浅析2009年全军碘酊含量测定

碘酊是部队医院常配制的消毒防腐药,主要用于皮肤感染和消毒.但如果碘的含量过低则达不到消毒作用,若碘化钾含量过高则对肌肉组织有较强的刺激性.笔者所在北京军区药品仪器检验所2009年对全军医院配制的66批碘酊进行了统一检验,现将结果报告如下.     

医疗机构制剂配制管理水平和质量标准亟待提高

国家药品监督管理局下发的<医疗机构制剂配制质量管理规范>(以下简称<规范>),已于2001年3月13日实行.2002年,我所对已取得医疗机构制剂配制许可证的8家省级医疗机构的43个品种、89批自制普通制剂进行了抽查检验,其中不合格的5批,不合格率为 5.6%.     

新疆医疗机构制剂配制质量管理规范检查缺陷分析及建议

目的 探讨新疆医疗机构制剂配制质量管理规范检查缺陷项目的分布特点,为加强医疗机构制剂配制质量管理提供监管思路.方法 在对新疆医疗机构制剂室地域分布和配制剂型分析的基础上,汇总分析2019年开展的医疗机构制剂配制质量管理规范现场检查的缺陷项目.结果 新疆医疗机构制剂室在人员培训、设施设备、物料管理、配制管理和质量控制管理...     

2009、2010年军队医疗机构自制碘甘油69批次质量评价

目的 对军队医疗机构自制的碘甘油质量进行评价.方法 抽取军队医疗机构自制碘甘油69批次,按标准进行检验.结果 69批次碘甘油中有3批次不合格,占总批次的4.3%,其中1批次装量不合格,2批次碘含量不合格.碘和碘化钾含量范围在95%～100%的分别为46批次和32批次.结论 大部分军队医疗机构配制的碘甘油质量可靠,但包装及标签存在一些问题,有待改进.     

医疗机构制剂质量和质量标准现状分析

2004年,在全省整顿医疗机构制剂工作中,我所对辖区内10家医疗机构的109个品种,327批自制制剂进行了质量标准复核和样品检验.发现医疗机构制剂质量及质量标准存在较多问题.     

医疗机构制剂室的设计要求及质量管理

为保证医疗机构制剂质量,首先必须设置符合制剂配制要求的场所、设备、仪器,建立健全各种软件系统,并配备从事制剂配制及质量管理、检验的专业技术人员。经省级药品监督管理部门现场检查,达到标准要求者,发给《医疗机构制剂许可证》,并取得医疗机构制剂批准文号后方可进行配制,     

再谈配制碘酊的几点体会

碘酊是医院常配制的制剂之一,配制的质量与其方法有关,我们经多年的实践,并参加医院检查工作,发现某些医院在配制碘酊时,操作方法存在问题,碘和碘化钾含量偏低,本文仅就此项的配制体会报告如下.     

浅述医疗机构制剂工作的连环管理

《医疗机构制剂配制质量管理规范》 (以下简称《规范》) ,已于 2 0 0 1年 3月 13日发布实行。从此 ,医疗机构制剂配制与检验有了基本准则。认真执行《规范》 ,做好医疗机构制剂工作的连环 (即一环扣一环 )管理 ,确保医疗机构制剂质量 ,保证患者使用医疗机构制剂安全有效 ,是每位制剂人员、安全监管人员的神圣职责。1　医疗机构制剂管理第一环 :写出应做的 ,让制剂行为有章可循医疗机构制剂涉及配制与检验两大部分 ,各部分又涉及方方面面 ,技术性强 ,需要一套完整的规章制度、规程、标准等供遵循。主要应有 :(1)制剂配制、检验人员《规范》与…     

浅述医疗机构制剂工作的连环管理

《医疗机构制剂配制质量管理规范》（以下简称《规范》)，已于2001年3月13日发布实行。从此，医疗机构制剂配制与检验有了基本准则。认真执行《规范》，做好医疗机构制剂工作的连环（即一环扣一环）管理，确保医疗机构制剂质量，保证患者使用医疗机构制剂安全有效，是每位制剂人员、安全监管人员的神圣职责。　　医疗机构制剂管理第一环：写出应做的，让制剂行为有章可循　　医疗机构制剂涉及配制与检验两大部分，各部分又涉及方方面面，技术性强，需要一套完整的规章制度、规程、标准等供遵循。主要应有：　　1、制剂配制、检验人员《…     

消毒液生产质量控制的研究

目的 加强医院药剂科消毒液配制的质量控制。方法 从消毒液配制、检验、配发等环节加强管理。药检室建立了成品有效氯含量测定方法。用于对每批成品的检验,同时进行稳定性考察。结果 采用置换碘量法进行成品有效氯的含量测定是可行的,通过加强质量控制,2003年6月以来,3S批成品全部符合规定,成品在贮存期内质量稳定。结论 医院药剂科加强消毒液配制的质量控制是必要的,方法是可行的。     

Stability of the constituents of Calendula,milk-thistle and passionflower tinctures by LC-DAD and LC-MS

As a part of our investigations on the stability of tinctures, we evaluated 40 and 60% v/v tinctures of Calendula flower, Milk-thistle fruit and Passionflower. These preparations are widely employed in phytotherapy, thus Calendula is used externally for anti-inflammatory properties, Milk-thistle and Passionflower are employed for hepatic injuries and in tenseness with difficulty in falling asleep, respectively. Aim of this work was to assess the chemical stability of their active or marker constituents from accelerated and long-term testing by using HPLC. For Calendula flower and Passionflower active constituents are not known, however, flavonoids seem to have a crucial importance for the activity, and thus are considered the markers of Calendula and of Passionflower. Active constituents of Milk-thistle are represented by silymarin that is a phytocomplex mainly constituted by three flavolignans: silybin, silychristin and silydianin. Our investigation showed a very low thermal stability of the constituents from accelerated and long-term testing and determined by HPLC-DAD and -MS analyses and was related both to the class of flavonoids and water content of the investigated tinctures. Thus, shelf-lives at 25 degrees C of the most stable tincture (Passionflower 60% v/v) was about 6 months and only about 3 months the stability of Milk-thistle tinctures.     

New methods for the quality control of a homeopathic matrix tincture of greater celandine

Homeopathic matrix tinctures of greater celandine (Chelidonium majus L.) were obtained using freshly collected and dried plant material (roots). The samples analyzed by GC-MS showed the presence of a combination of alkaloids including canadine, stylopine, homochelidonine, protopine, dihydronitidine, norchelerythrine, dihydroberberine, and norsanguinarine. Some of these compounds (dihydroberberine, norchelerythrine, and norsanguinarine) were present only in the tinctures prepared from dried material and not detected in the preparations obtained using freshly collected raw material. New methods for the quality control of homeopathic matrix tinctures of celandine root have been developed using qualitative chemical reactions and TLC on Sorbfil plates eluted in an ethyl acetate-ethanol-0.1 M sodium hydroxide (6: 3: 2) solution with reference to the standard solutions of sanguirythrine (sanguinarine + chelerythrine) and berberine in ethanol. The spots (adsorption bands) on the TLC plates are detected using a modified Dragendorff’s reagent. Alkaloids are extracted from tinctures with chloroform. Quantitative estimation of the total alkaloid content (recalculated for sanguirythrine) was carried out by UV spectrophotometry at 278 nm. The total alkaloid content in homeopathic matrix tinctures obtained from freshly collected raw material varies within 0.015–0.032%, and in that from dried material, within 0.028–0.081%. __________ Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 39, No. 11, pp. 40–45, November, 2005.     

Evaluation of the content and stability of the constituents of mother tinctures and tinctures: the case of Crataegus oxyacantha L. and Hieracium pilosella L

As a part of our investigations on the content and stability of herbal drug preparations, we evaluated the content and stability of tinctures and mother tinctures of Hawthorn leaves and flowers and Hawkweed. Hawthorn preparations are mainly used by patients with cardiac diseases; Hawkweed is employed for the treatment of cellulitis and obesity due to its diuretic properties. Both tinctures (DER 1:5) and mother tinctures (DER 1:10) are herbal preparations reported in the European Pharmacopoeia. The first preparation is obtained using dried herbal drugs; the latter is a homoeopathic preparation obtained with fresh plant material, often used in substitution of tinctures. The aim of this work was to assess the qualitative and quantitative profile of the constituents of the investigated preparations and the chemical stability of their marker constituents from long-term testing using HPLC assays. Characteristic constituents of Hawthorn leaves and flowers are flavonoids such as vitexin-2'-O-rhamnoside and hyperoside and oligomeric procyanidins. Characteristic constituents of Hawkweed are caffeoyl-quinic acid derivatives, flavonoids and a coumarin:umbelliferone. Our investigation showed that Hawthorn mother tincture had a higher concentration of procyanidins with respect to the tincture but the stability of these constituents were very low in both preparations. Total flavonoidic content was 3.33 mg/ml, about 1.5 times more than the content of mother tincture and the shelf-life t(90) was about 7 months for both preparations. For Hawkweed preparations a content of caffeoyl-quinic acid derivatives (ca. 4 mg/ml) was found, but their stability was good only in the tincture. The concentrations of flavonoids and umbelliferone were two times as much in the tincture with respect to the mother tincture. Stability of these two classes of constituents was good for both preparations over a 9-month period.     

Analysis and stability of the constituents of Curcuma longa and Harpagophytum procumbens tinctures by HPLC-DAD and HPLC-ESI-MS

In the present study two methods based on liquid chromatography with diode array detection (HPLC-DAD) coupled to an electrospray ionisation (ESI-MS) interface were developed for the determination of constituents in the tinctures (60%, v/v, DER 1:5) of turmeric (Curcuma longa L.) and Devil's claw (Harpagophytum procumbens L.). The developed simple and effective assays permitted the quality control of both tinctures. The aim of this work was to assess the qualitative and quantitative profile of the constituents of two widely marketed commercial preparations and to evaluate chemical stability of their marker constituents during accelerated thermal stability test by HPLC analysis. Characteristic constituents of C. longa rhizomes are the curcuminoids, whereas characteristic constituents of H. procumbens are acylated iridoid glycosides and phenylethylalcohols. Constituents of Devil's claw tincture (mainly iridoids) were more stable than curcuminoids of turmeric.     

医疗器械国家监督检验工作引发的思考

目的为医疗器械科学监管决策提供参考。方法对2009年医疗器械国家监督检验工作中遇到的样品、检验方法、检验依据的标准等问题进行分析讨论。结果与结论提出对国家抽验工作管理和注册产品标准管理的几点建议。     

Quality criteria of homoeopathic mother tinctures: considerations regarding suitable tests for homoeopathic monographs

Quantitative determination of markers may improve quality control of herbal homoeopathic mother tinctures. Since the activity of homoeopathic medicinal products does not depend on the specific content of such markers, appropriate substances can be selected according to analytical aspects only. We tested carbohydrates, amino acids, total polyphenols and flavonols in different mother tinctures. The results obtained with the latter two groups of substances imply that corresponding tests might be useful for inclusion into pharmacopoeial monographs.     

壬基酚聚氧乙烯醚络合碘消毒液的研制及其效果和安全性评价

目的:研制开发一种适用于皮肤及创面外用的聚醇醚碘消毒液,并评价其效果及安全性。方法:拟定处方与工艺,制备消毒液并考察样品质量,采用加速法测定样品置于37℃温箱中0、90 d的有效碘含量,考察其稳定性;悬液定量杀菌试验计算样品作用0.5、1.5、3.0 min对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌的杀灭对数值,考察其杀菌效果;计算样品作用1.0min对人皮肤上自然菌的杀灭对数值,考察其皮肤消毒效果;急性经口毒性实验考察样品对小鼠的毒性;考察样品对家兔的皮肤刺激性;微核实验考察样品对小鼠的消毒效果。结果:样品的各项质量检查均符合规定;0 d和90 d有效碘的平均含量分别为5 276mg/L和5 140 mg/L,其有效碘下降率为2.58%,暂定该产品有效期为2年;含有效碘2 110 mg/L的消毒液作用0.5 min对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌的杀灭对数值各次均>5.00,对白色念珠菌的杀灭对数值各次均>4.00;对人皮肤上自然菌的平均最低杀灭对数值为1.21(>1.00);对小鼠急性经口无毒,对家兔无刺激性;微核实验结果呈阴性。结论:该制剂处方合理,制备工艺简单可行,质量可控,杀菌效果好,无毒,无刺激性,安全性较好。     

Antidepressant activity of some phytopharmaceuticals and phenylpropanoids

The antidepressant activity of some phytopreparations and phenylpropanoids was studied in white rats, which were subjected to the desperation test and neuropharmacological tests based on the antagonist activity with respect to reserpine, clofelin, and L-DOPA. The most pronounced effect was exhibited by the extract of Eleutherococcus senticosus, which produced a 56.4% decrease in the immobilization period in rats that was comparable with, albeit somewhat lower than the effect of amitriptyline (73.5%). The antidepressant effects of other phytopreparations decreased in the following order: Rhodiola rosea (53.8%), Echinacea purpurea (49%), and Schizandra chinensis (29.8%). Among phenylpropanoids, the maximum antidepressant effects were produced by syringin and rosavin (49.7% and 29.5%, respectively). The most pronounced antagonism with respect to reserpine was also observed for syringin. The tinctures of Echinacea purpurea and Schizandra chinensis, as well as phenylpropanoid triandrin produced the maximum antidepressant effect in the clofelin-induced depression test. An increase in the stimulating action of L-DOPA was observed upon the administration of rosavin and the tinctures of Schizandra chinensis and Echinacea purpurea. __________ Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 40, No. 11, pp. 33–38, November, 2006.     

Antioxidative, antiproliferative and biochemical effects in HepG2 cells of a homeopathic remedy and its constituent plant tinctures tested separately or in combination

Hepeel is a homeopathic remedy commonly used to treat primary and secondary functional disorders of the liver. It consists of highly diluted extracts from the following plants: Chelidonium from Chelidonium majus, L., Carduus marianus from Silybum marianum, L., Veratrum from Veratrum album L., Colocynthis from Citrullus colocynthis L., Lycopodium from Lycopodium clavatum L., Nux moschata from Myristica fragans, Houtt, and China from Cinchona pubescens, Vahl. The antioxidative, antiproliferative and biochemical effects in HepG2 hepatoblastoma cells of serial dilutions of these plant tinctures were tested, either separately or in various combinations. Upon damage of the cells with tert-butyl hydroperoxide, Carduus marianus, China and Nux moschata, in decreasing order, showed the strongest antioxidative effects. Greater than 95% inhibition of total production of malondialdehyde was reached with these three tinctures at dilutions of D4. The complete combination of the tinctures (COMB) realised in the homeopathic remedy showed an effect corresponding to the combined effects of the individual tinctures. The antiproliferative influence on the incorporation of 3H-thymidine into DNA in normal HepG2 cells was significant (p < 0.01) but relatively weak, and decreased in the order Carduus marianus, Chelidonium, Colocynthis and Veratrum. At a dilution of D4 Colocynthis showed the strongest inhibition (13.5%). The effect of the combination of Colocynthis and Veratrum was markedly higher (22.3%) than that of the individual tinctures, but was not additive. With this combination, cell numbers were reduced. COMB had similar effects on proliferation and cell numbers, with the antiproliferative effect starting at a dilution of 1:40. The conjugation of 3,4-dichloronitrobenzene with glutathione was induced only by Carduus marianus and COMB, while all other tinctures were ineffective. Neither the individual tinctures, nor COMB showed cytotoxic effects in the dilutions tested. These results demonstrate that the complete combination (COMB) realised in the homeopathic remedy and its constituents exert specific antioxidative, antiproliferative and biochemical effects on HepG2 cells which all point to a potential hepatoprotective and tumouristatic action.