Preparation Process, Pharmacological And Toxicologic Effects Of Wujin Granules

Lamb diarrhea, caused by Clostridium perfringenes, is a newborn lamb toxemia with the incidencerate of 10~40%, which is characterized by abdominal distension, persistent defecation of athero-feces orwatery feces and dehydration.The present studies the treatment of lamb dysentery by Chinese veterinarymedicine. According to traditional Chinese veterinary theory and advanced preparation process ofherbal products, the present study was to develop an herbal granules for prevention and control of lambdiarrhea.According to the stability of herbal preparation and the requirements of accessibility ofadministration in veterinary clinical practices, herbal granule was chose as the form of herbalpreparation for treatment lamb diarrhea. Based on the therapeutic principles of “antidarrhea astringent,or strengthening the spleen and stomach function”, an effective herbal preparation “Wujin Granule” wasdeveloped to treat lamb diarrhea based on the clinical effectiveness, and the optimized doses of WujinGranule is 1.2g/kg·bw, two times daily,with the lamb diarrhea disease cure rate was 89.3%, effectiverate was 96.4%.The optimized extraction process was established by herbal extraction process with L9(34)orthogonal trial for and granulation process based on the difficulty of granulation process and theparticles forming rate. The optimized extract process of Mangnolia officinalis was to use 10 times shareof 70% ethanol for reflux extraction for 1 hour two times, and obtain the Mangnolia officinalis extractby concentration under vacuum after merging the two extract, and the other 6 herbs includingEuphorbia humifusa Willd, Rhizoma Coptidis, and poria et,al was to use 10 times share of purifiedwater for decoction for 1 hour two times, and obtain the water extract with relative density 0.9~1.1 afterconcentration. The above two extracts were merged and concentrated to the herbal formula extractumwith relative density 1.31~1.35(50~55 ℃), and then Wujin Granule was prepared by adding the 4times share of soluble starch and sucrose powder(17:3). The thin-layer chromatographic detectingconditions of Euphorbia humifusa Willd, Rhizoma Coptidis, magnolia and poria in Wujin Granule wereestablished with TCL method, and the quantitative determination of berberine hydrochloride, magnololand honokiol in Wujin Granule were established with a high-Performance liquid chromatographicmethod.To evaluate the safety of Wujin granules, the acute and sub chronic toxicity test were assessed inmice and Wistar rat. Acute toxicity test showed the LD50>40g/kg·bw, and the maximum tolerated dosewas 160g/kg·bw, which was 80 times as much as the clinical dose. Sub-chronic toxicity test indicatedthat Wujin Granules had no negative effect on increased body weight, behavior,blood indexes, serumbiochemistry indexes and organ indexes. It turns out that the Wujin Granules was not to be toxic ifadministed.Wujin Granules had some beneficial effects including antidiarrheal, anti-inflammatory andabirritation function by intestinal propulsion movement test, lamb isolated ileum motility assay,inhibition test of senna-induced diarrhea, auricle swelling inhibition test and torsion body methodanalgesic test.In conclusion, the herbal granules used in the present study might be a rational herbal formula, andwas proven to be safe and had antidiarrhea, anti-inflammatory, analgesic effects, and its preparationprocess was stable, practicable, thus Wujin Granules could represent a potential effective herbalpreparation for neonatal lamb diarrhea.