目的：比较两个企业的磷酸可待因片剂的处方优劣。方法：检测两个企业的磷酸可待因的片剂、原料和辅料的细胞毒性。结果：A企业片剂的IC50值为0.169 mg·ml^-1,B企业片剂的IC50值为0.140 mg·ml^-1,两企业片剂的IC50值差异有统计学意义（P〈0.05）；两企业原料的IC50值差异无统计学意义（P〉0.05）。结论：两企业磷酸可待因片剂的细胞毒性差异主要由辅料不同导致,A企业处方优于B企业。

Objective:To compare the formula of codeine phosphate tablets produced by two enterprises. Methods: IC50 of the tablets and raw material of codeine phosphate, and the excipients from two enterprises was detected respectively. Results:IC50 of the tablets from A enterprise was 0. 169 mg·ml-1 , that from B enterprise was 0. 140 mg·ml-1 , and the difference was statistically sig-nificant(P 0. 05). Conclusion: The difference in cytotoxicity of codeine phosphate tablets is manly induced by the excipients, and the products from A enterprise are better than those from B enterprise.

为了制备紫茎泽兰基芳香型防蛀缓释剂，通过可压性和开放式体外释放实验，确立了适宜在片剂中添加的吸附剂和赋形剂，并探讨了制剂组成和制备工艺条件对片剂释放性能的影响，通过药效试验测定片剂的药效。结果表明，微粉硅胶具有较好的可压性及控释作用，适宜添加在片剂中；以紫茎泽兰草粉为裁体，在10MPa压力下可成功制备外形完好的紫茎泽兰基芳香防蛀缓释片剂，片剂中紫茎泽兰草粉用量可高达片剂质量的76％（m／m），且香味持留时间可达3个月以上；薰衣草香精的加入不仅能掩盖草粉的不愉悦气味，还能提高片剂的药效。本研究中芳香防蛀缓释剂的成功制备，不仅拓宽了紫茎泽兰的综合利用范围，也为国内防蛀剂市场提供了一个具有增香的多功能防蛀缓释剂。

In order to prepare the aromatic and mothproofing sustained-release tablets based on eupatorium powders, the absorbents and excipients appropriately incorporated into the tablets were selected by using compression formulation experiment and in vitro release experiment. The influence of the compositions of the tablets and formulation conditions on the release kinetics was investigated using in vitro dynamic release experiments. The efficacies of tablets were evaluated by test insects. The results showed that: Micro-silica powders appropriately incorporated into the tablets had good compressibility and controlled-release effect. The sustained-release tablets could be successfully prepared by using eupatorium powders as a carrier and the formulation pressure of 10 MPa. The obtained lavender flavor-containing eupatorium-based tablets had good appearance and the maximum amount of eupatorium powders could reach 76% (m/m) of the quality of the tablet, and the release of lavender flavor from t

作为生产控制的一部分,通常需对片剂生产的外观质量进行中控检查。本研究是针对片剂特定水平缺陷,通过研究其生产工艺过程能力以确定批的缺陷率(质量水平),并应用于产品批的放行标准。同时依据质量持续性管理的理念,制定取样计划用于持续性片剂外观质量水平评估和控制。

As a part of the manufacturing instructions, an in-process check is usually required to inspect the speciifc defects in tablets. A new sampling strategy based on the quality management concept was described. A quality level (batch defect rate) was established by the study of the capability of production process, which could be used as quality control metric. Meanwhile, an acceptance sampling plan was established based on the concept of continuous quality management so as to be applied to the assessment and control of continuously tablet visual quality.

通过对不同载体、营养成分(碳源和氮源)及粘合剂的筛选,研制出了一种便于储存和运输、并可在棉花根部施用的解淀粉芽孢杆菌X-278(以下简称X-278)片剂,并测定了片剂的贮存稳定性;采用利福平标记法,测定了X-278片剂在棉花根、茎及根际土壤中的定殖能力;采用随机区组设计法研究了X-278片剂、X-278发酵液及枯草芽孢杆菌可湿性粉剂对棉花黄萎病的田间防治效果。结果表明:以硅藻土为载体,以质量分数为15%的葡萄糖为碳源,以质量分数为30%的花生饼为氮源,质量分数为20%的淀粉浆为粘合剂,通过干法压片得到了外观完整、光洁,色泽均匀且具有一定稳定性的X-278片剂,其含水量(质量分数)为0.5%,活菌含量为7.4×107cfu/g,未检测到有其他杂菌存在,各指标均符合标准;在棉花根部施用X-278片剂40 d后,X-278的最高定殖量在棉花根内为1.56×103cfu/g,在茎中为3.6×103cfu/g,在根际土壤中达3.8×106cfu/g,持效期达60 d;田间试验结果表明,X-278片剂对棉花黄萎病的防治效果均优于其发酵液及枯草芽孢杆菌可湿性粉剂,当X-278片剂施用量为0.6 g/株时,对棉花黄萎病的防效达到86.34%。

Through the screening of different carriers, nutrients ( carbon and nitrogen) and adhesives, the tablets of Bacillus amyloiquefaciens X-278 ( X-278 in short ) was developed, which could be applied in cotton root and was convenient for storage and transportation. The storage stability of the tablets was detected. By rifampicin labeling method, the colonization ability of X-278 in cotton root, stem, and in rhizosphere soil were determined. The field control efficacy of X-278 tablets, X-278 fermentation liquor, and Bacillus subtilis wettable powder to cotton verticillium wilt were studied byrandomized block design method. The results showed that using diatomite as carrier, mass fraction of 15% glucose as carbon source, mass fraction of 30% peanut cake as nitrogen source, mass fraction of 20% starch as adhesive, tablets of X-278 with smooth appearance and uniform color could be developed by dry pressing method. The moisture content of the tablets was 0?5%, and the living bacteria content w

为了验证自制中药复方片剂的安全性，确定中草药配伍提取后制成的片剂的毒性，采用小鼠急性毒性试验方法测定小鼠半数致死量（LD50）。结果表明，复方中药片剂对小鼠腹腔的 LD50＝42884 mg／kg ，其Dmin＝10000 mg／kg ，Dmax ＝80000 mg／kg ，M LD＝16822 mg／kg ，LD50的95％可信限为35222．77～50545．23 mg／kg。注射剂量为47604 mg／kg的小鼠，其肝脏肿大，边缘呈暗红色，易碎，肾脏肿大不明显；而61742 mg／kg与80079 mg／kg的小鼠肝脏和肾脏均肿大，肝脏表面呈现紫红色，其切面呈暗红色，质地软易碎，肠系膜略有充血现象，其他脏器无眼观变化。根据毒理学评价标准，LD50＞10000 mg／kg属于无毒性物质，本试验证实中药复方片剂对小鼠安全无毒。

In order to evaluate the applied reliability and ascertain the toxicity of the self‐made traditional Chinese herbal compound medicine ,the experiment of acute toxicity and the determination of LD50 of the self‐made traditional Chinese herbal compound medicine was conducted in mice with different doses .The result showed that the LD50 of traditional Chinese herbal compound medicine was 42 884 mg per kg weight , the minority of the doses was 10 000 mg per kg weigh ,the maximum of the doses was 80 000 mg per kg weight ,the MLD was 16 822 mg per kg weight and the 95% confidence interval was from 35 222 .77 to 50 545 .23 mg per kg weight .Dissected symptom of died mice showed that the liver of 47 604 mg per kg weight was enlarged and fragiler with dark red of edge ,but the kindney''s pathological change wasn''t obvi‐ous .However ,the liver and kindney from 61 742 to 80 079 mg per kg weight were enlarged and its surface was purple ,the mesentery bleeding slightly ,but the other