不同厂家盐酸克林霉素胶囊溶出度的比较

目的：考察在不同PH值溶出介质中.不同厂家盐酸克林霉素胶囊的体外溶出情况.方法：采用桨法,转速50转/分钟.不同PH值的溶出介质900ml.测定溶出度,绘制溶出曲线.结果：显示在PH1.2.PH4.0.PH6.8.水的溶出介质中.各厂家的胶囊溶出曲线有较大差异.结论：盐酸克林霉素胶囊的内在质量需进一步提高.     

Formulation and in vivo evaluation of membrane-moderated transdermal therapeutic systems of nicardipine hydrochloride using carvone as a penetration enhancer

A membrane-moderated transdermal therapeutic system (TTS) of nicardipine hydrochloride was developed using 2%w/w hydroxy propyl cellulose (HPC) gel as a reservoir system containing 8%w/w of carvone as a penetration enhancer. The permeability flux of nicardipine hydrochloride through ethylene vinyl acetate (EVA) copolymer membrane was found to increase with an increase in vinyl acetate content in the copolymer. The effect of various pressure-sensitive adhesives (MA-31, MA-38, or TACKWHITE A 4MED) on the permeability of nicardipine hydrochloride through EVA 2825 membrane (28%w/w vinyl acetate) or EVA 2825 membrane/skin composite also was studied. The results showed that nicardipine hydrochloride permeability through EVA 2825 membrane coated with TACKWHITE A 4MED/skin composite was higher than that coated with MA-31 or MA-38. Thus, a new TTS for nicardipine hydrochloride was formulated using EVA 2825 membrane coated with a pressure-sensitive adhesive TACKWHITE A 4MED and 2%w/w HPC gel as reservoir containing 8%w/w of carvone as a penetration enhancer. The bioavailability studies in healthy human volunteers indicated that the TTS of nicardipine hydrochloride, designed in the present study, provided steady-state plasma concentration of the drug with minimal fluctuations for 23 hr with improved bioavailability in comparison with the immediate-release capsule dosage form.     

Ion-activated in situ gelling systems for sustained ophthalmic delivery of ciprofloxacin hydrochloride

The poor bioavailability and therapeutic response exhibited by the conventional ophthalmic solutions due to precorneal elimination of the drug may be overcome by the use of in situ gel forming systems that are instilled as drops into the eye and undergo a sol-gel transition in the cul-de-sac. Our present work describes the formulation and evaluation of an ophthalmic delivery system of an antibacterial agent, CPH, based on the concept of ion-activated in situ gelation. Gelrite gellan gum, a novel ophthalmic vehicle that gels in the presence of mono or divalent cations, present in the lacrimal fluid was used alone and in combinations with sodium alginate as the gelling agent. The developed formulations were therapeutically efficacious and provided sustained release of the drug over an 8-hr period in vitro.     

注射用盐酸大观霉素细菌内毒素检查法标准修订

目的修订注射用盐酸大观霉素细菌内毒素检查法质量标准。方法按《中国药典》2005年版二部,修改本品细菌内毒素限值,并研究注射用盐酸大观霉素对细菌内毒素检查试验的干扰情况。结果3.333mg.mL^-1的供试品稀释液对试验无干扰作用。结论本品可采用细菌内毒素检查法,并修订了本品细菌内毒素检查法质量标准。     

不同pH值丁卡因咽喉部表面麻醉药代动力学实验研究

本文研究了不同ｐＨ值丁卡因溶液咽喉部给药后药代动力学。１２只家兔随机分为ｐＨ７．４组或４．７组，咽喉部粘膜表面分别喷雾ｐＨ７．４或４．７丁卡因溶液，５ｍｇ／ｋｇ．高效液相色谱法测定丁卡因血药浓度。ｐＨ７．４与４．７丁卡因溶液药代动力学参数分别为３．１８±３．０４和１．２９±０．７４ｍｉｎ；Ｃｍａｘ分别为３１８．２９±１７５．５９和８７８．８１±３４７．２９ｎｇ／ｍｌ；Ｔｐｅａｋ分别为２．５２±１．１２和１．７９±０．４０ｍｉｎ：Ｖｄ分别为１３．６０±７．４０和４．３０±２．００ｍｌ／ｋｇ；Ｃｌｓ分别为３０２．５６６±１６４．２５和１５３．８７±８４．２２ｎｇ．ｍｌ－１／ｍｉｎ，组间均有显著差异（Ｐ＜０．０５或＜０．０１）。小鼠肠肌组织中ｐＨ值７．４和４．７丁卡因含量分别为６．３７±３．２和１．３８±１．２０ｍｇ／ｇ（Ｐ＜０．０１）。结果表明ｐＨ值７．４丁卡因溶液分布到血液中速度慢，血药浓度低，组织浓度高，代谢快，不易发生中毒。     

盐酸多柔比星脂质体注射液与葡萄糖和氯化钠注射液的配伍稳定性研究

目的 研究盐酸多柔比星脂质体注射液与5%葡萄糖注射液和0.9%氯化钠注射液的配伍稳定性。方法 盐酸多柔比星脂质体注射液分别与5%葡萄糖注射液和0.9%氯化钠注射液配伍后,考察配伍溶液的外观、pH值、脂质体的粒径、含量和包封率,采用HPLC测定含量,色谱柱为LichrospherC18柱（250mm×4.6mm,5μm）,以含0.01mol·L1十二烷基硫酸钠的0.02mol·L1磷酸溶液-乙腈-甲醇（500∶500∶60）为流动相,流速1.0mL·min1,柱温30℃,检测波长254nm,进样量20μL;离子树脂交换法测定包封率。结果 盐酸多柔比星脂质体注射液与0.9%氯化钠注射液配伍后,6h内溶液的外观、pH值、脂质体的粒径和含量均无变化,包封率下降约5%;与5%葡萄糖注射液配伍后,6h内溶液外观、pH值、脂质体的粒径、含量和包封率均无变化。结论 临床中盐酸多柔比星脂质体注射液不宜与0.9%氯化钠注射液配伍,宜与5%葡萄糖注射液配伍。     

HPLC法同时测定林可霉素利多卡因凝胶中林可霉素和盐酸利多卡因的含量

目的:完善该药品中林可霉素的测定方法,建立盐酸利多卡因的含量测定方法.方法:用ODS柱,以O.05mol/L的硼砂溶液(用85%磷酸调节pH5.0)-甲醇-乙腈(60:35:5)为流动相,流速O.7ml/min,检测波长214nm.结果:林可霉素浓度在0.14～0.28mg/ml,利多卡因浓度在0.10～0.20mg/ml之间,峰面积与进样浓度呈良好的线性关系(r=0.9999和r=0.9998),重现性RSD分别为0.23%和0.25%.结论:该方法能快速简便地同时测定两组分的含量,结果准确可靠.     

胶态二氧化硅对盐酸莫西沙星片的影响

目的 考察胶态二氧化硅对盐酸莫西沙星片的影响。方法 通过改变胶态二氧化硅的用量、改变胶态二氧化硅的过筛目数、改变胶态二氧化硅的混合时间,制备不同盐酸莫西沙星片。通过对比总混颗粒的粉体性质、片剂的溶出。综合评价胶态二氧化硅对盐酸莫西沙星片影响。结果 胶态二氧化硅的用量、胶态二氧化硅的过筛目数、胶态二氧化硅的混合时间均会对盐酸莫西沙星片质量造成影响。结论 提高胶态二氧化硅的用量,减小筛网的孔径,增加混合的时间,均会提高总混颗粒的流动性及可压性,提高片剂硬度,减小片剂的脆碎度,并能加快片剂的崩解,提高溶出速率。     

HPLC法测定盐酸丁丙诺啡注射液中5-羟甲基糠醛

目的：建立高效液相色谱法检查盐酸丁丙诺啡注射液中5-羟甲基糠醛。方法：采用Diamonsil C18（4.6mm×250mm,5μ）,甲醇-乙腈-2%醋酸铵溶液-冰醋酸（60：10：40：5）为流动相,流速为1.0ml/min,检测波长为284nm,柱温为30℃。结果：5-羟甲基糠醛色谱峰与主峰能够达到有效分离,检测限为0.752ng/ml,定量限为4.512ng/ml,平均回收率为99.9%（RSD=1.2%）。结论：本法简便,灵敏、准确、专属性强,可用于盐酸丁丙诺啡注射液中5-羟甲基糠醛的检查。     

奥洛他定滴眼液治疗变态反应性结膜炎的临床观察

目的观察奥洛他定滴眼液在变态反应性结膜炎中的临床疗效。方法入选变态反应性结膜炎患者56例（88眼）,给予患者0．196盐酸奥洛他定滴眼液,每眼1滴,早晚各1次,共7d。观察治疗前后变态反应性结膜炎各项症状与体征的变化情况。结果奥洛他定滴眼液治疗变态反应性结膜炎的总有效率为94．696．变态反应性结膜炎的各项症状和体征均得到显著的改善。治疗期间未观察到明显的不良反应。结论奥洛他定滴眼液治疗变态反应性结膜炎具有较好的疗效和安全性。