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目前,四川省内有多个厂家生产穿琥宁制剂,为完善其质量标准,为制剂无菌检查提供方法依据。穿琥宁为制备穿琥宁注射液及注射用穿琥宁冻干粉针的原料,其制剂应作无菌检查。本实验拟为穿琥宁注射剂的无菌检查提供方法。我们对三个厂家生产的穿琥宁进行了抑细菌及抑真菌试验,结果表明,在试验设计的浓度下,穿琥宁对细菌及真菌均无抑制作用。故可用直接加入法检查本品的无菌。
At present, there are a number of manufacturers in Sichuan Province Chuanhuning preparations, in order to improve its quality standards, provide a method for the preparation of sterile test. Chuanhuning for the preparation of Chuanhuning injection and injection of chuanhuning freeze-dried powder for raw materials, the preparation should be checked for sterility. This experiment is intended to provide a method for the sterile test of Chuanhuning injection. We conducted a test of bacteriostasis and fungistasis against chuanhuning produced by three factories. The results showed that chuanhuning had no inhibitory effect on bacteria and fungi at the designed experimental concentration. It can be used directly to check the sterility of this product.