穴位注射卡介菌多糖核酸治疗支气管哮喘疗效观察

目的:观察卡介菌多糖核酸不同给药途径对支气管哮喘疗效的差异。方法:将60例支气管哮喘患者随机分为穴位注射组30例和肌肉注射组30例。穴位注射组将卡介菌多糖核酸注射液于双侧肺俞穴处行穴位注射,前15d每日1次,双侧肺俞穴各注射1mL,15d以后隔日注射1次,连续用药3个月;肌肉注射组将卡介菌多糖核酸注射液2mL注射于一侧臀部,给药时间同穴位注射组。比较治疗后两组肺功能及免疫球蛋白情况及停药3个月后两组症状、体征积分及哮喘控制测试(ACT)得分。结果:两组治疗后肺功能、IgE、IgG、症状体征积分、ACT得分均较治疗前改善(P0.01),但穴位注射组的改善作用优于肌肉注射组(P0.01,0.05),停药3个月后穴位注射组症状体征积分、ACT得分仍优于肌肉注射组(P0.01)。结论:穴位注射较肌肉注射卡介菌多糖核酸能更快速、持久控制患者症状、体征,能更显著改善肺功能、降低IgE,是治疗支气管哮喘的有效方案。     

An eco-friendly HPLC-UV method for the determination of risedronate in its bulk and tablet dosage form with application to content uniformity,dissolution and stability testing

Risedronate is a nitrogen-containing bisphosphonate for the treatment and prevention of postmenopausal osteoporosis. The current work aims to develop a novel green HPLC-UV method for the rapid analysis of risedronate sodium in bulk and tablet formulation. The analyzed samples were separated on Waters Atlantis dC18 (150 mm × 3.9 mm; 5 μm) column using a green mobile phase consisting of potassium phosphate buffer pH 2.9 and potassium edetate buffer pH 9.5 in a ratio of 1:2, the final pH was adjusted to 6.8 with phosphoric acid, the mobile phase was pumped at a rate of 1.0 mL/min, with column temperature set at 30 °C, eluted samples were detected at 263 nm and the chromatographic run time was 3.0 min. The method was found to be linear over the concentration range of 14–140 μg/mL with a correlation coefficient (r²) of 0.9994. Accuracy and precision were evaluated from three QC samples (LQC, MQC and HQC) together with the five calibrators where the percentage accuracy was found to be 101.84%. Processed quality control samples of risedronate sodium were tested for stability at different conditions, short term, long term and freeze- thaw stability. The current method was further extended to study the content uniformity of Actonel® tablets following United States Pharmacopoeia (USP) guidelines. The proposed method was fully validated as per ICH guidelines.     

基于黄酮类成分含量构成特征和体外抗病毒活性的不同产地黄芩的质-效评价研究

目的:评价黄芩道地药材与非道地药材中主要黄酮类成分含量构成特征及其抗病毒活性,以探讨黄芩药材的质-效关系及药效物质基础。方法:制备8批不同产地黄芩(S1~S8)的水提物冻干粉,采用超高效液相色谱法测定水提物中黄芩苷、汉黄芩苷、黄芩素、汉黄芩素等4种黄酮类成分的含量并计算其含量构成比。按不同产地黄芩的黄酮类成分含量构成比,制备上述4种成分混合物作为对应的黄酮类成分模拟样品(E1~E8)。以利巴韦林为阳性对照,采用MTT法和细胞病变程度法,考察8批黄芩水提物样品及其对应的模拟样品对人喉癌细胞Hep-2的半数有毒浓度(TD50)和对呼吸道合胞病毒(RSV)的半数抑制浓度(IC50),并计算治疗指数(TI)。采用SPSS 17.0软件对黄芩苷、汉黄芩苷、黄芩素、汉黄芩素含量与其抗RSV活性(IC50值)进行Pearson相关性分析。结果:样品S4(产地为河北承德)的黄芩苷、汉黄芩苷含量最高,样品S6(产地为内蒙古-2)的黄芩素、汉黄芩素含量最高;上述4种成分含量最低的分别为样品S6、S6、S7(产地为北京)、S4。样品S4中黄酮苷类成分含量较高,相应的苷元类成分含量较低,其黄芩苷、汉黄芩苷、黄芩素、汉黄芩素的含量构成比为1∶0.224∶0.111∶0.013;样品S6中黄酮苷类成分含量较低,相应的苷元类成分含量较高,上述4种成分的含量构成比为1∶0.241∶0.713∶0.106。不同产地黄芩水提物对Hep-2细胞的TC50均高于50μg/mL,对RSV的IC50为11.11~51.74μg/m L,TI为1.86~5.20;其对应的黄酮类成分模拟样品的TC50为23.11~52.23μg/mL,对RSV的IC50为4.87~14.61μg/mL,TI为1.85~4.75。道地产区(河北承德)黄芩(S4)的水提物及其对应模拟样品(E4)的抗RSV作用最强。相关性分析显示,4种黄酮类成分的含量与其抗病毒活性的相关系数均小于0.5,两者无显著相关性。结论:当黄芩中4种主要黄酮类成分的含量构成比为1∶0.224∶0.111∶0.013时,其对RSV的抑制作用较强。道地产区黄芩样品具有较优的黄酮类成分构成特征,该特征可能是道地药材发挥最佳抗病毒疗效的重要物质基础。     

基于内容分析法的中医类APP现状分析

随着手机APP对人们日常工作和生活方式的改变，中医类APP日益得到关注。文章基于内容分析法对目前中医类APP现状进行梳理，分析存在的问题，对未来中医类APP的设计和开发提出建议。以每一个APP为分析单元，从一般情况、主要功能、用户评价等3个方面进行分析，建立了7个维度22个细目的编码体系，进行频数统计和分析。发现目前中医类APP功能丰富，用户广泛，成为中医药服务及中医科学传播的重要载体，具有良好的用户粘度及巨大市场需求，但存在质量良莠不齐、内容资源不佳等问题。提出中医类APP开发应符合中医药发展战略的方向，应进一步规范中医类APP隐私政策和相关法律法规；并探索中医类APP的评价标准和评价指标体系，促进和规范中医类APP的质量提升和不断发展。     

A phase II,single-center,randomized, double-blind,parallel control clinical study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine

BackgroundThis was a single-center, randomized, double-blind, parallel control study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine with tetanus toxoid (TT) conjugate protein, in infants and toddlers of 3–35 months old.Method720 participants were stratified according to the age of 3–5 months old, 6–11 months old, and 12–35 months old and randomly assigned with an equal ratio to two different dose groups, i.e., 40- and 20-μg doses. Blood samples were taken from all participants before the first vaccination and 30 days after the full-course vaccination to detect the serogroups ACYW meningococcal antibodies. All adverse events occurred within 30 days after vaccination of each dose, and serious adverse events occurred within six months after full-course vaccination were collected for safety evaluation. This study was registered at the China drug trial registration with the identifier CTR 20182031.ResultsAfter 30 days of full-course vaccination, 92.78 % (95 % CI: 85.70 %-100.00 %) showed the immune response against all serogroups in both high-dose and low-dose groups by rabbit serum bactericidal antibody assay (rSBA) and the geometric mean titer (GMT) of all serogroups showed a high level (74.6–505.8, 95 % CI: 56.4–615.7). However, no significant difference between different dose groups was observed (P > 0.05). The common local and systemic adverse events in both groups were redness (3 %-7%), and fever (26 %-65 %), respectively. In addition, the grade 3 adverse event related to the vaccine was fever (1.67 %-12.50 %). No serious adverse event was reported to be associate with the vaccination.ConclusionThe serogroups ACYW meningococcal polysaccharide conjugate vaccine was safe and effective in the population aged 3–35 months. The vaccine efficacy and safety of the 20-μg dose group were not less than that of the 40-μg dose group.     

Arguments Used in Public Comments to Support or Oppose the US Department of Agriculture’s Minimum Stocking Requirements: A Content Analysis

Background

In 2016, the US Department of Agriculture (USDA)’s Supplemental Nutrition Assistance Program (SNAP) Retailer Rule proposed several changes for SNAP-authorized retailers, including: requiring retailers to have at least 85% of their food sales come from items that are not cooked or heated on site before or after purchase; requiring stores to stock seven varieties of qualifying foods from four staple food groups; requiring stores to carry perishable foods in three of the four staple groups; requiring stores to carry six units of qualifying foods at all times (depth of stock); disqualifying multiple ingredient foods and accessory foods from counting toward depth of stock requirements.

《中国药典》“维生素D测定法”中计算公式的讨论

目的：对《中国药典》（2015年版）四部通则0722“维生素D测定法”中计算维生素D总量公式进行了深入探讨。方法：在检验中发现所得结果与根据标准公式计算所得存在着差异。经过推算,并考察比较了近几版中国药典和几种国外药典（USP,EP,BP,JP）中的文本描述,分析了产生差异的原因,给出了改进建议。结果与结论：本工作可为完善《中国药典》维生素D含量计算方法提供参考。 ?     

UPLC-MS/MS法测定黄杨宁制剂中的环维黄杨星D的含量

摘 要 目的：建立超高效液相色谱 串联质谱法（UPLC MS/MS）快速测定黄杨宁制剂中环维黄杨星D的含量。方法: 采用UPLC MS/MS法。色谱柱为Waters ACQUITY UPLC BEH C18柱（100 mm×2.1 mm,1.7 μm）,流动相为乙腈 含0.1%甲酸的0.01 mol·L-1甲酸氨溶液,梯度洗脱,流速为0.35 ml·min-1,柱温为30℃,进样量为5 μl。离子源为电喷雾（ESI）离子源,正离子模式,工作模式为多反应监测模式（MRM）。结果:环维黄杨星D的线性范围为15.58～1 558.00 ng·ml-1（r=0.999 5）;平均加样回收率为97.7%（RSD=3.8%,n=6）。结论:该方法快速、简便、准确、重复性好,适用于黄杨宁制剂的质量控制。     

折光率快速测定碘海醇注射液含量的方法研究

摘 要 目的：建立折光率与碘海醇注射液的化学计量关系。方法: 采用Rudolph J257与Mettler Toledo RE40D折光仪对多企业生产的碘海醇注射液进行测定,将折光率与电位滴定法测得的含量结果建立化学计量关系式C=2.828R-3.769。结果:对76批次样品的电位滴定测得的含量结果与经折光率计算得到的模拟结果进行比较,模拟结果与实测结果的相对偏差小于2%,辅料不干扰测定。结论:本法简便、快速、准确,可用于碘海醇产品的过程控制及市场监督。