Injection Danhong (powder For Injection) Quality Evaluation Method

Danhong injectable powder was composed of Salvia miltiorrhiza and Carthamus tinctorius for curing coronary heart disease and angina, etc. The present study provides a method to determine the index components in Danhong. injectable powder by high performance liquid chromatography. Besides, high performance liquid chromatographic fingerprint chromatogram was established for the herb and the injection. The integrated quality assessment of Salvia miltiorrhiza, Carthamus tinctorius and Danhong injectable powder was developed.To establish a method for the determination of active components in Danhong injectable powder by RP-HPLC. The separation was performed on a Luna C₁₈ analytical column (250mm×4.6mm, 5μm) with the mobile phase consisting of 0.05% phosphoric acid and acetonitrile with gradient elution mode at the flow rate of 1.0 mL·min^-1. The detection was set at 280nm. This method was applied to determine 4 compounds in 10 different Danhong injectable power successfully. The standard curves were linear over the range of 56.3～338μg·mL^-1 for danshensu (r=0.9997); 7.92～47.2μg·mL^-1 for protocatechuic aldehyde (r=0.9996); 16.4～98.2μg·mL^-1 for hydroxysafflower yellow A (r=0.9997) and 32.0～193μg·mL^-1 for salvianolic acid B (r=0.9999). The average recoveries of danshensu, protocatechuic aldehyde, hydroxysafflower yellow A and salvianolic acid B were 99.7% (RSD=2.7%), 99.3% (RSD=2.9%), 99.2% (RSD=1.6%), 98.8% (RSD=2.8%) respectively. The method is simple and accurate with a good reproducibility and can be used as a quality control method for Danhong injectable powder.High performance liquid chromatographic fingerprint chromatogram was established for Salvia miltiorrhiza, Carthamus tinctorius and Danhong injectable powder. The chromatographic condition included Luna C₁₈ analytical column (250mm×4.6mm, 5μm) with the mobile phase consisting of 0.05% phosphoric acid (A) and acetonitrile (B) with gradient elution mode. The following gradient procedure was used: 0～80min, 0%～33% B; 80～85min, 33%～40% B; 85～100min, 40% B. The detection was set at 280nm. Under the same chromatography condition, HPLC fingerprints of Salvia miltiorrhiza, Carthamus tinctorius, the intermediate and the injection were determined.the Hierarchical cluster was applied to the fingerprints of Salvia miltiorrhiza and the 19 batches of Salvia miltiorrhiza was divided into two grades. Among them the gradeⅠwas commendatory and the gradeⅡwas general. Mutual pattern was established from 11 batches in the grade I by using the f'mgerprint chromatogram software required to use by the Chinese Pharmacopoeia Committee. Similarity calculations were studied by comparing the HPLC fingerprint chromatograms of Salvia miltiorrhiza and mutual pattern. The result of the commendatory should be all over 0.95 and the other samples were the general. Mutual pattern was established from 13 batches of Carthamus tinctorius. Similarity calculations were studied by comparing the HPLC fingerprint chromatograms of the Carthamus tinctorius and mutual pattern. The results of commendatory were above 0.95. The Danhong injectable power mutual pattern was established on the basis of the data from 10 batches of Danhong injectable power. The similarity between the samples of Danhong injectable power and the mutual pattern were calculated and the sample whose similarity result over 0.95 was eligible.