Objective: to analyze the influence of different dissolution evaluation methods on the level of pharmaceutical preparations, and to sort out the application strategies for improving the level of pharmaceutical prepara...Objective: to analyze the influence of different dissolution evaluation methods on the level of pharmaceutical preparations, and to sort out the application strategies for improving the level of pharmaceutical preparations. Methods: 100 paracetamol tablets were screened out and then divided into 2 groups according to the blind selection method, specifically referring to: the observation group and the control group, each group is 50 tablets, among which, the observation group selected 0.04%NaOH solution as the dissolution medium, and then the dissolution was evaluated;In the control group, phosphate buffer with PH 6.8 was selected as the dissolution medium, and then the dissolution was evaluated. The dissolution amount and dissolution percentage (80%) of the two groups were determined separately. Results: in terms of the changes of dissolution volume, percentage of dissolution and other indicators, the observation group far exceeded the control group. However, in terms of the average dissolution time, the observation group was significantly smaller than the control group, and the difference between the two groups was significant, with a statistical advantage (P < 0.05). Conclusion: since the evaluation methods of dissolution are different, there are obvious differences in the changes in the level of pharmaceutical preparations. If the level of pharmaceutical preparations is to be gradually improved, the best dissolution evaluation method must be selected before the corresponding test results can be obtained.展开更多
文摘Objective: to analyze the influence of different dissolution evaluation methods on the level of pharmaceutical preparations, and to sort out the application strategies for improving the level of pharmaceutical preparations. Methods: 100 paracetamol tablets were screened out and then divided into 2 groups according to the blind selection method, specifically referring to: the observation group and the control group, each group is 50 tablets, among which, the observation group selected 0.04%NaOH solution as the dissolution medium, and then the dissolution was evaluated;In the control group, phosphate buffer with PH 6.8 was selected as the dissolution medium, and then the dissolution was evaluated. The dissolution amount and dissolution percentage (80%) of the two groups were determined separately. Results: in terms of the changes of dissolution volume, percentage of dissolution and other indicators, the observation group far exceeded the control group. However, in terms of the average dissolution time, the observation group was significantly smaller than the control group, and the difference between the two groups was significant, with a statistical advantage (P < 0.05). Conclusion: since the evaluation methods of dissolution are different, there are obvious differences in the changes in the level of pharmaceutical preparations. If the level of pharmaceutical preparations is to be gradually improved, the best dissolution evaluation method must be selected before the corresponding test results can be obtained.
