荆花胃康胶丸在成熟型疣状胃炎射频治疗术后的疗效观察

目的观察荆花胃康胶丸在成熟型疣状胃炎射频治疗术后的疗效观察。方法选取我院经胃镜检查诊断为成熟型疣状胃炎120例，随机分为A、B、C组，每组40例，内镜下射频治疗后，A组给予雷贝拉唑钠肠溶胶囊10mg，1次／d；B组给予荆花胃康胶丸160mg，3次／d；C组联合使用荆花胃康胶丸及雷贝拉唑钠肠溶胶囊，剂量同前，各组均治疗4周。对比3组腹痛程度、疼痛持续时间及创面愈合情况。结果B组与A组比较，腹痛持续时间差异无统计学意义（P〉0．05），但腹痛评分明显减低，差异有统计学意义（P〈0．05）；C组在腹痛评分及腹痛持续时间上明显优于A组和B组。从创面愈合情况看，A纽愈合率为90％，B组为80％，C纽为100％，3组间差异有统计学意义（χ^2=8．89，P〈0．05）。结论荆花胃康胶丸在治疗疣状胃炎射频治疗术后疼痛及促进创面愈合方面表现出其独特的优势，联合使用雷贝拉唑，可达很好的效果。     

Efficacy and safety of dexmethylphenidate extended-release capsules in adults with attention-deficit/hyperactivity disorder.

BACKGROUND: This multicenter, randomized, fixed-dose, double-blind, placebo-controlled study evaluated efficacy of extended-release dexmethylphenidate (d-MPH-ER) in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Randomized adults with ADHD (n=221) received once-daily d-MPH-ER 20 mg, 30 mg, or 40 mg or placebo for 5 weeks. The primary efficacy variable was change from baseline to final visit in DSM-IV ADHD Rating Scale (ADHD-RS) total score. Secondary efficacy parameters included the proportion of patients with improvement>or=30% in ADHD-RS total score and final scores on Clinical Global Impressions-Improvement (CGI-I) scale. RESULTS: Of 218 evaluable patients, 184 completed the study. All d-MPH-ER doses were significantly superior to placebo in improving ADHD-RS total scores. Placebo scores improved by 7.9; d-MPH-ER, 20 mg, improved by 13.7 (p=.006); d-MPH-ER, 30 mg, improved by 13.4 (p=.012); and d-MPH-ER, 40 mg, improved by 16.9 (p<.001). Overall distribution of CGI-I ratings at final visit was significantly better with each d-MPH-ER dosage than with placebo. There were no unexpected safety or tolerability concerns, based on experience with racemic methylphenidate (MPH) in adults and dexmethylphenidate (d-MPH) in children. CONCLUSIONS: Once-daily d-MPH-ER at 20 mg, 30 mg, or 40 mg is a safe and effective treatment for adults with ADHD.     

Application of a Biomagnetic Measurement System (BMS) to the Evaluation of Gastrointestinal Transit of Intestinal Pressure-Controlled Colon Delivery Capsules (PCDCs) in Human Subjects

Purpose. For determination of the transit time through various partsof the gastrointestinal (GI) tract, we developed a method that providesthe location of disintegration and drug release. This method involves GImagnetomarkergraphy (GIMG) using a 129-channel Shimadzu vectorbiomagnetic measurement system (BMS). Methods. To magnetically label the pressure-controlled colon deliverycapsule (PCDC) containing 75.0 ± 0.5 mg of caffeine as a tracer drug,small capsule caps containing 90 mg of ferric oxide powdered magnetite(Fe₂O₃) were attached to PCDCs. After orally administration to fastedhuman volunteers, saliva samples were collected hourly and salivarycaffeine concentration was measured. At the same time, locations ofthe magnetic PCDC were detected by BMS just after the PCDCs weremagnetized with the coils of a magnetic resonance imaging (MRI)system. The magnetic field distributions were analyzed and theestimated positions were shown on the MRI picture of the same subject'sabdominal structure. Results. We magnetized PCDC with permanent magnets or anelectromagnet before ingestion and the estimated locations of PCDC in the GItract exhibited high estimation error. In order to increase the precision ofestimated localization of PCDCs, PCDCs were magnetized within thecoils of the MRI. As a result, these PCDCs had strong magnetic dipolesthat were parallel to the sensor unit of BMS in every measurement,and therefore the spatial resolution of the PCDC's two-dimensionalpositions in the organs of the GI tract was within a range of severalmillimeters. Conclusions. GIMG is a powerful tool for the study of colon deliveryefficiencies of PCDCs. The main advantage of GIMG is the capabilityto obtain even more detailed knowledge of the behavior and fate ofsolid pharmaceutical formulations during GI passage.     

In Vitro and in Vivo Pharmacoscintigraphic Evaluation of Ibuprofen Hypromellose and Gelatin Capsules

PURPOSE: To evaluate the in vitro and in vivo characteristics of hypromellose (HPMC) capsules prepared using a gellan gum and potassium gelling system compared to conventional hard gelatin capsules. METHODS: The in vitro dissolution of ibuprofen gelatin and HPMC capsules was determined using the USP and TRIS buffers at pH 7.2. The effect of pH and composition of the media was determined using a model drug that is soluble throughout the pH range 1.2 to 7.2. In an 11 subject four-way crossover study, the gastrointestinal performance of ibuprofen gelatin and HPMC capsule formulations was evaluated using scintigraphy and pharmacokinetics following fasted and fed dosing. RESULTS: Acid conditions and the presence of K+ cations hinder HPMC capsule opening, whereas in water, dissolution is identical to that of gelatin. These effects are related to the nature of the gel network that is formed in the presence of cations. No significant difference in esophageal transit was observed. Although the in vivo opening times of HPMC capsules were longer than for their gelatin counterparts, no significant difference in the regulatory important pharmacokinetic metrics of C(max) and AUC was found between ibuprofen, gelatin and HPMC capsules. CONCLUSIONS: The in vitro performance of HPMC capsules differ from gelatin, which will require modification to dissolution testing methodology for certain drugs. However, for the class II BCS drug ibuprofen, the two capsule types were not statistically different when comparing AUC and C(max) values, which suggests that the in vitro differences have reduced in vivo relevance.     

益妇宁软胶囊对去卵巢大鼠雌激素受体及一氧化氮水平的影响

目的:观察益妇宁软胶囊(YFN)对去卵巢大鼠雌激素受体(ER)、一氧化氮(NO)和一氧化氮合酶(NOS)水平的影响。方法:50只SD雌性大鼠随机分为5组:正常对照组、模型对照组、已烯雌酚片组(DT组)、YFN大、小剂量组。给药4周后用放射免疫法测定大鼠血清雌二醇(E₂)水平,放射配体结合分析法测定子宫和主动脉ER数目,光镜下观察子宫组织病理学变化,同时测定主动脉NO,NOS水平和子宫指数。结果:YFN能明显升高大鼠去卵巢后降低的血清E₂水平、子宫指数及ER含量(P<0.05或P<0.01),改善子宫组织病理变化;提高主动脉ER 含量及NO,NOS水平(P<0.01或P<0.05)。结论:YFN可以治疗更年期综合征,同时防治心血管疾病的发生。     

HPLC法测定哮喘宁胶囊中盐酸麻黄碱的含量

目的建立哮喘宁胶囊中盐酸麻黄碱的含量测定方法.方法采用高效液相色谱法,Hypersil ODS填料色谱柱(4.6×250 mm,5μm);柱温40℃;进样量10μL;流动相:乙腈-0.05 mol/L磷酸二氢钠溶液(磷酸调节pH值至2.7)(22:78);流速:1.0 mL/min;检测波长:205 nm.结果盐酸麻黄碱在0.1005～0.5025μg范围内,进样量与峰面积积分值之间线性关系良好,r=0.9993;平均回收率为103.1%,RSD=1.81%.结论该方法简便准确,重现性好,可用于哮喘宁胶囊的质量控制.     

抗感止咳胶囊中绿原酸的HPLC法测定研究

目的:建立抗感止咳胶囊中绿原酸含量的测定方法.方法:RP-HPLC法,采用依利特ODS柱(C18,4.6×250mm,5μm),用乙腈-0.4%磷酸(9∶91)为流动相,流速为1.0mL/min,紫外检测波长为327nm.结果:在选定的实验条件下,绿原酸在0.126～0.630μg的范围内呈良好的线性关系,r＝0.9999,平均回收率98.4%,RSD=1.71%(n=6).结论:该法操作简便,结果准确,适合该制剂中绿原酸的含量测定.     

益妇宁软胶囊对去势大鼠免疫功能的影响

目的观察益妇宁软胶囊(YFN)对去势大鼠免疫功能的影响.方法 50只SD雌性大鼠随机分为5组:正常对照组、模型对照组、己烯雌酚片组、YFN大、小剂量组.给药4周后用放射免疫法测定大鼠血清雌二醇(E2)、白细胞介素2(IL-2)水平,放射配基受体结合分析法测定脾细胞雌激素受体(ER),光镜下观察胸腺病理组织学变化,测定大鼠体重及脏器指数.结果 YFN能明显升高大鼠去势后降低的血清E2、IL-2水平(P＜0.05或P＜0.01);提高脾脏指数及脾细胞ER含量(P＜0.05或P＜0.01);改善胸腺组织病理变化.结论 YFN可以改善去势大鼠的免疫功能.     

岩消胶囊对小鼠肝癌抑制作用的实验研究

目的研究岩消胶囊对小鼠肝癌的抑制作用。方法选取40只小鼠，随机分为空白对照组、阳性对照组、实验组，分别观察实体瘤重量、小鼠存活时间、实体瘤的形态学和对腹水癌细胞的直接杀伤死亡率。结果实验组的实体瘤重量显著降低（P〈0．01），抑瘤率达52．0％；小鼠存活时间明显延长，生命延长率81．6％（P〈0．01）；对腹水癌细胞有显著的杀伤作用（P〈0．05）。结论岩消胶囊能显著抑制小鼠肝癌细胞移植性肿瘤的生长，减轻瘤体重量；能显著延长荷瘤小鼠生存期；同时对肿瘤细胞有直接杀伤作用。     

软胶囊崩解迟缓现象机理的初步研究

分别测定甲醛处理后明胶胶片的平衡溶胀量、蛋白质溶出量和氨基酸残基含量,考察常用附加剂对明胶中氨基酸残基含量的影响.结果表明,平衡溶胀量、溶出量和氨基酸残基含量之间呈良好线性关系.软胶囊的崩解迟缓与明胶中氨基酸残基的含量有关,加入丙二醇和山梨醇可使明胶中氨基酸残基含量显著下降,加入甘氨酸和焦亚硫酸钠则含量降低的幅度较小.