Metronidazole effervescence patch and technique of preparing the same

Abstract

The invention discloses a Metronidazole, Clotrimazole and Chlorhexidine Acetate Effervescent Tablet and the preparation method. Each tablet has the following proportion of contents: metronidazole 0.2 gram, clotrimazole 0.16 gram, acetic acid chlorhexidine acetate 0.008 gram, fumaric acid 0.108 to 0.162 gram, tartaric acid 0.012 to 0.018 gram, solium bicarbonate 0.12 to 0.18 gram, starch 0.02 to 0.04 gram, dextrin 0.003 to 0.007 gram, hydroxypropyl cellulose 0.007 to 0.013 gram, talc 0.01 to 0.017 gram, sodium dodecyl sulfate 0.01to 0.02 gram, and proper proportion of povidone K30 water solution. According to the preparation method, the components are mixed to produce granule (1) and granule (2); the talc, sodium dodecyl sulfate and the granule (1) and granule (2) are mixed uniformly; granule content is tested and according to the granule content, the tablet weight is identified for tabletting. The invention overcomes the shortages with prior art, enables the acetic acid chlorhexidine acetate to perform functions normally, performs synergistic effects of the three drugs, and greatly enhances the cure rate. Besides, the frothing volume is high, and within storage period, the quality is stable and the drug effects are not affected.

Description

technical field [0001] The invention relates to medicines, in particular to a bizoate effervescent tablet and a preparation process thereof. Background technique [0002] Shuangzotai is a commonly used non-prescription drug in gynecology, which belongs to the Pharmacopoeia product. Shuangzotai is a comprehensive drug for the treatment of vaginitis, among which metronidazole is the first choice drug for the treatment of trichomonas vaginitis; clotrimazole is a broad-spectrum antifungal drug, which has the best effect on candida vaginitis; It has been designated as a broad-spectrum fungicide, and has good curative effect on bacterial vaginosis and mixed vaginitis. The combined use of the above three main drugs has a synergistic effect, so the effect of Shuangzotai on the treatment of vaginitis is better than that of other single drugs. [0003] my country's patents have successively granted a number of patents for Shuangzoltai preparations, such as Shuangzoltai Cream, Shuang...

AI Technical Summary

Problems solved by technology

According to market feedback information: Shuangzotai effervescent tablets are widely used, but their efficacy is not good. Therefore, the applicant analyzed Shuangzotai effervescent tablets and found that Shuangzotai effervescent tablets are widely sold and used in the market. The components of the pharmaceutical preparations are all disclosed in Patent No. 94113652.3

Further research shows that the composition of No. 94113652.3 patent has obvious deficiencies: when Shuangzotai effervescent tablet takes effect on the affected area, citric acid, boric acid, and sodium carbonate in the composition react to generate sodium citrate or boric acid Sodium, thereby reducing the drug efficacy of chlorhexidine acetate, especially the curative effect on bacterial and mixed infections is greatly reduced, and the synergistic effect of the three drugs is significantly reduced

[0004] In addition, the preparation components disclosed in No. 94113652.3 patent affect the content determination of chlorhexidine acetate, and the content determination method of national standard YBH30862005 is unqualified for the determination of chlorhexidine acetate

[0005] The known Shuangzotai effervescent tablet also has a stability defect, that is, as the storage time prolongs, its foaming volume gradually decreases until it is unqualified, so that when the patient uses it within the validity period of the drug, the longer the storage time, the lower the drug quality. The effect is gradually reduced, and the patient does not know it, which can easily lead to misunderstandings in the treatment of the disease