胎盘肽注射液的研制及治疗外阴白斑的疗效
Preparation and therapeutic effect on white lesion of vulva of placenta polypeptide injection
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摘要: 目的: 研制胎盘肽注射液,并观察其治疗外阴白色病变的疗效。 方法: 以健康人胎盘为原料,采用冻融和超滤的方法制备了胎盘肽注射液。用福林-酚法测定多肽含量。观察了该注射液对156例外阴白色病变患者的疗效。 结果: 胎盘肽在20μg/mL至100μg/mL浓度范围内线性关系良好,平均回收率为100.16%,99.25%,98.59%,RSD分别为1.09,0.48,0.50(n=3)。治疗外阴白色病变的总有效率达100%。 结论: 胎盘肽注射液作为多肽类生化制剂,工艺简便可行,质量可控,临床疗效满意。Abstract: Objective: To prepare the placenta polypeptide injection and establish the standard of quality control and to evaluate the therapeutic effect on white lesion of vulva. Methods: The placenta polypeptide injection was made from healthy human placenta by the method of thaw and ultrafiltration.The content of polypeptide was determined by Lowry-method. Results: The linear relationship of placenta polypeptide was found from 20μg/mL to 100μg/mL.The average recovery of polypeptide was 100.16%,99.25% and 98.59%,respectively.RSD was 1.09,0.48 and 0.50,respectively(n=6).The overall clinical effective rate for white lesion of vulva was 100%. Conclusion: The placenta polypeptide injection is simple in preparation technique and feasible in quality control.No ad-verse drug reactions were found and the clinical effect is satisfactory.
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Key words:
- placenta polypeptide injection /
- preparation /
- white lesion of vulva /
- quality control
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