CN102764319A - Traditional Chinese medicine vagina effervescent tablets for curing cervical erosion of women and preparation method thereof - Google Patents
Traditional Chinese medicine vagina effervescent tablets for curing cervical erosion of women and preparation method thereof Download PDFInfo
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Abstract
The invention discloses traditional Chinese medicine vagina effervescent tablets for curing cervical erosion of women and a preparation method thereof. The effervescent tablets mainly comprise sophora flavescens, alum, bitter apricot seeds and borneol. The accessories comprise calcium sulfate, ethyl cellulose, hydroxypropyl cellulose, citric acid, sodium bicarbonate and povidone K30. The preparation method includes firstly producing the main raw materials into powder as required, then mixing the powder with the accessories, and performing granulation and performing to obtain the finished product. The traditional Chinese medicine vagina effervescent tablets have effects of clearing heat and drying damp, and removing slough and promoting growth of tissue regeneration; not only have antibacterial and anti-inflammation effects on inflammation caused by cervical erosion, can effectively promote growth of cervix epithelial cells and healing of erosion surfaces through effects of slough removing, growth of tissue regeneration promotion and astriction, so that principal and subordinate symptoms are cured simultaneously; and are safe and reliable in use and have no obvious adverse reactions or toxic and side effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine, especially a kind of Chinese medicine vagina effervescence of treating cervical erosion also relates to its preparation method.
Background technology
Cervical erosion is one of modal a kind of gynaecopathia of the women of child-bearing age, also is the principal disease that threatens WomanHealth.Doctor trained in Western medicine thinks that cervical erosion is not a kind of independently disease, but a kind of form of expression of chronic cervicitis, therefore, western medicine is main with anti-inflammation, and it is cured the symptoms, not the disease often, causes disease to be shown effect repeatedly, and often uses antibiotics, and side effect is bigger.According to theory of Chinese medical science, this disease belongs to the category of leukorrheal diseases, and its paathogenic factor mainly contains: insufficiency of the spleen mistake fortune, downward flow of dampness; It is not solid to suffer from a deficiency of the kidney, three aspects of Yu Huare in hyperactivity of fire caused by deficiency of YIN and the damp, and its symptom mainly contains: profuse leukorrhea, the matter thickness, shape that has such as foam, shape that has such as bean dregs or curdled milk, abnormal smells from the patient is smelly dirty, and pudendal pruritus is arranged more.The method of many clinically employing treating both the principal and secondary aspects of a disease is treated, and can play unique curative effect.The many of cervical erosion of Chinese medicine vagina administration treatment at present are main with traditional suppository, and effervescent formulation seldom.
Summary of the invention
For mostly the preparation that solves present Chinese medicine vagina administration treatment cervical erosion is suppository is main problem; The present invention provides a kind of can reach the Chinese medicine vagina effervescence of the treatment cervical erosion of treating both the principal and secondary aspects of a disease for cervical erosion, and its preparation method also is provided.
The technical scheme that the present invention adopts is: a kind of Chinese medicine vagina effervescence of treating cervical erosion is characterized in that: it is following whenever to process the required main raw materials in proportion of 1000 Chinese medicine vagina effervescence:
Radix Sophorae Flavescentis 1200g～2000g Alumen 150g～250g
Semen Armeniacae Amarum 100g～150g Borneolum Syntheticum 3g～8g
The Chinese medicine vagina effervescence of said treatment cervical erosion, the optimum ratio of whenever processing 1000 the required primary raw material of Chinese medicine vagina effervescence is:
Radix Sophorae Flavescentis 1600g Alumen 200g Semen Armeniacae Amarum 130g Borneolum Syntheticum 5g
The Chinese medicine vagina effervescence of said treatment cervical erosion, it is following whenever to process the required ratio of adjuvant of 1000 Chinese medicine vagina effervescence:
The Chinese medicine vagina effervescence of said treatment cervical erosion, it is following whenever to process the required ratio of adjuvant of 1000 Chinese medicine vagina effervescence:
Calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g, citric acid 240g,
Sodium bicarbonate 180g, polyvidone (K30) 2g, micropowder silica gel 10g, magnesium stearate 10g
The method for preparing of the Chinese medicine vagina effervescence of said treatment cervical erosion is characterized in that:
A. get Radix Sophorae Flavescentis powder and be broken into coarse powder, make solvent, flood after 24 hours, carry out percolation with 1% hydrochloric acid solution; Collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well, it is colourless to be washed with water to cleaning mixture, neutralizes with 0.2mol/L sodium hydroxide solution 250ml; 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide is collected 8 times of amount eluents, is neutralized to neutrality with 2% hydrochloric acid solution, reclaims ethanol; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use;
B. get Alumen and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use;
C. get Semen Armeniacae Amarum and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use;
D. get Borneolum Syntheticum and pulverize, cross 100 mesh sieves, subsequent use;
E. get citric acid 65 ℃ of oven dry in baking oven, pulverize, cross 100 mesh sieves, subsequent use;
F. polyvidone (K30) is used anhydrous alcohol solution, is mixed with 5% solution, and is subsequent use;
G. get Radix Sophorae Flavescentis extract 16g (being equivalent to crude drug 1600g), alumen powder 200g, Semen Armeniacae Amarum powder 130g, calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g mixing, put in the baking oven in 65 ℃ of bakings 4 hours, taking-up; Add citric acid 240g, sodium bicarbonate 180g again, stir, be sprayed on the granule with 40ml5% polyvidone (K30) ethanol solution; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds Borneolum Syntheticum powder 5g, micropowder silica gel 10g, magnesium stearate 10g again; Mixing is pressed into 1000, promptly gets product of the present invention.
The vagina effervescence that principal agent consumption that more than provides and supplementary product consumption scope are processed, its product quality all can meet the quality standard of formulating with reference to (appendix ID tablet) regulation of Chinese Pharmacopoeia (version in 2010).
The beneficial effect that adopts technical scheme provided by the invention to reach is: the Chinese medicine vagina effervescence that the present invention treats cervical erosion has the effect of heat clearing and damp drying, putrefaction-removing granulation-promoting; The inflammation that not only cervical erosion is caused has the effect of anti-inflammation; And can effectively promote the growth of cervical epithelial cells and the healing of rotten to the corn face through putrefaction removing, granulation promoting and astriction, reach the effect of treating both the principal and the secondary aspects of a disease at the same time.And the present invention is safe and reliable, no obvious adverse reaction or toxic and side effects.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail:
The primary raw material that the present invention treats the Chinese medicine vagina effervescence employing of cervical erosion is common raw material of Chinese medicine, and raw material sources are extensive, are easy to obtain, and the required primary raw material of Chinese medicine vagina effervescence of whenever processing 1000 is by weight ratio:
Sophora 1200g ~ 2000g Alum (calcined) 150g ~ 250g Bitter almond (Dan) 100g ~ 150g Borneol 3g ~ 8g.
The performance of raw material and effect are following in the above-mentioned prescription:
Radix Sophorae Flavescentis: be the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flauescens Ait..Nature and flavor: hardship, cold.Gui Jing: the heart, liver, stomach, large intestine, urinary bladder channel.Effect: heat-clearing and toxic substances removing, parasite killing, diuresis.Function with cure mainly: heat-clearing and toxic substances removing, parasite killing, diuresis.Be used for hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, external treatment trichomonal vaginitis.
Modern study proves: its Main Ingredients and Appearance of Radix Sophorae Flavescentis is alkaloids such as matrine, oxymatrine; It all has inhibition and killing action to antibacterial (as: staphylococcus aureus, group B streptococcus, escherichia coli, Bacillus proteus etc.), fungus (as: trichophyton, achorion, epidermophyton rubrum) and trichomonas vaginitis; It also has tangible antiinflammatory action; Can significantly resist the rat hindlimb swelling that mice auricular concha swelling property inflammation that Oleum Tiglii brings out and on Carrageenan are brought out, the exudative inflammation that the lumbar injection glacial acetic acid is brought out also has tangible effect.
Alumen is processed for Sulfates mineral alunite refines through processing.The main aqueous sulfuric acid aluminum potassium [KA1 (SO4) 2.12H2O] that contains).Nature and flavor: sour, puckery, cold.Gui Jing: lung, spleen, liver, large intestine.Function with cure mainly: external detoxifcation parasite killing, dampness removing to stop itchin.Can hold back skin ulcer by removing dampness behind the calcine, hemostasisization is rotten.For eczema eczema, Ding ear flow concentration, Yin Yang vaginal discharge, epistaxis teeth bleed, nasal polyps.
Modern study proves: the Alumen behind the calcine all has inhibition and killing action to antibacterial (as: staphylococcus aureus, group B streptococcus, bacillus pyocyaneus, Bacillus proteus, gonorrhea diplococcus etc.), fungus (as: Candida albicans, trichophyton, achorion, epidermophyton rubrum) and trichomonas vaginitis; Also has stronger coagulated protein effect; Can restrain wound, impel ulcer surface incrustation healing.
Semen Armeniacae Amarum is the dry mature seed of rosaceous plant Prunus armeniaca L.var.ansu Maxim. Prunus armeniaca L.var.ansu Maxin..Nature and flavor:: hardship, tepor, slightly poisonous.Gui Jing.Return lung, large intestine channel.Function cures mainly: sending down the abnormal ascending QI relieving cough and asthma, loosening bowel to relieve constipation.Be used for cough and asthma, the fullness in the chest abundant expectoration, blood deficiency Tianjin is withered, the dryness of the intestine constipation.
Modern study proves: its Main Ingredients and Appearance of Semen Armeniacae Amarum is amygdalin and Semen Armeniacae Amarum oil, and amygdalin has enhancing human body immunity and antitumor action, and Semen Armeniacae Amarum oil has antibacterial and anthelmintic action.
Borneolum Syntheticum is borneolum syntheticum, contains Borneolum Syntheticum (C10H180) and must not be less than 55.0%.Nature and flavor: hot, bitter, be slightly cold.GUIXIN, spleen, lung meridian.Function with cure mainly: the refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Be used for calentura coma, convulsions, the apoplexy syncope due to accumulation of phlegm, stagnation of QI sudden syncope, the attacked by pestiferous factors stupor, conjunctival congestion, aphtha, laryngopharynx swelling and pain, auditory meatus is suppurated.
Modern study proves: Borneolum Syntheticum all has inhibitory action to staphylococcus aureus, group B streptococcus, escherichia coli and pathogenic dermatophytes.
The Chinese medicine vagina effervescence method for preparing that the present invention treats cervical erosion prepares by following processing step:
A. earlier Radix Sophorae Flavescentis powder is broken into coarse powder, makes solvent, flood after 24 hours, carry out percolation with 1% hydrochloric acid solution; Collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well, it is colourless to be washed with water to cleaning mixture, neutralizes with 0.2mol/L sodium hydroxide solution 250ml; 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide is collected 8 times of amount eluents, is neutralized to neutrality with 2% hydrochloric acid solution, reclaims ethanol; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use;
B. get Alumen and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use;
C. get Semen Armeniacae Amarum and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use;
D. get Borneolum Syntheticum and pulverize, cross 100 mesh sieves, subsequent use;
E. get citric acid 65 ℃ of oven dry in baking oven, pulverize, cross 100 mesh sieves, subsequent use;
F. polyvidone (K30) is used anhydrous alcohol solution, is mixed with 5% solution, and is subsequent use;
G. get Radix Sophorae Flavescentis extract 16g (being equivalent to crude drug 1600g), alumen powder 200g, Semen Armeniacae Amarum powder 130g, calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g mixing, put in the baking oven in 65 ℃ of bakings 4 hours, taking-up; Add citric acid 240g, sodium bicarbonate 180g again, stir, be sprayed on the granule with 40ml5% polyvidone (K30) ethanol solution; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds Borneolum Syntheticum powder 5g, micropowder silica gel 10g, magnesium stearate 10g again; Mixing is pressed into 1000, promptly gets product of the present invention.
The vagina effervescence that principal agent consumption that more than provides and supplementary product consumption scope are processed, its product quality all can meet the quality standard of formulating with reference to (appendix ID tablet) regulation of Chinese Pharmacopoeia (version in 2010).
This prescription adopts diverse ways to prepare the back mixed pressuring plate according to the heterogeneity and the medicinal requirements of various medical materials.The recipe quantity of Radix Sophorae Flavescentis is bigger; Its Main Ingredients and Appearance is an alkaloid, adopts 1% hydrochloric acid solution to make solvent, and dipping extracts; Separate through cationic exchange resin adsorption; Carry out eluting, concentrate with the ethanol after the alkalization then, thereby reach extraction, purified purpose, obtain containing the higher Radix Sophorae Flavescentis extractum of active ingredient.Alum, bitter almond prescription volume is small, we use Chinese Pharmacopoeia statutory processing methods respectively fumed and Dan system directly after crushing, mixing with Sophora extract, adding the right amount of excipients for granulation.Borneolum Syntheticum is because amount is very little, and volatile when receiving high temperature, so after pulverizing separately, in the end one procedure just adds, and avoids the loss of this medicine in the course of processing.
Embodiment 1
Ingredients: Sophora 1200g Alum (calcined) 150g Bitter almond (Dan) 100g Borneol 3g
Preparation technology: a, the Radix Sophorae Flavescentis powder in will writing out a prescription is broken into coarse powder earlier, makes solvent with 1% hydrochloric acid solution, floods after 24 hours; Carry out percolation, collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well; It is colourless to be washed with water to cleaning mixture, with 0.2mol/L sodium hydroxide solution 250ml neutralization, 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide; Collect 8 times of amount eluents, be neutralized to neutrality, reclaim ethanol with 2% hydrochloric acid solution; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use.B, get Alumen in addition and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use.C, get Semen Armeniacae Amarum in addition and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use.D, get Borneolum Syntheticum in addition and pulverize, cross 100 mesh sieves, subsequent use.E, in addition get citric acid 65 ℃ of oven dry in baking oven, pulverizing, cross 100 mesh sieves, subsequent use.F, get polyvidone (K30) in addition and be made into 5% solution with anhydrous alcohol solution, subsequent use.G, get Radix Sophorae Flavescentis extract 12g (being equivalent to crude drug 1200g), alumen powder 150g, Semen Armeniacae Amarum powder 100g, calcium sulfate 150g, ethyl cellulose 15g, hyprolose 40g mixing then, put in the baking oven 65 ℃ of bakings 4 hours, take out; Add citric acid 180g, sodium bicarbonate 140g, mixing sprays 5% polyvidone (K30) anhydrous alcohol solution 30ml; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds 3g Borneolum Syntheticum powder and micropowder silica gel 8g, magnesium stearate 8g again; Mixing is pressed into 1000, promptly gets product of the present invention.
Embodiment 2
Ingredients: Sophora 2000g Alum (calcined) 250g Bitter almond (Dan) 150g Borneol 8g
Preparation technology: a, the Radix Sophorae Flavescentis powder in will writing out a prescription is broken into coarse powder earlier, makes solvent with 1% hydrochloric acid solution, floods after 24 hours; Carry out percolation, collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well; It is colourless to be washed with water to cleaning mixture, with 0.2mol/L sodium hydroxide solution 250m1 neutralization, 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide; Collect 8 times of amount eluents, be neutralized to neutrality, reclaim ethanol with 2% hydrochloric acid solution; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use.B, get Alumen in addition and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use.C, get Semen Armeniacae Amarum in addition and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use.D, get Borneolum Syntheticum in addition and pulverize, cross 100 mesh sieves, subsequent use.E, in addition get citric acid 65 ℃ of oven dry in baking oven, pulverizing, cross 100 mesh sieves, subsequent use.F, get polyvidone (K30) in addition and be made into 5% solution with anhydrous alcohol solution, subsequent use.G, get Radix Sophorae Flavescentis extract 20g (being equivalent to crude drug 2000g), alumen powder 250g, Semen Armeniacae Amarum powder 150g, calcium sulfate 250g, ethyl cellulose 25g, hyprolose 60g mixing then, put in the baking oven 65 ℃ of bakings 4 hours, take out; Add citric acid 300g, sodium bicarbonate 225g, mixing sprays 5% polyvidone (K30) anhydrous alcohol solution 50m1; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds 8g Borneolum Syntheticum powder and micropowder silica gel 12g, magnesium stearate 12g again; Mixing is pressed into 1000, promptly gets product of the present invention.
Embodiment 3
Ingredients: Sophora 1800g Alum (calcined) 220g Bitter almond (Dan) 140g Borneol 6g
Preparation technology: a, the Radix Sophorae Flavescentis powder in will writing out a prescription is broken into coarse powder earlier, makes solvent with 1% hydrochloric acid solution, floods after 24 hours; Carry out percolation, collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well; It is colourless to be washed with water to cleaning mixture, with 0.2mol/L sodium hydroxide solution 250ml neutralization, 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide; Collect 8 times of amount eluents, be neutralized to neutrality, reclaim ethanol with 2% hydrochloric acid solution; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use.B, get Alumen in addition and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use.C, get Semen Armeniacae Amarum in addition and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use.D, get Borneolum Syntheticum in addition and pulverize, cross 100 mesh sieves, subsequent use.E, in addition get citric acid 65 ℃ of oven dry in baking oven, pulverizing, cross 100 mesh sieves, subsequent use.F, get polyvidone (K30) in addition and be made into 5% solution with anhydrous alcohol solution, subsequent use.G, get Radix Sophorae Flavescentis extract 18g (being equivalent to crude drug 1800g), alumen powder 220g, Semen Armeniacae Amarum powder 140g, calcium sulfate 220g, ethyl cellulose 22g, hyprolose 55g mixing then, put in the baking oven 65 ℃ of bakings 4 hours, take out; Add citric acid 265g, sodium bicarbonate 200g, mixing sprays 5% polyvidone (K30) anhydrous alcohol solution 45ml; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds 6g Borneolum Syntheticum powder and micropowder silica gel 10g, magnesium stearate 10g again; Mixing is pressed into 1000, promptly gets product of the present invention.
Embodiment 4
Ingredients: Sophora 1600g Alum (calcined) 200g Bitter almond (Dan) 130g Borneol 5g
Preparation technology: a, the Radix Sophorae Flavescentis powder in will writing out a prescription is broken into coarse powder earlier, makes solvent with 1% hydrochloric acid solution, floods after 24 hours; Carry out percolation, collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well; It is colourless to be washed with water to cleaning mixture, with 0.2mol/L sodium hydroxide solution 250ml neutralization, 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide; Collect 8 times of amount eluents, be neutralized to neutrality, reclaim ethanol with 2% hydrochloric acid solution; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use.B, get Alumen in addition and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use.C, get Semen Armeniacae Amarum in addition and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use.D, get Borneolum Syntheticum in addition and pulverize, cross 100 mesh sieves, subsequent use.E, in addition get citric acid 65 ℃ of oven dry in baking oven, pulverizing, cross 100 mesh sieves, subsequent use.F, get polyvidone (K30) in addition and be made into 5% solution with anhydrous alcohol solution, subsequent use.G, get Radix Sophorae Flavescentis extract 16g (being equivalent to crude drug 1600g), alumen powder 200g, Semen Armeniacae Amarum powder 130g, calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g mixing then, put in the baking oven 65 ℃ of bakings 4 hours, take out; Add citric acid 240g, sodium bicarbonate 180g, mixing sprays 5% polyvidone (K30) anhydrous alcohol solution 40ml; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds 5g Borneolum Syntheticum powder and micropowder silica gel 10g, magnesium stearate 10g again; Mixing is pressed into 1000, promptly gets product of the present invention.
Made product quality all can meet the quality standard of formulating with reference to (appendix ID tablet) regulation of Chinese Pharmacopoeia (version in 2010) among the above embodiment.
Target level of product quality of the present invention:
1, character: these article are faint yellow to filemot tablet.
2, differentiate: 4 of these article are got in (1), add water 20ml, put in the hot bath, make the thawing layering; Stir, continue heating 5 minutes, take out; Put coldly, filter, filtrating shows the identification (appendix IV of Chinese Pharmacopoeia version in 2010) that potassium salt is differentiated (2) reaction and aluminum salt, sulfate.
(2) get 3 of these article, grind, put in the tool plug conical flask, add dehydrated alcohol 15ml, supersound process 30min takes out, and puts coldly, filters, and subsequent filtrate is as need testing solution; It is an amount of that other gets the Borneolum Syntheticum reference substance, adds dehydrated alcohol and process the solution that every 1ml contains 1mg, as reference substance solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2010 B) test, draw need testing solution, each 5ul of reference substance solution, put respectively on same silica gel g thin-layer plate; With cyclohexane extraction-ethyl acetate (8: 2) is developing solvent; Launch 10cm, take out, dry; Spray is with 10% phosphomolybdic acid ethanol solution, and 150 ℃ are heated to colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical blue spot.
(3) need testing solution of getting under the assay item is made need testing solution, and other gets matrine and sophoridine reference substance, and chlorination is copied into the solution that every 1ml contains 0.5mg, as reference substance solution.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2010) test, draw need testing solution 4 μ l, reference substance solution 2 μ l; Put respectively on same silica gel g thin-layer plate; (2: 3: 4: 0.2) be developing solvent, expansion was taken out with benzene-acetone-ethyl acetate-liquor ammoniae fortis; Dry, spray 60% alcoholic solution and bismuth potassium iodide test solution successively with 1% sodium nitrite.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show two identical orange speckles.
3, inspection pH value: get 2 of these article, add water 20ml, stir and make dissolving, filter, measure (an appendix VII of Chinese Pharmacopoeia version in 2010 G) in accordance with the law and measure, should be 3.0～5.5.
Other should meet each item regulation (appendix ID of Chinese Pharmacopoeia version in 2010) relevant under the effervescent tablet item.
4, assay: HPLC (an appendix VI of Chinese Pharmacopoeia version in 2010 D) is measured.
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler; Acetonitrile-buffer (0.02mol/L potassium dihydrogen phosphate-0.01mol/L certain herbaceous plants with big flowers alkyl sulfonic acid sodium-triethylamine 40: 30: 0.25,50% phosphoric acid is regulated pH7.00 ± 0.05) (20: 80) is a mobile phase; The detection wavelength is 220nm.Number of theoretical plate calculates by the matrine peak should be not less than 5000.
The preparation of reference substance solution: it is an amount of to get matrine reference substance (through the phosphorus pentoxide drying under reduced pressure more than 12 hours), accurate claim fixed, add the high purity water dissolving and quantitatively dilution process the solution that 1ml contains 0.3mg approximately.
The preparation of need testing solution: get 10 of these article, the accurate title, decide, and grinds, and precision takes by weighing 1.0g, puts in the 25ml volumetric flask; Add the about 20ml of methanol, 60 ℃ of ultrasonic 30min take out, and put coldly, add methanol constant volume to scale; Shake up, filter, the accurate subsequent filtrate 10ml that draws puts evaporate to dryness in the evaporating dish, with the high purity water dissolving and move in the 5ml volumetric flask; Standardize solution shakes up, and crosses the 0.45um microporous filter membrane, promptly gets.
Algoscopy: respectively accurate draw reference substance solution and need testing solution each 20 1, inject chromatograph of liquid, mensuration promptly gets.
Every of these article contain matrine (C
15H
24N
2O), must not be less than 2.5mg.
5. microbial check:
Meet Pharmacopoeia of People's Republic of China appendix of version in 2010 (XIII C) microbial limit test regulation; That is: antibacterial (≤100/g), mycete and yeast≤10/g, Staphylococcus aureus must not detect; Pseudomonas aeruginosa must not detect, and clostridium must not detect.
The test of pesticide effectiveness result of product of the present invention:
1, putrefaction-removing granulation-promoting effect test:
To rats after burn and through the wound surface area of the animal model of charrin disease tangible promotion healing effect is arranged with these article.
2, in-vitro antibacterial, anti-trichomonas vaginitis effect test:
These article were respectively 1: 160 escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa, group B streptococcus, Candida albicans, gonococcal least Mlc, and 1: 320,1: 160,1: 320,1: 640,1: 80; The time of killing to trichomonas vaginitis is: be 10 minute at 1: 20, and be 30 minute at 1: 80, and be 60 minute at 1: 160, and be 24 hour at 1: 320.
3, antiinflammatory test:
These article can obviously suppress mice auricle swelling and the rat paw edema due to the chondrus ocellatus Holmes due to the Oleum Tiglii, can also suppress the hypertrophy of mice cotton balls granulation tissue.
4, itching-relieving action test:
The be significantly improved effect of Cavia porcellus itch-threshold of these article.
The toxicity test result of product of the present invention:
1, acute toxicity test:
Product of the present invention is experimental subject with the female Wistar rats, gives dosage at 24 hours per vaginams and is the medicated powder of 2.28g/kg altogether, is equivalent to clinical plan with more than 200 times of daily dose.Administration finishes the back and observed 14 days continuously; The result shows that animal is movable during administration, generally situation is not seen obvious change; Performances such as hyperemia, edema are not seen in the vagina part yet, and body weight is not seen obvious change after 14 days, show that these article do not see that tangible acute toxic reaction is arranged.
2, long term toxicity test:
Product of the present invention is experimental subject with the female Wistar rats; Respectively every day vagina give that dosage is 0.447,0.223, the medicated powder of 0.111g/kg (be equivalent to respectively clinical daily dose 80,40,20 times); In 13 weeks of successive administration, high dose, middle dosage, low dosage (be equivalent to respectively clinical daily dose 80,40,20 times) are not seen obvious influence to general situation, body weight, food ration, organ coefficient, hematology, the blood parameters of animal.Pathological observation does not see that these article of 80,40,20 times that are equivalent to clinical daily dose produce the pathologic influence to relevant histoorgan.It is safe that prompting is used with dosage, approach by the clinical plan of these article.
Anaphylaxis of the present invention, irritation test result:
Product of the present invention is experimental subject with the rabbit, and every rabbit vagina gives these article, and 6 hours and 24 h observation vaginal mucosaes have or not irritative response and mark after administration; The result shows that animal is movable after administration, generally situation is not seen obvious change; Phenomenons such as hyperemia, edema are not seen in the vagina part yet, and every rabbit vagina gives the palace these article, is administered once every day; Successive administration 7 days; Vaginal mucosa is observed in the last administration after 6 hours and 24 hours have vacuum response and mark, and the result shows that animal movable, general situation during administration do not see obvious change, and phenomenons such as hyperemia, edema are not seen in the vagina part yet; Histopathologic examination does not see that vagina and uterus, ovarian group are woven with abnormal change yet, shows that stupid invention product multiple dosing does not have tangible zest effect yet; With the Cavia porcellus is subjects, observes the skin allergy of these article, and also not seeing has skin allergy.Prove that it is safe that this product uses.
Claims (5)
1. Chinese medicine vagina effervescence of treating cervical erosion is characterized in that: it is following whenever to process the required main raw materials in proportion of 1000 Chinese medicine vagina effervescence:
Radix Sophorae Flavescentis 1200g～2000g Alumen 150g～250g
Semen Armeniacae Amarum 100g～150g Borneolum Syntheticum 3g～8g.
2. according to the Chinese medicine vagina effervescence of the said treatment cervical erosion of claim 1, it is characterized in that: the optimum ratio of whenever processing 1000 the required primary raw material of Chinese medicine vagina effervescence is:
Radix Sophorae Flavescentis 1600g Alumen 200g Semen Armeniacae Amarum 130g Borneolum Syntheticum 5g.
3. according to the Chinese medicine vagina effervescence of the said treatment cervical erosion of claim 1, it is characterized in that: it is following whenever to process the required ratio of adjuvant of 1000 Chinese medicine vagina effervescence:
4. according to the Chinese medicine vagina effervescence of the said treatment cervical erosion of claim 1, it is characterized in that: it is following whenever to process the required ratio of adjuvant of 1000 Chinese medicine vagina effervescence:
Calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g, citric acid 240g,
Sodium bicarbonate 180g, polyvidone (K30) 2g, micropowder silica gel 10g, magnesium stearate 10g.
5. the method for preparing of the Chinese medicine vagina effervescence of the said treatment cervical erosion of claim 1 is characterized in that:
A. get Radix Sophorae Flavescentis powder and be broken into coarse powder, make solvent, flood after 24 hours, carry out percolation with 1% hydrochloric acid solution; Collect 10 times of amount percolates, through the 732 type cation exchange resin columns of having handled well, it is colourless to be washed with water to cleaning mixture, neutralizes with 0.2mol/L sodium hydroxide solution 250ml; 60% alcoholic solution eluting of reuse 0.016% sodium hydroxide is collected 8 times of amount eluents, is neutralized to neutrality with 2% hydrochloric acid solution, reclaims ethanol; Be evaporated to thick paste, get Radix Sophorae Flavescentis extract, subsequent use;
B. get Alumen and place in the forge furnace, forge to crisp with 230 ℃-250 ℃, be ground into fine powder, subsequent use;
C. get Semen Armeniacae Amarum and soak a moment with boiling water, take out peeling, drying is pulverized, and is subsequent use;
D. get Borneolum Syntheticum and pulverize, cross 100 mesh sieves, subsequent use;
E. get citric acid 65 ℃ of oven dry in baking oven, pulverize, cross 100 mesh sieves, subsequent use;
F. polyvidone (K30) is used anhydrous alcohol solution, is mixed with 5% solution, and is subsequent use;
G. get Radix Sophorae Flavescentis extract 16g (being equivalent to crude drug 1600g), alumen powder 200g, Semen Armeniacae Amarum powder 130g, calcium sulfate 200g, ethyl cellulose 20g, hyprolose 50g mixing, put in the baking oven in 65 ℃ of bakings 4 hours, taking-up; Add citric acid 240g, sodium bicarbonate 180g again, stir, be sprayed on the granule with 40ml 5% polyvidone (K30) ethanol solution; Stir, 16 mesh sieves are granulated, and 65 ℃ were dried by the fire 2 hours; Take out, granulate adds Borneolum Syntheticum powder 5g, micropowder silica gel 10g, magnesium stearate 10g again; Mixing is pressed into 1000, promptly gets product of the present invention.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105853629A (en) * | 2016-06-03 | 2016-08-17 | 王秀芬 | Pharmaceutical composition for treating cervicitis and preparing method thereof |
| CN112494619A (en) * | 2020-08-27 | 2021-03-16 | 新疆医科大学 | Traditional Chinese medicine effervescent tablet for treating cervical cancer and preparation method and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679755A (en) * | 2005-02-02 | 2005-10-12 | 广西康华药业有限责任公司 | Preparation of Chinese medicinal suppository for treating female chronic cervicitis |
| CN1679780A (en) * | 2005-02-01 | 2005-10-12 | 王衡新 | Chinese medicine preparation for treating gynecopathy, preparation and quality control thereof |
-
2012
- 2012-08-13 CN CN2012102867464A patent/CN102764319A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679780A (en) * | 2005-02-01 | 2005-10-12 | 王衡新 | Chinese medicine preparation for treating gynecopathy, preparation and quality control thereof |
| CN1679755A (en) * | 2005-02-02 | 2005-10-12 | 广西康华药业有限责任公司 | Preparation of Chinese medicinal suppository for treating female chronic cervicitis |
Non-Patent Citations (1)
| Title |
|---|
| 王熙平等: "***康***泡腾片的工艺研究", 《中国卫生产业》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105853629A (en) * | 2016-06-03 | 2016-08-17 | 王秀芬 | Pharmaceutical composition for treating cervicitis and preparing method thereof |
| CN112494619A (en) * | 2020-08-27 | 2021-03-16 | 新疆医科大学 | Traditional Chinese medicine effervescent tablet for treating cervical cancer and preparation method and application thereof |
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Application publication date: 20121107 |