正交试验优选当归补血口服液的超滤工艺

目的:优选当归补血口服液超滤工艺。方法:以黄芪甲苷、总多糖保留率为考察指标,以工作压强、药液温度、药材与提取液质量比为考察因素,采用正交试验优选当归补血口服液的超滤工艺。结果:优选工艺条件为超滤温度30Ⅳ,压强0.75 Mpa,药材与提取液质量比为1∶8。结论:优选出的超滤工艺有效成分保留率高、质量稳定、便于操作。     

超滤法和水醇法制备参麦注射液的实验比较研究

本文对超滤法和水醇法制备参麦注射液的工艺进行了比较。结果：超滤品色泽（黄棕色）明显深于水醇法，超滤品和水醇品的澄明度、热原、卫生学、刺激性检查均符合要求；超滤品中人参皂甙含量比水醇品高约４．４倍。认为超滤作为一种新技术用于参麦注射液的制备，在缩短制备工艺、提高有效成份含量、增加澄明度等方面，优于水醇法，是一种可行的制备工艺。     

超滤技术在一步法制备抑肽酶工艺中的应用

对超滤技术在一步法制备抑肽酶工艺中的洗脱液浓缩、脱盐和去热原上的应用效果与现有工艺进行了比较,结果表明使用超滤法的酶活性回收率达８８．６％,比活８１９０．８ ｋＵ／ｍｇ,适合工业化生产。     

奥斯曼生眉液超滤工艺的研究

目的：研究奥斯曼生眉液的超滤工艺。方法采用截留相对分子量分别为6000和30000的聚丙烯中空纤维膜,以超滤前后药液中吲哚苷和鞣质含量为指标,采用单因素考察和正交实验方法优选超滤的最佳工艺参数。结果截留相对分子质量为30000的超滤膜有较好的分离提纯效果,最佳工艺参数为：料液加水稀释5倍,调pH至6.0,常温、操作压力0.10Mpa的条件下膜分离3遍。结论超滤工艺能有效提高产品有效物的含量和解决产品稳定性问题。     

银杏叶提取工艺的研究

对银杏叶提取物的提取和精制工艺进行了研究，确定了提取溶剂、时间、次数及浓缩、干燥温度等提取工艺参数。比较了树脂吸附一次洗脱和二次洗脱以及超滤与树脂吸附相结合的精制工艺对产品质量及总黄酮收率的影响。结果表明，超滤与树脂吸附工艺所得产品的质量和收率最佳。     

连续板式超滤系统在头孢菌素C发酵液过滤提纯中的应用

目的比较连续板式超滤与间歇板式超滤在头孢菌素C发酵液过滤提纯中的效果。方法进行30批连续板式超滤与间歇板式超滤的对比试验。结果表明连续式板式超滤分离头孢菌素C发酵液具有膜污染程度小,清洗后膜通量易恢复,滤液质量好、滤液单位均一等优势。结论连续板式超滤更适应头孢菌素C的过滤分离及与后续提取工艺的整合。     

超滤和活性炭在注射剂生产工艺中的应用比较

目的比较超滤工艺和活性炭工艺在普通注射剂生产中去除热原的优缺点以及对产品质量的影响。方法①配制浓度为1000EU.mL-1的内毒素指示剂水溶液,分别考察超滤工艺和活性炭工艺去除内毒素指示剂的效果;②分别考察超滤工艺和活性炭工艺在10%的维生素C药液、3%的曲克芦丁药液、0.04%的法莫替丁药液中去除热原的效果及对产品质量的影响。结果①截留分子量为10000的超滤能有效的去除药液中的热原、微粒、病毒等异物,对产品的色泽和澄清度均有一定的改善作用,但对不同产品标示量的均一性会产生影响;②活性炭对产品的色泽有一定的改善,但去除热原的效果不明显,对药品主成分会产生一定的吸附作用。结论超滤去除热原的作用[1]和对产品质量的影响均要优于活性炭。     

中药提取液的膜分离工艺

将膜分离技术用于中药提取液,即以微滤去除提取液中的悬浮物,再以超滤去除大分子杂质。通过对微滤、超滤过程的考察及与传统的醇沉工艺的比较,认为采用膜分离工艺具有显著的优点。     

用超滤新技术生产人胎盘血白蛋白

人胎盘血白蛋白生产目前国内多采用盐析工艺。该工艺虽具有比低温乙醇法收率高,设备简单等优点,但生产周期长、难以控制热原、在制备较高浓度规格的制品时,还需采取其他相应方法,因此工艺复杂。据文献报道,国外已采用超滤法生产白蛋白,但国内尚未见报道。84年开始,我们结合原白蛋白生产工艺,用超滤代替末次盐析、透析以及进一步浓缩,并增加一步超滤去热原,解决了盐析工艺存在的问题。该项新技术已由浙江省医药总公司组织专家通过评议,将正式应用于生产。     

全国普通高等学校药学类本科专业目录修订论证会在南京召开

“超滤制备中药注射剂工艺曾荣获1984年国家发明四等奖。为了推广和普及此项新技术,空军北京医院药械科于1986年12月16日至19日在北京举办了第二期《超滤技术培训班》。来自全军各大军区、军医大学十三所医院的有关同志参加了学习。培训班较详细地作了“超滤概况”、“DUF     

Quantification of water content in biological tissues by proton nuclear magnetic resonance.

We have made quantitative measurements of water content in biological tissue using proton nuclear magnetic resonance (NMR). We evaluated the factors which affect the NMR signal intensity measurements in order to quantify the absolute water content of the tissue. It can be said that there is an optimum sample length to achieve the absolute value of water content using NMR. The integrated NMR water signal intensity was determined in the frequency domain. The absolute water content was measured gravimetrically. The NMR detectable water in brain and lung tissue was determined using the signal intensity of the analyzed tissue compared with the signal intensity for the same weight of distilled water. The NMR detectable water was 99% by weight for brain and 60% by weight for peripheral lung tissue. The NMR detectability of water in biological tissues varied for different tissues.     

Wide-ranging molecular mobilities of water in active pharmaceutical ingredient (API) hydrates as determined by NMR relaxation times

In order to examine the possibility of determining the molecular mobility of hydration water in active pharmaceutical ingredient (API) hydrates by NMR relaxation measurement, spin-spin relaxation and spin-lattice relaxation were measured for the 11 API hydrates listed in the Japanese Pharmacopeia using pulsed (1)H-NMR. For hydration water that has relatively high mobility and shows Lorentzian decay, molecular mobility as determined by spin-spin relaxation time (T(2)) was correlated with ease of evaporation under both nonisothermal and isothermal conditions, as determined by DSC and water vapor sorption isotherm analysis, respectively. Thus, T(2) may be considered a useful parameter which indicates the molecular mobility of hydration water. In contrast, for hydration water that has low mobility and shows Gaussian decay, T(2) was found not to correlate with ease of evaporation under nonisothermal conditions, which suggests that in this case, the molecular mobility of hydration water was too low to be determined by T(2). A wide range of water mobilities was found among API hydrates, from low mobility that could not be evaluated by NMR relaxation time, such as that of the water molecules in pipemidic acid hydrate, to high mobility that could be evaluated by this method, such as that of the water molecules in ceftazidime hydrate.     

水浴灭菌器布水均匀性确认方法研究

目的 建立一种确认水浴灭菌器布水均匀性的方法,对灭菌器布水均匀性进行评价.方法 通过对水浴灭菌器布水结构的分析,采用在布水口安装螺翼式水表对布水口的水量进行不同时间段的测量,对获得的数据进行显著性差异检验和相对标准偏差(RSD)分析,确认布水是否均匀.结果 通过对布水口单位时间的流量数据统计分析,显著性差异检验结果为15 min流量数据的P值为0.004(表示差异性极显著)、30 min流量数据的P值为0.963(表示差异性不显著)、60 min流量数据的P值为0.024(表示差异性显著);相对标准偏差结果在2.3%至2.9%之间.结论 相对标准偏差对螺翼式水表获得的布水口水量监测数据进行统计评价为确认水浴灭菌器布水均匀性提供了简便和准确的方法.     

Prediction of suitable amount of water addition for wet granulation

The purpose of this study was to predict the amounts of water addition suitable for pharmaceutical formulations in wet granulation, using a high-speed mixer or a fluidized bed granulator, before granulation trials. In order to determine the suitable amount of water addition, each excipient was first subjected to kneading with water in a mortar and a refractive near-infrared moisture sensor (IR sensor) measured the amount of water at the powder surface. Further by analysis the plot (output value of the IR sensor vs. amount of added water) for each excipient, the amount of water addition for granulation was determined for it. As a second step, two model formulations were designed and suitable amounts of water for granulation were predicted by summation of the obtained excipient values. The predicted value was compared with the experimental value for high-speed mixer granulation. The predicted and experimental amounts of water addition corresponded for the two model formulations, suggesting that the above method is useful for estimating suitable amounts of addition of water for formulations before granulation trials.     

An efficient screening approach for anti-Microcystis compounds based on knowledge of aquatic microbial ecosystem

To improve the efficiency of screening for anti-Microcystis compounds, we planned to use algae-lysing bacteria that kill the organisms of water blooms. A two step-screening process was carried out, i.e., the screening of algae-lysing bacteria and the selection of anti-Microcystis producers from the bacteria. Sources for the isolation of the bacteria were a co-cultivated fluid of a water sample with axenic Microcystis viridis, a water sample collected in a water bloom season, and a water bloom sample. The water bloom sample was the best source for the isolation of the algae-lysing bacteria and such bacteria were shown to exhibit potent activity. Seventeen strains out of 20 isolated algae-lysing bacteria produced anti-Microcystis activities, and one of the principles was the previously reported argimicin A. These results indicate that algae-lysing bacteria in water blooms may be good sources for potent and selective anticyanobacterial compounds.     

Quantification of the types of water in Eudragit RLPO polymer and the kinetics of water loss using FTIR

Coalescence of polymer particles in polymer matrix tablets influences drug release. The literature has emphasized that coalescence occurs above the glass transition temperature (T_g) of the polymer and that water may plasticize (lower T_g) the polymer. However, we have shown previously that nonplasticizing water also influences coalescence of Eudragit RLPO; so there is a need to quantify the different types of water in Eudragit RLPO. The purpose of this study was to distinguish the types of water present in Eudragit RLPO polymer and to investigate the water loss kinetics for these different types of water. Eudragit RLPO was stored in tightly closed chambers at various relative humidities (0, 33, 56, 75, and 94%) until equilibrium was reached. Fourier transform infrared spectroscopy (FTIR)-DRIFTS was used to investigate molecular interactions between water and polymer, and water loss over time. Using a curve fitting procedure, the water region (3100–3700 cm⁻¹) of the spectra was analyzed, and used to identify water present in differing environments in the polymer and to determine the water loss kinetics upon purging the sample with dry compressed air. It was found that four environments can be differentiated (dipole interaction of water with quaternary ammonium groups, water cluster, and water indirectly and directly binding to the carbonyl groups of the polymer) but it was not possible to distinguish whether the different types of water were lost at different rates. It is suggested that water is trapped in the polymer in different forms and this should be considered when investigating coalescence of polymer matrices.     

正交试验法优选急肝乐胶囊的提取工艺

目的优选急肝乐胶囊的提取工艺。方法川芎、公英先于80℃热水保温浸泡1 h,再与大黄、茵陈一起,利用正交试验法,考察100℃水浴煎煮时间、加水量、煎煮次数3因素、3水平对提取工艺的影响;以结合大黄素、结合大黄酚、阿魏酸为考察指标,用RP HPLC法测定各指标。结果结合大黄素、结合大黄酚总量的最佳提取工艺为100℃水浴煎煮15 min、加水量为药材重的12倍、煎煮2次,其中100℃水浴煎煮时间对结合大黄素、结合大黄酚的总量有非常显著性影响,加水量对其有显著性影响,煎煮次数影响不显著。阿魏酸的最佳提取工艺为100℃水浴煎煮20 min、加水量为药材重的12倍、煎煮3次,其中100℃水浴煎煮时间对阿魏酸的影响显著,加水量和煎煮次数没有显著性影响。结论急肝乐胶囊的最佳提取工艺为川芎、公英先于80℃热水保温浸泡1 h,再与大黄、茵陈一起,100℃水浴煎煮15 min,加水量为药材重的12倍,煎煮2次。     

The use of water as a diluent for bronchodilator nebuliser solutions

Inhalation of nebulised water can provoke bronchoconstriction in asthmatic patients. In the first part of this study, a community survey identified that about 20% of patients with home nebulisers currently use water as a diluent. In the second part of this study, the airways effect of the use of water as a diluent for nebulised beta agonist was investigated. Nineteen asthmatic subjects were administered nebulised 2.5 mg salbutamol, diluted with either 2 mL water or physiological saline, and forced expiratory volume in one second (FEV1) was measured at baseline and at regular intervals for 45 minutes after nebulisation. Although there was a trend towards a reduced bronchodilator response with water as diluent, the differences between the two diluents were not significantly different. Paradoxical bronchoconstriction was not observed when salbutamol was diluted with water. We conclude that the common practice of diluting bronchodilator nebuliser solution with water does not result in a significant reduction in the overall bronchodilator response.     

高风险注射剂生产企业制药用水系统微生物菌库的建立和分析

目的 建立某高风险注射剂生产企业制药用水系统微生物数据库，为企业制药用水系统污染微生物的有效控制和溯源调查提供指导。方法 连续4个季度对某大容量注射剂生产企业的纯化水系统和注射用水系统监控收集微生物，采用基于16S rRNA和ITS rDNA序列比对等方法鉴定污染微生物，结合微生物种属和来源信息进行分析，建立企业制药用水系统的微生物菌库。结果 共分离鉴定1 499株细菌和20株真菌，注射用水系统和纯化水系统的微生物分别占比9.0%和91.0%。纯化水系统中鞘氨醇单胞菌和甲基杆菌最多，分别占全部分离菌的28.9%和25.2%。注射用水系统中葡萄球菌和微球菌较多，分别占全部收集菌的24.9%和18.2%。纯化水系统中污染的微生物主要为革兰氏阴性菌，占污染微生物总数的67.0%。注射用水系统中污染的微生物主要为革兰氏阳性菌，占污染微生物总数的60.3%。制药用水系统中较为常见的真菌为杂色曲霉菌和产黄青霉。此外，经分析发现，纯化水系统的微生物在第二季度和第三季度数量占比较多，占全年微生物总量67.8%，第一季度和第四季度微生物数量则下降；注射用水系统微生物数量则在第二季度较多，其余3个季节数量差不多。结论 建立制药用水系统微生物菌库可指导制药用水系统的运行维护及消毒灭菌，同时也为高风险药品生产企业的微生物污染事件提供溯源调查基础。     

Effect of a mineral water on gastric emptying of patients with idiopathic dyspepsia

The antidyspeptic property of mineral waters has for many years been based on empirical data. In the present paper we evaluated the effects of one type of mineral water, Tettuccio water from Montecatini, on gastric emptying in patients with idiopathic dyspepsia. Fourteen subjects, eight patients with idiopathic dyspepsia and delayed gastric emptying at scintigraphy and six healthy subjects with normal gastric emptying were studied. The gastric emptying of mineral water was studied with a scintigraphic method and compared with that of tap water. In patients with idiopathic dyspepsia, gastric emptying of both waters was slower than in controls but the gastric emptying of mineral water was significantly faster than that of tap water, both in dyspeptic patients and in healthy subjects. In conclusion, this mineral water stimulates gastric emptying. Further studies are needed on the possible role of this water in the management of chronic idiopathic dyspepsia.