Determination of the Potency of Extracted, Purified and Formulated Insulin from the Pancreatic Organs of the Sudanese Beef Cattle

Abstract

The treatment of type 1 diabetes is mainly dependent on insulin therapy and current formulated insulin formulations are used for its control all over the world. The presented study was designed to evaluate the potency of extracted, purified and formulated insulin from the pancreatic organs of the Sudanese beef cattle. Twenty healthy rabbits were used to conduct the study following subcutaneous administration of the sample insulin, to determine the hypoglycemic effect and to analyze the potency of the testing insulin by the hypoglycemic seizure method, blood sugar method and glucose enzymatic colorimetric test (GOD-PAP) respectively. The potency of the injected insulin samples was estimated by comparing the variation in blood glucose levels produced in the treated animals with that produced by a standard insulin preparation under the suitable conditions of the blood sugar method. The results revealed that the potency of the testing beef insulin samples was slightly higher ( i . e ., 2.2 USP units/ml, 9%) compared to the standard and assumed potency of the prepared insulin preparations ( i . e ., 1-2 USP units/ml) which indicated that the solvents and diluents used to prepare the assay dilution might be of higher potency and must be diluted to such an extent that the testing insulin potency must be compatible with the standard dilutions. Furthermore, to determine the choice of an assay to analyze the potency of insulin preparations, not only the accuracy of the result but also the purpose for which the test is to be used and the time limit must be taken into consideration.