Secnidazole vaginal suppository and its preparation process

Abstract

The secnidazole vaginal suppository of the present invention is composed of the following components: main ingredient secnidazole 500g, auxiliary material 36 type mixed fatty acid glyceride 2300g, made into 1000 suppositories, each weighing 2.8 grams, the 36 type mixed Fatty acid glycerides are a mixture of triglycerides, diglycerides and monoglycerides, and the melting point of type 36 mixed fatty acid glycerides is 35-37°C. The drug of the secnidazole suppository of the present invention is directly absorbed through the vagina, and will not cause damage to the heart, kidney and liver after testing. The curative effect is good, there is basically no side effect, the proportion is simple, and the use is convenient. The invention also discloses the preparation process of the secnidazole vaginal suppository at the same time.

Description

technical field [0001] The invention relates to a secnidazole vaginal suppository, and also relates to a preparation process of the secnidazole vaginal suppository. Background technique [0002] Secnidazole (Secnidazole) belongs to 5-nitroimidazole compounds, 5-nitroimidazole drugs are characterized by selective toxicity to anaerobic microorganisms, but have no effect on facultative and aerobic microorganisms. The minimum trichomonad-killing concentration of secnidazole is 0.70 mg / L, that of metronidazole is 0.60 mg / L, and that of tinidazole is 1.125 mg / L. The minimum trichomonas killing of secnidazole is similar to that of metronidazole, but lower than that of tinidazole, and the 50% inhibitory concentration of secnidazole to Giardia lamblia trophozoites in vitro is 1 / 10 of that of metronidazole . [0003] The toxicity of secnidazole is extremely low, and the safe dose for long-term toxicity is 400mg / kg. The structure of 5-nitroimidazole drugs may have potential mutagenic...

AI Technical Summary

Problems solved by technology

[0006] At present, there are secnidazole injection, secnidazole tablets and secnidazole vaginal effervescent tablets at home and abroad, but the components of these preparations are more complicated

Such as Chinese patent 200310109011.5 secnidazole vaginal effervescent tablet and its production method, in addition to the active ingredient secnidazole, there are also medicinal disintegrants, adhesives, lubricants, wetting agents, fillers, etc. A variety of auxiliary materials, because there are many auxiliary materials, so the preparation process is also more complicated

[0007] Chinese patent publication number is that CN1548043A discloses a kind of secnidazole injection and preparation method thereof, and it is to take secnidazole as main medicine, adds the adjuvant that has isotonic adjustment effect to make, but this injection is harmful to the heart , Kidney and liver are damaged. According to the experimental data, after the injection of secnidazole injection, the heart beat amplitude is greatly reduced (0.41g-0.19g), while the creatinine and blood urea nitrogen of the kidney increase, and the blood urea nitrogen of the liver increases. The transaminase will increase, and it will decrease after 7 days of drug withdrawal, but it is also higher than that of no drug, which shows that secnidazole injection has caused a certain degree of damage to the heart, kidney, and liver functions

[0008] Chinese Patent Publication No. CN1973838A discloses a secnidazole tablet and a preparation method thereof. Made of cellulose sodium, cross-linked polyvinylpyrrolidone, polyvinylpyrrolidone or hypromellose, magnesium stearate, talcum powder, micro-powder silica gel, etc., the components and preparation process are very complicated

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