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.
Highlights
Blood sugar level refers to the amount of glucose in the blood and is a prime source of energy to the body cells, and it was transported via the bloodstream [1]
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
Summary
Blood sugar level refers to the amount of glucose in the blood and is a prime source of energy to the body cells, and it was transported via the bloodstream [1]. According to the American Diabetes Association, the blood glucose range for a diabetic patient should be 70 - 130 mg/dl before meals and less than. The blood sugar levels outside the normal range indicates a medical condition where a persistently higher level is termed as hyperglycemia and the lower level as hypoglycemia [5]. Diabetes mellitus is a disease characterized by persistent hyperglycemia and the most prominent disease related to failure of the blood glucose regulation. Different Insulin formulations from some esteemed manufacturing companies like Novo Nordisk, Sanofi-Aventis, Biocon and Eli Lily are used to lower the blood glucose levels (as hypoglycemic agent) and these are very much effective to regulate the blood glucose levels in diabetic patients [6]. The presented study was aimed to determine the potency of some unknown extracted, purified, and formulated insulin preparations
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