| Objective:To Chinese Rukang oral liquid for the people’s Liberation Army First, two hospital preparation (preparation approval number:South of words (2011) F16002), is mainly composed of potassium iodide, sodium thiosulfate and other components, for the improvement of preparation of potassium iodide solution, its pharmacological effects are mainly used to supplement the clinical medicine, breast lobular hyperplasia. Since 2005, in clinical application, the welcome is deep. The aims of this study is to further investigate its safety, pharmacodynamics and mechanisms invoved in.Methods:The mice were intragastric administration and intraperitoneal injection of Rukang oral liquid in acute toxicity test, the SD rats were randomly divided into Rukang oral liquid (90mg/kg), high dose group, middle dose group (36mg/kg), low dose group (9mg/kg) and the control group.Finally, continuous intragastric administration for long-term toxicity test were performed for 6 month.The rats were divided into normal control group, model control group, drug control group and low, medium and high dose Rukang oral liquid groups. Except for the normal control group, rats in other groups received 0.5mg/kg Estradiol Benzoate Injection,1 times a day, for 25 days. And then reveived 5mg/kg Huangtitong Zhusheye injection,1 times a day, for 5 days. After the model successfully reproduced, drug intervention were performed:the control group and the model control group was fed with distilled water 2mL/time,1 times a day, for 30 days. The control group were given drug tamoxifen tablets by 3mg/kg with distilled water suspension 2mL orally,1 times a day, for 30 days. Rukang oral liquid of low, middle and high dose groups, respectively, at 3.5 mg/kg,7 mg/kg,14 mg/kg was diluted with distilled water to 2mL gavage, respectively, equivalent to the adult dose 5 times,10 times,20 times,1 times a day, for 30 days. After the administration, quantitative detection of animal nipple diameter of breast tissue, the pathological examination and semi quantitative determination of estradiol were performed, and ELISA were used to measure the serum concentrations of E2, progesterone (P), prolactin (PRL), ER, PR, P53, and Oct4, Western Blot was used to detect the ER, PR, P53 and Oct4 expression in breast tissue, fluorescence quantitative PCR method was used to detect the expression of GnRH, GnRHR, and the expression of telomerase in breast tissues was detected by in situ hybridization.Results:the results of acute toxicity test showed that Rukang oral liquid in a wide range of safety, no toxic effect. The long-term toxicity test showed that the Rukang oral liquid in the clinical dose is safe, no obvious toxic reaction. The experimental results show that reducing the increased animal model of Rukang oral liquid can reduce the stimulation of estrogen induced E2, PRL and increased estrogen stimulated P, can also reduce the mammary gland hyperplasia caused by the increase and improve the nipple, breast tissue. At the same time, but also can reduce the expression of serum and breast tissue ER, PR, reduce the expression of P53, telomerase and Oct4, decrease the expression of GnRH in hypothalamus and pituitary GnRH receptor, from the aspects of reversal of hyperplasia of mammary glands, the treatment effect of the play. Rukang oral liquid group, the degree of hyperplasia of mammary glands decreased with increased dose, high dose group and improvement group similar to tamoxifen.Conclusion:Rukang oral liquid has a wide range of safe and has nontoxic. the treatment of Rukang oral liquid for mammary gland hyperplasia is significant effective,and the pharmacodynamics may be possibly through reducing the expression of serum and breast tissue ER, PR, hypothalamic GnRH and pituitary GnRH receptor expression.Rukang oral may prevent breast hyperplasia developing into breast cancer through reducing the three related markers P53, telomerase and Oct4 expression. |
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