CN1565496A - Gynecological inflammation treating powder and its preparation - Google Patents

Gynecological inflammation treating powder and its preparation Download PDF

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Publication number
CN1565496A
CN1565496A CN 03124606 CN03124606A CN1565496A CN 1565496 A CN1565496 A CN 1565496A CN 03124606 CN03124606 CN 03124606 CN 03124606 A CN03124606 A CN 03124606A CN 1565496 A CN1565496 A CN 1565496A
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scorching
preparation
technology
woman
radix
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CN 03124606
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Chinese (zh)
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毛友昌
毛小敏
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Individual
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Individual
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Abstract

The invention discloses a gynecological inflammation treating powder and its preparation, wherein process modification is introduced into the conventional capsule production process, the medicine is characterized inconvenient in use and quick effect, thus can be used for treating women's pelvic inflammation.

Description

Scorching relaxation grain of woman and preparation method
Technical field
This invention relates to the processing technology technical field of Chinese patent medical granule, relates in particular to scorching relaxation grain of woman and preparation method.
Background technology
Granule is a kind of form of Chinese drug commonly used, according to the relevant drug act of China, changes dosage form as a kind of new drug research, and former dosage form is the scorching relieving capsule of woman, has taken in country of the National Drug Administration standard for traditional Chinese medicines compilation (terrestrial reference rises GB partly).The technology of former dosage form is: Rhizoma Corydalis is beaten powder, and three flavor alcohol extractions such as Radix Salviae Miltiorrhizae are condensed into thick paste, and seven flavors such as medicinal residues and all the other RENKETENG decoct with water, and decocting liquid is condensed into thick paste, and with above-mentioned thick paste and fine powder mixing, drying is pulverized, and granulates encapsulated forming.This capsule dose is big, and ampoule is 5 large capsules, and the Ms is difficult to be accepted, and target level of product quality still can further improve, and this product forms is single simultaneously, far can not satisfy people's medication demand, and granule is compared the advantage that also has immediate effect with it.We use the modern pharmaceutical technology this product technology are done necessary the improvement based on this, 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 scorching relaxation grain of a kind of woman and preparation method, improve the quality of products and curative effect, make that the Ms is more pleased to take, to satisfy needs of medical treatment better.
The objective of the invention is such realization:
Scorching relaxation grain of woman and preparation method comprise the steps:
One, the prescription of the scorching relaxation grain of woman is formed
RENKETENG 1000-5500g Caulis Sargentodoxae 1000-5500g Radix Glycyrrhizae 100-550g
Folium Isatidis 100-550g Herba Taraxaci 300-1800g Radix Paeoniae Rubra 300-1800g
Radix Et Rhizoma Rhei (system) 200-1200g Radix Salviae Miltiorrhizae 300-1800g Rhizoma Polygoni Cuspidati 300-1800g
Fructus Toosendan (system) 300-1800g Rhizoma Corydalis (system) 300-1800g
Right amount of auxiliary materials is made 1000 bags altogether.
Its optimum formula is
RENKETENG 2250g Caulis Sargentodoxae 2250g Radix Glycyrrhizae 225g Folium Isatidis 450g Herba Taraxaci 675g
Radix Paeoniae Rubra 675g Radix Et Rhizoma Rhei (system) 450g Radix Salviae Miltiorrhizae 675g Rhizoma Polygoni Cuspidati 675g Fructus Toosendan (system) 675g
Rhizoma Corydalis (system) 675g right amount of auxiliary materials is made 1000 bags altogether.
Two, the scorching relaxation grain preparation technology of woman
Get the prescription Chinese crude drug and adopt suitable prepared to become granule, its preparation technology can adopt following technology, also can adopt other suitable technology.
11 flavor medicines cleaned respectively during technology one will be write out a prescription, and removed impurity, and it is standby to be up to the standards; Rhizoma Corydalis (system) is ground into fine powder; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati 60-95% ethanol extraction, seven flavors such as medicinal residues and all the other Caulis Loniceraes decoct with water, through being prepared from the scorching relaxation grain of woman.
Technology two is got in the prescription 11 flavor medicines and is cleaned respectively, removes impurity, and it is standby to be up to the standards; Get Rhizoma Corydalis (system) and use the 60-95% ethanol extraction; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati 60-95% ethanol extraction, seven flavors such as medicinal residues and all the other Caulis Loniceraes decoct with water, through being prepared from the scorching relaxation grain of woman.
11 flavor medicines cleaned respectively during technology three will be write out a prescription, and removed impurity, and it is standby to be up to the standards; Rhizoma Corydalis (system) is used acidic ethanol extraction; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati 60-95% ethanol extraction, seven flavors such as medicinal residues and all the other Caulis Loniceraes decoct with water, through being prepared from the scorching relaxation grain of woman.
Three, prepared by technology is the scorching relaxation grain of woman.
Rhizoma Corydalis can be ground into fine powder and uses in the prescription, also can adopt suitable technology to extract, can adopt alcohol extraction/first alcohol extraction again water carry/acidic ethanol extraction or other suitable technology extracts.Acidic ethanol is with the alcoholic solution of sour adjust pHs such as HAC/Hcl to each concentration of 4-5.
Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati can be ground into the fine powder application in the prescription, also can adopt suitable technology to extract, and can adopt alcohol extraction/first alcohol extraction technology that water is carried or other is suitable again to extract.
Seven flavors such as RENKETENG can take extraction process by water or other suitable technology to extract in the prescription.
The extraction process fit applications of above-mentioned each medicine is through being prepared from the scorching relaxation grain of woman.
Prepared granule is according to the difference of used adjuvant, can be made into the sugared type granule of Sugarless type/have.Added adjuvant can be in the technology: 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, starch, dextrin, sucrose, stevioside, Aspartane, magnesium stearate, essence or other suitable adjuvant one or more mix and use.
The technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, and the best is broken into 200-300 order fine powder for superfine powder.
The condition that decocting boils in the technology is: decoct 2-4 time, amount of water is doubly measured for the 6-15 of dose for the first time, and second and third time doubly measured for the 4-12 of dose, each 1-3 hour; The best is: decoct 3 times, amount of water is 10 times of amounts of dose for the first time, is 8 times of amounts of dose for the second time, 2 hours for the first time, and 1.5 hours for the second time, 1 hour for the third time.
The condition of alcohol extraction is for being solvent with 60-95% ethanol/acidic ethanol, with heating reflux method or percolation or other suitable method extraction in the technology.
Filterable method has direct influence to the size of dose in the technology, can adopt conventional to filter, centrifugal, ultrafiltration, add the method for filtrations/centrifugal/ultrafiltration behind the clarifier, the method that also can adopt other to suit.
Drying can adopt spray drying, vacuum drying or other suitable method in the technology.The vacuum drying temperature is controlled at 50-80 ℃, is preferably 60 ℃.Spray drying is for to be concentrated into extracting solution in right amount, and spray drying, inlet temperature are 100-200 ℃, leaving air temp 50-150 ℃; Best inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
The relative density of thick paste is 1.30-1.45 (60 ℃) in the technology, and the best is 1.35-1.40 (60 ℃).
The quality control of this product mainly is discriminating, inspection, three aspects of assay, on differentiating Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, Rhizoma Corydalis is carried out thin layer and differentiates; On checking to heavy metal must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths and carry out limit examine; On assay, Radix Paeoniae Rubra has been carried out quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes fully rationally, quality standard further improves, it is big to have overcome former dosage form dose, the deficiency of dysphagia, and have quick-acting advantages, enrich medicine variety, further satisfied and ensured people's medication demand.
The specific embodiment
Following embodiment can be for reference in order to further specify the present invention, but do not limit the scope of the invention thus.
Embodiment 1: 11 flavor medicines clean respectively in will writing out a prescription, and remove impurity, and it is standby to be up to the standards; Rhizoma Corydalis (system) is ground into fine powder, and is standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati extract secondary with alcohol heating reflux, each 2 hours.Merge extractive liquid, filters, and filtrate recycling ethanol is condensed into the thick paste that relative density is 1.35-1.40 (60 ℃), and is standby; Seven flavors such as medicinal residues and all the other Caulis Loniceraes decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into the thick paste that relative density is 1.35-1.40 (60 ℃), with above-mentioned thick paste and Rhizoma Corydalis fine powder mixing, dry, pulverize,, make granule with the appropriate amount of auxiliary materials mixing, drying, promptly.
Embodiment 2: get in the prescription 11 flavor medicines and clean respectively, remove impurity, it is standby to be up to the standards; Getting Rhizoma Corydalis (system), to be ground into fine powder standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati extract secondary with alcohol heating reflux, and each 2 hours, extracting solution filtered, and filtrate recycling ethanol is standby; Seven flavors such as medicinal residues and all the other Caulis Loniceraes decoct with water 3 times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate and the merging of said extracted liquid are concentrated into relative density 1.08 (60 ℃), and spray drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, granulate, drying, promptly.
Embodiment 3: 11 flavor medicines clean respectively in will writing out a prescription, and remove impurity, and it is standby to be up to the standards; Rhizoma Corydalis (system) is with 60% alcohol heating reflux three times, and each 1 hour, extracting solution was standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati extract secondary with alcohol heating reflux, and each 2 hours, above-mentioned two kinds of extracting solution filtered respectively, reclaim ethanol, and it is standby to be condensed into thick paste; The medicinal residues of Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati and all the other Caulis Loniceraes etc. seven flavor decocts with water 3 times, and 2 hours for the first time, second and third time 1 hour, collecting decoction filters, and it is standby to be condensed into thick paste; Above-mentioned thick paste merges and the appropriate amount of auxiliary materials mixing, and drying is pulverized, and with the appropriate amount of auxiliary materials mixing, makes granule, drying, promptly.
Embodiment 4: 11 flavor medicines clean respectively in will writing out a prescription, and remove impurity, and it is standby to be up to the standards; Rhizoma Corydalis (system), the acidic ethanol heating and refluxing extraction with 60% three times, each 1 hour, extracting solution was standby; Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati extract 2 times with alcohol heating reflux, and each 2 hours, above-mentioned two kinds of extracting solution filtered respectively, reclaim ethanol, are concentrated into standby in right amount; Seven flavors such as the medicinal residues of Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati and all the other Caulis Loniceraes decoct with water 3 times, and 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filters, and is concentrated into an amount of, with above-mentioned concentrated solution mixing, spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, makes granule, drying, promptly.

Claims (8)

1. scorching relaxation grain of a woman and preparation method is characterized in that:
(1) Rhizoma Corydalis is ground into the fine powder application in the prescription, and employing alcohol extraction/first alcohol extraction water is again carried/acidic ethanol extraction.
(2) Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Rhizoma Polygoni Cuspidati can be ground into the fine powder application in the prescription, and employing alcohol extraction/first alcohol extraction water is again carried.
(3) RENKETENG, Caulis Sargentodoxae, Radix Glycyrrhizae, Folium Isatidis, Herba Taraxaci, Radix Et Rhizoma Rhei, Fructus Toosendan seven flavors take extraction process by water to extract in the prescription.
(4) above-mentioned each medicine through extract, filter, concentrate, dry, add adjuvant and be prepared from the scorching relaxation grain of woman.
2. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that:, can be made into the sugared type granule of Sugarless type/have according to the difference of used adjuvant; Added adjuvant can be a 30 POVIDONE K 30 BP/USP in the technology 30, micropowder silica gel, starch, dextrin, sucrose, Aspartane, magnesium stearate, essence be a kind of/multiple mixing uses.
3. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: the technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, and the best is broken into 200-300 order fine powder for superfine powder.
4. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: the dry spray drying/vacuum drying method that adopts in the technology; The vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃, and spray drying is for to be concentrated into extracting solution in right amount, and spray drying, inlet temperature are 100-200 ℃, leaving air temp 50-150 ℃; Best inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
5. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: filter the method that adopts filtration behind conventional filtrations/centrifugal/ultrafiltration/add clarifier, centrifugal, ultrafiltration in the technology.
6. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: the condition that decocting boils in the technology is: decoct 2-4 time, amount of water is doubly measured for the 6-15 of dose for the first time, and second and third time doubly measured for the 4-12 of dose, each 1-3 hour.
7. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: the condition of alcohol extraction is extracted with heating reflux method/percolation for being solvent with 60-95% ethanol/acidic ethanol in the technology.
8. according to scorching relaxation grain of the described woman of claim 1 and preparation method, it is characterized in that: on quality control standard, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, Rhizoma Corydalis are carried out thin layer and differentiate; Have that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; The Radix Paeoniae Rubra detection by quantitative is arranged.
CN 03124606 2003-06-25 2003-06-25 Gynecological inflammation treating powder and its preparation Pending CN1565496A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101057894B (en) * 2006-04-21 2010-05-12 北京因科瑞斯生物制品研究所 Traditional Chinese medicine preparation for curing gynecologic and its preparation method
CN106692089A (en) * 2017-01-11 2017-05-24 恒拓集团广西圣康制药有限公司 Gynecologic inflammation relieving tablets and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101057894B (en) * 2006-04-21 2010-05-12 北京因科瑞斯生物制品研究所 Traditional Chinese medicine preparation for curing gynecologic and its preparation method
CN106692089A (en) * 2017-01-11 2017-05-24 恒拓集团广西圣康制药有限公司 Gynecologic inflammation relieving tablets and preparation method thereof
CN106692089B (en) * 2017-01-11 2020-05-12 恒拓集团广西圣康制药有限公司 Fuyanshu tablet and its preparation method

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