Detection method for quality fluctuation of Xueshuantong injection

A quality fluctuation and detection method technology, applied in the direction of material inspection products, testing pharmaceutical preparations, color/spectral characteristics measurement, etc., can solve the problems of high blood circulation activity, long detection time, poor universality, etc., and achieve strong specificity and low cost. Low, reproducible effect

Active Publication Date: 2018-06-29
BEIJING SHIJITAN HOSPITAL CAPITAL MEDICAL UNIVERSTY
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Problems solved by technology

[0004] Since the main active ingredient of Xueshuantong (freeze-dried) for injection is Panax notoginseng saponins, which have the functions of inhibiting platelet aggregation, anticoagulation, and antithrombosis, the quality fluctuation of different batches of Xueshuantong (lyophilized) for injection may lead to its blood-promoting activity. High, thus causing adverse reactions such as erythema, purpura and other microvascular bleeding
At present, antithrombin activity is often used to reflect the blood circulation effect of drugs. The detection methods include antithrombin titration, chromogenic substrate method, anticoagulant method, etc., but the accuracy is low, the detection time is long, and the universality is poor. It is difficult to achieve comprehensive, objective and accurate quality evaluation and control, and it is also difficult to avoid or reduce the occurrence of clinical adverse reactions caused by the quality problems of the drug itself.

Method used

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  • Detection method for quality fluctuation of Xueshuantong injection
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  • Detection method for quality fluctuation of Xueshuantong injection

Examples

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Embodiment 1

[0030] A detection method for quality fluctuation of Xueshuantong for injection, which comprises the steps of:

[0031] (1) Dissolve thrombin in 60% glycerol, subpackage, and store in EP tubes at -20°C; during the experiment, dilute its concentration to 1U / mL with normal saline;

[0032] (2) Add normal saline to the vial containing the Xueshuantong sample for injection to prepare a sample solution with a concentration of 100 mg / mL. The test sample is 17 batches of Xueshuantong for injection (lyophilized) collected from actual clinical use;

[0033] (3) Take 50 μL of Xueshuantong (freeze-dried) sample solution for injection and add it to a 96-well plate, then add 100 μL of 0.5% fibrinogen tris hydrochloric acid solution, place it in a microwell plate constant temperature oscillator and mix Evenly, add 50 μL of 1U / mL thrombin solution, shake for 30 s, with an amplitude of 1 mm and a frequency of 1440 rpm; after completion, the microplate reader dynamically monitors the absorbanc...

Embodiment 2

[0037] A detection method for quality fluctuation of Xueshuantong for injection, which comprises the steps of:

[0038](1) Dissolve thrombin in 60% glycerol, subpackage, and store in EP tubes at -20°C. During the experiment, dilute its concentration to 2U / mL with normal saline;

[0039] (2) Add physiological saline to the vial containing the Xueshuantong sample for injection to prepare a sample solution with a concentration of 150 mg / mL. The test sample is 17 batches of Xueshuantong for injection (lyophilized) collected from actual clinical use;

[0040] (3) Take 60 μL of Xueshuantong (freeze-dried) sample solution for injection and add it to a 96-well plate, then add 150 μL of 0.5% fibrinogen tris hydrochloric acid solution, and place it in a microplate constant temperature oscillator for mixing Evenly, add 60 μL of 1U / mL thrombin solution, shake for 30 s, with an amplitude of 1 mm and a frequency of 1440 rpm; after completion, the microplate reader dynamically monitors the a...

Embodiment 3

[0044] A detection method for quality fluctuation of Xueshuantong for injection, which comprises the steps of:

[0045] (1) Dissolve thrombin in 60% glycerol, subpackage, and store in EP tubes at -20°C. During the experiment, dilute its concentration to 5U / mL with normal saline;

[0046] (2) Add normal saline to the vial containing the Xueshuantong sample for injection to prepare a sample solution with a concentration of 200mg / mL. The test sample is 17 batches of Xueshuantong for injection (lyophilized) collected from actual clinical use;

[0047] (3) Take 80 μL of Xueshuantong (freeze-dried) sample solution for injection and add it to a 96-well plate, then add 200 μL of 0.5% fibrinogen tris hydrochloric acid solution, place it in a microwell plate constant temperature oscillator and mix Evenly, add 80μL of 1U / mL thrombin solution, shake for 30s, with an amplitude of 1mm and a frequency of 1440rpm. After the completion, the microplate reader will dynamically monitor the absorb...

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Abstract

The invention discloses a detection method for quality fluctuation of a Xueshuantong injection. The detection method comprises the following steps: 1) preparing a thrombin solution; 2) preparing a sample solution of the Xueshuantong injection, wherein the sample solution of the Xueshuantong injection is at least the 15 batch; 3) adding the sample solution of the Xueshuantong injection prepared inthe step 2) in a 96 orifice plate, adding a trismetyl aminomethane hydrochloric acid solution with the fibrinogen content being 0.5%, uniformly mixing the materials, adding the thrombin solution prepared in the step 1), uniformly shaking the materials, using an ELIASA for dynamic monitoring of absorbance of a system; and 4) data processing: when a reaction reaches a terminal point, employing a mean value-R-control chart for determining the quality fluctuation of the sample of the of the Xueshuantong injection. The method has the advantages of high sensitivity, strong specificity, good reappearance, and simpleness and rapidity, and provides the technical effect for early warning of the clinical adverse reaction of the Xueshuantong injection.

Description

technical field [0001] The invention relates to the field of quality control of traditional Chinese medicines, in particular to a detection method for quality fluctuation of Xueshuantong for injection. Background technique [0002] Traditional Chinese medicine injections are one of the important directions for the modernization of the Chinese medicine industry, but the occurrence of clinical adverse reactions caused by product quality fluctuations has seriously hindered the healthy development of the Chinese medicine injection industry. At present, the quality control methods based on the general principles of injection preparations and chemical analysis are difficult to effectively monitor the comprehensive quality fluctuations for the system with complex components of traditional Chinese medicine injections. Therefore, it has become an urgent problem to be solved to establish an effective method for early warning and evaluation of quality fluctuations of traditional Chines...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/31G01N33/15
CPCG01N21/31G01N33/15
Inventor 鄢丹张蕾闫琰唐进法王子豪杨智睿
Owner BEIJING SHIJITAN HOSPITAL CAPITAL MEDICAL UNIVERSTY
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