盐酸氨溴索注射液的制备工艺路线研究

Study on the preparation technology of ambroxol hydrochloride injection

目的研究盐酸氨溴索注射液的制备工艺方法。方法对缓冲剂用量、pH值、渗透压调节剂等条件进行了筛选,并考察制剂稳定性。用HPLC法检测含量及有关物质。结果加入0.1%枸橼酸钠、0.75%氯化钠,调p H值在4.8~5.2,控制温度121℃,制剂质量符合药典有关注射剂的质量标准。结论本品制备工艺可靠,适于工业生产,质量可控。

Objective To study the preparation process of ambroxol hydrochloride injection. Methods The conditions such as the dosage of buffer,p H and osmotic pressure regulator were selected,the preparation stability was also inspected. The content and related substances were determined by HPLC. Results Added 0.1% folic acid sodium and 0.75% sodium chloride,adjusted p H 4.8 ～ 5.2 and controlled the temperature to 121 ℃. The preparation quality comply with pharmacopoeial relevant injection quality standard. Conclusion The preparation technology of the product is reliable,suitable for industrial production,its quality is controllable.