Study on evaluation of toxicology and quality control of Yimusake tablet

The Yimusake tablet (YMSK-T) is a type of Xinjiang Uygur Medicine, which affects curing diseases of impotence and premature ejaculation. It has remarkable pharmacological effects that mainly involve improving the number and shape of smooth muscle cells in the corpus cavernosum and enhancing the relaxation and contraction function of corpus cavernosum smooth muscle.

The YMSK-T prescription, which consists of 11 traditional herbs, has significant pharmacological effects, however the evaluation of toxicology and quality control of the preparation has not yet been reported. Therefore, in this study, we evaluated the toxicology and quality control of YMSK-T to ensure its safety and effectiveness in clinical applications.

Male rats were divided into three groups and were given continuous gavage administration of high, medium and low concentrations of YMSK-T. To determine hematopoietic parameters, orbital blood was collected at regular intervals. At termination of the experiment, rats were dissected for histopathological examination. According to the function of the prescription medicinal materials, seven active components were selected for content determination under the same chromatographic condition of using 0.2% aqueous phosphoric acid (solvent A) and acetonitrile (solvent B) with a 40 min post time: 0-13 min, 20% →30% B; 13-26 min, 30% →72% B; 26-38 min, 72% →92% B; 38-40 min, 92% →96% B. The column was maintained at 25 °C and the total sample injection was 10 μL.

Our data showed that using a large dose (400X the dosage used in humans) of YMSK-T resulted in myocardium and liver damage, and eventually death of the rats. At sub-chronic toxicity, no significant differences were observed among indexes about relative organ weight, hematology, serum biochemistry and histopathological examination, and rats behaved normally. Our results also demonstrated that the YMSK-T dosage used was not toxic in the normal range. The linearity of each component was sufficient (correlation coefficients>0.9997). Moreover, the relative standard deviations of precision, repeatability, stability, and recovery were less than 2.0%, which showed that the method for determination of content was stable and reliable.

YMSK-T has been found to be relatively safe in a rat model, and the method of content determination can be used for quality control of YMSK-T. Toxicology and quality control studies indicated that, the drug is safe and effective for clinical application.