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Cefcapene pivoxil hydrochloride tablet preparation method capable of improving tablet quality

A cefcapine hydrochloride, quality technology, applied in the field of medicine, can solve problems such as complex methods, difficult operation, unfavorable clinical medication, etc., and achieve the effect of improving product quality

Inactive Publication Date: 2015-02-25
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the past, the method for preparing cefcapene pivoxil hydrochloride was complex and difficult to operate, and the quality control of the drug was not good, which was not conducive to clinical drug use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0028] The preparation method of the cefcapene hydrochloride tablet that can improve tablet quality comprises the following steps:

[0029] (4) Preparation of wet granules: mix and heat part of starch and pure water to make a binder solution, then mix cefcapene hydrochloride, remaining starch, hydroxypropyl cellulose, and sodium carboxymethyl starch in a stirring Stir and mix in the granulator for 5-10 minutes, then pressurize and spray the binder solution into the stirring granulator. After spraying, use the granulator's granulator to wet mix the above raw materials with its own cutting speed. get wet granules;

[0030] (5) Dry granulation: Send the wet granules into a fluidized bed for drying, then sieve and carry out dry granulation, then add magnesium stearate and pharmaceutical film coating premixed auxiliary materials for mixing to obtain dry granules;

[0031] (6) Tablet compression: the dry granules can be directly compressed into tablets.

[0032] Further, the stirr...

Embodiment 1

[0039] Using the above preparation method, the process parameters are as follows: the stirring speed of the granulator is 600rpm.

[0040] Step (1) After the liquid spraying is finished, the granulator continues to stir, and the stirring speed is 650rpm.

[0041] The cutting speed of the pelletizing knife was 3000 rpm.

[0042] The wet mixing time is 5 minutes.

[0043] The drying temperature of the fluidized bed is 70-80°C.

[0044] The weight component of a kind of cefcapene hydrochloride composition is:

[0045] Cefcapene Proxil Hydrochloride 120

[0046] Starch 45

[0047] Hydroxypropyl Cellulose 22

[0048] Sodium carboxymethyl starch 8

[0049] Magnesium stearate 0.8

[0050] Pharmaceutical film coating premix excipients 3.

[0051] The hardness of the product prepared in Example 1 was 5.4KN, the difference in tablet weight was 0.65%, and the disintegration time limit was 224s.

Embodiment 2

[0053] Similar to Example 1, the difference is:

[0054] The stirring speed of the granulator was 750 rpm.

[0055] Step (1) After the liquid spraying is finished, the granulator continues to stir, and the stirring speed is 680rpm.

[0056] The cutting speed of the pelletizing knife was 2800 rpm.

[0057] The wet mixing time is 8 minutes.

[0058] The drying temperature of the fluidized bed is 70-80°C.

[0059] A kind of weight component of cefcapene hydrochloride composition:

[0060] Cefcapene Proxil Hydrochloride 150

[0061] Starch 40

[0062] Hydroxypropyl Cellulose 18

[0063] Sodium carboxymethyl starch 12

[0064] Magnesium Stearate 1.5

[0065]Pharmaceutical film coating premix excipients 9.

[0066] The hardness of the product prepared in Example 2 was 5.2KN, the difference in tablet weight was 0.42%, and the disintegration time limit was 205s.

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PUM

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Abstract

The present invention discloses to a cefcapene pivoxil hydrochloride tablet preparation method capable of improving tablet quality. The preparation method comprises wet pelletizing, dry granulating and tabletting, wherein the wet pelletizing comprises: mixing and heating partial starch and purified water to prepare a binder solution, carrying out stirring mixing on cefcapene pivoxil hydrochloride, the remaining starch, hydroxypropyl cellulose and sodium carboxymethyl starch for 5-10 min in a pelleter having the stirring function, carrying out pressurization spraying of the binder solution into the pelleter at the stirring state, and carrying out wet mixing on the raw materials through the pelletizing cutter of the pelleter by adopting the self-cutting speed after completing the liquid spraying so as to obtain the wet particles. According to the present invention, the raw material addition, the stirring speed, the stirring time and the pelletizing speed during the preparation process are controlled so as to effectively improve the product quality.

Description

[0001] technical field [0002] The invention relates to the field of medicine, in particular to a preparation method of cefcapene hydrochloride tablets capable of improving tablet quality. Background technique [0003] Cefcapene pivoxil hydrochloride is used for the treatment of superficial infection caused by sensitive bacteria, deep skin infection, chronic pyoderma, secondary infection of wounds such as trauma, scald and surgical trauma, mastitis, thick around the anus, pharyngitis, laryngitis, Dental tissue infection, periodontitis, etc. At present, cefcapene hydrochloride is generally used in tablets because of the convenience of oral administration. However, cefcapene pivoxil hydrochloride is slightly soluble in ethanol and almost insoluble in water. How to improve its solubility and increase the dissolution rate of tablets has always been a subject of close attention in pharmaceutical preparations. [0004] In the past, the method for preparing cefcapene hydrochlori...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/546A61K47/38A61K47/36A61K47/12A61P31/04A61J3/10
Inventor 沈千万周璇刘萍
Owner SICHUAN PHARMA
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