药用淀粉辐照灭菌研究

STUDY ON RADIOSTERILIZATION OF PHARMACEUTICAL STARCH

６０Ｃｏγ射线辐照可显著降低药用淀粉中的微生物数量。研究结果表明：杂菌的Ｄ１０值为０７ｋＧｙ，适宜辐照剂量为３０～５０ｋＧｙ，辐照剂量与杂菌存活数之间呈显著的负相关（ｒ＝－０９０５３），辐照工艺的改变对灭菌效果有较大的影响。对５０ｋＧｙ辐照的药用淀粉进行毒性试验表明，用较低剂量辐照的药用淀粉无毒性反应、无致畸、致突变等遗传性病变，因此是安全、无害的。采用以上剂量灭菌的同时，不会导致淀粉自身理化性状和制药工艺性状的改变。

fter treated with γray, the loading of microble in pharmaceutical starch was decreased sharply. If the microble loading is in the range of 10～15×104, the optimum absorbed dose is 30～50kGy. The results showed that there was a significant relationship between absorbed dose and amount of survival bacteria. The D10 value of bacteria is 07kGy. On the other hand, change of radiation technology in the same radiation field could affect the result of radiosterilization. No toxicity was found with irradiated starch in the test period in mouse.