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Nifuratel nysfungin vaginal soft capsule and preparation process thereof

A technology of nifuratel nystatin and soft capsules is applied in the field of pharmaceutical preparations, which can solve the problems of lack of credibility, instability of nystatin to water, imbalance of beneficial vaginal flora and the like, and achieves improved preparation process, Improve drug stability and drug efficacy, promote the effect of restoring balance

Inactive Publication Date: 2015-03-25
JIANGSU YUEXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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)

Method used

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  • Nifuratel nysfungin vaginal soft capsule and preparation process thereof
  • Nifuratel nysfungin vaginal soft capsule and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Calculated according to the weight of 1000 capsules, the content components are: 500g of nifuratel, 33.4g of nystatin, 900g of soybean oil, and 100g of medicinal vaseline. The capsule shell components of the soft capsule are: 380g of gelatin, 182.4g of glycerin, 380g of water, 1g of sunset yellow, 2g of titanium dioxide, and 2g of ethylparaben.

[0058] According to the above formula, the operation process: (1) pre-treatment of raw materials, after passing nifuratel and nystatin through a 120-mesh sieve, and strictly avoiding light, take the prescription amount for later use; (2) prepare the prescription amount Vaseline, nifuratel, and nystatin are sequentially added into a stirring and insulating barrel filled with medicinal soybean oil, the temperature is 40°C, and the stirring speed is 800-1500rpm, until they are uniform and ready for use; (3) Preparation of soft capsule shell materials, ① Add the prescribed amount of ethylparaben, sunset yellow, and titanium dioxide...

Embodiment 2

[0060] Calculated according to the weight of 1000 capsules, the content components are: 500g of nifuratel, 33.4g of nystatin, 1000g of soybean oil, and 150g of medicinal vaseline. The capsule shell components of the soft capsule are: 380g of gelatin, 182.4g of glycerin, 380g of water, 1g of sunset yellow, 2g of titanium dioxide, and 2g of ethylparaben.

[0061] According to the above formula, adopt the same preparation method as Example 1 to prepare soft capsules. The inspection results are shown in Table 6.

Embodiment 3

[0063] Calculated according to the weight of 1000 capsules, the content components are: 500g of nifuratel, 33.4g of nystatin, 1000g of liquid paraffin, and 150g of medicinal vaseline. The capsule shell components of the soft capsule are: 380g of gelatin, 182.4g of glycerin, 380g of water, 1g of tartrazine, 2g of titanium dioxide, and 2g of methylparaben.

[0064] According to the above formula, adopt the same preparation method as Example 1 to prepare soft capsules. The inspection results are shown in Table 6.

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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,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/48A61K47/44A61K47/02A61P15/02A61P31/04A61P31/10A61P33/02A61K31/422
CPCA61K31/7048A61K9/0034A61K9/4825A61K31/422A61K47/02A61K47/44A61K2300/00
Inventor 胡玉乾翟富民朱亚东
Owner JIANGSU YUEXING PHARMA
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