CAJ | 학술논문

目的对盐酸曲马多滴丸剂型的制备工艺进行研究。采用正交试验法选取最佳制备工艺。方法通过对盐酸曲马多滴丸制备过程的试验，确定了药物与基质的比例。选择药液温度、冷凝液上部温度、滴头与冷凝液的距离、滴速等4因素,每个因素取三个水平，按L9(3)4正交表安排试验。讨论了影响滴丸圆整度及丸重差异的因素。结果盐酸曲马多与基质的用量配比：药物：PEG-4000：PEG-6000：吐温-80为0.6：1.5：1：0.5，采用药液温度为70℃，冷凝液上部温度为30℃，滴头与冷凝液的距离7cm，以30滴min-1的滴速滴入二甲基硅油中的工艺条件最佳。结论该制备工艺制备方法简便易行，适用于滴丸剂型的工业化生产。
목적대염산곡마다적환제형적제비공예진행연구。채용정교시험법선취최가제비공예。방법통과대염산곡마다적환제비과정적시험，학정료약물여기질적비례。선택약액온도、냉응액상부온도、적두여냉응액적거리、적속등4인소,매개인소취삼개수평，안L9(3)4정교표안배시험。토론료영향적환원정도급환중차이적인소。결과염산곡마다여기질적용량배비：약물：PEG-4000：PEG-6000：토온-80위0.6：1.5：1：0.5，채용약액온도위70℃，냉응액상부온도위30℃，적두여냉응액적거리7cm，이30적min-1적적속적입이갑기규유중적공예조건최가。결론해제비공예제비방법간편역행，괄용우적환제형적공업화생산。
Objective This article studies the technical preparation of Tramadol Hydrochloride pills..To seek the optimum techniques by orthogonal test.Methods The proportion between the extracts and primary substance were determined by a series of tests. To arrange the test according to the L9(3)4 orthogonal table, we select four factors as temperature of drug solution, temperature of refrigerant upper part, drop distance for head with refrigerant and dropping rate, each of which took three levels. The roundness of pills as well as their weight deviation are discussed.Results The proportion between the Tramadol Hydrochloride and primary substance is: TH: PEG-4000: PEG-6000: Tween-80=0.6: 1.5: 1: 0.5. The optimum technique was that the temperature of drug solution was70℃, the temperature of 30℃, drop distance for head with refrigerant was 7cm and the dropping rate into Dimethyl Silicone oil was30 drops min-1.Conclusion This preparation method is simple and suitable for both laboratory test and industrial production.