癃开颗粒抗前列腺增生的药理毒理研究

Pharmacodynamics and toxicoligy of Longkai Granules against prostatic hyperplasia

目的:探讨癃开颗粒口服给药抗前列腺增生的药效与毒性作用。方法:给小鼠癃开颗粒,测定正常幼年小鼠和丙酸睾丸素皮下注射或尿生殖窦植入诱发前列腺增生模型动物的前列腺指数、前列腺组织内DNA含量、血清酸性磷酸酶活性、精囊和睾丸湿重;检测单次给药的小鼠最大给药量,考察3个月连续给药的Wistar大鼠或Beagle犬长期毒性反应。结果:癃开颗粒20、40 g/kg(Qd×20 d)能降低正常幼年小鼠前列腺的重量及该组织内DNA的含量,10、20、40 g/kg(Qd×10 d)能抑制丙酸睾丸素引起的小鼠前列腺腹叶的增生,20、40 g/kg(Qd×30 d)能抑制植入胎鼠尿生殖窦引起的小鼠前列腺腹叶的增生;100 g/kg(Qd×13 w)能使大鼠前列腺呈轻度萎缩状态,腺上皮由柱状向扁平移生,腺腔变小,停药4周未见消失;癃开颗粒ig对小鼠的最大给药量为200 g/kg;癃开颗粒给大鼠10、40、100 g/kg或给Beagle犬12、60 g/kg(Qd×13周),未发现有明显的毒性反应。结论:癃开颗粒口服给药能抑制前列腺增生且无明显毒性反应。

AIM： To demonstrate the inhibitoary effects of Longkai Granules （LKG） against experimental prostatic hyperplasia and evaluate its toxicity on animals taking the granules orally. METHODS： The prostate exponent, DNA content in prostate tissue,the activity of acid phosphatase in serum or the wet weight of spermatophores and testicles in normal immature mice and in the hyperplasia model mice induced by subcutaneous injecting testooslerone spropionate or by implanting of the urogenital sinus were determined after administrating of LKG intragastrically to the mice. The single maximum dosage of LKG in mice and its long-term （ 13 weeks） toxicity in Wistar rats and Beagle dogs in orally was evaluated. RESULTS： LKG could decrease the weights of prostates and DNA content in the tissue in the normal immature mice in the amount of 20 and 40 g/kg once a day. LKG, in the amount of both 10,20 and 40 g/kg for 10 days and 20 and 40 g/kg for 30 days, could inhibit the hyperplasia of ventral prostates in the model mice induced respectively by the injection of testooslerone spropionate and by implanting urogenital sinus. LKG, in the amount of 100 g/kg for 13 weeks to Wistar rats, would lead to prostatic atraphy in alight degree, and its epithelial cells change in shape from column to flat and prostatic cavity being small, which did not recover in 4 weeks after stopping administration of tested drug to the animals. The single maximum dosage by ig in mice was 200 g/kg. There was no significant toxicity reaction in rats in the amount of 10,40 and 100 g/kg for 13 weeks or in Beagle dogs in the amount of 12 and 60 g/kg for 13 weeks. CONCLUSION： LKG can inhibit the prostatic hyperplasia and shows no visible toxic reaction in animals orally.