药用辅料壳聚糖及其制剂冰硼膜实验研究

Experimental Study on Chitosan Used as An Excipient and Its Preparation Borneolum and Borax Pellicle

目的评价壳聚糖的安全性和组织相容性及其制剂冰硼膜治疗口腔溃疡的疗效。方法选取健康小型猪及不同品系小鼠和SD大鼠进行壳聚糖药理毒理学试验研究。通过对健康家兔贴敷冰硼膜,观察其对家兔局部黏膜的影响及全身反应情况;建立家兔口腔溃疡模型,并设冰硼散对照组,观察冰硼膜对溃疡愈合时间的影响。结果一般药理试验研究表明,试验组与对照组比较各组小型猪的生命体征变化无明显差异,不同途径给药其差异无统计学意义;急性毒性试验未测出LD50,小鼠最大耐受量达4980mg/(kg.bw)。冰硼膜与冰硼散比较,对家兔Ⅰ型口腔溃疡的疗效无明显优势(P>0.05),但可明显缩短Ⅱ型口腔溃疡的愈合时间;试验前后,冰硼膜组家兔的全身状况及局部黏膜无明显变化。结论壳聚糖对小型猪神经系统、心血管系统和呼吸系统无明显毒副作用,口服及腹腔注射安全性均较好;冰硼膜可以明显缩短Ⅱ型口腔溃疡的愈合时间。

Objective To evaluate the safety and histocompatibility of chitosan used as an excipient and the curative effect of borne- olum and borax pellicle on treating dental ulcer. Methods Pharmaco - toxicological experimental study on chitosan was done to healthy min - pigs and different lines of Jimpy mice and SD rats, The effect of borneolum and borax pellicle was observed on healthy rabbits＇ focal mucosa and general reaction by sticking it to them, and on healing time of ulcer through establishing rabbits dental ulcer model and laying control group of borneolum and borax powder. Results General pharmacological experimental study showed that the variation of min - pigs＇ vital sign had no obvious difference between experimental group and control group, and that given drugs by different ways had no statistical significance. LD50 wasn＇t got in acute toxicity experiment, and to J impy mice, maximal torlerable dose was 4980mg/（ kg · bw）, The curative effect of borneolum and borax pellicle on rabbit Ⅰ type dental ulcer had no obvious predominance comparing with borneolum and borax powder（ P 〉 0.05 ） , however, it can shorten curative time obviously on lI type dental ulcer. Simultaneously, the general reaction and focal mucosa of borneolum and borax pelliele group had no obvious variation before and after the test. Conclusions Chitosan has no effect on min - pigs＇ nerve, cardiovascular and respiratory system ; and it is relatively safe given by mouth or peritoneal injection. The borneolum and borax pellicle can shorten curative time obviously on Ⅱ type dental ulcer.