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Method for measuring potency of gentamycin sulfate and bismuth carbonate capsules

A technology of bismuth carbonate capsules and gentamicin, applied in biochemical equipment and methods, microbiological determination/inspection, etc., can solve problems such as poor reproducibility, large error in taking the test product, and low accuracy of content determination results, etc. problems, to achieve high precision, improve accuracy, and solve inaccurate content determination

Inactive Publication Date: 2013-01-09
NORTH CHINA PHARMA COMPANY
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When used for the determination of gentamicin bismuth carbonate capsules, a large amount of foam will be produced during the dilution process of the drug solution, which will lead to large errors in the amount of the test product, low accuracy and poor reproducibility of the content determination results, etc.

Method used

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  • Method for measuring potency of gentamycin sulfate and bismuth carbonate capsules
  • Method for measuring potency of gentamycin sulfate and bismuth carbonate capsules

Examples

Experimental program
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Effect test

Embodiment 1

[0030] Content determination of gentamicin bismuth carbonate capsules produced by North China Pharmaceutical Group Preparation Co., Ltd. with batch number 0604001:

[0031] (a) Preparation of the test solution: get the gentamicin bismuth carbonate capsules under the difference in loading amount, mix evenly after shelling, accurately weigh an appropriate amount of the original drug powder, put in a 100ml volumetric bottle, add an appropriate amount of sterilized water to produce a large amount of Foam, add 3 drops of oleic acid dropwise, add sterilized water to accurately dissolve, shake to dissolve gentamycin, quantitatively make a suspension containing about 1000 units per 1ml, let it stand for 2 hours, and measure it precisely Put 5ml of the clear solution in a 50ml bottle, dilute to the mark with PH7.8 phosphate buffer solution, shake well, the solution concentration is 100 units / ml, accurately measure 5ml of the test solution at 100 units / ml, and put them in 50ml and 100ml ...

Embodiment 2

[0036] Content determination of gentamicin bismuth carbonate capsules produced by North China Pharmaceutical Group Preparation Co., Ltd. with batch number 0604001:

[0037] (a) Preparation of the test solution: get the gentamicin bismuth carbonate capsules under the difference in loading amount, mix evenly after shelling, accurately weigh an appropriate amount of the original drug powder, put in a 100ml volumetric bottle, add an appropriate amount of sterilized water to produce a large amount of Foam, add 3 drops of silicone oil dropwise, add sterilized water to accurately dissolve, shake to dissolve gentamicin, quantitatively make a suspension containing about 1000 units per 1ml, let it stand for 2 hours, and accurately measure the supernatant Put 5ml of the test solution in a 50ml bottle, dilute to the mark with PH7.8 phosphate buffer solution, shake well, the solution concentration is 100 units / ml, accurately measure 5ml of the test solution at 100 units / ml, put it in the 50...

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Abstract

The invention discloses a method for measuring potency of gentamycin sulfate and bismuth carbonate capsules, comprising the following steps: (a) preparing solution of a test product: precisely weighing a proper amount of bulk drug powder and then placing in a volumetric flask (100ml), adding a proper amount of sterile water to dissolve the powder, then dropwise adding a defoaming agent to obtain constant-volume and quantitative suspension (about 1000 units / ml), and precisely weighing 5ml of supernate and then placing in a bottle (50ml), wherein solution concentration is respectively 10 units / ml and 5 units / ml; (b) preparing the solution of a standard product: taking a proper amount of standard gentamicin (1mg is equivalent to 638 units), adding a proper amount of sterile water to dissolvethe gentamicin, and quantitatively obtaining solution (about 1000 units / ml) as stock solution; and (c) respectively taking comparison products and the test solution for sample application, culturing and finally measuring by a two-dose method. The method of the invention is a proprietary method for detecting the potency of the gentamycin sulfate; and the method has high accuracy and good repeatability.

Description

technical field [0001] The invention relates to a detection method for drug content, in particular to a detection method for the potency of gentamicin sulfate bismuth carbonate capsules. Background technique [0002] Gentamicin Sulfate Bismuth Carbonate Capsules is a compound preparation commonly used clinically for chronic ulcerative enteritis, dysentery, and acute enteritis. Each gentamicin sulfate bismuth carbonate capsule contains 40,000 units of gentamicin sulfate (calculated as gentamicin) and 600 mg of bismuth subcarbonate. At present, since there is no exclusive detection method for this preparation, the manufacturer follows the national drug standard WS-10001-(HD-0525)-2002- According to the regulations of 2007, it was determined by potency method with reference to the content of gentamicin sulfate. Since the assay method was originally designed for the raw material of gentamicin sulfate. When it is used for the determination of gentamicin bismuth carbonate capsu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/18
Inventor 韩翠忍尹书芳于莉王志良刘书睿赵霞路玉锋
Owner NORTH CHINA PHARMA COMPANY
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