| Objective:This experiment studied the main pharmacodynamic effects,toxicity and quality standards of ShenJingZi.That is,to explore the safety,effectiveness and quality control of ShenJingZi.Through modern pharmacological and pharmacodynamic studies on the effect of renal diuretic detumescence,the diuretic effect and mechanism of diuresis were explored;a preliminary study on the toxicity of renal sperm was conducted to provide further toxicity studies and clinical safety drug use and toxicity monitoring.Reference materials;preliminary exploration and identification of chemical components of ShenJingZi,establishment of renal sperm quality standards.Methods:（1）The morphological identification,microscopic identification,moisture examination,ash content,and acid-insoluble ash content of ShenJingZi were examined.Elements in porcine-derived ShenJingZi and bovine-derived ShenJingZi were analyzed by plasma emission mass spectrometry.The results were analyzed by SIMCA-P 14.1.And SPSS17.0 software for different batches of porcine-derived renal sperm and bovine-derived renal sperm were identified to distinguish the organic components of renal sperm.The description of ShenJingZi traits and microscopy,the detection of ash and moisture,and preliminary establishment of quality standards for ShenJingZi.（2）Castration of 5 mg·（kg·d）-1 testosterone propionate in castrated rats was used to produce a rat model of benign prostatic hyperplasia,and different doses of renal sperm were given(divided into 10 mg·kg-1 group of renal sperm,20 mg·kg-1 group,40 mg·kg-1group and 80 mg·kg-1 group,finasteride and prohexamone were used as positive control agents,and 5 h water load metabolic urine volume and 24 h metabolic urine volume were selected.Prostate organ coefficient,seminal visceral organ coefficient,rat serum acid phosphatase（PAP）level,serum testosterone（T）level,serum estradiol（E2）level,and pathological changes of prostate tissue were used as evaluation indicators for the model group,Different doses of renal sperm group,finasteride group and Qianliekang group were evaluated.To explore the pharmacodynamics and optimal dose of renal sperm in rats with benign prostatic hyperplasia.（3）Rat saline-loaded metabolic model was duplicated,and the diuretic hydrochlorothiazide was used as a positive control agent.Different doses of renal sperm（divided into high-dose group,middle-dose group,and low-dose group）were used to intervene for 1d,3d,5d,and 7d.The metabolic urine volume was measured from 1h to 6h in saline-loaded model rat,9d and 14d,and the diuretic effect of renal spermatozoa on saline-loaded model rats was explored.The mechanism of renal diuresis was explored.（4）The toxicity test of rat was performed after 2 weeks of routine dose of renal sperm.The possible toxicological symptoms,nature and extent of the rats were observed.The histopathological examination of the main organs was performed and 11 serum biochemical indicators were performed.an examination.Through a mouse acute toxicity test,mice were given a single clinical dose of 100-fold ShenJingZi for maximum acute tolerance tolerance.Results:（1）The elemental composition of the renal sperm differs depending on the original genus.The main element of the porcine-derived ShenJingZi is calcium,and the main element of the bovine-derived renal sperm is magnesium,which can be combined with SIMCA-P 14.1 by ICP-MS and 17.0 by SPSS software.Jiyuan ShenJingZi were identified and classified.Initially establish the quality standard of ShenJingZi.（2）There was significant statistical significance（p<0.01）between the administration of urine volume in the 4th week of renal sperm and the urine volume in the model group and the blank group.The model was successfully replicated.There were statistically significant differences in metabolic urine volume between 5 hours of water load and urine volume in the model group for 5 hours of renal spermatozoa in different dosage groups,Qianliekang group,and Finasteride group（p<0.05）;Prostate organ index The model group had significant statistical significance（p<0.01）compared with the blank group.After administration of different doses of renal sperm,the organ index was effectively reduced;the serum PAP,T,and E2 levels were significantly higher in the model group and the blank group（p<0.05）can be effectively reduced after different doses of renal sperm.The optimal dose of renal sperm in rats with benign prostatic hyperplasia is medium dose,which is 20mg·kg-1..（3）There was no significant difference in the negative urine volume control group between 1h to 6h saline-loaded model rats 1d,3d,5d,7d,9d,and 14d and the high-dose,middle-dose,and low-dose groups.（4）There were no visible toxicities in rats after 2 weeks of renal sperm clinical dose administration.No pathological changes were observed in histopathology.Serum biochemical indicators were normal in all groups.There was no statistical comparison between high dose,medium dose,low dose,and blank groups.Differences（p>0.05）.The renal sperm was given clinically equal doses 100 times in a single dose to mice without death.Conclusion:The main component of bovine-derived ShenJingZi is magnesium salt,and the main component of porcine-derived ShenJingZi is calcium salt,which can be distinguished and differentiated by ash and ICP-MS to establish the quality standard of ShenJingZi.Renal spermatozoa had a diuretic effect on the 5-h water load model of rats with BPH induced by testosterone propionate,and renal sperm could effectively improve BPH rat model of benign prostatic hyperplasia.The optimal dose of renal sperm in rats with benign prostatic hyperplasia is medium dose,which is 20 mg·kg-1.The diuretic mechanism of renal sperm differs from that of the diuretic,hydrochlorothiazide.It does not act directly on the kidneys to produce a diuretic effect on water-loaded model rats,probably by inhibiting the proliferation of prostate tissue in the rat or by causing the proliferating prostate tissue to retract.The clinical dose of renal sperm was non-toxic to rats for 2 weeks.The maximum tolerated dose of ShenJingZi to mice was 100 times higher than the clinical dose.The above experimental results basically achieved the quality control,effectiveness and safety of ShenJingZi. |
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