超微粉碎技术提高损伤胶囊溶出度的研究

目的研究超微粉碎技术对损伤胶囊溶出度的影响.方法以有效成分的溶出量及三七皂苷 R1为指标,对不同粉碎技术制备的损伤胶囊和损伤散进行溶出度和含量测定比较.结果 损伤胶囊(超微细粉)较损伤散(普通细粉)在薄层色谱图上的斑点大且显色深,限时溶出量提高 4.66 %,三七皂苷R1的含量提高 6 %.结论 超微粉碎技术能提高损伤胶囊的溶出度,为确立损伤胶囊的制备工艺提供了依据.     

强骨胶囊治疗原发性骨质疏松症(骨量减少)的临床研究

目的探讨强骨胶囊防治原发性骨质疏松症(骨量减少)的作用及其机制.方法观察骨量减少(肾阳虚证)患者161例,121例采用随机分组、双盲双模拟对照的方法,其中治疗组61例、骨松宝颗粒对照组60例,其余40例为强骨胶囊开放治疗组.观察中医证候疗效及骨痛、骨密度改变情况.结果强骨胶囊治疗组中医证候总有效率为95.08%,愈显率为60.66%;强骨胶囊开放治疗组分别为92.50%、52.50%;骨松宝颗粒对照组分别为83.33%、31.67%.治疗组中医证候疗效明显优于对照组(P＜0.01).强骨胶囊治疗组骨痛的总有效率为91.08%,愈显率为70.49%;强骨胶囊开放治疗组分别为92.50%、72.50%;骨松宝颗粒对照组分别为81.67%、48.33%;治疗组对骨痛的疗效明显优于对照组(P＜0.01).经过治疗前后双能X线骨密度测定,治疗后治疗组腰椎2-4骨密度平均上升0.02%,股骨粗隆骨密度平均上升5.58%,股骨颈骨密度平均下降0.37%;开放治疗组上述三项分别为上升0.80%、上升3.21%、下降1.36%;对照组分别为下降0.86%、上升0.84%、上升0.40%.结论强骨胶囊治疗原发性骨质疏松症骨量减少疗效确切.     

慢性低O2高CO2大鼠血管内皮生长因子表达及参一胶囊的影响

目的 :探讨血管内皮生长因子 (VEGF)在低氧性肺动脉高压形成中的意义及参一胶囊对其影响。方法 :采用ELISA法、透射电镜、原位杂交技术等方法 ,观察正常对照组、低O2 高CO2 4周组、低O2 高CO2 4周 参一胶囊组大鼠肺动脉平均压 (mPAP)、右心室重量比 (RV LV S)、血清和肺组织的VEGF的含量、肺细小动脉的超微结构、肺组织VEGFmR NA表达的变化。结果 :低O2 高CO2 组大鼠的mPAP、RV LV S、血清和肺组织的VEGF的含量明显高于正常对照组 (P <0 .0 1)。低O2 高CO2 4周 参一胶囊组大鼠mPAP、RV LV S、血清VEGF显著低于低O2高CO2 组 (P <0 .0 1) ,肺组织的VEGF的含量也低于低O2 高CO2 组 (P <0 .0 5 )。低O2 高CO2 组大鼠肺细小动脉中膜平滑肌细胞明显增生、胶原纤维较正常对照组增多 ,低O2 高CO2 4周 参一胶囊组较低O2 高CO2 组则明显减轻。原位杂交显示低O2 高CO2 组大鼠肺细小动脉VEGFmRNA较正常对照组明显增加 (P <0 .0 1) ,而低O2 高CO2 4周 参一胶囊组与低O2 高CO2 组比较 ,则明显降低(P <0 .0 5 )。结论 :VEGF参与了慢性低氧性肺动脉高压的形成 ,参一胶囊可通过抑制VEGF的作用而有效地降低肺动脉高压     

胶囊内镜对小肠疾病的诊断价值

目的研究M2A胶囊内镜对胃肠道特别是小肠病变的检出率及病变类型,探讨胶囊内镜对小肠疾病的诊断价值.方法运用M2A胶囊内镜对37例疑诊小肠疾病和体检者进行检查.结果疑诊小肠疾病组发现小肠病变18处,包括克罗恩病、小肠寄生虫、回肠淋巴瘤、回肠Mechel憩室、小肠海绵状血管瘤、小肠息肉样病变、小肠糜烂、回肠末端炎、十二指肠炎或溃疡、十二指肠囊肿,病变检出率为81.8%,诊断阳性率为68.2%(15/22);高于体检组.两组病例M2A胶囊内镜在消化道不同部位的运行时间比较无显著差异,胶囊内镜平均工作时间,获取照片数量无显著差异,胶囊内镜图片质量佳,病人耐受性好.结论胶囊内镜对疑诊小肠疾病的病变检出率较高,而且安全无创,可以作为小肠疾病检查的首选方法.     

Suicidal poisonings with methadone in France: Results of a two year national survey by the Toxicovigilance Network

Context. Methadone is used in France since March 1995, only for opioid maintenance treatment, in a syrup form. For the launching of a capsule form in April 2008, French health authorities requested a prospective survey of all cases involving exposure to methadone in either of the two available pharmaceutical forms. Objective. The aim was to document, in different circumstances and compare the safety of the new capsule form to the syrup. This report presents the findings of one arm of the study, devoted to methadone-related suicide attempts. Materials and method. From April 15, 2008 to April 15, 2010, all self-injurious methadone poisonings notified to or managed by the French Toxicovigilance Centers network were included. Analysis mainly focused on patients’ age and gender, estimated quantity ingested, eventual concomitantly taken substances, distribution of symptoms, and site of treatment. Results. 135 methadone-related suicide attempts were recorded. Analysis showed identical epidemiologic and clinical patient characteristics for the two pharmaceutical forms. Ten deaths occurred. The only discrepancy was a higher incidence of suicide attempts in the capsule group. However, as the number of capsule-treated patients increased during the second year, this difference remained significant but tended to decrease. Discussion. Combining these results with Pharmacovigilance and Addictovigilance arms, health authorities estimated that the benefit/risk balance of this new pharmaceutical form remains positive. They revised their position on requirements for prescribing and dispensing of the capsule form, and made them slightly easier. Following this, this “suicide” arm of Toxicovigilance survey was suspended, whereas the second one, concerning accidental pediatric methadone-related poisonings, has been extended until April 2014. Conclusion. In France, suicide attempts were more likely to occur with the capsule formulation. The clinical severity of intoxication was similar between the capsule and liquid forms.     

Tablet and Capsule Hydrophilic Matrices Based on Heterodisperse Polysaccharides Having Porosity-Independent In Vitro Release Profiles

The purpose of the study was to investigate the release-controlling action of a swellable hydrophilic material based on heterodisperse polysaccharides (HP) in relation to the initial pore structure of the formulations. HP-based granules were produced under carefully controlled conditions and compacted into matrix tablets having equivalent tablet thickness. Quantification of pore structure using mercury porosimetry showed that the tablets had substantially different pore volumes and pore size distributions. Dissolution studies demonstrated that release of a water-soluble model compound, benzamide, from swollen matrices was affected neither by total porosity nor median pore diameter of the initial dry matrix. To extend the concept of porosity-independent release further, HP-based formulations containing either diclofenac sodium or propranolol HCl were contained within hard gelatin capsules in the form of uncompacted granules. This produced a dosage form with a high intraparticulate porosity in the dry state. Equivalent weights of the same formulations were also compacted into tablets. The in vitro release profiles from matrix tablets compacted from any of the formulations did not differ significantly from release profiles obtained when the same materials were contained uncompacted in hard gelatin capsules.     

HPLC-ELSD法测定安多霖胶囊中黄芪甲苷

目的 建立高效液相色谱–蒸发光散射检测器（HPLC-ELSD）法测定安多霖胶囊中黄芪甲苷的方法。方法 采用Ultimate色谱柱（250 mm×4.6 mm，5 μm），流动相为乙腈–超纯水（32∶68），体积流量为1 mL/min，漂移管温度40 ℃，蒸发光散射检测器雾化气体为氮气，体积流量为2.7 L/min，载气压力350 kPa，进样量20 μL。结果 黄芪甲苷在1.59～10.60 μg呈良好的线性关系，r=0.999 5，平均回收率为99.11%，RSD为2.58%（n=6）。结论 本方法简便准确，重现性好，可用于安多霖胶囊的质量控制。     

坤泰胶囊对大鼠胚胎和胎仔的发育毒性研究

目的 评价SD孕鼠在致畸敏感期（怀孕第6～15天）ig给予坤泰胶囊溶液对SD大鼠的母体毒性、胚胎-胎仔毒性和致畸性。方法 雌性SD大鼠低、中、高剂量组在怀孕第6～15天内分别ig给予2.5、5、10 g/(kg?d) 坤泰胶囊成品粉溶液，对照组给予双蒸水。试验期内每天观察动物的一般情况和临床毒性表现；记录孕鼠的体质量；在怀孕第20天进行剖腹检查，摘取卵巢和子宫，观察黄体数、着床数、胚胎生存及死亡情况、生存胎仔的外观、性别、体质量、骨骼及脏器发育等指标。结果 孕鼠及胚胎、胎仔发育的上述各观察指标未见明显异常，与对照组比较无显著差异。结论 在本实验条件下，坤泰胶囊成品粉未见明显的母体毒性与胚胎和胎儿发育毒性。     

囊袋收缩综合征的手术治疗

目的探讨白内障超声乳化术后囊袋收缩综合征的手术治疗效果。方法对12例（12只眼）白内障超声乳化术后并发囊袋收缩综合征进行囊袋松解术，观察术后视力及并发症情况。结果12只眼术后视力均有提高，10只眼视力〉10．4，2只眼视力0．1～0．3，无明显并发症发生。结论囊袋松解术是治疗重度囊袋收缩综合征的有效方法。