An HPTLC method for the determination and the purity control of ciprofloxacin HCl in coated tablets

A high-performance thin-layer chromatographic method (HPTLC) has been developed for the determination and the purity control of a synthetic fluoroquinolone antibiotic ciprofloxacin hydrochloride in coated tablets when desfluoro compound, ethylene diamine compound, by-compound A and fluoroquinolonic acid are considered as impurities. Silica gel F₂₅₄ was used as a stationary phase and a mixture of acetonitrile, ammonia 25%, methanol and methylene chloride (1:2:4:4, v/v/v/v) as a mobile phase. The method was validated in terms of linearity (range), selectivity (placebo and related compounds), precision, accuracy (Recovery), system suitability (repeatability, peak symmetry, resolution) and impurities limit of detection (LOD). The analysis of variance (ANOVA) and t-test were applied to correlate the results of ciprofloxacin hydrochloride determination in coated tablets by means of the HPTLC method and the official British Pharmacopoeia (BP 1999) high-performance liquid chromatographic (HPLC) method.     

Heilungsprozess des Knorpels in Verbindung mit PDS-Folie

Background and objective. To correct severe septal deformities, it is often necessary to perform an extracorporal septoplasty with temporary removal of the deviated septal cartilage, followed by straightening and reimplantation into the nose as free graft. The utilization of a compound graft, which sutures the cartilage fragments to a resorbable polydioxanon (PDS) foil, facilitates this technique immediately while simultaneously ensuring support of the nasal dorsum. Patients/Methods. On account of the good clinical experiences (during the past 3 years 71 patients have been treated using this method), we investigated the biological properties of the foil and its degradation products in connection with cartilage in an animal model from a histological point of view. In five rabbits, a 0.15-mm-thick PDS foil was implanted in combination with the cartilage into the outer ear. The follow-up period was between 2 and 25 weeks. Results. The results showed the following: (1) Up to the tenth week, the foil maintains the original structure; (2) The foil will be completely resorbed after 25 weeks; (3) The cartilage underneath the foil is protected from necrosis; (4) The degradation products of the polydioxanon do not interfere with the healing process; (5) Concerning the regeneration of cartilage, the foil acts as a guarding splint; (6) After resorption, almost no scar tissue remains. Conclusions. Due to the fact that the PDS foil endonasal implant means no additional risk to the patient, we can recommend the compound graft for simplification of extracorporal septoplasty.     

薄膜包衣对头孢氨苄胃内漂浮片的影响

目的：考察薄膜包衣对头孢氨苄胃内漂浮片释药特性和起漂性能的影响。方法：采用3种不同型号欧巴代（Opadry、Omdry Ⅱ和OpadryAMB）膜材和3种渗透性的丙烯酸树脂[Eudragit RL 30D、RS 30D和RL 30D／RS 30D（1：1）]对头孢氨苄胃内漂浮片包衣，分别以Oparary和Eudragit RL 30D／RS 30D（1：1）对4，6，9，12kg硬度的片剂包衣，增重1％-3％，考察上述包衣条件对头孢氨苄胃内漂浮片释放特性和起漂性能的影响。结果：3种不同型号欧巴代包衣、不同包衣增重及4种硬度片芯包衣的片剂与未包衣片相比，释放特性无明显变化，起漂时间均大于15min，比未包衣前显著延长；6—9kg硬度片芯以渗透性适宜的Eudragit RL 30D／RS 30D（1：1）包衣，增重1％-2％均能保证15min内起漂，释药特性与未包衣前无明显变化。结论：对水具有渗透性、能束缚二氧化碳气体并具有一定抗张强度的衣材是胃内漂浮片优选的包衣材料.     

黄芪、黄连复方有效成分对二亚硝基哌嗪诱导气虚状态大鼠鼻咽上皮组织癌前病变的影响

目的观察二亚硝基哌嗪在正常状态和气虚状态大鼠鼻咽上皮细胞的诱癌效率差异以及黄芪、黄连复方有效成分的防护作用。方法SD大鼠每日力竭游泳10min,连续30d以建立气虚状态模型,然后分组,每组动物10只。DNP皮下注射法诱癌,并应用黄芪、黄连复方有效成分进行干预。干预完成后200天,分别取各组动物鼻咽黏膜行常规病理组织学和超微病理观察。结果力竭游泳联合DNP诱癌组动物中,鼻咽黏膜上皮细胞出现癌前病变例数（n1=8）显著多于单纯DNP诱癌组（n2=3,P〈0.05）,而应用益气解毒中药干预后,该类动物鼻咽黏膜上皮细胞癌前病变例数显著降低（n3=3,P〈0.05）。结论气虚状态下,实验动物鼻咽黏膜上皮细胞对DNP诱癌效应更加敏感,而黄芪、黄连复方活性成分能够有效阻逆该类病理过程。     

白芍总苷微孔渗透泵片中芍药苷的含量测定

目的建立用RP-HPLC法测定白芍总苷微孔渗透泵控释片中芍药苷含量的方法。方法采用Diamonsil C_(18)色谱柱(5μm,250mm×4.6mm),以甲醇-水-磷酸(体积比33:67:0.2)为流动相,检测波长230nm。结果芍药苷质量浓度在20～100μg/ mL范围内线性关系良好(r=0.9995),平均加样回收率100.6%(n=6)。结论本法准确、简便、专属性强,可用于白芍总苷微孔渗透泵控释片的质量控制。     

正交试验优选复方苦黄乳膏乳化工艺

目的:优选复方苦黄乳膏的乳化工艺。方法:采用正交试验法,以所制乳膏离心分层后油层的高度为考察指标,对影响乳膏稳定性的主要因素进行优选。结果:最佳工艺为油相硬酯酸∶单硬酯酸甘油酯∶羊毛脂∶液体石蜡∶白凡士林=4∶1∶2∶2∶1,乳化剂用量为4%,亲水疏水平衡值为13,乳化温度为80℃。结论:优选得到的工艺稳定可行,可为工业化生产提供理论依据。     

高效液相色谱法测定复方红景天口服液中红景天苷含量

目的测定复方红景天口服液中红景天苷的含量。方法采用高效液相色谱法，色谱柱为Agilent HC—C18柱，流动相为乙腈-水（8：92），检测波长为275nm，流速为1．0mL／min，柱温为20℃。结果红景天苷质量浓度在10．9～196．2μg／mL范围内与峰面积线性关系良好，r=0．9999（n=6），平均回收率为100．5％，RSD=0．01％（n=6）。结论该方法灵敏、准确、重现性好，可用于复方红景天口服液中红景天苷的含量测定。     

高效液相色谱法测定复方刺五加糖浆中紫丁香苷含量

目的建立复方刺五加糖浆的含量测定方法。方法采用高效液相色谱法测定复方刺五加糖浆中紫丁香苷的含量。以甲醇-水（8：2）为流动相，以岛津VP—ODSC18柱（5μm4．6×150mm）为固定相，检测波长为265nm。结果紫丁香苷在0．0805～1．61μg范围内有良好的线性关系，r=0．9997。平均回收率为97．4％（n=6），RSD=0．55％。结论该法操作简便准确，可作刺五加糖浆中紫丁香苷的质量控制方法。     

RP-HPLC法测定罗红霉素片中罗红霉素的含量

目的建立罗红霉素片含量测定的高效液相色谱法,并与微生物检定法、紫外分光光度法的测定结果进行比较。方法采用Agilent-C18色谱柱（4.6 mm×250 mm,5μm）;0.067 mol·L^-1磷酸二氢铵（三乙胺调节pH6.5）-乙腈（3∶2）,加入1%的三乙胺,用磷酸调节pH7.2为流动相;流速1.0 ml·min^-1;检测波长211 nm;柱温30℃。结果罗红霉素在2.14～42.80 mg·L^-1的浓度范围内有良好的线性关系（r=0.999 9）,平均回收率为97.8%,RSD为0.78%（n=5）。结论三种含量测定方法的结果相近,均可用于罗红霉素片的含量测定。     

多目标决策——理想点法对维生素C片的质量再评价

目的：建立用理想点法多目标决策理论评价制剂质量的方法。方法：用理想点法建立相应的模型，对2001～2005年间抽验的维生素C片的检验数据进行加工，计算，得出质量评价结果。结果：理想点法和模式识别法评价维生素C片的质量，结果基本一致，但理想点法评价分级更细，计算简便，易于推广。结论：用理想点法多目标决策理论评价制剂质量可行，有一定价值。