Method for preparing voriconazole tablets by powder direct compression method

A technology for voriconazole tablets and voriconazole, which is applied in the field of medicine, can solve the problems of low yield of finished products, poor stability of voriconazole tablets, complicated preparation process and the like, and achieves the effects of fast dissolution rate, protection stability and high yield

Pending Publication Date: 2021-02-12
ZHUHAI EBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The preparation raw material of existing voriconazole tablet is generally voriconazole, excipient, filler, binding agent, disintegrant and lubricant, and its preparation method is: wet granulation, and preparation process is: will except lub...

Method used

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  • Method for preparing voriconazole tablets by powder direct compression method
  • Method for preparing voriconazole tablets by powder direct compression method
  • Method for preparing voriconazole tablets by powder direct compression method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Dosing according to the prescription amount of 1,000 voriconazole tablets

[0056] Voriconazole is placed in a pulverizer and pulverized to obtain voriconazole powder, its D 10 5~15μm, D 50 30~50μm, D 90 80-100 μm.

[0057] Put 200g of voriconazole powder, 250g of lactose monohydrate, 84g of pregelatinized starch, 30g of povidone K30 and 30g of croscarmellose sodium in a hopper mixer for 6.7 minutes and then put them in a granulator to sieve , the sieve aperture is 1.91mm, and the premixed material is obtained;

[0058] 6g of magnesium stearate was added to the premixed material and mixed for 3.5min, then placed in a tablet press, and compressed under the condition of 14.0kN to obtain voriconazole tablets with a hardness of 156.4N;

[0059] 5g of lactose, 4g of titanium dioxide, 3g of triethylglyceride and 3g of hypromellose were uniformly mixed and then added to 60g of distilled water under stirring conditions to obtain a coating solution;

[0060] The voriconazol...

Embodiment 2～3

[0062] Prepare voriconazole tablet according to the method of embodiment 1, the preparation conditions of embodiment 2~3 are as shown in table 1:

[0063] The preparation conditions of table 1 embodiment 1~3

[0064]

[0065]

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Abstract

The invention provides a method for preparing voriconazole tablets by a powder direct compression method and relates to the technical field of medicines. The invention provides a method for preparingvoriconazole tablets by a powder direct compression method. The method comprises the following steps of premixing voriconazole, an excipient, a filler, an adhesive and a disintegrating agent to obtaina premixed material; sieving and mixing the premixed material, mixing the sieved and mixed material with a lubricant, and tabletting to obtain voriconazole tablets; the voriconazole tablets being coated with a coating solution, voriconazole tablets being obtained, and the coating solution containing a coating material; the voriconazole bulk drug, the excipient, the filler, the adhesive, the disintegrating agent and the lubricant being in a powder state. The voriconazole tablet is obtained by adopting a powder direct compression method, mixing the raw materials and then directly tabletting andcoating, granulation is not needed, the process is simple, and the prepared voriconazole tablet finished product is high in yield, high in disintegration and dissolution speed, good in stability andsuitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for preparing voriconazole tablets by a powder direct compression method. Background technique [0002] The structure of voriconazole is shown in Formula 1. It is an azole antifungal drug with broad-spectrum antifungal effects. It can be used against bacteria with low sensitivity to antifungal drugs in vitro, such as pathogenic fungi such as actinomycetes and Fusarium. Has a bactericidal effect. [0003] [0004] The preparation raw material of existing voriconazole tablet is generally voriconazole, excipient, filler, binding agent, disintegrant and lubricant, and its preparation method is: wet granulation, and preparation process is: will except lubricant Raw material mixing-granulation-fluidized bed drying-screening-adding lubricant and mixing-tabletting, the preparation process is relatively complicated, the yield of finished product is low and the prepared voric...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/36A61K47/38A61K31/506A61P31/10
CPCA61K9/2095A61K9/2059A61K9/2866A61K31/506A61P31/10
Inventor 吴浩山钟桂雄陈柳颖汪承英
Owner ZHUHAI EBANG PHARMA
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