CN102266305B - Bifonazole vagina effervescent tablet and preparation method thereof - Google Patents
Bifonazole vagina effervescent tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a bifonazole vagina effervescent tablet. The tablet comprises the following components in part by weight: 80-120 parts of bifonazole, 200-400 parts of sodium bicarbonate, 60 to 120 parts of low-substitution hydroxypropylcellulose, 70 to 180 parts of microcrystalline cellulose, 50 to 100 parts of lactose, 60 to 180 parts of sodium starch glycolate, 10 to 30 parts of adhesive, 200 to 400 parts of organic acid, and 5 to 20 parts of lubricant. The invention also discloses a preparation method of the bifonazole vagina effervescent tablet. In the preparation method, production equipment of common tablets is adopted, the process is simple, and the cost is low; and the prepared vagina effervescent tablet has the advantages of large foaming volume, stable quality, as well as convenience for preservation, carriage, transportation and storage, quick disintegration, convenience for use, quick response, high bioavailability, well acceptance by patients and the like.
Description
Technical field
The present invention relates to a kind of vagina effervescence, be specifically related to a kind of bifonazole vagina effervescence external preparation and preparation method thereof, belong to the synthetic and preparing technical field of medicine.
Background technology
According to statistics, the sickness rate of gynaecopathia is more than 65%, and sickness rate is rejuvenation trend, had a strong impact on women's work and life.Monilial vaginitis claims colpitis mycotica again, be common in anemia of pregnant woman, youngest daughter, diabetic and accept a large amount of estrin treatment persons, the primiparity gravid woman has approximately and suffers from this disease more 80%, 20～30 years old patient can account for 80% of ill sum, about 5～10% patient is associated with trichomonacide, and it is mainly by due to the candida albicans infection.Modal symptom is that leucorrhea is many, and the scorching hot pruritus of pudendum and vagina involves urethra, also diseases such as frequent micturition, urgent micturition, dysurea can be arranged.
Bifonazole is imidazole antimycotics, has the broad-spectrum antifungal effect, and to dermatophytes, yeast, mycete and other fungus, as chaff shape fish-scale mycete, corynebacterium minutissimum is effective.In vitro tests shows that this medicine mainly is sterilization to the effect of dermatophytes (as Trichophyton), and mainly is antibacterial to saccharomycetic effect.The same with other imidazoles, this medicine has the 14-of inhibition Demethylation, makes it to form ergosterol, can reduce the generation of mevalonic acid, makes it to form Squalene, and influences the synthetic of fungus ergosterol.This medicine can see through infected skin well, and the rapid and longer duration of effect was held time above 48 hours.
Pearl is read commonly encountered diseases and the frequently-occurring disease that bacterium property vulvovaginitis is the women, and local application's effect is better than systemic administration, and side effect is little, and for meeting clinical needs, existing bifonazole has dosage forms such as vaginal tablet and ointment.Vagina effervescence is another kind of intravaginal drug exterior-applied formulation, and curative effect is accelerated in the disintegrate of can foaming rapidly after its suction, reduces toxic and side effects, but by retrieval at present not to the research of bifonazole vagina effervescence dosage form.In addition, the preparation method of conventional effervescent tablet is not easy to control the gas foaming amount, and meeting water is process gas, causes that effervescent tablet expands, is out of shape, breaks etc., and very easily deliquescence is rotten, has inconvenience in use.
Summary of the invention
The purpose of this invention is to provide a kind of bifonazole vagina effervescence, its steady quality, disintegrate is rapid, bioavailability is high, easy to use.
Another object of the present invention provides the preparation method of this bifonazole vagina effervescence, and this method is optimized technology and improved, and has overcome the uppity defective of original preparation method gas foaming amount, the products obtained therefrom steady quality.
Technical scheme of the present invention is as follows:
A kind of bifonazole vagina effervescence, it is characterized in that comprising the following weight parts composition: 80～120 parts of bifonazoles, 200～400 parts of sodium bicarbonate, 60～120 parts of low-substituted hydroxypropyl celluloses, 70～180 parts of microcrystalline Cellulose, 50～100 parts of lactose, 60～180 parts of carboxymethylstach sodium, 10～30 parts of binding agents, 200～400 parts of organic acid, 5～20 parts of lubricants.
Described binding agent is at least a in hypromellose and the 30 POVIDONE K 30 BP/USP 30, and described organic acid is at least a in citric acid, tartaric acid and the fumaric acid; Described lubricant is magnesium stearate, Polyethylene Glycol or sodium lauryl sulphate.
The molecular weight of described Polyethylene Glycol is 4000-6000.
Above-mentioned vagina effervescence is preferably filled a prescription and is (weight portion): 100 parts of bifonazoles, 270～350 parts of sodium bicarbonate, 70～100 parts of low-substituted hydroxypropyl celluloses, 80～120 parts of microcrystalline Cellulose, 50～80 parts of lactose, 90～120 parts of carboxymethylstach sodium, 15～25 parts of binding agents, 270～350 parts of organic acid, 5～10 parts of lubricants.
The preparation method of bifonazole vagina effervescence of the present invention is characterized in that:
(1) get various compositions, pulverized 80 mesh sieves respectively, standby;
(2) low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose and carboxymethylstach sodium being divided equally is 2 parts, portion and bifonazole, sodium bicarbonate mix homogeneously, with the alcoholic solution of binding agent soft material processed, crossing 14 mesh sieves granulates, wet granular is dry down at 65～75 ℃, cross 14 mesh sieve granulate, get granule A;
(3) get remaining low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose and carboxymethylstach sodium, with the organic acid mix homogeneously, with the alcoholic solution soft material processed of binding agent, crossing 14 mesh sieves granulates, wet granular is dry under 65～75 ℃, crosses 14 mesh sieve granulate, gets granule B;
(4) gained granule A and granule B and mix lubricant is even, tabletting, namely.
In the above-mentioned preparation method, with the alcoholic solution soft material processed of binding agent, the mass concentration of binding agent in ethanol is 5-10%, and the volumetric concentration of used ethanol is 60～95%.
When above-mentioned preparation granule A and granule B, the alcoholic solution of adhesive therefor is identical.
Though the present invention's usefulness is general adjuvant, but prepare the used adjuvant of effervescent tablet now and do not have too big improvement, do not consider influencing each other between the adjuvant, the inventor finds under study for action, between the adjuvant cooperatively interact and adjuvant between the relation of consumption the quality of product is existed very big influence, on the basis of this discovery, the inventor has carried out a large amount of experiments, chosen the adjuvant of suitable bifonazole, determined the matching relationship between each adjuvant, obtained vagina effervescence of the present invention, the vagina effervescence of gained all satisfies the pharmacopeia requirement on disintegration and gas release, is easy in use be accepted by patient.
In addition, traditional method is not easy to control the gas foaming amount, in use, storage, transportation, all there is inconvenience, the present invention adopts sodium bicarbonate and organic acid to meet the soda acid system of aquatic product carbon dioxide as foaming agent and disintegrating agent, and sodium bicarbonate and organic acid amount in the prescription screened, in the preparation they are separately made different granules in addition, carry out mixed pressuring plate at last, make gas foaming obtain effective control, convenient in use.
The vagina effervescence of gained of the present invention can make vagina effervescence in the foaming disintegrate rapidly of intravaginal suction back, principal agent is distributed to intravaginal fast, accelerate curative effect, reduce toxic and side effects, because a large amount of foams that disintegrate produces have increased medicine and have contacted with the direct of diseased region, bring into play its curative effect effect better, so effervescent tablet also is used for the control medication of vagina etc., patient is more taken like a shot.
Vagina effervescence gas release of the present invention is big, steady quality, be convenient to preserve, carry, transport and store, have advantages such as disintegrate is quick, easy to use, onset is rapid, bioavailability is high, patient takes like a shot, adopt the production equipment of conventional tablet during preparation, technology is simple, cost is low, the products obtained therefrom steady quality.
The specific embodiment
The invention will be further described by the following specific embodiment, but be not restricted to following explanation, also should not be construed as any limitation of the invention.The volumetric concentration of used ethanol is 60～95%.
Embodiment 1
Vagina effervescence consists of: 100 parts of bifonazoles, 200 parts of sodium bicarbonate, 60 parts of low-substituted hydroxypropyl celluloses, 70 parts of microcrystalline Cellulose, 50 parts of lactose, 87 parts of carboxymethylstach sodium, 30 10 parts of 30 POVIDONE K 30 BP/USPs, 215 parts in tartaric acid, 8 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 65 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤2% in 65 ℃, take out, with 14 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 0.8g.
Embodiment 2
Vagina effervescence consists of: 100 parts of bifonazoles, 265 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl celluloses, 100 parts of microcrystalline Cellulose, 70 parts of lactose, 60 parts of carboxymethylstach sodium, 10 parts of hypromelloses, 275 parts of citric acid, 20 parts of Polyethylene Glycol.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% hypromellose soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 70 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% hypromellose soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 70 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and Polyethylene Glycol mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1g.
Embodiment 3
Vagina effervescence consists of: 80 parts of bifonazoles, 290 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl celluloses, 70 parts of microcrystalline Cellulose, 60 parts of lactose, 90 parts of carboxymethylstach sodium, 30 24 parts of 30 POVIDONE K 30 BP/USPs, 300 parts in tartaric acid, 8 parts of Polyethylene Glycol, 2 parts of sodium lauryl sulphates.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 70 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 70 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and Polyethylene Glycol, sodium lauryl sulphate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1g.
Embodiment 4
Vagina effervescence consists of: 100 parts of bifonazoles, 300 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl celluloses, 120 parts of microcrystalline Cellulose, 80 parts of lactose, 70 parts of carboxymethylstach sodium, 30 20 parts of 30 POVIDONE K 30 BP/USPs, 300 parts of citric acid, 10 parts of Polyethylene Glycol.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 70 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 70 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and Polyethylene Glycol mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.1g.
Embodiment 5
Vagina effervescence consists of: 100 parts of bifonazoles, 230 parts of sodium bicarbonate, 120 parts of low-substituted hydroxypropyl celluloses, 130 parts of microcrystalline Cellulose, 100 parts of lactose, 160 parts of carboxymethylstach sodium, 15 parts of hypromelloses, 240 parts of citric acid, 5 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.1g.
Embodiment 6
Vagina effervescence consists of: 100 parts of bifonazoles, 300 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl celluloses, 80 parts of microcrystalline Cellulose, 50 parts of lactose, 115 parts of carboxymethylstach sodium, 30 25 parts of 30 POVIDONE K 30 BP/USPs, 320 parts in tartaric acid, 10 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.1g.
Embodiment 7
Vagina effervescence consists of: 100 parts of bifonazoles, 350 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl celluloses, 100 parts of microcrystalline Cellulose, 50 parts of lactose, 95 parts of carboxymethylstach sodium, 30 25 parts of 30 POVIDONE K 30 BP/USPs, 370 parts of fumaric acid, 5 parts of magnesium stearate, 5 parts of Polyethylene Glycol.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate, Polyethylene Glycol mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.2g.
Embodiment 8
Vagina effervescence consists of: 90 parts of bifonazoles, 310 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl celluloses, 150 parts of microcrystalline Cellulose, 100 parts of lactose, 165 parts of carboxymethylstach sodium, 30 30 parts of 30 POVIDONE K 30 BP/USPs, 200 parts in tartaric acid, 140 parts of citric acid, 15 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid, citric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.3g.
Embodiment 9
Vagina effervescence consists of: 110 parts of bifonazoles, 380 parts of sodium bicarbonate, 120 parts of low-substituted hydroxypropyl celluloses, 140 parts of microcrystalline Cellulose, 50 parts of lactose, 170 parts of carboxymethylstach sodium, 20 parts of hypromelloses, 400 parts of citric acid, 18 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% hypromellose soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 5% hypromellose soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.4g.
Embodiment 10
Vagina effervescence consists of: 120 parts of bifonazoles, 390 parts of sodium bicarbonate, 110 parts of low-substituted hydroxypropyl celluloses, 180 parts of microcrystalline Cellulose, 70 parts of lactose, 180 parts of carboxymethylstach sodium, 30 30 parts of 30 POVIDONE K 30 BP/USPs, 400 parts in tartaric acid, 20 parts of magnesium stearate.
Preparation method: various supplementary materials are pulverized respectively, crossed 80 mesh sieves, standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.5g.
Experimental example
Inspection method: get 10 in 25ml tool plug scale test tube (internal diameter 1.5cm), precision adds water 2ml, put in 37 ℃ ± 1 ℃ water-bath after 5 minutes, drop into 1 of bifonazole vagina effervescence in each pipe respectively, close plug, the volume of the maximum gas release of observation in 20 minutes, average foam volume should be no less than 6ml, and what be less than 4ml must not surpass 2, the results are shown in Table 1.
Result of the test shows, bifonazole vagina effervescence gas release of the present invention, and the result all meets " the gas release requirement of 2010 editions two middle effervescent tablets of Chinese pharmacopoeia.
Claims (2)
1. the preparation method of a bifonazole vagina effervescence, it is characterized in that: consist of: 80 parts of bifonazoles, 290 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl celluloses, 70 parts of microcrystalline Cellulose, 60 parts of lactose, 90 parts of carboxymethylstach sodium, 30 24 parts of 30 POVIDONE K 30 BP/USPs, 300 parts in tartaric acid, 8 parts of Polyethylene Glycol, 2 parts of sodium lauryl sulphates;
Preparation method is: various supplementary materials pulverized respectively, crossed 80 mesh sieves, and standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 70 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 70 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and Polyethylene Glycol, sodium lauryl sulphate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1g.
2. the preparation method of a bifonazole vagina effervescence, it is characterized in that: consist of: 120 parts of bifonazoles, 390 parts of sodium bicarbonate, 110 parts of low-substituted hydroxypropyl celluloses, 180 parts of microcrystalline Cellulose, 70 parts of lactose, 180 parts of carboxymethylstach sodium, 30 30 parts of 30 POVIDONE K 30 BP/USPs, 400 parts in tartaric acid, 20 parts of magnesium stearate;
Preparation method is: various supplementary materials pulverized respectively, crossed 80 mesh sieves, and standby; Get bifonazole, the sodium bicarbonate of recipe quantity, part low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 14 order nylon mesh, wet granular is dried to moisture≤1% in 75 ℃, take out, with 14 order nylon mesh granulate, get granule A; With tartaric acid and residue low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, lactose, carboxymethylstach sodium mixing, with the alcoholic solution of 10% 30 POVIDONE K 30 BP/USP 30 soft material processed, granulate with 16 order nylon mesh, wet granular is dried to moisture≤2% in 75 ℃, take out, with 16 order nylon mesh granulate, get granule B; With granule A, granule B and magnesium stearate mix homogeneously; Use special-shaped stamping, namely get required effervescent tablet, every 1.5g.
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Inventor after: Wang Haohua Inventor after: Liu Hong Inventor after: Wang Qingsheng Inventor after: Gao Hengzhong Inventor after: Liu Yongxia Inventor after: Xia Chunmei Inventor after: Song Jinyan Inventor after: Qin Changjin Inventor after: Ma Quanlong Inventor before: Ma Quanlong Inventor before: Liu Hong Inventor before: Qin Changjin Inventor before: Gao Hengzhong Inventor before: Liu Yongxia Inventor before: Wang Qingsheng Inventor before: Wang Haohua Inventor before: Xia Chunmei Inventor before: Song Jinyan |
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