CN104491304A - Gynecological vaginal discharge prevention tablet and preparation method thereof - Google Patents

Gynecological vaginal discharge prevention tablet and preparation method thereof Download PDF

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Publication number
CN104491304A
CN104491304A CN201410731930.4A CN201410731930A CN104491304A CN 104491304 A CN104491304 A CN 104491304A CN 201410731930 A CN201410731930 A CN 201410731930A CN 104491304 A CN104491304 A CN 104491304A
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China
Prior art keywords
carbon dioxide
ground
extracting solution
dry
discharge prevention
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CN201410731930.4A
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Chinese (zh)
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不公告发明人
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Priority to CN201410731930.4A priority Critical patent/CN104491304A/en
Publication of CN104491304A publication Critical patent/CN104491304A/en
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Abstract

The invention discloses a gynecological vaginal discharge prevention tablet and a preparation method thereof. The gynecological vaginal discharge prevention tablet is characterized by being prepared by the following steps: taking 128g of caltrop, 8g of folium artemisiae argyi, 363g of cortex ailanthi, 363g of golden cypress, 363g of poria cocos, 120g of colla corii asini and 363g of Chinese yam; extracting by using a CO2 super critical extraction method; drying at a reduced pressure; crushing into a nano dry paste by using a high-performance nanoimpact mill; and adding functional auxiliary materials to prepare the gynecological vaginal discharge prevention tablet. The disintegration time of the prepared gynecological vaginal discharge prevention tablet is remarkably shortened, and the curative effect is remarkably superior to that of a marketed gynecological vaginal discharge prevention tablet, so that a positive effect is obtained.

Description

A kind of FUKE ZHIDAI PIAN and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of FUKE ZHIDAI PIAN and preparation method thereof.
Background technology
FUKE ZHIDAI PIAN heat clearing and damp drying, convergence leukorrhagia stopping.For chronic cervicitis, the damp-heat type red and white leukorrhea disease that endometritis encolpitis etc. causes.Commercially available FUKE ZHIDAI PIAN is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides FUKE ZHIDAI PIAN that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 130 ~ 170g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained FUKE ZHIDAI PIAN 1000.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Fructus Tribuli: China's coastal port one ministerial standard.This product is the dry mature fruit of zygophyllaceae plant Fructus Tribuli Tribulus terrestris L..Tap plant during fruit maturation in autumn, dry, lay fruit, removing impurity.
Folium Artemisiae Argyi: China's coastal port one ministerial standard.This product is the dried leaves of feverfew Chinese mugwort Artemisia argyi Levi.et Vant..Pluck when summer, flower was not opened, removing impurity, dries.
Cortex Ailanthi: China's coastal port one ministerial standard.This product is quassia ailanthus altissima (mill.) swingle Ailanthus altissima(Mill.) the dry root bark of Swingle or dried bark.The whole year all can strip, and dries, or scrapes off rough bark and dry.
Cortex Phellodendri: China's coastal port one ministerial standard.This product is the dry bark of rutaceae wampee Phellodendron chinenseSchneid..Practise and claim " Cortex Phellodendri ".After stripping bark, removing rough bark, dries.
Poria: China's coastal port one ministerial standard.This product is On Polyporaceae Poria Poria cocos(Schw.) dry sclerotia of Wolf.Excavate more than the 7-9 month, dig out rear removing silt, bank up after " diaphoresis ", spread out and dry in the air to dry tack free, then " diaphoresis ", after extremely now scatter and disappear in wrinkle, the large portion of internal moisture for several times repeatedly, dry in the shade, be called " Poria "; Or fresh Poria is pressed different parts cutting, cloudy in, be called " Cortex Sclerotii Poriae " and " Poria block ".
Colla Corii Asini: China's coastal port one ministerial standard.This product be the dry skin of equine species donkey Equus asinus L. or Cortex Dictamni through decocting, the concentrated solid gum made.
Rhizoma Dioscoreae: China's coastal port one ministerial standard.This product is the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea opposita Thunb..Winter, stem and leaf was excavated after withering, and cut macroradical head, cleaned, and removing crust and fibrous root are dry; Also have and select loose straight dry Rhizoma Dioscoreae, put in clear water, be dipped into without the dry heart, vexed, trim two ends, be twisted into plank cylindric, dry, polishing, practise and claim " light yam ".
Fructose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Pregelatinized Starch: Chinese Pharmacopoeia version two ministerial standard in 2010.
Crospolyvinylpyrrolidone: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Hypromellose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Micropowder silica gel: Chinese Pharmacopoeia version two ministerial standard in 2010.
Leucine: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above FUKE ZHIDAI PIAN all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Four detailed description of the invention
Specific embodiments of the invention 1
Get Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 15Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow 20L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 130g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 35g, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, micropowder silica gel 15g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional leucine 7g, granulate, tabletting, obtained FUKE ZHIDAI PIAN 1000.
Specific embodiments of the invention 2
Get Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 25Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 170g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 45g, hypromellose 35g, micropowder silica gel 25g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional leucine 9g, granulate, tabletting, obtained FUKE ZHIDAI PIAN 1000.
Specific embodiments of the invention 3
Get Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 150g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 40g, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional leucine 8g, granulate, tabletting, obtained FUKE ZHIDAI PIAN 1000.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make FUKE ZHIDAI PIAN.Actual effect of the present invention is investigated below with the FUKE ZHIDAI PIAN that embodiment 3 is obtained:
(1) embodiment 3 FUKE ZHIDAI PIAN and commercially available FUKE ZHIDAI PIAN contrast disintegration
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 FUKE ZHIDAI PIAN and commercially available FUKE ZHIDAI PIAN contrast table disintegration
The above results shows, FUKE ZHIDAI PIAN prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available FUKE ZHIDAI PIAN.
(2) embodiment 3 FUKE ZHIDAI PIAN and commercially available FUKE ZHIDAI PIAN treat chronic cervicitis, the damp-heat type red and white leukorrhea disease clinical observation on the therapeutic effect that endometritis encolpitis etc. causes
1 case scenario
Statistics outpatient service and inpatient, observe chronic cervicitis altogether, damp-heat type red and white leukorrhea disease case 100 example that endometritis encolpitis etc. causes, 60 years old mean age.Patient is divided into two groups, test group takes embodiment 3 FUKE ZHIDAI PIAN, and matched group takes commercially available FUKE ZHIDAI PIAN.
2 efficacy assessment standards
According to new Chinese medicine guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 FUKE ZHIDAI PIAN and commercially available FUKE ZHIDAI PIAN clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, FUKE ZHIDAI PIAN prepared by the present invention is in treatment chronic cervicitis, evident in efficacy higher than commercially available FUKE ZHIDAI PIAN during the damp-heat type red and white leukorrhea disease that endometritis encolpitis etc. causes, p < 0.05.

Claims (3)

1. a treatment chronic cervicitis, the Chinese medicine of the damp-heat type red and white leukorrhea disease that endometritis encolpitis etc. causes, it is characterized in that getting Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 130 ~ 170g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained FUKE ZHIDAI PIAN.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 130 ~ 170g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained FUKE ZHIDAI PIAN.
3. the preparation method of Chinese medicine according to claim 1, gets Fructus Tribuli 128g, Folium Artemisiae Argyi 8g, Cortex Ailanthi 363g, Cortex Phellodendri 363g, Poria 363g, Colla Corii Asini 120g, Rhizoma Dioscoreae 363g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add fructose 130 ~ 170g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, pregelatinized Starch 35 ~ 45g, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained FUKE ZHIDAI PIAN.
CN201410731930.4A 2014-12-06 2014-12-06 Gynecological vaginal discharge prevention tablet and preparation method thereof Withdrawn CN104491304A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105748886A (en) * 2016-04-08 2016-07-13 广州暨南生物医药研究开发基地有限公司 Folium artemisiae argyi-containing pharmaceutical composition for treating endometritis and preparation method thereof
CN107823379A (en) * 2017-11-20 2018-03-23 贵州浩诚药业有限公司 Gynaecologic leucorrhea removing agent and preparation method thereof
CN109528486A (en) * 2019-01-15 2019-03-29 河南羚锐制药股份有限公司 A kind of self-heating smoke-less moxibustion plaster

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105748886A (en) * 2016-04-08 2016-07-13 广州暨南生物医药研究开发基地有限公司 Folium artemisiae argyi-containing pharmaceutical composition for treating endometritis and preparation method thereof
CN107823379A (en) * 2017-11-20 2018-03-23 贵州浩诚药业有限公司 Gynaecologic leucorrhea removing agent and preparation method thereof
CN109528486A (en) * 2019-01-15 2019-03-29 河南羚锐制药股份有限公司 A kind of self-heating smoke-less moxibustion plaster

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Application publication date: 20150408