Nifuratel and nystatin vaginal soft capsule raw material pretreatment method and preparation preparation method

A technology of nifuratel nystatin and nifuratel, applied in capsule delivery, antifungal agents, pharmaceutical formulations, etc., can solve the problems of drug stability reduction, aggregation and agglomeration, poor effect, etc., and achieve operational Convenience, high bioavailability and low cost

Active Publication Date: 2021-09-03
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

Method used

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  • Nifuratel and nystatin vaginal soft capsule raw material pretreatment method and preparation preparation method
  • Nifuratel and nystatin vaginal soft capsule raw material pretreatment method and preparation preparation method
  • Nifuratel and nystatin vaginal soft capsule raw material pretreatment method and preparation preparation method

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preparation example Construction

[0054] The third aspect of the present disclosure relates to a method for preparing nifuratel nystatin vaginal soft capsules, the method comprising the following steps:

[0055] Step (1) Nifuratel pretreatment: Nifuratel is wet granulated with an additive solution to obtain Nifuratel granules, and the additive solution is that a surfactant or a wetting agent is added to a solvent, Prepared by completely dissolving the surfactant or wetting agent;

[0056] Step (2) preparation of dispersion liquid: adopt vegetable oil to add suspending agent, mix evenly, obtain dispersion liquid;

[0057] Step (3) preparing a dispersion suspension: adding the preservative, nystatin, and the nifuratel granules obtained in step (2) to the dispersion obtained in step (4), and dispersing evenly to obtain a dispersion suspension;

[0058] Step (5) prepares the capsule skin;

[0059] Step (6) pressing pellets.

[0060] In a specific embodiment, before step (1), a pulverization step may also be inc...

Embodiment 1

[0071] Embodiment 1: Nifuratel pretreatment method

[0072] (1) Add the surfactant or wetting agent glycerin and / or SDS into the solvent water to completely dissolve it to obtain an additive solution.

[0073] (2) Nifuratel is added to a high-shear wet granulation pot or a fluidized bed granulation pot, and the additive solution is used for wet granulation for a period of time, so that the surface of the hydrophobic raw material is modified, and then dried, that is Obtain nifuratel highly dispersed powder particles. The wetting and dispersing effect of nifuratel in suspension can be improved by using nifuratel highly dispersed fine powder particles.

Embodiment 2

[0074] Embodiment 2: the preparation of nifuratel nystatin dispersion suspension

[0075] (1) Preparation of dispersion liquid: add vegetable oil to suspending agent, heat to 38° C., stir for 90-120 minutes, and mix well to obtain dispersion liquid.

[0076] (2) Preparation of dispersion suspension: add preservative to the dispersion, add nystatin at 38°C, stir for 30 minutes to disperse evenly, continue to add nifuratel high-dispersion powder particles into the dispersion , Stir with a disperser for 150 minutes to disperse evenly and obtain a dispersion suspension.

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Abstract

The invention provides a pretreatment method of nifuratel, and the pretreatment method comprises a pretreatment step of performing wet granulation on nifuratel to prepare high-dispersion fine powder particles. The preparation of the nifuratel high-dispersion fine powder particles includes the following steps: the nifuratel and an additive solution are subjected to wet granulation and drying to obtain high-dispersion fine powder particles, wherein the additive solution includes a surfactant or a wetting agent. The invention further provides a nifuratel pharmaceutical preparation prepared by the method. A preparation process of a soft capsule preparation includes the following steps of preparing a suspension from the nifuratel high-dispersion fine powder particles and nystatin, and performing pelleting to prepare the nifuratel-containing soft capsule preparation. The amount of related substances in the nifuratel pharmaceutical preparation prepared by the preparation method provided by the invention can be obviously reduced, the dissolution characteristic is good and the stability is high, the bioavailability is high, the wettability and content uniformity of an insoluble drug are improved, and meanwhile, the preparation method has the beneficial effects of simplicity and convenience in operation, low cost, no need of special equipment and easiness in application to industrial production.

Description

technical field [0001] The disclosure belongs to the field of pharmacy and pharmacy, and specifically relates to a pharmaceutical preparation and a preparation method thereof, in particular to a raw material pretreatment method and a preparation preparation method of nifuratel nystatin vaginal soft capsules. Background technique [0002] Suspension refers to the heterogeneous dispersion system formed by the insoluble solid drug dispersed in the liquid medium in the form of particles. It has the advantages of large drug loading capacity, preventing oxidative hydrolysis of drugs, masking bad smell of drugs, and being easy to swallow. It is a pharmaceutical dosage form that is simple to prepare and widely used. However, as a thermodynamically unstable system, suspensions have problems such as ion aggregation and sedimentation. The stability of the suspension depends on the sedimentation of the particles, the crystallization state, the wetting of the particles, the electrical p...

Claims

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Application Information

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IPC IPC(8): A61K31/422A61K9/16A61K47/26A61K47/10A61K47/20A61K9/48A61K31/7048A61K47/06A61K47/44A61P15/02A61P31/04A61P31/10A61P33/02
CPCA61K9/1682A61K9/1617A61K9/1641A61K31/422A61K31/7048A61K9/4858A61K47/44A61K47/06A61K9/4825A61P15/02A61P31/04A61P33/02A61P31/10A61K2300/00
Inventor刘镇段月晓张泽刘畅陈冲李小臣彭艳
OwnerBEIJING JINCHENG TAIER PHARMA CO LTD