Nifuratel nysfungin vaginal soft capsule and preparation process thereof

Abstract

The invention discloses a nifuratel nysfungin vaginal soft capsule and a preparation process thereof. The nifuratel nysfungin vaginal soft capsule comprises nifuratel, nysfungin, matrix and a moisturizer, wherein a soft capsule shell comprises gelatin, a plasticizer, water, a bacteriostatic agent, a pigment and an opaquing agent; lactobacillus is effectively protected when bacteria, mycete, trichomonad and the like are killed; restoration of balance of vaginal beneficial flora is facilitated; and through improvement of the prescription and the prepration process, the medicine stability and the medicinal effectiveness are greatly improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a nifuratel nystatin vaginal soft capsule and a preparation process thereof. Background technique [0002] Nifuratel (Nifuratel) is a broad-spectrum antibacterial drug that belongs to the class of furazolidone (this class of drugs also includes nitrofurazone, furadantin, and furazolidone). Nifuratel was developed and launched by Italian company Poli Industria Chimica S.p.A in the 1960s. It has been marketed and used in more than 20 countries around the world. Play a strong and effective killing effect, but rarely produce any acute and chronic side effects. Due to its multi-faceted therapeutic effects, it has a significant curative effect on all kinds of vaginitis caused by bacteria, trichomonas or fungal infection. [0003] Nystatin, also known as nystatin, is a yellow or brown powder with a grain-like odor and strong hygroscopicity. It is unstable to light,...

AI Technical Summary

Problems solved by technology

[0005] First of all, there are many domestic drugs for treating gynecological inflammation. Many drugs can kill or inhibit single or multiple pathogenic bacteria. It is easy to relapse after dispensing, and more often, the adverse reaction rate is high, which is difficult for patients to accept; secondly, due to the instability of nystatin and the immature production process, it is easy to cause partial failure of the product within the validity period, which seriously affects the quality of the product. Uniformity and therapeutic effect

[0006] Chinese patent CN 103599120 A discloses a nifuratel nystatin soft capsule suppository and a preparation method thereof, from which many disadvantages can be seen: ① the ethanol in the prescription lacks an instruction for use, if it is the material in the content, It is definitely unreasonable. Due to the existence of ethanol, long-term storage will soften the soft capsule shell, resulting in leakage, which seriously affects the forming, storage and stability of the soft capsule; ②The water in the prescription also lacks instructions, and there is no clear water Attribution (content, soft capsule shell), if it exists in the content, long-term storage will also soften the soft capsule shell, resulting in leakage, which will seriously affect the storage time limit and validity period

Moreover, nystatin is unstable to water, and the introduction of water will inevitably affect the product quality and drug effect; ③ there is no regulation and description on the formula of the soft capsule shell in the prescription, which lacks credibility; The preparation of the shell gum solution is explained, which is not convincing; ⑤ In the examples, only the data analysis of its toxicology and clinical effects is carried out, and no data analysis is carried out for the content of the invention (stability)

Images