CN1899285A - Mycoporin vaginal soft capsule and its preparing method - Google Patents
Mycoporin vaginal soft capsule and its preparing method Download PDFInfo
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- CN1899285A CN1899285A CN 200610043163 CN200610043163A CN1899285A CN 1899285 A CN1899285 A CN 1899285A CN 200610043163 CN200610043163 CN 200610043163 CN 200610043163 A CN200610043163 A CN 200610043163A CN 1899285 A CN1899285 A CN 1899285A
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Abstract
The present invention relates to soft mycosporin capsule for vagina and its preparation process. Each of soft mycosporin capsules contains mycosporin in 50-300 mg and medicinal supplementary material vaseline and paraffin, and the capsule shell contains gelatin in 10 weight portions and glycerin in 4.0-5.5 weight portions. The preparation process includes the steps of dissolving gelatin in water and adding glycerin and proper amount of preservative, vacuum deairing, mixing mycosporin and medicinal supplementary material, and pressing into soft capsule. Compared with available mycosporin preparation forms, the soft mycosporin capsule has the advantages of stable quality, convenient carrying and administration, and fast leaching of the effective components.
Description
Technical field
The present invention relates to a kind of Mycoporin vaginal soft capsule and preparation method thereof.
Background technology
Incomplete statistics according to World Health Organization (WHO), in recent years, gynaecopathia incidence rate among the women has reached more than 65%, constituted important gang in the subhealth state colony, the morbidity numeral that annual women's urogenital system infects has reached 3.33 hundred million person-times, thereby has driven the development in global Amino-Cerv market.In China, women of child-bearing age's gynaecopathia incidence rate is about 70%, and many women all can be subjected to the interference of urinary system infection in various degree, have had a strong impact on normal work and life.
Monilial vaginitis is a kind of common gynaecopathia, due to candida albicans infection.Clinical manifestation is mainly vulva pruritus and the leucorrhea stiff bean dregs sample that is white in color.The primary disease sickness rate is only second to trichomonal vaginitis.The pH value that is suitable for most the candidiasis breeding is 5.5-6.5, glycogen increases in vagina, when acidity increases, promptly breeding causes inflammation rapidly, so be more common in anemia of pregnant woman, diabetic and accept a large amount of estrogen persons, as prolonged application antibiotics, changed the mutual inhibition relation between the intravaginal microorganism, candidiasis is bred and cause infection.Candidiasis can be present on people's oral cavity, intestinal and the vaginal mucosa and not cause that symptom, the candidiasis at these three positions can infect mutually, susceptible disease when local environmental condition is fit to.Clinical manifestation is: pudendum is very itched, causalgia; Also frequent micturition can be arranged, dysurea and sexual anhedonia; Vaginal secretions increases, the stiff that is white in color bean dregs sample or tunica albuginea shape; Vaginal mucosa hyperemia, surface can have the white plates thin film that is difficult for peeling off.
In the gynecological infection medication market, the oral agents of western medicine gynecological inflammation is mainly based on systemic antibiotic and antifungal drug, make a general survey of current gynecological infection medication market, product is divided into oral medicine and medicine for external use two big classifications substantially, and medicine for external use also more and more is subjected to the favor of consumer.Kai Fa gynecological's chemicals is in occupation of main positions clinically, and especially the application of suppository and solution is more.2004, domestic main medical market, gynecological inflammation medication market scale is about 52.8 hundred million yuan, than increasing by 16.84% last one year; According to domestic analysis institution statistics, gynecological inflammation medication market increased by 11.70% than 2004 in 2005, and market scale reaches 6,000,000,000 yuan.
From future market prospect, China Amino-Cerv market will be with average annual 10% digital steady-state growth.Under such market environment, how to avoid the harmful competition of homogeneity, walk the road of differentiation production and marketing, be the important topic of pendulum in face of numerous pharmacy corporations.
Clotrimazole is an imidazoles broad-spectrum antifungal medicine, and various funguses such as candidiasis, aspergillosis, phycomycete, dematiaceous fungi, cryptococcus, tinea bacterium etc. are all had inhibitory action.Deeps such as candidiasis, aspergillosis, cryptococcus (lung, stomach, intestinal, urinary tract, meninges etc.) are infected and the septicemia produce effects, superficial mycosis is also had certain curative effect.Also can be used for double infection that the microbial purulent leukorrhea of yeast, sensitive bacterial cause etc. in addition.Can see that from clinical observation for many years the clotrimazole bolt is used for the candidal vulvovaginitis determined curative effect, safety is reliable, is subjected to extensive patients and medical personnel's welcome deeply.
With clotrimazole is that " clotrimazole bolt, clotrimazole medicine film, the clotrimazole cream " of main effective ingredient produced by State Food and Drug Administration approval.But the onset of clotrimazole bolt clinical response is slow; Clotrimazole medicine film, clotrimazole cream use inconvenient at gynecology.
Summary of the invention
The purpose of this invention is to provide a kind of is the external novel drugs dosage form of the treatment gynaecopathia of main effective ingredient with clotrimazole, and this dosage form steady quality is easy to use effective.
Another object of the present invention provides the preparation method of this medicine.
Product of the present invention is made of medicinal liquid and softgel shell two large divisions, it is characterized in that medicinal liquid contains the clotrimazole of effective dosage as effective ingredient, and contain pharmaceutic adjuvant, contain 10 parts in gelatin in the softgel shell, glycerol 4.0-5.5 part (weight ratio) and antiseptic, opacifier, medicinal liquid by weight every contain clotrimazole 50-300 milligram, the granularity of clotrimazole is a 80-140 purpose powder.
Described pharmaceutic adjuvant is vaseline and paraffin.
Described antiseptic is following one or more: ethylparaben, methyl parahydroxybenzoate, Oleum Caryophylli, propylene glycol, sorbic acid, sorbic acid methyl ester, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, butyl p-hydroxybenzoate calcium, Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, benzyl alcohol, benzoic acid.
Described opacifier is a titanium dioxide.
Every Mycoporin vaginal soft capsule comprises following component: calculate with gram
Medicinal liquid: clotrimazole 0.05-0.3
Vaseline 0.4-1.2
Paraffin 0.8-1.5
Glue: gelatin 0.05-1.5
The 40-55% of glycerin gelatine amount
Distilled water 0.05-1.5
Opacifier 0.001-0.05
Antiseptic 0.0001-0.003.
Annotate: optimum formula is only for the present invention is further illustrated, and the scope of product of the present invention is not subjected to the limitation of this optimum formula.
Preparation method is:
Vaseline after paraffin and the heating is fully stirred evenly, and natural cooling adds the clotrimazole fine powder again, and stirring is also crossed the colloid mill mixing, and is standby.
In changing the glue jar that gelatin is first with an amount of distilled water immersion swelling, add glycerol, an amount of opacifier, antiseptic, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity extremely, put into the adjustable steady glue bucket of temperature, the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould.
Using method: vagina administration.After cleaning the clotrimazole soft capsule is placed the vagina depths.Every night once, one time one.Continuous 7 days is a course of treatment.
Clotrimazole belongs to antifungal agent, and clotrimazole crude drug quality standard records on two ones the 235th page of Chinese Pharmacopoeia version in 2005.
[title] clotrimazole
[English name] Clotrimazole
[chemical name] 1-[(2-chlorphenyl) benzhydryl]-1H-miaow base
[structural formula]
[molecular formula and molecular weight] C
22H
17ClN
2344.84
The clotrimazole pharmaceutical research shows in vitro tests multiple fungus is had lethal effect, but to the in vivo test of animal infection modal inefficacy then, and toxic and side effects is big, so only limit to external; Clotrimazole can suppress alexinic secretion, and the intestinal mucosa immunologic function is had certain influence; Candida albicans bacterium, candida tropicalis bacterium are all responsive to ketoconazole powder, clotrimazole powder, various dose, and different treatment natural law ketoconazoles there are differences with clotrimazole effervescent tablet treatment rat candida albicans bacterium vaginitis fungus negative conversion rate and no medicine matched group; Clotrimazole has tangible bacteriostasis and sterilization effect to superficial mycosis, and is relatively poor to Fonsecaea pedrosor and sporotrichum schenckii effect, and Candida albicans and Cryptococcus histolyticus are not had obvious inhibitory action.
Simultaneously be with the clotrimazole preparation of raw material such as clotrimazole bolt, clotrimazole medicine film, clotrimazole cream clinical practice for many years, reliable curative effect is arranged.
Below be Mycoporin vaginal soft capsule disintegration, melt and become time limit, dissolution comparative study test.
One, instrument and reagent:
ZB-1C disintegration tester (Precision Instrument Factory, Tianjin Univ.); RBY-4 melts and becomes time limit instrument (Tianjin Pharmacopoeia Standard Instrument Factory); RC-6 dissolution instrument (Tianjin Guoming Medicine Equipment Co., Ltd.).
Mycoporin vaginal soft capsule (20050216,20050217,20050218, Shangzhou, Shangluo City thousand standing grain plant Pharmaceutical Co., Ltds produce); Clotrimazole bolt (050414,050516,050520, Dongxin Pharmaceutical Co., Ltd., Hubei Prov. produces); Clotrimazole bolt (050611,050616,050619, Rui Jin, Jiangxi three nine-day periods after the winter solstice pharmaceutcal corporation, Ltd produces).
Two, method and result
1, the method and the result of comparative study test disintegration:
The stainless steel shaft of hanging basket by the upper end hung on the metal rack, immerse in the 1000ml beaker, and screen cloth fills temperature and is 37 ± 1 ℃ water apart from beaker bottom 25mm in the beaker when regulating the hanging basket position it being descended, and screen cloth is at underwater 15mm place when regulating height of water level hanging basket being risen.
Get our company's production Mycoporin vaginal soft capsule and commercially available clotrimazole bolt by " 2005 editions appendix inspections of Chinese pharmacopoeia, method: sample thief is each 6 respectively, in disintegration somascope hanging basket, add plate washer, starting switch, hanging basket oscilaltion, the record whole disintegrates of sample and the time by screen cloth.The results are shown in Table 1.
Regulation: the whole disintegrates of planted agent in 60 minutes.
2, melt method and the result who becomes time limit comparative study test:
Get our company's production Mycoporin vaginal soft capsule and commercially available clotrimazole bolt by " 2005 editions appendix inspections of Chinese pharmacopoeia, sample thief is each 3 respectively, after room temperature is placed 1 hour, become in the overtime check instrument hanging basket respectively at melting, in separately the sleeve of packing into, and fix with hook, vertical respectively the immersion fills in the container of 37.0 ± 0.5 ℃ of water that are no less than 4L, its upper end position should be adorned a tumbler at underwater 90mm place in the container, overturn this device once in solution every 10 minutes.The results are shown in Table 1.
Regulation: the suppository of water-soluble base should all dissolvings in 60 minutes.
3, dissolution comparative study test method and result:
Algoscopy: by " 2005 editions appendix first methods of Chinese pharmacopoeia (changeing the basket method) are checked, measure the solvent 900ml that handles through the degassing, inject in each process container of dissolution instrument, and heating makes solvent temperature remain on 37 ℃ ± 0.5 ℃, adjust rotating speed and make it stable.Get 6 of test samples, drop into respectively in 6 commentaries on classics baskets, will change basket and fall in the container, pick up counting immediately, to sample fully by behind the screen cloth, an amount of in the sample point draw solution, filter through 0.45 μ m microporous filter membrane immediately, being sampled to filtration certainly should finish in 30 seconds.Get filtrate, measure, write down dissolution time, calculate every stripping quantity according to following content assaying method.The results are shown in Table 1.
The result judges: by indicating cubage, all should be not less than prescribed limit for indicating 80% of content.
Content assaying method: (1). reference substance solution preparation precision takes by weighing clotrimazole reference substance 50mg, puts in the tool plug conical flask, adds chloroform 20ml and makes the clotrimazole dissolving.
(2). test liquid preparation sample ceaselessly stirs after the stripping of dissolution instrument, makes mix homogeneously, and precision takes by weighing filtrate 300ml (being equivalent to clotrimazole 50mg approximately), puts in the tool plug conical flask, adds chloroform 20ml and makes the clotrimazole dissolving.
(3). titrant dioctylis sulfosuccinas natricus test solution (compound method is seen the pharmacopeia appendix).
(4). indicator solution dimethyl yellow-solvent blue 19 mixing indicator solution.
(5). assay method gets reference substance solution and need testing solution adds water 20ml, dilute sulfuric acid 5ml and dimethyl yellow-solvent blue 19 mixing indicator solution 0.4ml, with the titration of dioctylis sulfosuccinas natricus test solution, powerful jolting during to nearly terminal point, continuing titration to chloroform layer is cervinus by green transition.
(6). computational methods consume the ratio calculation of the volume (ml) of dioctylis sulfosuccinas natricus test solution according to the two.
| Sample | Disintegration (minute) | Melt the change time limit (minute) | Dissolution | |
| Dissolution time (minute) | Content (%) | |||
| 20050216 | 15 | 17 | 17 | 90.0 |
| 20050217 | 16 | 18 | 19 | 92.0 |
| 20050218 | 18 | 20 | 20 | 91.5 |
| 050414 | 39 | 40 | 42 | 81.5 |
| 050516 | 41 | 42 | 41 | 84.0 |
| 050520 | 42 | 44 | 42 | 82.7 |
| 050611 | 36 | 36 | 38 | 85.0 |
| 050616 | 38 | 37 | 37 | 86.3 |
| 050619 | 37 | 37 | 35 | 85.0 |
Conclusion: by above-mentioned contrast test as can be known, all sample disintegrates and in 60 minutes by screen cloth, meet " 2005 editions requirements of Chinese pharmacopoeia, but soft capsule for vagina disintegration that our company produces and melt that to become the time limit shorter, the softgel shell cracking is very fast; Aspect dissolution, medicinal liquid discharges easily, at short notice the dissolution height.Show that Mycoporin vaginal soft capsule is a kind of administering mode preferably.
Below be Mycoporin vaginal soft capsule stability test data and conclusion
In order to investigate this product quality stability situation, pertinent regulations according to National Drug Administration's " medicine registration management way " and Mycoporin vaginal soft capsule quality standard, Mycoporin vaginal soft capsule to different storage periods has carried out the total quality investigation, now test method and result is reported as follows:
One, test method
Normal room temperature reserved sample observing method.
Two, test sample
Mycoporin vaginal soft capsule, batch number (20050216,20050217,20050218), thousand standing grain plant Pharmaceutical Co., Ltds provide by Shangzhou, Shangluo City.The aluminium-plastic panel packing, the listing packing, every batch is stayed 300 boxes, 4 in every box.Packing Intact.
Three, instrument and reagent
1, instrument water-bath, baking oven, analytical balance, chromatography cylinder, RBY-4 melt and become time limit instrument (Tianjin Pharmacopoeia Standard Instrument Factory), exsiccator, clean work station, autoclave, incubator.
2, reagent petroleum ether, methanol, chloroform, diisopropyl ether, sodium hydroxide, sodium carboxymethyl cellulose, silica gel G (tlc analysis usefulness, Haiyang Chemical Plant, Qingdao).
3, reference substance clotrimazole (lot number: 100037-200306, for assay usefulness, Nat'l Pharmaceutical ﹠ Biological Products Control Institute provides).
Four, normal room temperature reserved sample observing chamber condition
Keep sample 20 square metres of chamber areas, room ventilation, protection against the tide, lucifuge facility are good, and indoor temperature is 20 ℃～30 ℃ during the reserved sample observing, relative humidity 30～60%.
Five, detection method
By the sampling at regular time and quantity from the chamber that keeps sample respectively of design time 0,1,2,3,6,12 month in the table, each lot number is respectively got 30 boxes at every turn, by " requirement and regulation that Chinese pharmacopoeia version in 2005 is one one, regular timing sampling is tested.
Six, experimental result is seen the product inspection result, sees Table 1,2,3.
(lot number: 20050216) stability test is observed table one to Mycoporin vaginal soft capsule
| Keep sample the time (moon) | The date of inspection | Character | Content uniformity | Thin layer is differentiated | Disintegration (min) | Clotrimazole content (%) | Health examination | ||
| Antibacterial (individual/g) | Mycete and yeast (individual/g) | The control bacterium | |||||||
| 0 1 2 3 6 12 | 05.02.16 05.03.17 05.04.17 05.05.17 05.08.17 06.02.17 | Be milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository, and content is the simple ointment that fat-soluble matrix is made | Up to specification up to specification | Detecting clotrimazole detects clotrimazole and detects clotrimazole and detect clotrimazole and detect clotrimazole and detect clotrimazole | 15 17 23 25 29 33 | 106.6 106.5 106.3 106.4 106.3 106.1 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | Do not detect |
(lot number: 20050217) stability test is observed table two to Mycoporin vaginal soft capsule
| Keep sample the time (moon) | The date of inspection | Character | Content uniformity | Thin layer is differentiated | Disintegration (min) | Clotrimazole content (%) | Health examination | ||
| Antibacterial (individual/g) | Mycete and yeast (individual/g) | The control bacterium | |||||||
| 0 1 2 3 6 12 | 05.02.17 05.03.17 05.04.17 05.05.17 05.08.17 06.02.17 | Be milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository, and content is the simple ointment that fat-soluble matrix is made | Up to specification up to specification | Detecting clotrimazole detects clotrimazole and detects clotrimazole and detect clotrimazole and detect clotrimazole and detect clotrimazole | 16 17 22 27 31 36 | 98.0 97.8 97.9 97.8 97.6 97.3 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | Do not detect |
(lot number: 20050218) stability test is observed table three to Mycoporin vaginal soft capsule
| Keep sample the time (moon) | The date of inspection | Character | Content uniformity | Thin layer is differentiated | Disintegration (min) | Clotrimazole content (%) | Health examination | ||
| Antibacterial (individual/g) | Mycete and yeast (individual/g) | The control bacterium | |||||||
| 0 1 2 3 6 12 | 05.02.18 05.03.17 05.04.17 05.05.17 05.08.17 06.02.17 | Be milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository; Content is that the simple ointment that fat-soluble matrix is made is milky oval soft shell suppository, and content is the simple ointment that fat-soluble matrix is made | Up to specification up to specification | Detecting clotrimazole detects clotrimazole and detects clotrimazole and detect clotrimazole and detect clotrimazole and detect clotrimazole | 18 21 26 28 32 37 | 103.1 102.9 102.7 102.8 102.6 102.2 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 | Do not detect |
Seven, conclusion
Normal room temperature through the Mycoporin vaginal soft capsule sample of three lot numbers (20050216,20050217,20050218) has been carried out 12 months by a definite date quality investigation that keeps sample, the result shows: every index all meets Mycoporin vaginal soft capsule quality standard (draft) and " each pertinent regulations under two items of Chinese pharmacopoeia version in 2005, show having good stability of this product, effect duration can fix tentatively 1.5 years.
Soft capsule dosage form of the present invention as can be seen compared with prior art has following advantage from above contrast experiment and stability experiment:
(1), substrate enclose medicine, solved suppository medicine and substrate effectively and lost evenly and the inconstant problem of weight, both guaranteed stability of drug, and after using, the very fast cracking of softgel shell, drug release rate is fast, clinical reflection is rapid-action.
(2), the bioavailability height, can effectively avoid the gastrointestinal reaction and the liver first-pass effect of human body.
(3), the soft capsule for vagina production technology is compared with ordinary suppository technology, is that the master makes softgel shell with original substrate, and medicine is carried out enclose, has strengthened medicine stability.And dosage, administering mode, method all do not have change.
(4), contain a certain amount of antiseptic and opacifier, prevented that effectively gelatin, glycerol substrate from mildewing rotten.Study on the stability meets the requirements.
(5), Technology advanced person, adopt the preparation technique of soft capsule, be fit to modern industrialization production.
The specific embodiment
Detailed component of the present invention is provided by the following example; but protection scope of the present invention is not limited to this, and every of soft capsule contains the amount of principal agent-clotrimazole to be determined, considers economic factor and easy to prepare; select the size of every ball, finally can determine the liquid formula of embodiment.
Embodiment 1
Component amount (gram/grain)
Medicinal liquid: clotrimazole 0.15
White vaseline 0.82
Liquid Paraffin 1.22
Glue: gelatin 0.350
Glycerol 0.140
Distilled water 0.350
Titanium dioxide 0.01
Ethylparaben 0.0007
Preparation method:
White vaseline heating back and liquid Paraffin are fully stirred evenly, and natural cooling adds the clotrimazole fine powder again, and stirring is also crossed the colloid mill mixing, and is standby.
In changing the glue jar, gelatin is used earlier the distilled water immersion swelling, add glycerol, titanium dioxide, ethylparaben, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is put into the adjustable steady glue bucket of temperature to being the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould, typing is dry, cleans, and selects, packing, promptly.
Embodiment 2
Component amount (gram/grain)
Medicinal liquid: clotrimazole 0.3
Vaseline 1.2
Liquid Paraffin 1.5
Glue: gelatin 0.5
Glycerol 0.27
Distilled water 0.5
Titanium dioxide 0.05
Methyl parahydroxybenzoate 0.003
Preparation method:
White vaseline heating back and liquid Paraffin are fully stirred evenly, and natural cooling adds the clotrimazole fine powder again, and stirring is also crossed the colloid mill mixing, and is standby.
In changing the glue jar, gelatin is used earlier the distilled water immersion swelling, add glycerol, titanium dioxide, methyl parahydroxybenzoate, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is put into the adjustable steady glue bucket of temperature to being the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould, typing is dry, cleans, and selects, packing, promptly.
Embodiment 3
Component amount (gram/grain)
Medicinal liquid: clotrimazole 0.05
Vaseline 0.4
Hard paraffin 0.4
Glue: gelatin 0.2
Glycerol 0.1
Distilled water 0.2
Titanium dioxide 0.001
Oleum Caryophylli 0.0001
Preparation method:
At first in the time of 50 ℃, hard paraffin is melted, then with heating after vaseline fully stir evenly,, natural cooling again adds the clotrimazole fine powder, stirs and also crosses the colloid mill mixing, and is standby.
In changing the glue jar, gelatin is used earlier the distilled water immersion swelling, add glycerol, titanium dioxide, Oleum Caryophylli, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is put into the adjustable steady glue bucket of temperature to being the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould, typing is dry, cleans, and selects, packing, promptly.
Embodiment 4
Component amount (gram/grain)
Medicinal liquid: clotrimazole 0.1
Vaseline 0.4
Hard paraffin 0.8
Glue: gelatin 0.35
Glycerol 0.14
Distilled water 0.35
Titanium dioxide 0.007
Propylene glycol 0.001
Preparation method:
At first in the time of 50 ℃, hard paraffin is melted, then with heating after vaseline fully stir evenly, natural cooling again adds the clotrimazole fine powder, stirs and also crosses the colloid mill mixing, and is standby.
In changing the glue jar, gelatin is used earlier the distilled water immersion swelling, add glycerol, titanium dioxide, propylene glycol, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is put into the adjustable steady glue bucket of temperature to being the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould, typing is dry, cleans, and selects, packing, promptly.
Embodiment 5
Component amount (gram/grain)
Medicinal liquid: clotrimazole 0.2
Vaseline 1
Liquid paraffin 1
Lactic acid 0.127
Tartaric acid 0.12
Sodium bicarbonate 0.13
Tween 80 0.004
Glue: gelatin 0.5
Glycerol 0.25
Distilled water 0.5
Titanium dioxide 0.02
Sorbic acid 0.001
Preparation method:
White vaseline heating back and liquid Paraffin are fully stirred evenly, and natural cooling adds lactic acid, tartaric acid, sodium bicarbonate, tween 80 again; Mix homogeneously adds the clotrimazole fine powder again, and stirring is also crossed the colloid mill mixing, and is standby.
In changing the glue jar, gelatin is used earlier the distilled water immersion swelling, add glycerol, titanium dioxide, sorbic acid, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is put into the adjustable steady glue bucket of temperature to being the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould, typing is dry, cleans, and selects, packing promptly gets the effervescent soft capsule.
Claims (6)
1, a kind of Mycoporin vaginal soft capsule, constitute by medicinal liquid and softgel shell two large divisions, it is characterized in that medicinal liquid contains the clotrimazole of effective dosage as effective ingredient, and contain pharmaceutic adjuvant, contain 10 parts in gelatin in the softgel shell by weight, glycerol 4.0-5.5 part, and antiseptic and opacifier, medicinal liquid by weight every contain clotrimazole 50-300 milligram, the granularity of clotrimazole is a 80-140 purpose powder.
2, Mycoporin vaginal soft capsule as claimed in claim 1 is characterized in that described pharmaceutic adjuvant is vaseline and paraffin.
3, Mycoporin vaginal soft capsule as claimed in claim 1, it is characterized in that described antiseptic is following one or more: ethylparaben, methyl parahydroxybenzoate, Oleum Caryophylli, propylene glycol, sorbic acid, sorbic acid methyl ester, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, butyl p-hydroxybenzoate calcium, Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, benzyl alcohol, benzoic acid.
4, Mycoporin vaginal soft capsule as claimed in claim 1 is characterized in that described opacifier is a titanium dioxide.
5, Mycoporin vaginal soft capsule as claimed in claim 1 is characterized in that every Mycoporin vaginal soft capsule comprises following component: calculate with gram
Medicinal liquid: clotrimazole 0.05-0.3
Vaseline 0.4-1.2
Paraffin 0.8-1.5
Glue: gelatin 0.05-1.5
The 40-55% of glycerin gelatine amount
Distilled water 0.05-1.5
Opacifier 0.001-0.05
Antiseptic 0.0001-0.003.
6, preparing according to claim 1, the method for Mycoporin vaginal soft capsule is:
Vaseline after paraffin and the heating is fully stirred evenly, and natural cooling adds the clotrimazole fine powder again, and stirring is also crossed the colloid mill mixing, and is standby,
In changing the glue jar that gelatin is first with an amount of distilled water immersion swelling, add glycerol, an amount of opacifier, antiseptic, heating, stir, make it the fused uniform gelatin that becomes, the bubble in the glue is removed in decompression, reconcentration is the 28000-32000 millipoise at 70-80 ℃ of following estimated viscosity extremely, put into the adjustable steady glue bucket of temperature, the medicinal liquid for preparing is poured in the medicinal liquid bucket, suppress soft capsule with mould.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610043163 CN1899285A (en) | 2006-07-14 | 2006-07-14 | Mycoporin vaginal soft capsule and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610043163 CN1899285A (en) | 2006-07-14 | 2006-07-14 | Mycoporin vaginal soft capsule and its preparing method |
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| Publication Number | Publication Date |
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| CN1899285A true CN1899285A (en) | 2007-01-24 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109464444A (en) * | 2018-12-29 | 2019-03-15 | 天津凯茵科技有限公司 | One kind being used for gynaecology's antifungal compound clotrimazole composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109464444A (en) * | 2018-12-29 | 2019-03-15 | 天津凯茵科技有限公司 | One kind being used for gynaecology's antifungal compound clotrimazole composition |
| CN109464444B (en) * | 2018-12-29 | 2021-03-09 | 青岛大学附属医院 | Compound clotrimazole composition for gynecological antifungal |
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