The invention provides a multi-index
quality control method of a tanshinone-
trimetazidine Chinese and
western medicine compound medicament, which comprises the following steps of: selecting indexes: determining three types of core detection indexes, including characteristic components:
tanshinone IIA (a representative component of tanshinone) and
trimetazidine (a
western medicine active component); safety indexes are related substances (such as tanshinone degradation products and
trimetazidine oxidation products); the
homogeneity index is content homogeneity (component content deviation in a single
dose unit); the detection method comprises the following steps: simultaneously determining characteristic components and related substances by adopting a
high performance liquid chromatography (HPLC) method, and pre-treating a sample: taking 0.5 g of compound medicament
powder, adding 50mL of
methanol, carrying out ultrasonic extraction for 30 minutes (the power is 300W and the frequency is 40kHz), filtering, and taking a subsequent filtrate as a
test solution. Multi-index cooperative control: characteristic components, related substances and content uniformity are detected at the same time, the quality of the compound medicament is comprehensively reflected, and the limitation of a single index is avoided.