目的 探索小兒咳喘靈原藥提取液高效絮凝除雜工藝，更好地去除雜質(zhì)，保留有效成分，提高藥液的澄清度及其穩(wěn)定性。方法 采用殼聚糖對小兒咳喘靈口服液原藥提取液進(jìn)行絮凝處理，以有效成分綠原酸保留率、鞣質(zhì)和蛋白質(zhì)的去除率及藥液濁度作為主要衡量指標(biāo)，考察絮凝劑用量、絮凝溫度、攪拌速度及攪拌時間對絮凝效果的影響，以期得到適宜的絮凝工藝條件。結(jié)果 確定了殼聚糖絮凝小兒咳喘靈口服液原藥提取液的最佳絮凝工藝為藥液溫度30 ℃，加入殼聚糖0.75 g/L，先在攪拌槳葉片頂端線速度為1.31 m/s的條件下快速攪拌120 s，再在0.26 m/s的速度下攪拌15 min，絮凝后的藥液在分離因數(shù)為1 430條件下離心20 min，此時綠原酸的保留率為94.6%，鞣質(zhì)和蛋白質(zhì)的去除率分別為44.7%和51.6%，藥液濁度為1.1 NTU。藥液靜置存放90 d后濁度僅為3.5 NTU，穩(wěn)定性突出。與醇沉法相比，殼聚糖對于小兒咳喘靈原藥提取液的絮凝除雜效果良好，有效成分綠原酸及多糖的保留率分別提高了6.3%和25.8%，鞣質(zhì)去除率提高21.6%，藥液的濁度僅是醇沉濁度的1/4，放置3個月藥液濁度的上升幅度僅為醇沉法的1/5。結(jié)論 絮凝法可以用于小兒咳喘靈口服液原藥液的凈化除雜工藝。

Abstract: Objective To find out an efficient flocculation process of herbs water-extraction solution of Xiao’er Kechuanling Oral Liquid, remove impurities, reserve more active components of solution, and improve solution clarity and stability. Methods The natural macromolecule flocculant chitosan was applied to purify herbs water-extraction solution of Xiao’er Kechuanling Oral Liquid. The influences of the flocculant dosage, flocculation temperature, mixing speed and time on flocculation effect were investigated, and the optimal process conditions were obtained based on the retention rate of chlorogenic acid, removal rate of tannin and protein, and the turbidity degree of the supernatant solution. Results The optimum flocculation process conditions were as follows: the flocculation temperature was 30 ℃, the chitosan dosage was 0.75 g/L, the tip velocity of propeller was 2.6 m/s and the fast mixing time was 120 s, then the tip velocity of propeller was 0.52 m/s and the slow mixing time was 15 min, and after that the treated solution was centrifuged for 20 min at centrifuging factor 1 430. At the optimal process condition point, the retention rate of chlorogenic acid was 94.6%, the removal rate of tannin and protein was 44.7% and 51.6%, respectively, the turbidity degree was 1.1 NTU and only 3.5 NTU after 90 d of the storage duration of the supernatant solution. Compared with ethanol precipitation, the flocculation effect of water-extraction solution of Xiao’er Kechuanling Oral Liquid with chitosan had distinct advantages that the content of chlorogenic acid and polysaccharide and the removal rate of tannin was improved by 6.3%, 25.8%, and 21.6% respectively, the turbidity degree was only 1/4 of the solution treated by ethanol precipitation, and three months later the rise of turbidity degree was 1/5 of that by ethanol precipitation. Conclusion Flocculation technology could be used in the purification process of the extract of Xiao’er Kechuanling Oral Liquid.

國家重大新藥創(chuàng)制科技重大專項綜合性新藥研究開發(fā)項目子課題（2009ZX09301-008）；國家自然科學(xué)基金資助項目（21276195）