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Nifuratel nysfungin vaginal soft capsule and preparation method thereof

A technology of nifuratel nystatin and nifuratel, which is applied in capsule delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., and can solve the problems of decreased drug stability, aggregation and agglomeration, and affecting drug efficacy, etc. problem, to achieve the effect of prolonging the residence time, good dispersion effect and rapid onset of action

Active Publication Date: 2021-06-18
BEIJING JINCHENG TAIER PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method currently used to prepare the suspension and add surfactants or wetting agents is to add it to soybean oil and mix it, such as adding glycerin and Tween 80 to soybean oil for hot-melt mixing, but it is highly hydrophobic to insoluble The dispersion of raw materials such as nifuratel is still not effective, and there is a phenomenon of aggregation and agglomeration, which leads to a decrease in drug stability and affects drug efficacy
[0005] At present, related products use soybean oil, white petrolatum and other compositions as auxiliary materials to prepare soft capsule liquid medicines, but in practice, the viscosity and rheology have not been studied and controlled. Absorption has an important impact, specifically the adhesion of the liquid medicine, which has a longer release time in the vagina, significantly improving the speed and time of the drug acting on the bacteria, and the area is large

Method used

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

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specific Embodiment approach

[0048] In the first aspect of the present disclosure, it is related to the preparation method of nifuurobuimicin vaginal soft capsules, including the following steps:

[0049] S1: Soybean oil and nitrates are wetly grinded, and the ground speed is 10-25m / s. The slurry temperature is controlled in the grinding process of 45 ° C, the grinding time is 1-5 h, and finally ground to the nitzo. The trail is controlled at 100 nm-100 μm, and the viscosity is below 2000 cp, and the yield stress is 1.8-2.0 Pa to obtain a polishing liquid;

[0050] S2: After the hot melt, the white Vaseline, cool down to 60-65 ° C, add it to the grinding liquid, ground the rotational speed 10-25m / s, and the polishing slurry temperature is below 45 ° C, grind 0.5-1h during the grinding process. The control viscosity is less than 2500CP and the yield stress is 2.0-2.2Pa, and the prefabricated product is obtained;

[0051] S3: At 25-45 ° C, hydroxybenzyl and pattimecin were sequentially added to the prefabri...

Embodiment 1

[0072] Prepared by quotation by quotation:

[0073] Capsule content: Nitretus 300-600 mg, soybean oil 984-995 mg, Soybean oil 984-995 mg, Bai Vaselin 5-16 mg, hydroxyethyl ketzate 1-5 mg.

[0074] Caps: Gee 2000-3000mg, glycerol 800-1200 mg, water 2000-3000 mg, titanium dioxide 5-15 mg, sunset yellow 3-5 mg and optionally preservative 1-5 mg. .

[0075] S1: Soybean oil and nitrates are wetly grinded, and the ground speed is 10-25m / s. The slurry temperature is controlled in the grinding process of 45 ° C, the grinding time is 1-5 h, and finally ground to the nitzo. The trail is controlled at 100 nm to 100 μm, and the viscosity is below 2000 cp, and the yield stress is 1.8-2.0 Pa to obtain a polishing liquid.

[0076] S2: After the hot melt, the white Vaseline, cool down to 60-65 ° C, add it to the grinding liquid, ground the rotational speed 10-25m / s, and the polishing slurry temperature is below 45 ° C, grind 0.5-1h during the grinding process. The control viscosity is below 2...

Embodiment 2

[0081] According to the weight of 1000 grains, the amount of raw materials is coated, for example:

[0082] Capsule content: Nitretus 500mg, soybegs 20,000 units, soybean oil 990mg, white Vaselin 10mg, hydroxybenzene 2mg.

[0083] Caps: 2500 mg of gelatin, 1000mg of glycerol, 2500 mg of water, titanium dioxide 8 mg, sunset yellow 4 mg, preservative 2 mg. .

[0084] S1: Soybean oil and nitrates are wetly grinded, and the ground speed is 10-25m / s. The slurry temperature is controlled in the grinding process of 45 ° C, the grinding time is 1-5 h, and finally ground to the nitzo. The trail is controlled at 100 nm-100 μm, the viscosity is below 2000 cp, the yield stress value of 1.9 Pa, and the abrasive liquid is obtained.

[0085] S2: After the hot melt, the white Vaseline, cool down to 60-65 ° C, add it to the grinding liquid, ground the rotational speed 10-25m / s, and the polishing slurry temperature is below 45 ° C, grind 0.5-1h during the grinding process. The control viscosity...

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Abstract

The invention provides a preparation method of a nifuratel nysfungin vaginal soft capsule. The preparation method comprises the steps of wet grinding, preparation of a prefabricated product, preparation of contents, preparation of capsule skins, pelleting and the like. Through controlling rheological parameters such as viscosity, yield stress value and the like of the grinding liquid, the prefabricated product, the contents and the like and controlling the particle size of each component in each preparation step, the dispersion effect of nifuratel and nysfungin in soybean oil is improved and takes effect quickly, and meanwhile, the preparation stability of the vaginal capsule is improved; and through improving the rheology performance, the soft capsule liquid medicine can be better adhered to vagina mucosa, the residence time is prolonged, and the treatment effect is improved.

Description

Technical field [0001] The present disclosure belongs to the field of pharmaceutical and pharmaceutical, and more particularly to a pharmaceutical preparation and a preparation method thereof, and more particularly to a nifuurolatin vaginal soft capsule and a preparation method thereof. Background technique [0002] Nifuratel is a broad-spectrum antibacterial drug, which is a furanone, has been listed in more than 20 countries in the world. So far, there have been more than 30 years, and the bacteria, tridat and mold, such as women's reproductive system. Strong, effective killing, and rarely produce any urgent, chronic side effects. Due to its multi-faceted therapeutic effects, both vaginitis caused by bacterial, drippers or mold infections are significant. [0003] Formomycin, polylene antifungal drug, a broad spectrum antifungal effect, is the membrane permeability enhancer, most sensitive to Candida. Sensitive to Quercus, hair sputum, steadic bacteria, epidermis, and Microspor...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/422A61K31/7048A61K47/44A61K47/06A61K47/42A61P15/02A61P31/04A61P31/10A61P33/02
CPCA61K9/0034A61K9/4825A61K9/4858A61K31/422A61K31/7048A61P15/02A61P31/04A61P31/10A61P33/02A61K2300/00
Inventor 李洁段月晓刘洪亮向宏艳陈冲高银辉李阳孙艳华黄海玉
Owner BEIJING JINCHENG TAIER PHARMA CO LTD
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