20味超微粉碎技术制备中药配方颗粒急性毒性研究

目的对比观察西洋参、天麻、三七、琥珀、鹿角、沉香、紫河车、青黛、浙贝母、血蝎、水牛角、川贝母、白及、大黄、金沙牛、番泻叶、羚羊角、檀香、水蛭、蜈蚣20味同批次中药材所制备粗粉剂（传统粉碎）、超微粉和超微配方颗粒的急性毒性，明确超微粉碎技术制备全部中药配方颗粒的安全剂量范围。方法在预实验基础上，每味中药均取80只雌雄各半NIH小鼠，随机均分为空白组、粗粉剂组（过80目）、超微粉组（过300目）和超微配方颗粒（过300目）4组．小鼠禁食不禁水12h后称重，各药分别以0．4mL／10g体质量最大浓度灌胃，空白对照组以等容去离子水灌胃，每天3次、共1d，连续14d观察动物出现的各种反应。结果在观察的14d内，大部分药物小鼠仅出现I级可逆性不良反应；体重与空白组小鼠相比无显著性差异，也无任何动物死亡；20味中药饮片不同剂型的最大给药量为临床剂量的26．64～1519．20倍。结论超微粉碎技术试制全部20味中药配方颗粒与同批次中药饮片的粗粉剂和超微粉均为无毒性药物，临床可安全使用。

Acute Toxicity Study of 20 Kinds Chinese Medicinal Dispensing Granule Made by Superfine Comminution Technology

Objective To compare the acute toxicity differences between coarse powder （ CP ）, ultrafine powder （UP） and uhrafine Chinese medicinal dispensing granule （UCMDG） three formulations of 20 kinds Chinese medicine Panax quinquefolium L., Gastrodiaelata BI., Panax pseudoginseng （Burkill）, Ambrum, Cervus elaphus Linnaeus, Aquilaria agaUocha Roxb, Placenta Hominis, Baphicacanthus cusia （Nees） Brem., FritiUaria thunbergii Miq., Daemoaorops draco BL. Bubalus bubalis L., Fritillaria cirrhosa D. Don, Rhizoma BletiUae, Radix et Rhizoma Rhei, Myrmeleon formicarius Linnaeus, Cassia angustifolia Vahl, Saiga tatarica L., Santalum album L., Hirudo, Xcolopednra ] from the same batch of TCM decoction pieces, to value the safe dose range of UCMDG. Methods Based on preliminary experiments, 80 NIH mice of half gender were randomly divided into control group, coarse powder （ CP, 80 mesh）, ultrafine powder （ UP, 300 mesh） , and UTDG group （300 mesh） 4 groups for every Chinese medicine, after fasted for 12 h and weighted, drugs was orally administered in accordance with 0.4 mL/10 g body weight 3 times in one day with maximum concentration, the control group was given deionized water instead, responses of animals were observed for 14 d. Results Animals in some drugs groups only displayed reversible toxicity reactions, body weights shown no significant difference compared with control groups but no animals died in thel4 d, and the maximum administration doses of 20 different Chinese medicine were 26.64-1 519.20 times than clinical doses. Chinese medicine from the same batch of TCM comminution technology are non-toxic. UCMDG Conclusion CP, UP, and UCMDG 3 formulations of the 20 kinds of decoction pieces made by traditional can be used safely in clinical. grinding technology and superfine