Bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as index

A pharmacodynamic and hypoglycemic technology, applied in the field of efficacy evaluation, can solve the problems of bioequivalence of pharmacokinetic parameters evaluation, and achieve the effect of improving evaluation consistency
CN109529055AInactive Publication Date: 2019-03-29金日制药(中国)有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
金日制药(中国)有限公司
Publication Date
2019-03-29
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a bioequivalence evaluating method for medicines for reducing blood sugar by using pharmacodynamics as an index, and relates to a three-cycle three-cross bioequivalence evaluating method by using pharmacodynamics parameters of blood sugar concentration as an evaluating index, wherein the medicines are mainly alpha-glycosidase inhibitor type medicines. Examines are divided into three groups randomly, and are respectively subjected to medicine test of reference medicines, contrast medicines and vacancy medicines at the three-cycle experiment stage, and then are subjected to glucose load experiment, and besides, blood samples within 4 hours are collected, and concentration determination results of glucose in serum are recorded as the blood sugar concentration. Evaluating parameters include the largest blood sugar concentration difference (delta Cmax) of the examinees under the condition of being subjected to medicine test of the reference medicines or the contrast medicines and the vacancy medicines; and the 2-4-hoursblood sugar concentration-time area under curve difference (delta AUC0-n) of the examinee under the condition of being subjected to medicine test of reference medicines or contrast medicines or vacancy medicine. The judgment standard lies in that the equivalence standard lies in that the 90% confidence interval of the group geometric mean valueratio of the delta Cmax to the delta AUC0-n in the evaluating parameters of a test preparation and the contrast medicines needs to fall in the range of 80%-125%.
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Description

technical field

[0001] The invention provides a bioequivalence evaluation method for hypoglycemic drugs with pharmacodynamics as an index, which belongs to the field of medical technology, and specifically relates to a three-cycle three-cross bioequivalence evaluation method with blood glucose concentration as a pharmacodynamic index. The method of the present invention The method can be used in clinical medicine and clinical evaluation of drug efficacy. Background technique

[0002] Bioequivalence evaluation compares the test drug with the reference drug through biological indicators. However, the absorption and distribution of the drug in the body is too low, and the concentration of the drug and its metabolites in plasma and / or urine cannot be determined by existing detection methods In some cases, pharmacodynamic indicators should be considered for evaluation.

[0003] Acarbose, voglibose, miglitol and other α-glucosidase inhibitor hypoglycemic drugs act on α-glucosida...

Claims

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