Above-mentioned volatile oil adds an amount of beta-schardinger dextrin-, and to make volatile oil beta cyclodextrin inclusion complex standby; Get above-mentioned dried cream powder, volatile oil beta-ring paste clathrate and appropriate amount of auxiliary materials, mixing, pill, drying, coating, promptly.

Embodiment 2: 13 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Rhizoma Curcumae, that Rhizoma Dioscoreae powder is broken into fine powder is standby; All the other rhizoma sparganic etc. ten are ground into coarse powder simply, decoct with water 2 hours for the first time 3 times, second and third time each 1 hour, collecting decoction filters, it is 1.08-1.10 (60 ℃) that filtrate is concentrated into relative density, spray drying is collected dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.

Claims

1. the preparation method of a Fuyankang pill, described Fuyankang pill is prepared by following Chinese medicine raw materials by weight proportion: Radix Paeoniae Rubra 120-240g, Rhizoma Smilacis Glabrae 200-400g, rhizoma sparganic 120-240g, Fructus Toosendan 120-240g, Rhizoma Curcumae 120-240g, Rhizoma Corydalis 120-240g, Semen Euryales 200-400g, Radix Angelicae Sinensis 200-400g, Radix Sophorae Flavescentis 120-240g, Rhizoma Cyperi 80-160g, Cortex Phellodendri 120-240g, Radix Salviae Miltiorrhizae 200-400g, Rhizoma Dioscoreae 240-480g, and this Chinese medicine raw materials by weight proportion prepares the 1000g pill; It is characterized in that the following technology of process:

Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Fructus Toosendan, Rhizoma Curcumae, Rhizoma Corydalis, Semen Euryales, Radix Angelicae Sinensis, Radix Sophorae Flavescentis, Rhizoma Cyperi, Cortex Phellodendri, Radix Salviae Miltiorrhizae, Rhizoma Dioscoreae 13 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; 13 flavor medicated powder are broken into coarse powder or are cut into decoction pieces, add water steaming and decocting 2-4 time, it is standby to collect volatile oil and water boiling liquid; Water boiling liquid merges, and filters, and filtrate is condensed into thick paste or concentrate drying, and to make dried cream powder standby; Volatile oil is with cyclodextrin inclusion compound or standby with an amount of anhydrous alcohol solution; Get thick paste or dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, pill, promptly; Or thick paste or dried cream powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.

2. according to the preparation method of the described Fuyankang pill of claim 1, it is characterized in that the preparation of cyclodextrin of volatile oil clathrate, cyclodextrin adopts a kind of in beta-schardinger dextrin-, the HP-, and the ratio of volatile oil and beta-schardinger dextrin-is 1ml:5-15g.