Determination of the Dissolution of Cibenzoline Succinate Tablets by HPLC / 中国药房

OBJECTIVE:To establish a method for determination of the dissolution of cibenzoline succinate tablets. METHODS: The content of cibenzoline succinate was determined by HPLC and computed based on the peak area in the external reference method. The chromatographic column was Diamonsil C18. The mobile phase consisted of acetonitrile-phosphoric acid(40∶60). The detective wavelength was set at 230 nm. The dissolution was determined by paddle method. RESULTS: The linear range of cibenzoline succinate was 1～40 ?g?mL-1(r=0.999 9) and the average recovery rate was 97.70%(RSD=0.14%).The dissolution rates of 3 batches of samples at 15 min were all above 80%.CONCLUSION: The established method is simple,rapid and accurate,and it is applicable for the determination of the dissolution of cibenzoline succinate tablets.

Pharmacoepidemiological Studies on Evaluation and Promotion of the Rational Use of Antiarrhythmic Drugs / 薬剤疫学

To evaluate and promote the rational use of antiarrhythmic drugs, a series of pharmacoepidemiological studies were performed. First, studies on hypoglycemia induced by cibenzoline were performed. The mechanism of the hypoglycemic effect of cibenzoline is related to an increase in insulin secretion. A significantly increased risk of hypoglycemia was observed in patients treated with cibenzoline in a case-controlled study. In particular, close attention should be paid to the occurrence of cibenzoline-induced hypoglycemia in elderly patients, those receiving high doses and in those with reduced renal function. After the introduction of TDM, the risk of hypoglycemia associated with cibenzoline use decreased together with an increase of the percentage of patients whose serum concentrations of cibenzoline had been measured. Dose adjustment based on TDM was beneficial for patients treated with cibenzoline in order to prevent hypoglycemia. In general, drugs are used in accordance with an approved dosage regimen in the expectation of an appropriate balance between efficacy and toxicity. However, a difference was seen between the approved dosage and the actual dose in cibenzoline therapy. Secondly, prescription research of several antiarrhythmic drugs was performed at five national hospitals. Antiarrhythmic drugs were used in lower doses than the approved dosage in clinical practice in Japan. Differences were seen between the approved dosage and the actual dose, and remarkable variations were seen in the dose distribution among the hospitals. The discrepancy between the approved dosage and practical dosage suggests that there is doubt as to whether the approved dosing regimens for antiarrhythmic drugs are appropriate.