| The article mainly studied on the stabilities of eight kinds of the commonly used medicine in the clinic, including Puerarin, Aminophylline, Acyclovir, Ganciclovir, Fluconazole, Lincomycin, Clindamycin Phosphate and Azithromycin. Eight kinds of infusion injection were chosen to mix with the eight tested drugs, which were made in China Otsuka Pharmaceutical Co,.Ltd. The appearance, the pH value, the non-soluble particulate and the content were studied to observe the stability of the combinations. The experiments can offer the theoretical guide, so that the medicine can be mixed safely and reasonably in the clinic.First of all, the article studied the stabilities of above-mentioned eight kinds of medicine respectively with Sodium Lactate Ringer's Injection, Compound Sodium Lactate and Glucose Injection, Compound Sodium Lactate and Sorbitol Injection, Electrolytes and Glucose Composition R2A, M3A, M3B, MG3 and R4A injection at room temperature in six hours. RP-HPLC was used to observe the content changes of eight kinds of medicine. The pH value, non-soluble particulate and appearance of mixtures were also observed. The mixtures were all clear and produced neither gas nor sediment. There were no visible changes in terms of the pH value and non-soluble particulate in 6 hours at room temperature. The content dropped by more than 60% of their initial levels and could hardly keep the curative effect when Azithromycin was mixed with Electrolytes and Glucose Composition R2A injection, while the content dropped by less than 10% of their initial levels when Azithromycin mixed with the other seven kinds of infusion injection. The other seven kinds of medicine mixing with the eight kinds of infusion injection maintained more than 95% of their initial levels. The experiments proved that the mixtures of Azithromycin injection with 8 infusion solutions except Glucose Composition R2A injection, and the other seven tested drugs mixing with eight kinds of infusion injections were stable in 6 hours, and can be mixed safely in the clinic.Puerarin injection was chosen as the model medicine from the eight kinds of tested drugs. In the clinic Puerarin injection was usually used with Shenmai injection. In order to study the compatible stabilities scientifically, FR-HPLC was used to study the content changes and the pharmacokinetic behavior in rats before and after mixing with Shenmai injection. The results indicated that the content maintained more than 95% of their initial levels in 6 hours at room temperature. The pharmacokinetic behavior of Puerarin in rats before and after mixing with Shenmai injection fitted to the two-compartment model. The value of R2 was larger than 0.997 and it could manifest that the compartment model was fitted well. The results of t1/2α and t1/2β were about 2.6 min and 25.6 min which indicate that Puerarin distributed and eliminated quickly. Comparing the Pharmacokinetics parameters in the two kinds of situation, analysis of variance for log-transformed date of AUC(0-t),AUC(0-∞) and Cmax, Cmax had no statistically significant difference, while AUC(0-t) and AUC(0-∞) had significant difference for P-value less than 0.05. After mixing with Shenmai injection the value of AUC(0-t) and AUC(0-∞) were larger than Puerarin injection being used individually. The experiments initially proved that Puerarin was in coordination with Shenmai injection in rats and the two kinds of medicine were compatible safely in the clinic. |
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