Method for checking total number of aerobic bacteria of ranitidine hydrochloride capsules

A technology of ranitidine hydrochloride and aerobic bacteria, which is applied in the field of medical inspection, can solve problems such as the interference of the total number of aerobic bacteria, and achieve stable and reliable detection results

Inactive Publication Date: 2020-06-05
GUANGZHOU MEDCAN PHARMATECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The weak antibacterial effect of ranitidine hydrochloride capsules and insoluble materials interfere with the total number of aerobic bacteria. No relevant literature has been found to report the microbial inspection method of ranitidine hydrochloride capsules

Method used

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  • Method for checking total number of aerobic bacteria of ranitidine hydrochloride capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Take 10 g of ranitidine hydrochloride capsules and place them in a sterile Erlenmeyer flask, add pH 7.0 sterile sodium chloride-peptone buffer solution to dilute to 100ml, shake to disperse evenly, and prepare a 1:10 test solution. The 1:10 test solution in the shaped bottle is placed in the large-volume side of the special bag of the homogenizer with filter function, fully patted in the beating instrument for 30 seconds, and the test solution on the small-volume side after filtration is taken as the rough filter 1:10 For the test solution, take 20ml of the rough filter 1:10 test solution and dilute it to 100ml with pH7.0 sterile sodium chloride peptone buffer to make a 1:50 test solution, take 1ml of the 1:50 test solution, and add it to the plate Immediately inject 20ml of tryptone soy agar medium, mix well, solidify, culture at 33°C for 3 days, and measure the number of colonies.

experiment example 1

[0017] Experimental example 1 Applicability test of counting method

[0018] The comparison of the advantages and disadvantages of different inspection methods can be carried out according to the applicability test of the counting method in General Rule 1105 "Microbial Limit Test of Non-sterile Products: Microbial Enumeration Method" in the 2015 edition of the "Chinese Pharmacopoeia". Proceed as follows:

[0019] (1) Bacterial solution preparation

[0020] ① Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis.

[0021] Take fresh cultures of Staphylococcus aureus, Pseudomonas aeruginosa, and Bacillus subtilis that have been cultured at 30-35°C for 18-24 hours, and use 0.9% sterile sodium chloride solution to make 5,000-10,000 cfu per 1 mL bacterial suspension;

[0022] ②Candida albicans

[0023] Take the fresh culture of Candida albicans cultured at 20-25°C for 2-3 days, and use 0.9% sterile sodium chloride solution to make a bacterial suspension containing ...

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Abstract

The invention belongs to the technical field of medical inspection, and specifically relates to a method for checking total number of aerobic bacteria of ranitidine hydrochloride capsules. The methodcomprises the following process: taking 10 g of ranitidine hydrochloride capsules in a sterile conical flask, adding a sterile sodium chloride peptone buffer of pH7.0 to dilute to 100 ml, shaking theconical flask to disperse the solution evenly, preparing a test solution of 1:10, placing the full amount of 1:10 test solution of the conical flask on a large volume side of a special bag with a homogenizer with filtering function, conducting fully tapping for 30 seconds in a tapping instrument, taking the test solution on the small volume side after filtration as the test solution of 1:10 for coarse filtration, taking 20 ml of the test solution of 1:10 for coarse filtration to be diluted to 100 ml by using the sterile sodium chloride peptone buffer of pH7.0, preparing a test solution of 1:50, adding 1 ml of the test solution of 1: 50 into a plate, injecting 15-20 ml of trypsin soybean pepton agar culture medium immediately, conducting mixing evenly, solidifying, and incubating at 30-35 DEG C for 3-5 days, and determining the number of colonies. According to the present invention, the operation steps of the method are simple, and the inspection results are stable and reliable.

Description

technical field [0001] The invention relates to a method for checking the total number of aerobic bacteria in ranitidine hydrochloride capsules, belonging to the technical field of medical testing. Background technique [0002] Ranitidine Hydrochloride as Histamine H 2 Receptor blocker, can inhibit basic gastric acid secretion and stimulated gastric acid secretion, and can also inhibit the secretion of pepsin. Ranitidine hydrochloride capsules are used to relieve gastric pain, heartburn (heartburn), acid reflux. [0003] In the 2015 edition of "Chinese Pharmacopoeia", the general rules of tablets require that tablets need to undergo microbial limit inspection, which includes the inspection of the total number of aerobic bacteria. The weak bacteriostatic effect of ranitidine hydrochloride capsules and insoluble materials interfere with the inspection of the total number of aerobic bacteria. At present, no relevant literature has been found to report the microbial inspection...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/06
CPCC12Q1/06
Inventor 吴学婷张欣柳莹黄和意尹海滨江文敏
Owner GUANGZHOU MEDCAN PHARMATECH
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