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Preparation method of cephalexin preparation

A cephalexin preparation and preparation technology, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve problems such as decreased fluidity, difficulty in control, thermal instability, etc. The reduction of potency, the protection of the moisture content of the finished product, and the effect of easy control

Pending Publication Date: 2019-08-06
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is unstable to water and heat, and has hygroscopicity. After absorbing moisture, it will cause changes in physical and chemical properties such as agglomeration, decreased fluidity, deliquescence, and crystal form changes, which will affect product stability, effectiveness, safety and other internal qualities.
[0003] The existing cephalexin capsule production process generally uses raw materials and auxiliary materials for full powder filling. Although the degradation process of raw materials without granulation and high temperature and high humidity has been solved, the filling time difference fluctuates greatly and is difficult to control. Therefore, a Appropriate production process is particularly important for the quality stability of cephalexin capsules

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Cefalexin 200.00kg

[0026] Starch talcum powder auxiliary material particles 160.98kg

[0027] Carboxymethyl starch sodium 7.02kg

[0028] Preparation process: first mix talcum powder and corn starch in a certain proportion, add 4% starch slurry for wet granulation, dry, and sieve to obtain starch talcum powder auxiliary material particles with a particle size that meets the requirements, and then add the prescribed amount of cephalexin , auxiliary material granules, and sodium starch glycolate are mixed evenly according to the process sequence, and the capsules are filled to obtain the product.

Embodiment 2

[0030] Cefalexin 197.56kg

[0031] Starch talcum powder auxiliary material particles 158.86kg

[0032] Carboxymethyl starch sodium 6.93kg

[0033] Preparation process: first mix talcum powder and corn starch in a certain proportion, then add starch slurry for wet granulation, drying, and sieving to obtain starch talcum powder auxiliary material particles with a particle size that meets the requirements, and then add the prescribed amount of cephalexin and auxiliary material particles , Carboxymethyl Starch Sodium are mixed evenly according to the process sequence, and filled into capsules to obtain.

Embodiment 3

[0035] Cefalexin 198.00kg

[0036] Starch talcum powder auxiliary material particles 159.04kg

[0037] Carboxymethyl starch sodium 6.94kg

[0038] Preparation process: first mix talcum powder and corn starch in a certain proportion, then add starch slurry for wet granulation, drying, and sieving to obtain starch talcum powder auxiliary material particles with a particle size that meets the requirements, and then add the prescribed amount of cephalexin and auxiliary material particles , Carboxymethyl Starch Sodium are mixed evenly according to the process sequence, and filled into capsules to obtain.

[0039] Table 1 Determination results of cephalexin capsule content, water content and filling difference (%)

[0040] .

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Abstract

The invention provides a preparation method of a cephalexin preparation. The method comprises the steps of preparation of auxiliary materials, and total mixing, filling and packaging of a raw materialand the auxiliary materials. The preparation method improves the stability, effectiveness and safety of the product by improving the production process of cephalexin.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of cephalexin preparations. Background technique [0002] Cephalexin, chemical name (6R,7R)-3-methyl-7-[(R)-2-phenylacetamido]-8-oxo-5-thia-1-azabicyclo[4,2 ,0] oct-2-ene-2-formic acid monohydrate is a class of broad-spectrum semi-synthetic antibiotics with a wide bactericidal spectrum, strong antibacterial effect, resistance to penicillinase, high clinical curative effect, and less common allergic reactions than penicillin. It is widely used clinically. However, it is unstable to water and heat, and has hygroscopicity. After absorbing moisture, it will cause changes in physical and chemical properties such as agglomeration, decreased fluidity, deliquescence, and crystal form changes, which will affect product stability, effectiveness, and safety. [0003] The existing cephalexin capsule production process generally uses raw materials ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/545A61K47/36A61K47/02A61P31/04
CPCA61K31/545A61K9/5084A61K47/36A61K47/02
Inventor 姚珊丁新辉周事农彭辑李敏杨培鑫刘浩徐云徐兰香
Owner KAMP PHARMA
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