Study of Sustained Release Phenylpropanolamine Hydrochloride Hydrophilic Matrix Tablets Containing Hydroxypropylmethylcellulose K100M and Carbopol 971P

选用HPMC K100M和卡波普971P为骨架材料，粉末直接压片法制备骨架片，考察释放度，反相高效液相色谱法检测盐酸苯丙醇胺（PPA·HCl）的浓度。释药曲线均符合Higuchi方程（R＞0．98，P＜0．01）。运用正交设计法，以美国市场的PPA·HCl缓释片Acutrim^R为对照，相似因子f2值为指标，筛选获得了最优处方。其工艺重现性合格。研制片在0．1mol·L^-1 HCl,H2O(pH6.5)，磷酸盐缓冲液（PBS）pH5.0,6.8和7.4的介质中，以及在0.1mol·L^-1HCl中释放2h，转移至PBS6．8中释放10h，相对于对照品的f2值为63－74，表明在各介质中两制剂的释药曲线相似。释药影响因素的考察结果表明：在本实验考察的范围内，骨架片在水中的释药速率与HPMC K100M和卡波普971P的用量呈负相关。HPMC K100M和卡波普971P的比例（保持聚合物总用量相同），硬脂酸镁量和骨架片硬度对释药速率无显著性影响。

Pharmacokinetics of Moclobemide Sustained Release Tablets after Multiple Oral Dose Administration in Healthy Volunteers

To investigate the pharmacokinetic characteristics of moclobemide sustainedrelease tablets after multiple oral dose administration in healthy Chinese volunteers. MethodsMoclobemide sustained release tablets were given as a multiple oral dose regimen of 300 mg oncedaily for five consecutive days to 12 healthy volunteers. The concentrations of moclobemide inplasma were determined by reversed-phase high performance liquid chromatography. The partialpharmacokinetic parameters were calculated using 3p97 pharmacokinetic program. Results Theconcentration-time profile fitted an one-compartment model best. The steady-state pharmacokineticparameters of moclobemide sustained release tablets after multiple oral doses were as follows:C_(max) was (1 950 +- 156) μg· L^(-1), T_(max) was (6.00 +-1.55) h, T_(1/2(kel)) was (3.14 +-0.12)h, AUC_(ss 0-24) was (22 836 +- 1 842) μg·h· L^(-1), MRT was (7.68+-0.36) h, CL/F_((s)) was(20.2+-2.1) L·h^(-1), and V/F_((c)) was (91.4+-9.4) L, respectively. No marked adverse events werenoted during this study. Conclusion The formulation has a sustained-release effect and goodtolerance in the healthy volunteers, which provides useful information for clinical practice.

Preparation and <i>in Vitro</i>Drug Release Evaluation of Once-Daily Metformin Hydrochloride Sustained-Release Tablets

The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitro drug release rate of MHSRT and the commercial tablets Fortamet? made in the United States of America in water was fitted with zero order kinetic equation, and Ritger-Peppas kinetic equation in 0.1 M HCl and pH 6.8-phosphate buffer, respectively. The similarity factor f2 values of MHSRT in three different dissolution medium were 82, 80 and 74, respectively in comparison with imported Fortamet?, which were all greater than 50. The results of storage-stability showed that MHSRT were stable for at least 6 months under stress condition (40℃ ± 2℃, RH 75% ± 5%). Therefore, in this study, MHSRT were successfully prepared using optimized formulation technologies that meet mass produce. The in vitro release behavior of MHSRT was almost similar to that of imported Fortamet?.

Preparation and Pharmacokinetic Characterization of Sustained Release Melatonin Tablet

Aim To prepare the sustained release melatonin tablet with HPMC matrix and study its pharmacokinetics and bioavailatility. Methods HPMC was used as matrix to formulate the sustained release tablet. The influences of the size of melatonin, type and amount of HPMC, drug loading, type and amount of additives, and compressing pressure were investigated. Plasma concentration of melatonin in dogs after intravenous injection of two doses and oral administration of sustained release tablets and unmodified release capsules was detected by HPLC using fluorescence detector. Results The drug release from sustained release tablets was influenced by the size of melatonin, type and amount of HPMC, drug loading, and type and amount of additives. Melatonin was found to fit two compartment model after intravenous injection, AUC was proportional to doses, and t(1/2β) of two doses has no significant difference. Relative bioavailability of melatonin sustained release tablet to normal capsule was 83.8%, and absolute bioavailability was 3.75% for sustained release tablet and 4.49% for capsule. Conclusion The melatonin sustained release tablet was well formulated. The absolute bioavilability for oral administration of either sustained release tablet or unmodified release capsule of melatonin was less than 5%. The bioavailability of melatonin sustained release tablet was lower than that of unmodified release capsule, but MRT of sustained release tablet was significantly longer than that of capsule.

HPLC Method for the Determination of Tamsulosin Hydrochloride in Sustained Release Tablets

The development and validation of an isocratic high performance liquid chromatographic method is described for the determination of tamsulosin hydrochloride in sustained release tablets. The determination was performed on a Diamonsil BDS C18 column with a mobile phase consisting of a mixture of acetonitrile, methanol and 0 5% phosphoric acid solution (20∶30∶50, V/V/V ) at a flow rate of 1 0 mL/min. UV detection was made at 274 nm. The linear range for tamsulosin hydrochloride was 0 81-8 10 μg/mL. The mean recovery was 99 8% ( S R=0 7%, n =9), and the precision was found to be 0 45% ( n =9). The proposed method can be used for routine analysis of tamsulosin hydrochloride in sustained release tablets.

Efficacy of Metoprolol Succinate Sustained Release Tablets Combined with Wenxin Granules in the Treatment of Coronary Heart Disease Arrhythmia

Objective:To explore the effect of metoprolol succinate sustained-release tablets combined with Wenxin Granules in the treatment of coronary heart disease patients with arrhythmia.Methods:The research objects were 50 patients with arrhythmia who were treated in our hospital from September 2019 to September 2020.According to different treatment methods,they were divided into observation group(Wenxin Granule+metoprolol succinate treatment)and control group(metoprolol succinate treatment),25 cases in each group.The curative effects of the two groups were compared.Results:After treatment,there was no significant difference in rnn50,RMSSD,sdnni and SDANN between the two groups(P>0.05).Compared with the control group,the SDNN in the observation group was higher than that in the control group(P<0.05);Before treatment,there was no significant difference in the above indexes between the two groups(P>0.05);The effective rates of the observation group and the control group were 92.00%and 68.00%respectively,and the curative effect of the observation group was higher than that of the control group(P<0.05);There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:In the treatment of patients with coronary heart disease and arrhythmia,Wenxin Granule Combined with metoprolol succinate sustained-release tablets has significant effect,which can effectively improve the dynamic electrocardiogram indexes of patients,improve the clinical efficacy,and has high safety.

Pharmacokinetic Study on Lovastatin Sustained-release Tablet and Sustained-release Capsule in Begal Dogs

This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.

Evaluation of gum mastic(Pistacia lentiscus) as a microencapsulating and matrix forming material for sustained drug release

In this study, a natural gum mastic was evaluated as a microencapsulating and matrixforming material for sustained drug release. Mastic was characterized for its physicochemical properties. Microparticles were prepared by oil-in-oil solvent evaporation method. Matrix tablets were prepared by wet and melt granulation techniques. Diclofenac sodium(DFS) and diltiazem hydrochloride(DLTZ) were used as model drugs. Mastic produced discrete and spherical microspheres with DLTZ and microcapsules with DFS. Particle size and drug loading of microparticles was in the range of 22–62 μm and 50–87%, respectively. Increase in mastic:drug ratio increased microparticle size, improved drug loading and decreased the drug release rate. Microparticles with gum: drug ratio of 2:1 could sustain DLTZ release up to 12 h and released 57% DFS in 12 h. Mastic produced tablets with acceptable pharmacotechnical properties. A 30% w/w of mastic in tablet could sustain DLTZ release for 5 h from wet granulation,and DFS release for 8 h and 11 h from wet and melt granulation, respectively. Results revealed that a natural gum mastic can be used successfully to formulate matrix tablets and microparticles for sustained drug release.

Blue emitting CsPbBr3 perovskite quantum dot inks obtained from sustained release tablets

Blue emitting perovskite ink obtained from cesium lead halide quantum dots bearing chlorine(CsPbClxBr3-x,0<x<3)suffers from the low photoluminescence quantum yield and poor stability.Cesium lead bromine(CsPbBr3)quantum dots free of chlori ne have more stable crystalstructure and fewer crystal defects.Precise control of crystal sizes and surface passivation comporients of CsPbBr3 quantum dots is crucial for the best use of quantum confinement effect and blueshift of emission wavelength to blue region.Here,by polymerizing acrylamide under UV-light irradiation to form polymer gel networks in dimethyl sulfoxide(DMSO)with CsPbBr3 precursors and passivating agents trapped,wesuccessfully prepared novel sustained release tablets with different shapes and sizes.Thanks to the limitation of the polymer networks onsolve nt releasi ng,the resulting CsPbBr3 qua ntum dots have the average size of 1.1±0.2 nm.On the basis of the excelle nt quantum confin eme nteffect and optimized surface passivation,the obtained PQD ink can emit high quality blue light for more than 6 weeks.This work elucidates anew and convenient technique to prepare blue emission perovskite quantum dots ink with high stability and photoluminescence qua ntumyield and provides a great potential technology for the preparation of perovskite optoelectronic devices.

Development of curcumin floating tablets based on low density foam powder

The floating drug delivery system (FDDS) has become increasingly attractive system for gastroretentive dosage forms because it can prolong gastric retention time and improve drug bioavailability (1)Using low density material of polypropylene foam powder is one of the interesting approaches for FDDS development. This floating system has initial low density so it can float immediately without lag time.

盐酸坦洛新缓释片联合生物反馈电刺激治疗Ⅲ型前列腺炎的疗效及对尿动力学指标的影响

目的探讨盐酸坦洛新缓释片联合生物反馈电刺激治疗Ⅲ型前列腺炎的疗效及对尿动力学指标的影响。方法选取2020年11月至2023年7月长江大学附属荆州医院收治的86例Ⅲ型前列腺炎患者作为研究对象,按照随机数字表法分为对照组和观察组,每组43例。对照组采用生物反馈电刺激治疗,观察组采用生物反馈电刺激联合盐酸坦洛新缓释片治疗。比较两组临床疗效、治疗前后美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)评分、尿动力学指标、炎性因子水平、免疫功能指标、焦虑自评量表(SAS)评分、生活质量量表(QOL)评分、不良反应发生率。结果治疗后,观察组NIH-CPSI评分低于对照组(P<0.05)。观察组治疗总有效率高于对照组(P<0.05)。治疗后,观察组最大自由尿流率高于对照组,残余尿量和最大逼尿肌压力低于对照组(P<0.05)。治疗后,观察组肿瘤坏死因子-α(TNF-α)、白介素(IL)-8、IL-1β水平均低于对照组(P<0.05)。治疗后,观察组CD4^(+)和CD4^(+)/CD8^(+)高于对照组,CD8^(+)低于对照组(P<0.05)。治疗后,观察组SAS评分低于对照组,QOL评分高于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论盐酸坦洛新缓释片联合生物反馈电刺激可缓解Ⅲ型前列腺炎患者的临床症状,改善尿动力学指标,提高临床疗效。

利肺胶囊联合茶碱缓释片治疗慢性喘息性支气管炎的临床效果研究

目的探讨利肺胶囊联合茶碱缓释片治疗慢性喘息性支气管炎的临床效果。方法选取2022年3月至2023年12月山西省肿瘤医院收治的90例慢性喘息性支气管炎患者为研究对象。按照随机数字表法将90例患者分为对照组和观察组,各45例。对照组在基础治疗基础上加用茶碱缓释片进行治疗,观察组在基础治疗基础上采用利肺胶囊联合茶碱缓释片进行治疗。比较2组的总有效率、临床症状改善时间、血气指标、炎症因子和药物不良反应发生率。结果观察组总有效率高于对照组[93.3%(42/45)比77.8%(35/45)],差异有统计学意义(P=0.036)。观察组喘息、咳嗽、痰多的改善时间短于对照组,差异均有统计学意义(均P<0.05)。治疗后2组动脉血氧分压水平均高于治疗前且观察组高于对照组,动脉血二氧化碳分压、C反应蛋白、白细胞介素6及降钙素原水平均低于治疗前且观察组均低于对照组,差异均有统计学意义(均P<0.05)。2组药物不良反应发生率比较差异无统计学意义(P=0.609)。结论利肺胶囊联合茶碱缓释片治疗慢性喘息性支气管炎可获得较好的临床效果,能有效改善患者的血气指标和体内炎症反应,且安全性较好。

琥珀酸美托洛尔缓释片联合阿托伐他汀钙片治疗冠心病的效果

目的:观察琥珀酸美托洛尔缓释片联合阿托伐他汀钙片治疗冠心病的效果。方法:选取2021年8月—2022年8月广东药科大学附属第一医院收治的冠心病患者60例为研究对象,采用随机数字表法分为联合组和对照组,各30例。联合组使用琥珀酸美托洛尔缓释片联合阿托伐他汀钙片治疗,对照组使用阿托伐他汀钙片治疗。对比两组血液流变学指标水平、心功能指标水平、心绞痛症状、治疗效果、不良反应发生率。结果:治疗后,两组全血还原黏度、高切还原黏度、低切还原黏度降低,联合组低于对照组(P<0.05);治疗后,两组左心室收缩末期内径、左心室舒张末期内径降低,左室射血分数升高,联合组优于对照组(P<0.05);治疗后,两组心绞痛每周发作次数减少,持续时间缩短,联合组优于对照组(P<0.05);联合组治疗总有效率高于对照组(P=0.022);两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:琥珀酸美托洛尔缓释片联合阿托伐他汀钙片治疗冠心病的临床效果显著,可改善心肌供血,增强心功能,减轻心绞痛症状且未增加不良反应发生率。

盐酸羟考酮缓释片治疗原发性肺癌患者放化疗期间神经病理性疼痛的临床观察

目的探讨盐酸羟考酮缓释片治疗原发性肺癌患者放化疗期间神经病理性疼痛的临床效果。方法选取2019年6月至2022年6月三二〇一医院收治的原发性肺癌放化疗期间神经病理性疼痛患者108例,按照随机数字表法分为对照组(54例)、12 h滴定组(26例)及24 h滴定组(28例)。对照组给予盐酸吗啡片口服治疗,12 h滴定组及24 h滴定组采用盐酸羟考酮缓释片口服治疗。比较3组患者的一般资料、治疗后不同时点疼痛缓解率及暴发痛次数、治疗前后睡眠质量及生存质量和不良反应发生率。结果3组患者性别、年龄、TNM分期及疼痛数字评分法评分比较,差异均无统计学意义(均P>0.05)。12 h滴定组、24 h滴定组治疗1 d后疼痛缓解率均高于对照组,差异均有统计学意义(均P<0.05)。3组治疗1、2、3 d后暴发痛次数比较,差异均有统计学意义(均P<0.05),3组治疗2、3、7 d后暴发痛次数均少于治疗1 d后(均P<0.05),治疗1、2、3 d后,12 h滴定组和24 h滴定组暴发痛次数均少于对照组,12 h滴定组少于24 h滴定组(均P<0.05)。3组治疗前匹兹堡睡眠质量指数(PSQI)、晚期癌症患者生活质量量表(EORTC QLQ-C15-PAL)评分比较,差异均无统计学意义(均P>0.05),治疗7 d后PSQI、EORTC QLQ-C15-PAL评分比较,差异均有统计学意义(均P<0.05)。3组间不良反应发生率比较,差异无统计学意义(P>0.05)。结论原发性肺癌患者放化疗期间神经病理性疼痛应用盐酸羟考酮缓释片尤以间隔12 h作滴定剂量调整治疗可获得良好的疼痛缓解率,使暴发痛次数有所减少,且不提高不良反应发生率,具有较高安全性。

曼月乐和优思悦对宫腔镜下子宫内膜息肉治疗术后管理的效果比较

目的:探讨左炔诺孕酮宫内缓释系统(曼月乐)和屈螺酮炔雌醇片Ⅱ(优思悦)对宫腔镜下子宫内膜息肉(EP)电切术后患者的治疗效果,并分析两者对患者子宫内膜厚度及预防复发的临床价值。方法:回顾性分析2019年9月至2020年9月在本院行宫腔镜EP电切术治疗且术后完成1年随访的161例EP患者临床资料,根据术后治疗方法分为两组,将术后采取曼月乐治疗的79例EP患者临床资料,纳入实验组,将术后采取优思悦治疗的82例EP患者临床资料,纳入对照组;使用倾向性评分匹配法分析两组基线资料,以1∶1比例用近邻法匹配两组患者,共匹配成功51对。比较并记录两组术前、术后3、6、9、12个月时,子宫内膜厚度、月经量(参照月经失血图评估)、息肉复发率等相关数据。结果:术后复发率;术后3、6、9、12个月时,两组子宫内膜厚度均低于术前,并逐月降低,且实验组低于对照组,两组间上述指标水平组间时点、组间时点交互比较(P<0.05);术后3、6、9、12个月时,两组月经失血图评分均低于术前,并逐月降低,且实验组低于对照组,两组间上述指标水平组间时点、组间时点交互比较(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:曼月乐和优思悦均可降低宫腔镜EP术后患者子宫内膜厚度,但曼月乐相较于优思悦可有效改善患者月经量,降低复发率,同时安全性较好。

超高效液相色谱-串联质谱法定量分析羟考酮纳洛酮缓释片中基因毒性杂质7,8-二脱氢纳洛酮

目的建立羟考酮纳洛酮缓释片中潜在基因毒性杂质7,8-二脱氢纳洛酮的超高效液相色谱-串联质谱(UHPLC-MS/MS)检测方法。方法色谱柱为Waters Acquity CSH C 18(2.1 mm×150 mm,1.7μm),以0.77 g·L^(-1)乙酸铵水溶液(冰醋酸调节pH为5.0)为流动相A,以乙腈为流动相B,梯度洗脱,流速为0.5 mL·min-1,柱温为50℃。采用多反应监测(MRM)模式,对羟考酮纳洛酮缓释片中的7,8-二脱氢纳洛酮进行定量检测。结果7,8-二脱氢纳洛酮浓度在1.2~48 ng·mL^(-1)范围内具有良好的线性关系。检测限和定量限分别为0.6 ng·mL^(-1)和1.2 ng·mL^(-1)。低、中、高3个浓度的加样回收率在93%~99%之间(n=9),RSD为2.4%。结论该方法灵敏度高、专属性强,可用于羟考酮纳洛酮缓释片中7,8-二脱氢纳洛酮杂质的含量测定,为羟考酮纳洛酮缓释片杂质控制提供科学依据和定量分析方法。

Clinical Study on Sustained Release Tablat ot TripterygiumWilfordii in Treating Rheumatoid Arthritis

Adopting prospective, multi-center, random, single-blind and equal rank-control methods,226 patients with rlieumatoid arthritis (RA) were divided into two groups. The 114 patients ot the test groupwere treated with oral sustained release tablets of Tripterygium Wiltordii (TW-SR) , 2 tablets twice a day for4 weeks, 112 patients of the control group received tablets of Tripterygium Wiltordii(TW) orally 2 tablets 3times per day for 4 weeks. Testing results showed thetotal effective rates of the two groups were 92 . 11%and 90. 65 % , respectively (P >0. 05) . The adverse reaction rate of TW-SR was 20 . 18% , which was low-er than that of TW group of 70. 54% (P < 0. 01 ) . Results of pre-clinical pharmacologic experimental studydemonstrated that TW-SR has obvious anti-inflammatory , analgesic and immunosuppressive actions the sameas TW, while the toxicity of TW-SR was less than that of TW significantly.

阿利沙坦酯联合硝苯地平缓释片对中重度原发性高血压伴心绞痛疗效和安全性的研究

目的观察阿利沙坦酯联合硝苯地平缓释片对中重度原发性高血压伴心绞痛疗效和安全性。方法选取2021年1月至2022年1月佛山市中医院禅城高新区医院老年医学科收治的符合纳入标准的120例中重度原发性高血压伴心绞痛患者,根据随机数表法分为研究组和对照组,每组各60例。对照组使用硝苯地平缓释片Ⅰ治疗,研究组在对照组基础上联合阿利沙坦酯片治疗,疗程为12周。治疗前后测量诊室血压并进行动态血压监测,评估降压效果,计算血压达标率。记录治疗期间两组心绞痛发作持续时间、发作频率、硝酸甘油用量,评估心绞痛改善情况。测量治疗前后患者生命体征,并行血尿常规、血糖、胆固醇、三酰甘油、尿素氮、肌酐、尿酸、血电解质、转氨酶、血清肌酐等实验室检查,记录治疗期间不良反应发生情况。结果治疗后,两组诊室收缩压(SBP)和舒张压(DBP)均较治疗前降低,且研究组低于对照组(P<0.05)。治疗后,两组24 h SBP、24 h DBP、白昼SBP(dSBP)、白昼DBP(dDBP)、夜间SBP(nSBP)和夜间DBP(nDBP)均降低,且研究组低于对照组(P<0.05)。研究组降压总有效率高于对照组(P<0.05)。两组与同组治疗2周后和治疗4周后比较,治疗8周后和治疗12周后两组血压达标率均增加(P<0.05)。治疗后,两组心绞痛发作持续时间、发作频率、硝酸甘油用量均较治疗前减少,且研究组低于对照组(P<0.05)。研究组心绞痛改善总有效率高于对照组(P<0.05)。两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论阿利沙坦酯联合硝苯地平缓释片治疗中重度原发性高血压伴心绞痛疗效显著,有效降压并维持血压稳定的同时,还可改善心绞痛症状,且安全性较高,具有临床应用价值。

硫酸沙丁胺醇气雾剂与茶碱缓释片治疗急诊老年哮喘的临床效果

目的 探讨硫酸沙丁胺醇气雾剂与茶碱缓释片治疗急诊老年哮喘的临床效果。方法 80例急诊老年哮喘患者,应用计算机随机数字表法将所有患者分成常规组与联合组,每组40例。常规组患者使用硫酸沙丁胺醇气雾剂吸入治疗,联合组患者采用硫酸沙丁胺醇气雾剂吸入治疗联合茶碱缓释片口服治疗。比较两组患者治疗前后第1秒用力呼气容积、炎性因子[白细胞介素(IL)-4、IL-13、γ-干扰素(IFN-γ)]水平以及临床疗效、不良反应发生率。结果 治疗4、8周,两组组患者第1秒用力呼气容积均高于治疗前,联合组第1秒用力呼气容积分别为(2.47±0.21)、(2.62±0.17)L,均高于常规组的(2.03±0.23)、(2.16±0.11)L(P<0.05)。联合组临床总有效率90.00%高于常规组的67.50%(P<0.05)。治疗2、8周,两组患者IL-4、IL-13、IFN-γ水平均低于治疗前,联合组患者IL-4分别为(12.03±1.52)、(10.47±1.61)pg/ml,低于常规组的(15.98±1.47)、(12.69±1.63)pg/ml, IL-13分别为(195.26±21.69)、(182.36±27.98)pg/ml,低于常规组的(213.98±21.66)、(200.48±26.39)pg/ml, IFN-γ分别为(8.36±0.62)、(5.17±0.32)pg/ml,低于常规组的(10.47±0.69)、(7.69±0.36)pg/ml(P<0.05)。联合组不良反应发生率22.50%与常规组的17.50%比较,差异无统计学意义(P>0.05)。结论 硫酸沙丁胺醇气雾剂联合茶碱缓释片用于治疗急诊老年哮喘既有较好的安全性,还能提升抑制炎症反应、提升呼吸功能的作用。

基于体外溶出评价方法对硝苯地平缓释片(Ι)一致性评价研究

建立硝苯地平缓释片(Ⅰ)体外溶出评价方法,以原研制剂为参比,评价本公司一致性研究前后的自研制剂(以下简称自制1、自制2),为质量一致性提供依据。选取0.3%吐温80的不同pH值(pH值1.0,pH值4.0,pH值6.8,水)溶液为溶出介质,采用高效液相色谱法考察0.25,0.5,1,2,3,10,12 h的释放度,从而建立体外溶出曲线方法,并进行了方法学验证,最后采用相似因子法(f_(2))将自研制剂与参比进行比较。结果表明,建立的本品体外溶出曲线方法的专属性、线性、精密度、准确度、滤膜吸附、溶液稳定性各项指标均符合要求;自制1与参比溶出行为不一致且f_(2)小于50,调整处方工艺后,自制2与参比体外溶出行为一致,且f_(2)均大于50。本品建立的体外溶出评价方法准确可靠,自制1与参比体外溶出不一致;自制2与参比溶出曲线相似,体外溶出一致。