RESUMEN
Based on the concept of quality marker (Q-marker) and the application of Q-marker in traditional Chinese medicine, the quality control methods of Chinese materia medica injections were put forward, taking salvianolic acids for injection as an example. Through the analysis of components, efficacy and pharmacokinetics, it has been identified that the Q-marker of salvianolic acids for injection were salvianolic acid B, rosmarinic acid, lithospermic acid, salvianolic acid D, and salvianolic acid Y. The quality control system of multi-index content determination, fingerprint, near infrared on-line control, and biological quality control was established with Q-marker as the core. It provides a reference for the new ideas of quality control of Chinese materia medica injection.
RESUMEN
OBJECTIVE:To investigate the compatibility stability of Salvianolic acid for injection (SAFI) combined with 8 kinds of common solvents. METHODS:Referring to package inserts,SAFI was collected and combined with 0.9% Sodium chlo-ride injection,5% Glucose injection,10% Glucose injection,Compound sodium chloride injection,Mannitol injection,Glycerol fructose and sodium chloride injection,Sodium lactate Ringer's injection,Glucose and sodium chloride injection,250 mL each re-spectively,and then sealed in the dark at the room temperature. The appearance of mixtures were observed,pH value,the number of insoluble particles,maximal absorption wavelength and maximal absorbance were detected,and the contents of salvianolic acid B,rosmarinic acid,lithospermic acid and salvianolic acid Y in mixtures were determined by HPLC at 0,1,2,4,8 h after mix-ing. RESULTS:Under above condition,no obvious change was found in appearance or pH values of the mixtures within 8 h. Maxi-mal absorption wavelength ranged 284.5-286.0 nm. After mixed with Mannitol injection,the number of particles≥10μm(1-8 h af-ter mixing)and particles ≥25 μm(4-8 h after mixing)exceeded the scope of Chinese Pharmacopoeia(2015 edition);the maxi-mal absorbance changed significantly(RSD=9.17%,n=5);the relative content of salvianolic acid B,rosmarinic acid,lithosper-mic acid and salvianolic acid Y decreased by more than 10%(RSD=14.65%,6.45%,8.97%,12.49%,n=5);after mixed with Sodium lactate Ringer's injection,the relative content of rosmarinic acid and lithospermic acid changed greatly (RSD=14.57%, 7.28%,n=5);after mixed with 5% Glucose injection(4-8 h after mixing)and Glycerol fructose and sodium chloride injection(8 h after mixing),the relative content of rosmarinic acid were less than 90%(RSD=6.30%,4.86%,n=5);and the number of particles ≥25μm exceeded the scope of phamcopoeia after mixing with Glycerol fructose and sodium injection(0 h). The number of insoluble particles in other mixtures were in line with the standard of pharmacopoeia;maximal absorbance had no significant change(RSD<5%,n=5),and the relative content change of analytes were all less than 10%. CONCLUSIONS:Clinical appli-cation of SAFI combined with Mannitol injection,Sodium lactate Ringe's injection and Glycerol fructose and sodium injecrion should be avoided. After mixed with 5% Glucose injection,SAFI should be used within 4 h. SAFI can be compatible with 0.9%Sodium chloride injection,10% Glucose injection,Compound sodium chloride injection and Glucose and sodium chloride injec-tion.