CN105287703A - Preparation method of Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation) - Google Patents
Preparation method of Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation) Download PDFInfo
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- CN105287703A CN105287703A CN201510662632.9A CN201510662632A CN105287703A CN 105287703 A CN105287703 A CN 105287703A CN 201510662632 A CN201510662632 A CN 201510662632A CN 105287703 A CN105287703 A CN 105287703A
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Abstract
The invention belongs to the field of pharmacy, and in particular relates to a Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation). The effervescent tablet is prepared from the following traditional Chinese medicinal raw materials and adjuvant materials: 500g of radix sophorae flavescentis, 400g of picrasma quassioides, 400g of fructus cnidii, 100g of dried alum, 5g of pearl layer powder, 10g of borneol, 4g of menthol, 40g of berberine hydrochloride and 60g of boric acid; and the adjuvant materials include the following components: an acid agent, an alkaline agent, a filling agent, a disintegrating agent and a lubricating agent. The preparation method, during preparing, is subject to a tablet cultivating technology, so that the stability of a finished product is effectively improved.
Description
Technical field
The invention belongs to pharmaceutical field, relate to one and treat colpitic effervescent tablet and preparation method thereof, be specifically related to a kind of FUYANPING vagina effervescence and preparation method thereof.
Technical background
Vaginitis and colpitis.Normal healthy women vagina has nature defense function due to the intrusion of feature to pathogen of anatomical tissue.As closing of vaginal orifice, vagina front and rear wall is close to, the hypertrophy of vaginal epithelial cell under estrogenic impact and cells of superficial layer keratinization, vagina acid-base degree keeps balance, the breeding of the pathogen of adaptation alkalescence is suppressed, and neck tube mucus is in alkalescence, when the natural defense function of vagina is damaged, pathogen is easy to invade, and causes colpitis.
Vaginitis is common gynaecopathia.Although the medicine for the treatment of this kind of disease has a variety of, effect is not very desirable.By Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae, Fructus Cnidii, dried Alumen, Margarita layer powder, Borneolum Syntheticum, Mentholum, berberine hydrochloride, the FUYANPING preparation that the compositions such as boric acid are combined into, therapeutic effect is more outstanding, and it has heat-clearing and toxic substances removing, dampness leukorrhagia stopping, killing parasites for relieving itching.For dampness-heat of the liver, profuse leukorrhea, yellow skin is as pus, or in foam water from washing rice sample, its gas is smelt as of rotten fish, pudendum flushing, and swelling is itched pain, vexedly sleeps less, and bitter taste breast is vexed; Infusorian, fungus, bacterial vaginitis, vulvitis are shown in above-mentioned sign person.
Product sold comprises in the market, FUYANPING is fallen apart, fuyanping capsules, the dosage forms such as FUYANPING vagina effervescence, through carrying out experimentation to existing FUYANPING vagina effervescence, we find that FUYANPING vagina effervescence exists a lot of problem in process of production, comprise sticking, sliver, hardness is inadequate, there is the phenomenon of aerogenesis at storage period, thus made product unstable, finally have influence on the quality of product and the safety of medicine.
For this reason, the present invention, by adjusting FUYANPING vagina effervescence preparation method, effectively can improve the stability of FUYANPING vagina effervescence, effectively solves aerogenesis often appears in product problem at storage period, make effervescent tablet have lasting gas release, improve the quality of products and curative effect.
Summary of the invention
The object of the invention is to provide the features such as one treats colpitic effervescent tablet, and it is good that this effervescent tablet has quality stability, evident in efficacy.
FUYANPING vagina effervescence of the present invention, passes through mixing by acid particles and alkali grain, makes after tabletting:
The prescription of FUYANPING:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 90-110g
Alkaline agent 100-120g
Filler 160-170g
The preparation of FUYANPING effervescent tablet: after acid particles and alkali grain mixing, add Mentholum and Borneolum Syntheticum, adding
Enter lubricant and fluidizer, after tabletting, make FUYANPING vagina effervescence;
Wherein, the preparation of described dried cream powder:
Get 500g Radix Sophorae Flavescentis, 400g Ramulus Et Folium Picrasmae and 200g Fructus Cnidii and be ground into middle powder, according to the percolation under Chinese Pharmacopoeia version in 2010 annex I O extractum and fluid extract item, with ethanol as solvent, percolation, collect percolate, reclaim ethanol and be condensed into thick paste, adding 40g berberine hydrochloride, 5g Margarita layer powder and appropriate disintegrating agent, mix thoroughly, dry, for subsequent use, obtain dried cream powder
Wherein, sour agent is selected from: citric acid, citric acid, tartaric acid, the one in malic acid or two or more;
Wherein, alkaline agent is selected from: sodium bicarbonate, a kind of or two or more in sodium carbonate;
Wherein, filler is selected from: starch, dextrin, pregelatinized Starch, microcrystalline Cellulose, the one in sucrose or two or more;
Wherein, disintegrating agent is selected from: carboxymethyl starch is received, cross-linked pvp, cross-linking sodium carboxymethyl cellulose, the one in hyprolose or two or more;
Wherein, lubricant is selected from: magnesium stearate, the one in Pulvis Talci or two or more;
Wherein, fluidizer is selected from: micropowder silica gel.
Concrete, effervescent tablet of the present invention, passes through mixing by acid particles and alkali grain, makes after tabletting:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 100g
Alkaline agent 110g
Filler 165g.
Preferably, effervescent tablet of the present invention, passes through mixing by acid particles and alkali grain, makes after tabletting:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 90-110g
Sodium bicarbonate 100-120g
Pregelatinized Starch and microcrystalline Cellulose 160-170g.
Preferred further, effervescent tablet of the present invention, passes through mixing by acid particles and alkali grain, makes after tabletting:
FUYANPING vagina effervescence prescription is as follows:
The formula of acid particles
The formula of alkali grain:
Preparation technology:
Acid particles is mixed with alkali grain, after mixing, sprays into Borneolum Syntheticum and Mentholum ethanol, after adding 15g micropowder silica gel mixing, add 4.5g magnesium stearate mixed pressuring plate;
Support sheet: be placed with by slice, thin piece in the hermetic container of dry discolour silica gel, place 5 days foster sheets, packaging, to obtain final product;
Wherein, the preparation technology of acid particles: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain granulates;
Wherein, the preparation technology of alkali grain: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain alkali granule;
Wherein, the preparation technology of dried cream powder:
Get 500g Radix Sophorae Flavescentis, 400g Ramulus Et Folium Picrasmae and 200g Fructus Cnidii and be ground into middle powder, according to the percolation under Chinese Pharmacopoeia version in 2010 annex I O extractum and fluid extract item, with ethanol as solvent, percolation, collect percolate, reclaim ethanol and be condensed into thick paste, add 40g berberine hydrochloride, 5g Margarita layer powder and carboxymethyl starch sodium, mix thoroughly, dry, for subsequent use, obtain dried cream powder.
Another object of the present invention is the preparation method providing vagina effervescence.
Preparation method of the present invention, comprises the following steps: by acid particles, and alkali grain mixes, and adds Mentholum and Borneolum Syntheticum, adds lubricant and fluidizer, tabletting, supports sheet, packaging.
Wherein, the preparation of acid particles of the present invention:
Above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain acid particles.
Wherein, the preparation of alkali grain of the present invention:
Above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain alkali grain.
Preferably, the preparation method of vagina effervescence of the present invention, be processed into by following composition:
FUYANPING vagina effervescence prescription is as follows:
The formula of acid particles
The formula of alkali grain:
Preparation technology:
Acid particles is mixed with alkali grain, after mixing, sprays into Borneolum Syntheticum and Mentholum ethanol, after adding 15g micropowder silica gel mixing, add 4.5g magnesium stearate mixed pressuring plate;
Support sheet: be placed with by slice, thin piece in the hermetic container of dry discolour silica gel, place 5 days foster sheets, packaging, to obtain final product;
Wherein, the preparation technology of acid particles: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain granulates;
Wherein, the preparation technology of alkali grain: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain alkali granule;
Wherein, the preparation technology of dried cream powder:
Get 500g Radix Sophorae Flavescentis, 400g Ramulus Et Folium Picrasmae and 200g Fructus Cnidii and be ground into middle powder, according to the percolation under Chinese Pharmacopoeia version in 2010 annex I O extractum and fluid extract item, with ethanol as solvent, percolation, collect percolate, reclaim ethanol and be condensed into thick paste, add 40g berberine hydrochloride, 5g Margarita layer powder and carboxymethyl starch sodium, mix thoroughly, dry, for subsequent use, obtain dried cream powder.
Preparation method of the present invention is not limited to above-mentioned preparation method.
The research of chip technology supported by effervescent tablet of the present invention
Put in exsiccator by FUYANPING effervescent tablet, effervescent tablet is put into quicklime, the desiccant such as discolour silica gel, airtightly carry out foster sheet, foster sheet completes to be packed.This desiccant is not limited to quicklime, and discolour silica gel etc. absorb the material of moisture, and also comprising other can other dehydration material, and the moisture absorption in slice, thin piece is fallen by its principle, and then keeps the low moisture of slice, thin piece, then packs.Other dehydrant as concentrated sulphuric acid, dehydrant, the dehydration such as dewatering screen material.
The preparation of solution:
The preparation of Borneolum Syntheticum and Mentholum ethanol: by joining in ethanol after Borneolum Syntheticum and Mentholum mixing, to obtain final product.
Preparation containing 6% polyvidone PVPK30 alcoholic solution of 3% polyoxyethylene sorbitan monoleate: get 12gPVPK30 and add ethanol to 194g stirring and dissolving, then add 6g polyoxyethylene sorbitan monoleate stirring and dissolving, to obtain final product.
Beneficial effect of the present invention is further illustrated below by way of experimental data:
Experiment one, stability experiment
The medicine prepared according to the method for the embodiment of the present invention 1 carries out Acceleration study, accelerates 6 months, the result of detection following (lot number: 20141201):
Experiment two, comparative experiments:
Experimental group: the FUYANPING vagina effervescence of the embodiment of the present invention 1
Matched group: the FUYANPING vagina effervescence that existing market is sold
Experimental result shows: the effervescent tablet of matched group exists and there are problems, sticking, sliver after placing for a long time, and hardness is inadequate, has occurred the phenomenon of aerogenesis, greatly reduce the stability of product at storage period.
Comparatively speaking, effervescent tablet stability of the present invention is better, does not occur the phenomenon of aerogenesis, and makes effervescent tablet have lasting gas release, effectively improve the quality of products and stability at storage period, prolongation medicine
Shelf-life.
Experiment three, recipe determination experiment
According to gas release, hardness, the fineness on surface carries out comprehensive grading, and prescription 2 score value is the highest, effervescent tablet best in quality.
FUYANPING vagina effervescence of the present invention, relative to existing product, has the following advantages:
1, along with the time lengthening of foster sheet, gas release is higher.
2, effectively product hardness is improved, pressing plate of being more convenient for.
3, effectively aerogenesis problem in product storage is solved.
4, in order to reduce costs, adopt discolour silica gel, can put into baking oven and toast, Reusability when discolour silica gel color reddens, rest the sheet time is decided to be 5 days simultaneously.Certainly be not limited to 6 days, 7 days, or the time is longer, viewed from this test, taked by slice, thin piece desiccant by moisture absorption slice, thin piece, effervescent tablet obtains beyond thought result, and its effervescent effect is more remarkable, in clinical practice, the gas release of slice, thin piece more strengthens, and is conducive to the curative effect improving medicine.
Concrete enforcement technical approach
By following specific embodiment, the present invention is further illustrated, but not as restriction of the present invention.
Embodiment 1
FUYANPING vagina effervescence prescription is as follows:
Above nine tastes, get Radix Sophorae Flavescentis, Ramulus Et Folium Picrasmae and Fructus Cnidii 200g and be ground into middle powder, according to the percolation (Chinese Pharmacopoeia version in 2010 annex I O) under extractum and fluid extract item, use 80% ethanol as solvent, flood after 48 hours, carry out percolation with the speed of 3ml/kgmin, collect percolate, reclaim ethanol and be condensed into thick paste, add berberine hydrochloride, Margarita layer powder and carboxymethyl starch sodium, mix thoroughly, 80 DEG C of oven dry, for subsequent use; Obtain dried cream powder.
Technique
Acid particles
The preparation technology of granulates: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain granulates.
Alkali grain
The preparation technology of alkali granule: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain alkali granule.
Tabletting: mixed with alkali granule by granulates, after mixing, sprays into Borneolum Syntheticum and Mentholum ethanol, after adding 15g micropowder silica gel mixing, adds 4.5g magnesium stearate mixed pressuring plate.Slice, thin piece is placed with in the hermetic container of dry discolour silica gel, places 5 days foster sheets, packaging.
Claims (9)
1. a FUYANPING vagina effervescence, passes through mixing by acid particles and alkali grain, makes after tabletting:
The prescription composition of FUYANPING:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 90-110g
Alkaline agent 100-120g
Filler 160-170g
The preparation of FUYANPING effervescent tablet: after acid particles and alkali grain mixing, add Mentholum and Borneolum Syntheticum, adding lubricant and fluidizer, making FUYANPING vagina effervescence after tabletting;
Wherein, the preparation of described dried cream powder:
Get 500g Radix Sophorae Flavescentis, 400g Ramulus Et Folium Picrasmae and 200g Fructus Cnidii and be ground into middle powder, according to the percolation under Chinese Pharmacopoeia version in 2010 annex I O extractum and fluid extract item, with ethanol as solvent, percolation, collect percolate, reclaim ethanol and be condensed into thick paste, adding 40g berberine hydrochloride, 5g Margarita layer powder and appropriate disintegrating agent, mix thoroughly, dry, for subsequent use, obtain dried cream powder
Wherein, sour agent is selected from: citric acid, citric acid, tartaric acid, the one in malic acid or two or more;
Wherein, alkaline agent is selected from: sodium bicarbonate, a kind of or two or more in sodium carbonate;
Wherein, filler is selected from: starch, dextrin, pregelatinized Starch, microcrystalline Cellulose, the one in sucrose or two or more;
Wherein, disintegrating agent is selected from: carboxymethyl starch is received, cross-linked pvp, cross-linking sodium carboxymethyl cellulose, the one in hyprolose or two or more;
Wherein, lubricant is selected from: magnesium stearate, the one in Pulvis Talci or two or more;
Wherein, fluidizer is selected from: micropowder silica gel.
2. vagina effervescence according to claim 1, is characterized in that, passes through mixing, make after tabletting by acid particles and alkali grain:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 100g
Alkaline agent 110g
Filler 165g.
3. vagina effervescence according to claim 1, is characterized in that, passes through mixing, make after tabletting by acid particles and alkali grain:
The formula of acid particles:
The formula of alkali grain:
Dried cream powder 90-110g
Sodium bicarbonate 100-120g
Pregelatinized Starch and microcrystalline Cellulose 160-170g.
4. vagina effervescence according to claim 1, is characterized in that, passes through mixing, make after tabletting by acid particles and alkali grain:
The formula of acid particles:
The formula of alkali grain:
5. the preparation method of the vagina effervescence of claim 1, is characterized in that, comprises the following steps: by acid particles, and alkali grain mixes, and adds Mentholum and Borneolum Syntheticum, adds lubricant and fluidizer, tabletting, supports sheet, packaging.
6. the preparation method of vagina effervescence according to claim 5, is characterized in that, the preparation of acid particles: mixed by above powder, add 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain acid particles.
7. the preparation method of vagina effervescence according to claim 5, is characterized in that, the preparation of alkali grain: mixed by above powder, add 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, and 75 DEG C of oven dry, 14 order granulate, obtain alkali grain.
8. the preparation method of vagina effervescence according to claim 5, is characterized in that, is processed into by following composition:
FUYANPING vagina effervescence prescription is as follows:
The formula of acid particles
The formula of alkali grain:
Preparation technology:
Acid particles is mixed with alkali grain, after mixing, sprays into Borneolum Syntheticum and Mentholum ethanol, after adding 15g micropowder silica gel mixing, add 4.5g magnesium stearate mixed pressuring plate;
Support sheet: be placed with by slice, thin piece in the hermetic container of dry discolour silica gel, place 5 days foster sheets, packaging, to obtain final product;
Wherein, the preparation technology of acid particles: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain granulates;
Wherein, the preparation technology of alkali grain: above powder is mixed, adds 6% 30 POVIDONE K 30 BP/USP containing 3% polyoxyethylene sorbitan monoleate
30alcoholic solution soft material, 16 orders are granulated, 75 DEG C of oven dry, and 14 order granulate, obtain alkali granule;
Wherein, the preparation technology of dried cream powder:
Get 500g Radix Sophorae Flavescentis, 400g Ramulus Et Folium Picrasmae and 200g Fructus Cnidii and be ground into middle powder, according to the percolation under Chinese Pharmacopoeia version in 2010 annex I O extractum and fluid extract item, with ethanol as solvent, percolation, collect percolate, reclaim ethanol and be condensed into thick paste, add 40g berberine hydrochloride, 5g Margarita layer powder and carboxymethyl starch sodium, mix thoroughly, dry, for subsequent use, obtain dried cream powder.
9. the preparation method of vagina effervescence according to claim 5, it is characterized in that, preparation method is as follows: effervescent tablet is put into quicklime, the desiccant such as discolour silica gel, airtightly carries out foster sheet, foster sheet completes to be packed, this desiccant is not limited to quicklime, and discolour silica gel etc. absorb the material of moisture, and also comprising other can other dehydration material, moisture absorption in slice, thin piece is fallen by its principle, and then keeps the low moisture of slice, thin piece; As: concentrated sulphuric acid, dehydrant, the dehydration such as dewatering screen material.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510662632.9A CN105287703A (en) | 2015-10-14 | 2015-10-14 | Preparation method of Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation) |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510662632.9A CN105287703A (en) | 2015-10-14 | 2015-10-14 | Preparation method of Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation) |
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| CN105287703A true CN105287703A (en) | 2016-02-03 |
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| CN201510662632.9A Pending CN105287703A (en) | 2015-10-14 | 2015-10-14 | Preparation method of Fuyanpingyindao effervescent tablet (applied to vagina for relieving gynecological inflammation) |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102335229A (en) * | 2011-09-26 | 2012-02-01 | 江西济民可信药业有限公司 | Preparation method of gynecological inflammation clearing vaginal effervescent tablet |
| US20130028844A1 (en) * | 2010-01-29 | 2013-01-31 | Mahmut Bilgic | Preparations for effervescent formulations comprising cephalosporin and uses thereof |
-
2015
- 2015-10-14 CN CN201510662632.9A patent/CN105287703A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20130028844A1 (en) * | 2010-01-29 | 2013-01-31 | Mahmut Bilgic | Preparations for effervescent formulations comprising cephalosporin and uses thereof |
| CN102335229A (en) * | 2011-09-26 | 2012-02-01 | 江西济民可信药业有限公司 | Preparation method of gynecological inflammation clearing vaginal effervescent tablet |
Non-Patent Citations (1)
| Title |
|---|
| 杨明: "《中药药剂学》", 3 July 2012, 中国中医药出版社 * |
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Application publication date: 20160203 |