胰腺康口服液质量标准的研究

目的:建立胰腺康口服液的质量标准。方法:采用薄层色谱法对本口服液中黄芪的有效成份进行定性鉴别;建立薄层扫描法对黄芪中的黄芪甲苷进行定量测定。结果:薄层色谱法中明显地检出黄芪甲苷的斑点;黄芪甲苷在0.998~2.994μg范围内线性关系良好,r=0.9990,平均回收率99.22%,RSD=1.35%。结论:所建立的方法简便、专属性强,可有效地控制胰腺康口服液的质量。     

百年康口服液的稳定性研究

百年康口服液是由黄芪、酸枣仁、桑椹、甘草、枸杞子、炒麦芽、陈皮、大枣、牛蛙酶解液组成。主要用于年老体弱 ,食欲不振 ,营养不良 ,失眠多梦者 ;脑外伤 ,儿童弱智与智力低下者 ;产后、术后及癌症患者身体虚弱者。百年康口服液处方中黄芪、甘草及陈皮均含有皂苷 ,参照文献 [1 ]根据皂苷与香草醛 -硫酸的显色反应 ,以黄芪中黄芪甲苷为测定指标 ,采用恒温加速法考察百年康口服液中总皂苷的稳定性 ,并推测其有效期 ,为贮存和使用该药提供了参考依据。1　仪器、试药1.1　仪器 :75 2 C紫外分光光度计 (上海第三分析仪器厂 )1.2　试剂 :正丁醇…     

红花口服液的稳定性研究

目的：考察红花口服液的稳定性。方法：利用加速试验、长期试验对红花口服液的稳定性进行考察,采用高效液相色谱法测定红花口服液中羟基红花黄色素A的含量,色谱条件：Hypersil ODS C18（250mm×4.6mm,5μm）色谱柱,流动相∶甲醇∶乙腈∶0.02%磷酸水溶液（14∶2∶84）;流速：1.0mL·min-1;柱温：25℃,检测波长：402nm。结果：加速试验、长期试验稳定性良好,产品外观、pH值、吸收度及有效成分含量等项目没有显著变化,结果均符合要求。结论：红花口服液在室温条件下贮存,24个月内各项指标可符合质量标准要求。     

布洛芬口服液的稳定性研究

目的：通过考察布洛芬口服液的稳定性,确定其有效期。方法：在不同温度、湿度和时间下,取样检测其性状、pH值、含量的变化。结论：通过检测结果确定布洛芬口服液在不同温度、湿度条件下贮存的有效期。     

十味骨康口服液的稳定性研究

目的考察十味骨康口服液的稳定性和有效期。方法进行影响因素试验、加速试验和长期试验,考察项目有性状、鉴别、装量、相对密度、PH值和微生物限度检查。结果影响因素试验、加速试验和长期试验的各考察项目均符合规定（性状：本品为棕褐色液体;气微,味甜、微苦;放置后有少量沉淀。鉴别：供试品色谱中,在与对照药材淫羊藿、白芍、补骨脂色谱相应的位置上,显相同颜色的斑点,阴性对照无干扰。装量：均不小于10．0ml／支。相对密度：均不低于1．02。PH值：PH为3.5—5．5。微生物限度：细菌数〈10个／ml,霉菌和酵母菌数〈10个／ml,没有检出大肠埃希菌和活螨）。结论十味骨康口服液稳定性良好,有效期为两年。     

微生态调节剂—953口服液的稳定性研究

根据化学动力学原理，采用恒温加速试验法，对953口服液稳定性进行了研究．以齐墩果酸成分为指标，测定其含量，预测该制剂的t0.9为14个月，半衰期t1/2=92.4个月．     

盐酸美沙酮口服液的稳定性研究

目的对盐酸美沙酮口服液进行稳定性研究。方法采用紫外分光光度法测定其含量,采用薄膜过滤法对其进行微生物限度检查。结果盐酸美沙酮口服液的性状、鉴别、pH值、微生物限度均未发生明显改变,含量呈下降趋势。结论通过加速试验表明,盐酸美沙酮口服液的物理稳定性较好,含量受温度、湿度影响较大。     

正交试验法优选咽康口服液工艺

用正交试验法，以总黄酮含量为指标，对咽康口服液的提取工艺进行优选。实验结果表明：加水量、煎煮时间、醇沉浓度三因素中加水量对该制剂总黄酮含量具有显著性影响，其最佳工艺条件：加水量为药材量的10倍，煎煮时间为30min，醇沉浓度为50％。     

健脑安神口服液的制备及稳定性试验

介绍健脑安神口服液的制备、稳定性试验。该品由氨基酸、枸杞、酸枣仁、五味子、远志制成。以含氮测定法测定留样观察和热加速试验样品中氨基酸的含量。结果表明该品使用期可暂订为22个月。     

归芪养血口服液的工艺优化及稳定性研究

目的 采用正交试验法设计对归芪养血口服液的制备工艺进行优化,以阿魏酸含量为考察指标,筛选出最佳的制备工艺,并通过评估优化工艺下阿魏酸含量的稳定性,以期为归芪养血口服液高效、高质生产提供理论指导及参考借鉴.方法 本研究根据实践经验,通过正交试验,选用L9(34)正交试验表,考察加水量(A)、乙醇沉淀浓度(B)、pH(C)...     

昂立舒渴口服液的加速稳定性试验

目的　考察昂立舒渴口服液的稳定性 ,推测其在室温下的有效期。方法　采用经典恒温法 ,昂立舒渴口服液中总黄铜含量随时间变化属 1级降解反应 ,计算出室温反应速度常数 k=4.361× 1 0 -6/h。结果　用经典恒温法推算在室温下的有效期为 2 .75年。结论　昂立舒渴口服液在室温下是稳定的     

Stability of oral liquid preparations of methylergometrine

The stability of an oral ready to-use form of methylergometrine (0.05 mg/mL), which provides a convenient volume for administration (5 mL), was evaluated over a forty-seven-day period at different temperatures (5 degrees C and room temperature) without light in order to assign a shelf life. Methylergometrine was assayed by a stability-indicating HPLC method with diode array detection. The drug undergoes degradation under basic conditions and dry heat (50 degrees C). All the peaks of the degraded product were resolved from the standard drug with significantly different retention times. Statistical analysis proves that the method is reproducible and accurate for estimation of the intact drug. The pH of samples was monitored periodically for changes. Samples were also visually inspected for any colour change, precipitation or crystallization. At least, 96% of the initial methylergometrine concentration remained throughout the 47-day study period. Over the test period, no significant change was observed in the pH or colour of any of the samples. No degradation products were revealed. This study allowed an oral ready to use solution of methylergometrine (0.05 mg/ml) to be prepared, with a shelf life of more than one month (47 days) when stored at room temperature without light.     

Stability of nizatidine in extemporaneous oral liquid preparations

The stability of nizatidine in extemporaneous oral liquid preparations stored at room and refrigerated temperatures was studied. Preparations containing nizatidine in a final concentration of approximately 2.5 mg/mL were made by mixing the contents of a 300-mg nizatidine capsule with commercial juices (Gatorade, Stokely-Van Camp; Cran-Grape, Ocean Spray; apple juice, Sundor Brands; and V8 vegetable juice, Campbell Soup) and with aluminum hydroxide-magnesium hydroxide suspension (Maalox, Rorer). A control solution was prepared in water. Samples of each preparation were stored at 15-30 degrees C and at 5 degrees C. Initially and after 4, 8, 24, and 48 hours of storage, the samples were visually inspected, tested for pH, and analyzed in triplicate by high-performance liquid chromatography for nizatidine content. No appreciable changes in appearance or pH occurred. The only extemporaneous preparations with greater than 10% loss of nizatidine potency at 48 hours were the Cran-Grape and V8 preparations at room temperature. There was no correlation between pH of the preparations and changes in drug concentration. In the Maalox and V8 preparations, the drug powder did not dissolve uniformly. In all the preparations tested, nizatidine was stable for at least eight hours at refrigerated and room temperatures. In all except the Cran-Grape and V8 preparations, the drug was stable for 48 hours under both storage conditions.     

Stability of dolasetron in two oral liquid vehicles.

The stability of dolasetron 10 mg/mL over 90 days when prepared as an oral liquid formulation from commercially available tablets in both strawberry syrup and a sugar-free vehicle was studied. A liquid suspension of dolasetron mesylate 10 mg/mL was prepared from commercially available dolasetron tablets, OraPlus, and Ora-Sweet or strawberry syrup. Six samples of each formulation were prepared and stored in amber plastic bottles. Three samples of each formulation were refrigerated (3-5 degrees C) and three were stored at room temperature (23-25 degrees C). A 1-mL sample was withdrawn from each of the 12 bottles immediately and after 7, 14, 30, 60, and 90 days. After further dilution to an expected concentration of 10 micrograms/mL with sample diluent, the solutions were assayed in duplicate using high-performance liquid chromatography. The samples were also inspected for color and odor changes, and the pH of each sample was determined. The stability-indicating capability of the dolasetron assay was determined by forced degradation of four separate 10-mg/mL samples exposed to direct sunlight for 90 days. There were no detectable changes in color, odor, or taste and no visible microbial growth in any sample. At least 98% of the initial dolasetron concentration remained throughout the 90-day study period for all samples. An extemporaneously compounded oral liquid preparation of dolasetron mesylate 10 mg/mL in a 1:1 mixture of Ora-Plus and strawberry syrup or Ora-Sweet was stable for at least 90 days when stored at 3-5 or 23-25 degrees C.     

Stability of tiagabine in two oral liquid vehicles.

The stability of tiagabine hydrochloride in two extemporaneously prepared oral suspensions stored at 4 and 25 degrees C for three months was studied. Tiagabine is used for adjunctive therapy for the treatment of refractory partial seizures. It is currently available in a tablet dosage form, which cannot be used in young children who are unable to swallow and given doses in milligrams per kilogram of body weight. No stability data are available for tiagabine in any liquid dosage form. Five bottles contained tiagabine 1 mg/mL in 1% methylcellulose:Simple Syrup, NF (1:6), and another five bottles had tiagabine 1 mg/mL in Ora-Plus:Ora-Sweet (1:1). Three samples were collected from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days and analyzed by a stability-indicating high-performance liquid chromatographic method (n = 15). At 4 degrees C, the mean concentration of tiagabine exceeded 95% of the original concentration for 91 days in both formulations. At 25 degrees C, the mean concentration of tiagabine exceeded 90% of the original concentration for 70 days in Ora-Plus:Ora-Sweet formulation and for 42 days in 1% methylcellulose:syrup formulation. No changes in pH or physical appearance were seen during this period. The stability data for two formulations would provide flexibility for compounding tiagabine. Tiagabine hydrochloride 1 mg/,mL in extemporaneously prepared liquid dosage forms and stored in plastic bottles remained stable for up to three months at 4 degrees C and six weeks at 25 degrees C.     

乳康口服液的长期毒性试验研究

目的观察乳康口服液对大鼠长期给药所产生的毒性反应,为临床安全用药提供科学依据。方法将SD大鼠随机分为乳康口服液高剂量组(90mg.kg-1)、中剂量组(36mg.kg-1)、低剂量组(9mg.kg-1)和对照组,连续灌胃给药6个月,停药2周,进行恢复期观察。测定血液生化指标、脏器系数、解剖学及病理组织学改变。结果口服高、中、低剂量乳康口服液6个月后大鼠的体质量、脏器系数、血常规、血液生化指标、解剖学和病理组织学检查均正常,与对照组比较无明显差异。结论乳康口服液在临床剂量服用是安全的,无明显毒性反应。     

乳康口服液的急性毒性试验研究

目的观察乳康口服液的急性毒性,为临床安全用药提供科学依据。方法应用乳康口服液进行小鼠灌胃和腹腔注射急性毒性试验。结果小鼠灌胃乳康口服液最大耐受量（MTD）〉40mg.kg-1,日MTD〉120mg.kg-1,相当于人体用药日剂量的200倍;小鼠腹腔注射MTD〉25mg.kg-1,日MTD〉75mg.kg-1,相当于人体用药日剂量的125倍。结论乳康口服液用药安全范围较宽,无毒性作用。