Preparation of salidroside injection and its pharmacokinetics in rats
- Author:
Rui-Jun JU
1
Author Information
1. State Key Laboratory of Natural and Bio-mimetic Drugs and School of Pharmaceutical Sciences
- Publication Type:Journal Article
- Keywords:
HPLC;
Injection;
Pharmacokinetics;
Rat;
Ssalidroside
- From:
Chinese Pharmaceutical Journal
2012;47(18):1497-1502
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To prepare salidroside injection and study its pharmacokinetic parameters in rats. METHODS: With salidroside of high purity as bulk drug, the preparation process of salidroside injection was determinded by selecting the amount of active carbon for adsorption and sterilization process. The quality and stability of the injection were studied according to the methods and requirements of China pharmacopoeia. Salidroside injections were intravenously administered to ten rats via tail vein, and the pharmacokinetic parameter was calculated by pharmacokinetic software DAS3.0. RESULTS: After decoloration and adsorption by 0.1% (1000 mL injection containing 1 g of active carbon) active carbon, the prepared salidroside injections were a colorless and clear water solution. Sterilization temperature was set at 115°C. The content of salidroside injection was 90%-110% of the labeled amount. Stability studies showed that salidroside injections were stable under the accelerated condition (40°C, RH 75%) for 6 months and under the room temperature for 12 months. An HPLC method for analyzing plasma samples was set up. The limit of detection was 0.05 (μg·mL-1, and the limit of quantification was 0.2 μg·mL-1. The calibration curve was linearly in the range of 0.5-400.0 μg·mL-1, and the average recoveries were over 95%. The elimination half-life, apparent volume of distribution and clearance rate of salidroside in rats were 7.6 min, 324.0 and 32.0 mL·min-1·kg-1, respectively. CONCLUSION: The process of salidroside injection is suitable for pharmaceutical preparation and the final formulation is stable. The elimination half-life of salidroside in rats is short with a rapid clearance which is suitable to be developed for the use of clinical emergency treatment.
