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本实验的研究目的在于确定乳糖和钙盐作为片剂填充剂的内在溶出速率以及它们对药物溶出度的影响。将各种不同的填充剂制成非崩解片,浸入500 ml溶出介质中,以150 rpm的速度旋转。乳糖溶出试验所使用的溶出介质为脱气蒸馏水;钙盐的溶出介质为用脱气蒸馏水新配制的0.1 mol或0.01 mol的盐酸溶液。它们分别用氯化钾调节离子强度至0.25 mol,所有溶出试验都在37±0.2℃进行。用碘量法测定乳糖溶出量,用配位滴定法测定钙离子的溶出量。
The purpose of this study was to determine the intrinsic dissolution rates of lactose and calcium salts as tablet fillers and their effect on drug dissolution. Dissolve all kinds of different fillers into non-disintegrating tablets, immerse them in a 500 ml dissolution medium and spin at 150 rpm. The dissolution medium used for the lactose dissolution test is degassed distilled water; the dissolution medium for calcium salts is a 0.1 mol or 0.01 mol hydrochloric acid solution newly prepared with degassed distilled water. They adjusted the ionic strength to 0.25 mol with potassium chloride, respectively, and all the dissolution tests were performed at 37 ± 0.2 ° C. The amount of lactose eluted was determined by iodometry and the amount of calcium ion eluted was measured by coordination titration.