CN102266305B - Bifonazole vagina effervescent tablet and preparation method thereof - Google Patents

Abstract

The invention discloses a bifonazole vaginal effervescent tablet, which comprises: 80-120 parts of bifonazole, 200-400 parts of sodium bicarbonate, 60-120 parts of low-substituted hydroxypropyl cellulose, microcrystalline cellulose 70-180 parts, 50-100 parts of lactose, 60-180 parts of sodium starch glycolate, 10-30 parts of binder, 200-400 parts of organic acid, 5-20 parts of lubricant. The invention also discloses a preparation method thereof. Common tablet production equipment is used for preparation, the process is simple, and the cost is low. The obtained vaginal effervescent tablet has large foaming volume, stable quality, is convenient for preservation, carrying, transportation and storage, and has the advantages of disintegration It has the advantages of rapid solution, convenient use, rapid onset of effect, high bioavailability, and patient acceptance.

Description

Bifonazole vaginal effervescent tablet and its preparation method

technical field

The invention relates to a vaginal effervescent tablet, in particular to an external preparation of bifonazole vaginal effervescent tablet and a preparation method thereof, belonging to the technical field of pharmaceutical synthesis and preparation.

Background technique

According to statistics, the incidence of gynecological diseases is more than 65%, and the incidence is younger, seriously affecting women's work and life. Candida vaginitis, also known as fungal vaginitis, is common in pregnant women, young girls, diabetic patients and those receiving a large amount of estrogen therapy. About 80% of primiparous pregnant women suffer from this disease, and patients aged 20 to 30 can account for it. 80% of the total number of patients, about 5 to 10% of patients with trichomonas infection, which is mainly caused by Candida albicans infection. The most common symptoms are excessive leucorrhea, burning and itching of the vulva and vagina, spreading to the urethra, and symptoms such as frequent urination, urgency, and painful urination.

Bifonazole is an imidazole antifungal agent with broad-spectrum antifungal effect and is effective against skin fungi, yeasts, molds and other fungi, such as Mycobacterium furfur and Corynebacterium tiny. In vitro tests show that the drug's effect on skin fungi (such as trichophyton) is mainly bactericidal, while the effect on yeast is mainly bacteriostatic. Like other imidazole drugs, this drug can inhibit 14-demethylation, so that it can not form ergosterol, can reduce the production of mevalonate, so that it can not form squalene, and affect the growth of fungal ergosterol synthesis. The drug penetrates the infected skin well, acts quickly and lasts longer than 48 hours.

Candida vulvovaginitis is a common and frequently-occurring disease in women. The effect of topical medication is better than that of systemic medication, and the side effects are small. To meet clinical needs, existing bifonazole has dosage forms such as vaginal tablets and creams. Vaginal effervescent tablet is another external vaginal drug dosage form, which can quickly foam and disintegrate after absorbing water, speed up the curative effect, and reduce toxic and side effects. In addition, the conventional effervescent tablet preparation method is not easy to control the amount of gas foaming, and gas is produced when it meets water, resulting in expansion, deformation, rupture, etc. of the effervescent tablet, which is easily deliquescent and deteriorated, causing inconvenience during use.

Contents of the invention

The object of the present invention is to provide a bifonazole vaginal effervescent tablet, which has stable quality, rapid disintegration, high bioavailability and convenient use.

Another object of the present invention is to provide the preparation method of the bifonazole vaginal effervescent tablet, which optimizes and improves the process, overcomes the defect that the gas foaming amount of the original preparation method is not easy to control, and the quality of the obtained product is stable .

Technical scheme of the present invention is as follows:

A bifonazole vaginal effervescent tablet is characterized in that it comprises the following ingredients in parts by weight: 80-120 parts of bifonazole, 200-400 parts of sodium bicarbonate, 60-120 parts of low-substituted hydroxypropyl cellulose, 70-180 parts of microcrystalline cellulose, 50-100 parts of lactose, 60-180 parts of sodium starch glycolate, 10-30 parts of binder, 200-400 parts of organic acid, and 5-20 parts of lubricant.

The binding agent is at least one of hypromellose and povidone K30, and the organic acid is at least one of citric acid, tartaric acid and fumaric acid; the lubricant is stearic acid Magnesium, polyethylene glycol, or sodium lauryl sulfate.

The molecular weight of the polyethylene glycol is 4000-6000.

The preferred formulation of the above-mentioned vaginal effervescent tablet is (parts by weight): 100 parts of bifonazole, 270-350 parts of sodium bicarbonate, 70-100 parts of low-substituted hydroxypropyl cellulose, 80-120 parts of microcrystalline cellulose, 50-80 parts of lactose, 90-120 parts of sodium starch glycolate, 15-25 parts of binder, 270-350 parts of organic acid, and 5-10 parts of lubricant.

The preparation method of bifonazole vaginal effervescent tablet of the present invention is characterized in that:

(1) Take various ingredients, crush them through 80-mesh sieve, and set aside;

(2) Divide low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose and carboxymethyl starch sodium into 2 equal parts, mix one part with bifonazole and sodium bicarbonate evenly, and prepare it with ethanol solution of binder For soft materials, pass through a 14-mesh sieve to granulate, dry the wet granules at 65-75°C, pass through a 14-mesh sieve for granulation, and obtain Granule A;

(3) Take the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose and sodium starch glycolate, mix them with organic acid evenly, use the ethanol solution of the binder to make a soft material, and pass through a 14-mesh sieve to granulate. The wet granules are dried at 65-75°C, passed through a 14-mesh sieve, and granulated to obtain granule B;

(4) Mix the obtained granule A and granule B with the lubricant evenly, and press into tablets to obtain the product.

In the above preparation method, the ethanol solution of the binder is used to make the soft material, the mass concentration of the binder in ethanol is 5-10%, and the volume concentration of the ethanol used is 60-95%.

When the above-mentioned preparation of granule A and granule B, the ethanol solution of the binder used is the same.

Although what the present invention used is general auxiliary material, the auxiliary material used for preparing effervescent tablet is not greatly improved at present, does not consider the mutual influence between auxiliary material, the inventor finds in research, the mutual cooperation between auxiliary material and the The relationship of dosage has a great impact on the quality of the product. On the basis of this discovery, the inventor has carried out a large number of experiments, selected the auxiliary materials suitable for bifonazole, determined the coordination relationship between each auxiliary material, and obtained In the vaginal effervescent tablet of the present invention, the obtained vaginal effervescent tablet meets the requirements of the Pharmacopoeia in terms of disintegration time limit and foaming volume, and is easy to be accepted by patients during use.

In addition, the traditional method is not easy to control the amount of gas foaming, and there are inconveniences in use, storage, and transportation. The present invention uses an acid-base system in which sodium bicarbonate and organic acids meet water to produce carbon dioxide as a foaming agent and a disintegrating agent. And the amount of sodium bicarbonate and organic acid in the prescription was screened. In addition, they were separated into different granules during preparation, and finally mixed and pressed into tablets, so that the gas foaming was effectively controlled, and it was more convenient to use .

The vaginal effervescent tablet obtained by the present invention can make the vaginal effervescent tablet rapidly foam and disintegrate after absorbing water in the vagina, and the main drug can be quickly dispersed in the vagina to accelerate the curative effect and reduce toxic and side effects, and the large amount of foam produced due to disintegration increases The direct contact between the drug and the diseased part can better exert its curative effect, so the effervescent tablet is also used for the prevention and treatment of vaginal diseases, which makes patients more willing to accept it.

The vaginal effervescent tablet of the present invention has the advantages of large foaming volume, stable quality, easy preservation, carrying, transportation and storage, rapid disintegration, convenient use, rapid onset of effect, high bioavailability, and patient acceptance. Common tablet production equipment, simple process, low cost, and stable product quality.

Detailed ways

The present invention will be further described through the following specific embodiments, but it is not limited to the following description, nor should it be construed as any limitation of the present invention. The volume concentration of ethanol used is 60-95%.

Example 1

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 200 parts of sodium bicarbonate, 60 parts of low-substituted hydroxypropyl cellulose, 70 parts of microcrystalline cellulose, 50 parts of lactose, 87 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 10 parts, tartaric acid 215 parts, magnesium stearate 8 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 5% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 65°C until the water content is less than 1%, take them out, and use 14-mesh nylon sieve to granulate to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and sodium starch glycolate, make soft material with 5% ethanol solution of povidone K30, and granulate with a 14-mesh nylon sieve , dry the wet granules at 65°C until the water content is less than or equal to 2%, take them out, and use a 14-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets to obtain the obtained Effervescent tablets are required, each 0.8g.

Example 2

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 265 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl cellulose, 100 parts of microcrystalline cellulose, 70 parts of lactose, 60 parts of sodium starch glycolate, hydroxypropyl cellulose 10 parts of methylcellulose, 275 parts of citric acid, 20 parts of polyethylene glycol.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, make soft material with 5% hypromellose ethanol solution, granulate with 14-mesh nylon sieve, dry the wet granules at 70°C until the water content is ≤1%, take them out, and granulate with 14-mesh nylon sieve. Granule A is obtained; tartaric acid is mixed with remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, and soft material is made with 5% hypromellose ethanol solution, and a 16-mesh nylon sieve is used For granulation, dry the wet granules at 70°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and polyethylene glycol evenly; use special-shaped punching tablets, that is Get the required effervescent tablets, each 1g.

Example 3

Vaginal effervescent tablets are composed of: 80 parts of bifonazole, 290 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl cellulose, 70 parts of microcrystalline cellulose, 60 parts of lactose, 90 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 24 parts, tartaric acid 300 parts, polyethylene glycol 8 parts, sodium lauryl sulfate 2 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 70°C until the water content is less than 1%, take them out, and use 14-mesh nylon sieve to granulate to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 70°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B, polyethylene glycol, and sodium lauryl sulfate evenly; Special-shaped punching tablets, that is, the required effervescent tablets, each 1g.

Example 4

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 300 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl cellulose, 120 parts of microcrystalline cellulose, 80 parts of lactose, 70 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 20 parts, citric acid 300 parts, polyethylene glycol 10 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 70°C until the water content is less than 1%, take them out, and use 14-mesh nylon sieve to granulate to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 70°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and polyethylene glycol evenly; use special-shaped punching tablets to obtain the obtained Effervescent tablets are required, each 1.1g.

Example 5

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 230 parts of sodium bicarbonate, 120 parts of low-substituted hydroxypropyl cellulose, 130 parts of microcrystalline cellulose, 100 parts of lactose, 160 parts of sodium starch glycolate, hydroxypropyl cellulose 15 parts of methyl cellulose, 240 parts of citric acid, 5 parts of magnesium stearate.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to sieve to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 75°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets to obtain the obtained Effervescent tablets are required, each 1.1g.

Example 6

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 300 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl cellulose, 80 parts of microcrystalline cellulose, 50 parts of lactose, 115 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 25 parts, tartaric acid 320 parts, magnesium stearate 10 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to sieve to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 75°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets to obtain the obtained Effervescent tablets are required, each 1.1g.

Example 7

Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 350 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl cellulose, 100 parts of microcrystalline cellulose, 50 parts of lactose, 95 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 25 parts, fumaric acid 370 parts, magnesium stearate 5 parts, polyethylene glycol 5 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to sieve to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 75°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B, magnesium stearate, and polyethylene glycol evenly; use special-shaped stamping Tablets, that is, the required effervescent tablets, each 1.2g.

Example 8

Vaginal effervescent tablets are composed of: 90 parts of bifonazole, 310 parts of sodium bicarbonate, 100 parts of low-substituted hydroxypropyl cellulose, 150 parts of microcrystalline cellulose, 100 parts of lactose, 165 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 30 parts, tartaric acid 200 parts, citric acid 140 parts, magnesium stearate 15 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to sieve to obtain Granule A; mix tartaric acid, citric acid and the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and sodium starch glycolate, and use 10% povidone K30 ethanol solution to make a soft material, using 16 mesh Nylon sieve granulation, dry the wet granules at 75°C until the water content is ≤2%, take them out, and use a 16-mesh nylon sieve to adjust the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets , that is, the desired effervescent tablets, each 1.3g.

Example 9

Vaginal effervescent tablets are composed of: 110 parts of bifonazole, 380 parts of sodium bicarbonate, 120 parts of low-substituted hydroxypropyl cellulose, 140 parts of microcrystalline cellulose, 50 parts of lactose, 170 parts of sodium starch glycolate, hydroxypropyl cellulose 20 parts of methyl cellulose, 400 parts of citric acid, 18 parts of magnesium stearate.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix well with sodium, make soft material with 5% hypromellose ethanol solution, granulate with 14-mesh nylon sieve, dry the wet granules at 75°C until the water content is ≤1%, take them out, and granulate with 14-mesh nylon sieve. Granule A is obtained; tartaric acid is mixed with remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, and soft material is made with 5% hypromellose ethanol solution, and a 16-mesh nylon sieve is used For granulation, dry the wet granules at 75°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; punch tablets with special shapes, that is, Get the required effervescent tablets, each 1.4g.

Example 10

Vaginal effervescent tablets are composed of: 120 parts of bifonazole, 390 parts of sodium bicarbonate, 110 parts of low-substituted hydroxypropyl cellulose, 180 parts of microcrystalline cellulose, 70 parts of lactose, 180 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 30 parts, tartaric acid 400 parts, magnesium stearate 20 parts.

Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to sieve to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, use 10% povidone K30 ethanol solution to make a soft material, and granulate with a 16-mesh nylon sieve , dry the wet granules at 75°C until the water content is less than or equal to 2%, take them out, and use a 16-mesh nylon sieve to sieve the granules to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets to obtain the obtained Effervescent tablets are required, each 1.5g.

Experimental example

Inspection method: Take 10 25ml graduated test tubes with stoppers (inner diameter 1.5cm), add 2ml of water precisely, put them in a water bath at 37°C±1°C for 5 minutes, put 1 bifonazole vaginal effervescent tablet into each tube, tightly Plug, observe the volume of the maximum foaming volume within 20 minutes, the average foaming volume should not be less than 6ml, and if it is less than 4ml, it should not exceed 2 tablets, the results are shown in Table 1.

The test results show that the foaming volume of the bifonazole vaginal effervescent tablet of the present invention all meets the requirements for the foaming volume of the effervescent tablet in the second part of the "Chinese Pharmacopoeia" 2010 edition.

Claims (2)

1. A preparation method for bifonazole vaginal effervescent tablet, characterized in that: it consists of: 80 parts of bifonazole, 290 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl cellulose, microcrystalline cellulose 70 parts, 60 parts of lactose, 90 parts of sodium starch glycolate, 24 parts of povidone K30, 300 parts of tartaric acid, 8 parts of polyethylene glycol, 2 parts of sodium lauryl sulfate; The preparation method is as follows: crush various raw and auxiliary materials separately, pass through an 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, part of low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, carboxymethyl Mix starch sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 70°C until the water content is ≤1%, take them out, and use 14-mesh nylon sieve to granulate. Granule A is obtained; tartaric acid is mixed with remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, and soft material is made with 10% ethanol solution of povidone K30, and sieved with 16 mesh nylon Granules, dry the wet granules at 70°C until the water content is ≤2%, take them out, and sieve the granules with a 16-mesh nylon sieve to obtain granule B; mix granule A, granule B with polyethylene glycol and sodium lauryl sulfate evenly; Use special-shaped punching tablets to obtain the required effervescent tablets, each 1g. 2. A preparation method for bifonazole vaginal effervescent tablet, characterized in that: it consists of: 120 parts of bifonazole, 390 parts of sodium bicarbonate, 110 parts of low-substituted hydroxypropyl cellulose, microcrystalline cellulose 180 parts, 70 parts of lactose, 180 parts of sodium starch glycolate, 30 parts of povidone K30, 400 parts of tartaric acid, 20 parts of magnesium stearate; The preparation method is as follows: crush various raw and auxiliary materials separately, pass through an 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, part of low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, carboxymethyl Mix starch sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 75°C until the water content is ≤1%, take it out, and use 14-mesh nylon sieve to granulate. Granule A is obtained; tartaric acid is mixed with remaining low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch sodium, and soft material is made with 10% ethanol solution of povidone K30, and sieved with 16 mesh nylon Granules, dry the wet granules at 75°C until the water content is ≤2%, take them out, and sieve them with a 16-mesh nylon sieve to obtain granule B; mix granule A, granule B and magnesium stearate evenly; use special-shaped punching tablets to obtain Required effervescent tablets, each 1.5g.