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目的:优选灯盏细辛注射液的配伍条件,并考察配伍液的稳定性。方法:采用正交试验,以不溶性微粒数量和总黄酮含量为指标性成分考察温度、溶媒种类、溶媒用量3个影响因素,并对试验结果进行综合分析。按正交试验优选的配伍条件,配制3批样品,24 h内通过外观的观察、溶液不溶性微粒数量、pH以及总黄酮含量的变化来考察灯盏细辛注射液的配伍稳定性。结果:优选出灯盏细辛注射液最佳配伍条件为:温度25℃、取灯盏细辛注射液2支以0.9%氯化钠注射液250 ml作溶媒。24 h内配伍液的外观、不溶性微粒及pH均无明显变化,4 h内总黄酮的含量也无明显变化,而在4h后总黄酮的含量有一定程度的下降。结论:在临床用药剂量下,灯盏细辛注射液与0.9%氯化钠注射液250 ml 4 h内可稳定配伍。
Objective: To optimize the compatibility of Erigeron Breviscapine Injection and to investigate the stability of compatibility solution. Methods: Orthogonal test was used to determine the influencing factors of temperature, solvent type and solvent dosage based on the content of insoluble particles and total flavonoids. The test results were comprehensively analyzed. According to the optimum conditions of orthogonal experiment, three batches of samples were prepared, and the stability of the compatibility of the Erigeron Breviscapus injection was investigated within 24 hours by observing the appearance, the amount of insoluble particles, the pH and the content of total flavonoids. Results: The optimal compatibility conditions of Erigeron Breviscapus Injection were as follows: the temperature was 25 ℃, taking 2 parts of Erigeron Breviscapus injection as the solvent with 0.9% sodium chloride injection 250 ml. The appearance of the compatible liquid within 24 h showed no significant change in the insoluble particles and pH, no significant change in the content of total flavonoids within 4 h, but the content of total flavonoids decreased to a certain extent after 4 h. Conclusion: In the clinical dosage, Dengzhanxincin injection and 0.9% sodium chloride injection of 250 ml 4 h can be stable compatibility.