翻译资源

制剂处方及工艺的研究资料
Research Data on Preparation Prescription and Technics
1、处方：(以1000瓶、0.1 mg规格计)
Prescription: (counted by the specification of 0.1 mg, 1000bottles)
醋酸奥曲肽(以100％肽含量计) Octreotide acetate (counted as 100％ peptide)

                              制成1000瓶 Are made into 1000 bottles

2、处方依据：Evidence for the prescription:
2.1 剂型说明：醋酸奥曲肽的进口产品善宁（1ml：0.1mg）是安瓿包装的水针制剂，水针虽然生产工艺比冻干针生产工艺简单，但在使用、运输储存中易发生破碎，此外冻干产品一般也比水针制剂更稳定，考虑到生产单位的条件要求，我们选择醋酸奥曲肽的冻干剂型进行研究。
Formulations: the imported octreotide acetate product Sandostatin (1 ml: 0.1mg) is ampoule packaged water-agents. Although the technics for water-injection is simpler than that of the freeze-dried production, it is easier to break during the use or transportation. In addition, the freeze-dried products are generally more stable than water-agents. Taking into account the conditions and requirements of manufacturers, we have chosen the freeze-dried formulations of octreotide acetate for the study.

2.2 文献参考：在进口善宁的处方中，含有*，*作为pH调节剂。*是生产冻干制剂的常用赋形剂，用量一般为*，因进口产品制剂中含有该物质，故冻干制剂也选用该物质作为赋形剂，用量为*；在多肽产品制剂中，*也是常用的pH调节剂，而且不影响冻干工艺，因此可选用*调节处方pH值，用量*。
References: The imported Sandostantin contained * as the PH regulator. * is a commonly used excipient in freeze-dried formulations and the amount is generally *. Since it is used in imported products, it thus is chosen as the excipient in the freeze-dried preparations as well, with the amount of *. In peptide products, * is also commonly used as pH regulator, and it does not affect freeze-dried technics. Therefore, * can be chosen as the PH regulator in the prescription with the amount of *.

2.3 处方酸碱度研究：Research on the PH value of the prescription:
进口善宁的质量标准中，pH值规定为*，因冻干产品的稳定性不同于水针，我们对比了处方不同pH值条件下的产品稳定性，方法如下：称取*、*、*适量，加水溶解成*的奥曲肽溶液，将该溶液分为4份，分别用0.lmol/L氢氧化钠调pH*、*、*、*，将4种pH值溶液分别分装0.5ml/瓶、同时冷冻干燥，然后放入60℃烘箱中加速试验十天，观察产品降解情况，见表1。
In the quality standards of important Sandotatin, pH value is prescribed as *. Since the stability of the freeze-dried products is different from water-agentss, we compared the product stability at different PH values. The method is as follows: appropriate amount of * was dissolved by water into the octreotide solution of *. It was then divided into 4 parts, the PH of which were regulated by 0.1mol/L NaOH to *, *, * and * respectively. The four kinds of solutions with different PH values were then filled into 0.5 ml bottles and freeze-dried. They were then put into the oven at 60℃ for accelerated test for 10 days to see the degradation of the products. The results were as follows in table 1.

结果：样品在pH4.5以下易降解，见图5-1、5-2、5-3、5-4、5-5、5-6、5-7、5-8，因本品属碱性多肽，在偏酸性环境中稳定，参考善宁的pH值，故选定调节pH值为*。
Results: it was easier for the samples to degrade when the PH is lower than 4.5, see Fig 5-1, 5-2, 5-3, 5-4, 5-5, 5-6, 5-7 and 5-8. This product belonged to basic peptide and was more stable in acid environment. In reference to the PH of Sandotatin, the PH was finally decided at *.