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Method for quickly judging quality condition of meclofenoxate hydrochloride powder injection

A technology for meclofen axetil hydrochloride and powder injection, which is applied in the field of medicine, can solve the problems of unqualified content, difference in loading, unqualified meclofen axetil powder for injection, etc., and achieves the effects of long working time and large amount of data

Active Publication Date: 2017-05-31
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The inventor has been committed to the quality inspection of medicines for a long time, and has found that many commercially available meclofenoxate hydrochloride powder injections have unqualified phenomena, especially the difference in filling volume and unqualified content.

Method used

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  • Method for quickly judging quality condition of meclofenoxate hydrochloride powder injection
  • Method for quickly judging quality condition of meclofenoxate hydrochloride powder injection
  • Method for quickly judging quality condition of meclofenoxate hydrochloride powder injection

Examples

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Effect test

preparation example 1

[0060] Preparation Example 1: Preparation of Meclofenoxate Hydrochloride Powder for Injection

[0061] (1) Provide sterile meclofenoxate hydrochloride bulk drug;

[0062] (2) pulverize the meclofenoxate hydrochloride bulk drug under aseptic conditions, and monitor the diameter span value of the bulk drug particle in real time during the pulverization process;

[0063] (3) When the span value of the bulk drug granules is less than 5.5 (3.2 in this example, the Dv50 of the powder is 31um), stop pulverizing;

[0064] (4) Under aseptic conditions, the bulk drug obtained in step (3) is divided into glass bottles (250 mg per bottle), sealed, and obtained.

preparation example 2

[0065] Preparation Example 2: Preparation of Meclofenoxate Hydrochloride Powder for Injection

[0066] (1) Provide sterile meclofenoxate hydrochloride bulk drug;

[0067] (2) pulverize the meclofenoxate hydrochloride bulk drug under aseptic conditions, and monitor the diameter span value of the bulk drug particle in real time during the pulverization process;

[0068] (3) When the span value of the bulk drug granules is less than 5.5 (2.4 in this example, the Dv50 of the powder is 24um), stop pulverizing;

[0069] (4) Under aseptic conditions, the bulk drug obtained in step (3) is divided into glass bottles (100 mg per bottle), sealed, and the product is obtained.

preparation example 3

[0070] Preparation Example 3: Preparation of Meclofenoxate Hydrochloride Powder for Injection

[0071] (1) Provide sterile meclofenoxate hydrochloride bulk drug;

[0072] (2) pulverize the meclofenoxate hydrochloride bulk drug under aseptic conditions, and monitor the diameter span value of the bulk drug particle in real time during the pulverization process;

[0073] (3) When the span value of the bulk drug granule is less than 5.5 (5.3 in this example, the Dv50 of the powder is 37um), stop pulverizing;

[0074] (4) Under aseptic conditions, the bulk drug obtained in step (3) is divided into glass bottles (500 mg per bottle), sealed, and the product is obtained.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a method for quickly judging the quality condition of the meclofenoxate hydrochloride powder injection. The method comprises the following steps of (1) providing a meclofenoxate hydrochloride powder injection test sample; (2) determining the particle size and the particle size distribution of the test sample by using a laser scattering granularity distribution instrument and a light scattering method, and calculating Dv10, Dv50 and Dv90 values of test sample particles; (3) calculating the span of the test sample powder by the following formula: Span=(Dv90-Dv10) / Dv50; and (4) determining the quality condition of the meclofenoxate hydrochloride powder injection according to the result of the span value. The invention further relates to a method for preparing the meclofenoxate hydrochloride powder injection by virtue of the span parameter value. According to the method provided by the invention, the quality condition of the meclofenoxate hydrochloride powder injection can be quickly judged, and the obtained product has excellent property when the meclofenoxate hydrochloride powder injection is prepared by virtue of the method.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for quickly judging the quality status of meclofenoxate hydrochloride powder injection for injection, in particular to a method for quickly judging the meclofenoxate hydrochloride powder injection for injection by measuring the particle size distribution of laser diffraction method of quality status. Background technique [0002] Meclofenoxate Hydrochloride was artificially synthesized by Professor Thuillier of the French National Center for Scientific Research in 1957. Its chemical name is 2-(dimethylamino)ethyl p-chlorophenoxyacetate hydrochloride. China has been producing the drug since the 1960s (the trade name used to be cloxatexal). [0003] Clinically, meclofenoxate hydrochloride is a central stimulant drug that has been used for many years. It is mainly used for the treatment of traumatic brain injury coma, neonatal hypoxia, and mental confusion. Children's en...

Claims

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Application Information

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IPC IPC(8): G01N15/02
CPCG01N15/0211
Inventor 吴斌吴彬胡琴戴红王铁松王琳吴兆伟谢立
Owner BEIJING INST FOR DRUG CONTROL
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