基于唐代至民国时期文献的人参安全剂量研究

Study on safe dose of ginseng based on literatures from Tang dynasty to Republic period

目的通过唐代至民国时期文献数据分析,了解人参临床安全剂量范围。方法选择唐至民国具有权威性的方书与善用人参的代表性医家的代表作,从中筛选人参主要发挥安神功效的方剂,即症状或主治描述中包含失眠和/或多梦类症状的方剂。剔除无明确剂量、用于小儿的方剂。对所纳入的药物名称进行标准化处理。分别计算汤剂、煮散、丸散各剂型方剂中人参剂量的最大值、最小值、不同剂量区间频数以及80%CI,根据上述数据判断人参用于各剂型的安全剂量。结果共纳入14部经典著作,分别为唐代《备急千金要方》,宋代《太平惠民和剂局方》《太平圣惠方》和《圣济总录》,金元时期《内外伤辩惑论》《脾胃论》《兰室秘藏》和《丹溪心法》,明代《景岳全书》和《证治准绳·类方》,清代《临证指南医案》《辨证录》和《石室秘录》,民国时期《医学衷中参西录》,并从中筛选获得85首处方。人参用于汤剂剂型中,每日服用量为3.73~18.65 g;在煮散剂型中,每次用量为0.07~5.16 g。如症状中含有多梦,汤剂剂型每日服用量为7.46~11.19 g,煮散剂型每次用量为1.03~4.45 g;丸散剂中,成人每次用量为0.68~6.54 g,占全方总剂量12%~30%较适宜。结论人参用于汤剂时,成人每日用量不宜>18.00 g,剂量为7.00~11.00 g最佳;煮散剂时,成人每次用量不宜>5.00 g,剂量范围1.00~4.00 g最佳;用于丸散剂时,成人每次用量不宜>6.00 g,占全方总剂量12%~30%较适宜。

Objective To study the safe dose of Ginseng (Radix et Rhizoma Ginseng) through analysis of literature from Tang dynasty (618 AD) to Republic period (1949 AD). Methods The selection strategy for literature and prescriptions was made to acquire the formulae in need. The authoritative prescription-books from Tang Dynasty to Republic period, or representative books of the renowned doctors who was good at using Ginseng in that period were chosen. From the books above mentioned, prescriptions with Ginseng to tranquilize mind were included, in which insomnia and/or dreaminess were recorded as symptoms or clinical applications. Prescriptions without definite dose or only with dose for children were excluded. All herbal names were standardized according to current TCM terms. Then the maximum, minimum, frequency and 80% confidence interval of dose were studied. The dose range of Ginseng in deferent dosage form was discussed according to above data. Results Fourteen classical TCM books were included, from which 85 formulae were studied. In the form of root slices decoction, the applied daily dose of Ginseng ranged from 3.73 g to 18.65 g, while in the formulae with symptom of dreaminess, the dose ranged from 7.46 g to 11.19g. In the form of root powder decoction, the single dose range was 0.07 g to 5.16 g, while in the formulae with symptom of dreaminess, the dose range was 1.03 g to 4.45 g. In the form of pill or powder, the single dose range was 0.68 g to 6.54 g, and 12% to 30% in total dose of the prescription. Conclusion For the root slices decoction, the favorable dose range of Ginseng is between 7 g and 11 g, but not more than 18.00 g per day. For the root power decoction, the favorable dose range is from 1 g to 4.00 g, and the maximum single dose is 5.00 g. For pill or powder form, the maximum dose is 6.00 g, taking 12% to 30% in total prescription.