[Quality evaluation of Salvianolate for Injection by quantitative analysis of multi-components with single-marker].

Developing high-quality standard is useful for promoting the quality of traditional Chinese medicine injections, which could be evaluated by establishing the comprehensive quality control method. A method for simultaneous determination of salvianolic acid B, rosmarinic acid and lithospermic acid in Salvianolate for Injection was developed for quantitative analysis of multi-components with single-marker(QAMS). ZORBAX Eclipse Plus C_(18) chromatographic column was adopted, with 0.1% phosphoric acid and acetonitrile as mobile phase. The flow rate was set at 1 mL·min~(-1). The column temperature was set at 20 ℃, and the detection wavelength was 286 nm. Salvianolic acid B was used as internal reference. The relative correction factors of rosmarinic acid and lithospermic acid(f_(s/i)) were 0.58 and 0.94, respectively. About 85% of substances in Salvianolate for Injection were quantified by the established QAMS method. The analysis of different batches of intermediates and preparations during four years showed that the contents of salvianolic acid B were 77.1%-81.5% in intermediates and 70.5%-80.1% in preparations; The total content of rosmarinic acid and lithospermic acid was about 6%. The ratio of rosmarinic acid to lithospermic acid was(3.4∶1-10∶1) and(2.5∶1-5∶1), respectively, which showed that the ratio was more stable in preparation. The QAMS method established is feasible for comprehensive quality control of multiple components of in Salvianolate for Injection.

Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae).

OBJECTIVE: To systematically examine the post-marketing safety of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), identify the potential risk factors, and ensure its clinical safety. METHODS: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae). Data from I-IV clinical drug trials, hospital information systems (HIS), and spontaneous reporting systems (SRS) were also analyzed. RESULTS: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached more than 80%. The median lethal dose (LD50) calculated by the Bliss method was 1.49 g/kg, with 95% confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions (ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen (Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose. CONCLUSION: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.