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Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material

A technology of bromhexine hydrochloride and bacterial endotoxin, which is applied in the field of microbiological inspection to achieve the effect of reducing inspection costs

Inactive Publication Date: 2014-06-04
张嵩
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no literature report on the bacterial endotoxin inspection of bromhexine hydrochloride raw materials at home and abroad

Method used

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  • Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material
  • Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material
  • Method for detecting content of bacterial endotoxin of bromhexine hydrochloride raw material

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Embodiment Construction

[0008] (1) Determination of limit value

[0009] Formula: L=K / M

[0010] According to bromhexine hydrochloride instructions: "Intramuscular injection or intravenous injection. 4 mg once, 8-12 mg a day. Use after diluting with 0.9% sodium chloride injection or 5% glucose injection for intravenous injection." Determine the maximum dose for humans It is 12mg / h. K: The maximum acceptable endotoxin dose per kilogram of body weight per hour, expressed in EU / kg / hr, injection K=5EU / kg / hr.

[0011] L = K / M = 5 EU / kg / hr 12 mg / 60 kg / hr = 25 EU / mg

[0012] Considering that in actual use, bromhexine hydrochloride will be dis...

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Abstract

The invention aims at providing a sensitive and reliable method, and particularly relates to a method for quickly detecting the content of bacterial endotoxin of a bromhexine hydrochloride raw material. The method comprises the following steps of measuring bromhexine hydrochloride powder, dissolving the bromhexine hydrochloride powder in DMSO (dimethyl sulfoxide) to have the pre-interference experiment and find out the maximal dilution times; preparing a bromhexine hydrochloride test solution according to 1600 times of the maximal dilution times to have the interference experiment with two TAL (tachypleus amebocyte lysate) with the sensitivity of 0.25EU / ml from two different factories, finally confirming whether the interference factor exists or not, and determining the limit value of the bacterial endotoxin; diluting the bromhexine hydrochloride solution according to the non-interfered maximal valid dilution times, and then examining the bacterial endotoxin.

Description

technical field [0001] The invention belongs to the field of microbial inspection, and relates to a method for detecting bacterial endotoxin of bromhexine hydrochloride raw material, that is, a method for detecting the content of bacterial endotoxin in bromhexine hydrochloride raw material. Background technique [0002] Bromhexine hydrochloride is a mucolytic agent that can directly act on the bronchial glands to promote the release of lysosomes in mucus-secreting cells, which can differentiate and lyse mucopolysaccharide fibers in sputum, dilute the sputum, and make it easier to cough up. Clinically, it is mainly used for acute and chronic bronchitis, asthma, bronchiectasis, and emphysema, especially for those who have difficulty coughing up white sticky phlegm and critical emergencies caused by extensive obstruction of small bronchi by sputum. Bacterial endotoxin is a substance that can cause a series of physiological reactions such as fever and leukopenia in the human bod...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50G01N1/38
CPCG01N33/56911G01N33/94
Inventor 张嵩
Owner 张嵩
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