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摘要：Abstract

目的 为做好参麦注射液安全性再评价工作提供数据参考。
Objective: To provide reference data for the reassessment on the safety of Sheng Mei Injection.

方法 渗透压测定采用冰点测定法，对样品原液及其稀释液进行渗透压测定，并计算与氯化钠注射液渗透压的比值；溶血率测定采用分光光度法对样品原液及其稀释液进行溶血率测定。
Procedures: Adopt the Kryoscopy Method for Osmotic pressure measurements to the stock solutions and its diluents; also calculate its osmotic pressure ratio to sodium chloride injection; as for the measurement of hemolysis rate of the stock solutions and its diliuents, the spetrophotometry method is used.

结果 渗透压测定，样品原液均为低渗溶液，渗透压值在96～180mOsmol/kg之间，1→4¬～1→8稀释后与氯化钠注射液渗透压比可达0.9；溶血率测定，样品稀释倍数在小于1→16时，样品均存在不同程度的溶血（溶血率＞5%），1→16倍稀释时，仅有一批样品溶血率为15%，1→32倍稀释时，溶血率均小于5%。
Results: Osmotic pressure measurements: the stock solutions are all hypotonic solutions, the osmotic pressure values are between 96～180mOsmol/kg. After diluted 1→4¬～1→8, the osmotic pressure ratio to sodium chloride injection solution can reach 0.9.
Hemolysis rate measurements: When the dilution multiples of the samples are less than 1→16, there exists different levels of hemolysis in all the samples (hemolysis rate >5%), with 1→16 multiple dilution, only one batch of samples has 15% hemolysis; with 1→32 multiple dilutions, the rate is less than 5%.

结论 不同厂家生产的参麦注射液的渗透压和溶血率均存在明显差异，可用渗透压和溶血率来控制参麦注射液的质量。
Conclusion: There are obvious differences in both the osmotic pressure and hemolysis rate of Sheng Mei Injections from different manufacturers; the quality of Sheng Mei Injection can be controlled by applying osmotic pressure and hemolysis rate.

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Abstract: The purpose of doing a good job Shenmai injection safety re-evaluation of the work of reference data. Method of osmotic pressure was determined by freezing point method, the liquid samples and determination of dilute solution for osmotic pressure, and calculate the osmotic pressure and sodium chloride injection ratio; hemolysis rate was determined by spectrophotometry of liquid samples for hemolysis and dilution rate determination. Determination of the results of osmotic pressure, liquid samples are hypotonic solution, osmotic pressure values between 96 ~ 180mOsmol/kg in, 1 → 4 ¬ ~ 1 → 8 diluted with sodium chloride injection than osmotic pressure up to 0.9; hemolytic rate Determination of sample dilution in the less than 1 → 16, the samples have different degrees of hemolysis (hemolytic rate of> 5%), 1 → 16-fold dilution, only a number of sample hemolysis rate of 15%, 1 → 32-fold dilution , the hemolysis rate of less than 5%. Conclusions produced by different manufacturers Shenmai injection of the osmotic pressure and the hemolytic rate there is an obvious difference in osmotic pressure and the hemolytic rate can be used to control the quality of Shenmai injection.