香连胃漂浮片的制备及体外释放研究

目的制备香连胃漂浮片并考察其体外释放性能。方法以羟丙基甲基纤维素K4M(hydroxypropyl methylcellulose K4M,HPMC-K4M)、十六醇、碳酸氢钠(NaHCO3)、乳糖、聚维酮K30(povidone K30,PVP-K30)、硬脂酸镁为辅料,采用粉末压片法制备香连胃漂浮片;以盐酸小檗碱的累积释放度为指标考察制剂的体外释药性能;采用正交试验对HPMC-K4M、十六醇、NaHCO3用量进行优选。通过数据拟合方程探讨制剂中盐酸小檗碱、木香烃内酯的释药机制。结果最优处方为香连复方提取物60.0 g、HPMC-K4M30.0 g、十六醇8.0 g、NaHCO38.0 g、乳糖8.0 g、PVP-K304.8 g、硬脂酸镁1.2 g(200片量)。指标成分盐酸小檗碱和木香烃内酯的体外释药特性均符合Riger Peppas模型,为扩散与骨架溶蚀协同作用。结论成功制得香连胃漂浮片,漂浮滞后时间短,持续漂浮时间长,且具有缓释特性。     

愈骨疗伤片的处方筛选及制备工艺研究

  目的：优化愈骨疗伤片的制备工艺,筛选最优制剂处方。  方法：在考察提取物粒径基础上,以片剂中川续断皂苷溶出量作为考察指标,采用正交试验对搅拌速度、制粒速度和聚维酮K30浆液浓度三者关系进一步考察。采用单因素进一步优选润滑剂和包衣工艺条件。  结果：最佳的愈骨疗伤片处方为提取物颗粒中加入10%乳糖、7.5%羧甲基淀粉钠和2.5%聚维酮K30,以及0.5%硬脂酸镁混合后压片；采用低浓度乙醇包衣液进行包衣。  结论：制得的愈骨疗伤片制剂工艺稳定,包衣后改善了片剂的吸潮性,增加了产品的稳定性,更便于保存和运输。     

硫酸镁、硝苯地平和酚妥拉明治疗妊高症

目的探讨对妊娠高血压综合征患者给予硫酸镁联合硝苯地平以及酚妥拉明治疗的临床效果。方法抽取医院在2018年2月-2019年2月所接收的156例妊娠高血压综合征患者,将其按照数字随机表的方法分为单纯组和联合组,每组分别为78例。单纯组给予单纯的硫酸镁进行治疗,联合组在单纯组给予硝苯地平以及酚妥拉明进行联合治疗,比较患者的治疗效果。结果联合组的治疗有效率显著高于单纯组,治疗前血压水平差异无统计学意义(P>0.05),治疗后联合组的收缩压和舒张压水平均低于单纯组,P<0.05,两组差异有统计学意义。结论对妊娠高血压综合征患者给予硫酸镁联合硝苯地平和酚妥拉明进行联合治疗,有效改善患者的血压水平。     

双歧杆菌四联活菌片联合四联疗法对HP阳性胃溃疡患者血清TGF-β1、G17、PGI的影响

目的探讨双歧杆菌四联活菌片联合四联疗法对幽门螺旋杆菌(HP)阳性胃溃疡患者血清转化生长因子-β1(TGF-β1)、胃泌素17(G17)、胃蛋白酶原I(PGI)的影响。 方法选取HP阳性胃溃疡患者98例,随机均分为对照组和联合组。对照组采用四联疗法,联合组采用双歧杆菌四联活菌片联合四联疗法治疗。比较两组临床疗效、胃黏膜组织学评分、血清TGF-β1、PGI、G17、胃动素(MTL)、不良反应等情况。 结果联合组治疗总有效率高于对照组(P＜0.05)。与治疗前比较,治疗后两组胃黏膜组织学各项评分、TGF-β1、G17、PGI均降低,MTL升高,且联合组较对照组更为显著(P＜0.05)。联合组不良反应总发生率低于对照组(P＜0.05)。 结论双歧杆菌四联活菌片联合四联疗法治疗HP阳性胃溃疡患者疗效满意,可调节胃肠激素水平,安全性良好,具有临床应用价值。     

Synthesis and evaluation of the structural and physicochemical properties of carboxymethyl pregelatinized starch as a pharmaceutical excipient

A pregelatinized starch (PGS) was derivatized with sodium chloroacetate (SCA) in alcoholic medium under alkaline condition to produce carboxymethyl pregelatinized starch (CMPGS) with various degrees of substitution (DS). Influence of the molar ratio of SCA to the glucopyranose units (SCA/GU), reaction time, temperature and the amount of sodium hydroxide on the degree of substitution (DS) and the reaction efficiency (RE) was studied. An optimal concentration of 30% of NaOH, for a reaction time of 1 h at 50 °C and molar ratio (SCA/GU) equal to 1.0, yielded an optimal DS of 0.55 and a RE of 55%. SEM micrographs revealed that the carboxymethylation assigned the structural arrangement of CMPGS and caused the granular disintegration. Wide angle diffraction X-ray (XRD) showed that the crystallinity of starch was obviously varied after carboxymethylation. New bands in FTIR spectra at 1417 and 1603 cm⁻¹ indicated the presence of carboxymethyl groups. The solubility and viscosity of CMPGS increased with an increase in the degree of modification. In order to investigate the influence of DS on physical and drug release properties, CMPGS obtained with DS in the range of 0.12–0.55 was evaluated as tablet excipient for sustained drug release. Dissolution tests performed in phosphate buffer (pH 6.8), with Ibuprofen as drug model (25% loading) showed that CMPGS seems suitable to be used as sustained release excipient since the drug release was driven over a period up to 8 h. The in vitro release kinetics studies revealed that all formulations fit well with Korsmeyer-Peppas model and the mechanism of drug release is non-Fickian diffusion.     

胆宁片联合奥曲肽治疗急性胰腺炎的临床效果观察

[目的]观察胆宁片联合奥曲肽治疗急性胰腺炎的临床效果。[方法]将28例急性胰腺炎患者随机分为治疗组与对照组,各14例。治疗组以胆宁片联合奥曲肽治疗;对照组单用奥曲肽治疗。观察2组患者治疗后腹痛腹胀缓解时间、肠道功能恢复时间、白细胞计数变化、血淀粉酶、C反应蛋白(CRP)变化,并发症及住院天数等指标。[结果]治疗组在腹痛腹胀缓解时间、肠道功能恢复时间、血CRP、并发症控制等方面均优于对照组(P0.05),但2组血淀粉酶降低程度比较,差异无统计学意义(P0.05)。[结论]胆宁片联合奥曲肽在治疗急性胰腺炎有协同作用,可提高疗效,缩短住院时间。     

Single and Dual Drug Release Patterns from Shellac Wax-Lutrol Matrix Tablets Fabricated with Fusion and Molding Techniques

The objective of this investigation was to prepare the shellac wax matrix tablets by fusion and molding technique incorporated with Lutrol in different ratios to modify the hydrophobicity of matrix tablet. The matrix tablets with single drug were loaded either with propranolol hydrochloride or hydrochlorothiazide as hydrophilic and hydrophobic model drugs, and a dual drug formula was also prepared. The single and dual drug release patterns were studied in a dissolution apparatus using distilled water as medium. Propranolol hydrochloride released from matrix was easier than hydrochlorothiazide. Drug release from shellac wax matrix could be enhanced by incorporation of Lutrol. However retardation of drug release from some matrix tablets was evident for the systems that could form dispersion in the dissolution medium. The gel network from high content of Lutrol was hexagonal which was a dense and more compact structure than the other structures found when low amounts of Lutrol were present in the formula. Therefore, the formulae with high content of Lutrol could prolong drug release more efficiently than those containing low content of Lutrol. Hence shellac wax matrix could modulate the drug release with the addition of Lutrol. Sustainable dual drug release was also obtained from these developed matrix tablets. Thus shellac wax-Lutrol component could be used as a potential matrix tablet prepared with fusion and molding technique with excellent controlled drug release.     

盐酸贝那普利联合硝苯地平治疗高血压的疗效及对血管内皮功能的影响

目的:探讨盐酸贝那普利联合硝苯地平治疗高血压的疗效及对血管内皮功能的影响。方法:回顾性分析某院于2017年6月~2019年6月间收治的106例高血压患者的临床资料,所有患者均采用盐酸贝那普利联合硝苯地平治疗方案,治疗后对血压控制效果及血管内皮功能进行综合评价。结果:患者治疗后24h收缩压和舒张压均较治疗前降低(P<0.05);患者治疗后血管内皮功能显著改善,内皮素(ET)、一氧化氮(NO)和神经肽Y(NPY)水平均优于治疗前(P<0.05)。结论:盐酸贝那普利联合硝苯地平治疗高血压的效果较好,不仅能够有效控制血压水平,还能够改善患者血管内皮功能,可作为一种理想的治疗方案在临床推广应用。     

凉血散瘀方对肾虚血瘀型 IgA 肾病患者的疗效观察

〔摘 要〕 目的：分析凉血散瘀方加减辅助雷公藤多苷、醋酸泼尼松片治疗肾虚血瘀型 IgA 肾病患者的临床效果。 方法：选取三明市中西医结合医院 2019 年 6 月至 2020 年 6 月期间收治的 70 例肾虚血瘀型 IgA 肾病患者，依照治疗方案不同分为 观察组与对照组，各35例。对照组给予西药治疗；观察组在对照组基础上加用凉血散瘀方加减治疗。比较两组治疗效果。 结果：观察组患者治疗总有效率为 91.43 %，高于对照组的 71.43 %，差异具有统计学意义（P ＜ 0.05）。治疗前两组患者的尿红细 胞个数、血清肌酐（Scr）、血尿酸（SUA）、24 h 尿蛋白定量、Ⅳ 型胶原（C–Ⅳ）、基质金属蛋白酶组织抑制物 –1（TIMP–1） 及层粘连蛋白（LN）比较，差异无统计学意义（P ＞ 0.05）；治疗后两组患者的尿红细胞个数、Scr、SUA、24 h 尿蛋白 定量、C–Ⅳ、TIMP–1 及 LN 均低于治疗前，且观察组患者的尿红细胞个数、Scr、SUA、24 h 尿蛋白定量、C–Ⅳ、TIMP–1 及 LN 均低于对照组，差异具有统计学意义（P ＜ 0.05）。观察组患者不良反应发生率为 2.86 %，与对照组的 8.57 % 比较，差异无统计学意义（P ＞ 0.05）。 结论：凉血散瘀方联合雷公藤多苷、醋酸泼尼松片治疗肾虚血瘀型 IgA 肾病患者， 可进一步改善患者病情，调节血脂水平，改善肾脏纤维化，且安全性不受影响。