中药制药装备技术升级的政策、现状与途径分析

中药制药装备技术升级问题是影响中药行业节能、减排以及保障中药制剂质量的关键问题。现代制药工程技术的应用及新学科的发展在一定程度上促进了中药制药装备水平的提高。但长期以来,我国中药制药装备仍处于较低的水平,众多企业的制药装备仍停留在20世纪80年代的水平,其能耗高、污染大、效率低,严重制约着中药产业的可持续发展。在前期工作基础上着重分析了影响中药制药装备发展的瓶颈问题、国家相关政策导向及发展趋势;探讨中药制药装备技术升级的可能途径和新方法,助推中药产业的可持续健康发展,以力求实现中药制药过程的低碳和环境友好,同时保证中药制剂安全、有效及质量稳定。     

中药制药装备技术升级的政策、现状与途径分析

近年来,随着我国制药装备技术的不断发展,我国已成为世界制药机械最大生产国。但是,我国的中药制药装备技术整体上来说水平并不是很高,存在很多问题。例如说,我国中药制药装备重复,且相互仿制,高能耗等。只有提高我国的中药制药技术装备,才能更好地提升我国中药制药水平,振兴我国中药产业。现就我国中药制药装备技术升级的政策、现状与途径作一分析。     

提高中药制剂质量的几个环节

改革开放以来,尤其是入世以来,我国中药制药产业得到迅猛发展,已初步成为我国国民经济和社会发展中一项具有较强发展优势和广阔市场前景的朝阳产业。但从总体来看,中药制剂的发展仍存在不少问题,主要如下：中药制剂原药材质量不稳定;中药制剂处方缺乏严谨、简练、科学性;中药制剂工艺水平不高,技术含量较低;中药制剂质量量化标准缺乏或不完善,     

超临界CO2萃取技术在天然药物研究中的应用

中药发挥作用的物质基础是有效成分，有效成分的生成(种植)和取得(提取分离)是中药现代化的关键，这也是我国中药产业最薄弱的环节。解决中药现代化重大工程技术问题，寻求中药有效成分提取分离技术在规模化、产业化水平的技术突破，将有力地推动种植、制剂、质量控制等环节技术水平的提高。因此中药要参与国际市场竞争，实现中药现代化，必须改进传统中药制药的提取分离技术，发展高效实用的提取分离新技术，如树脂吸附技术、膜分离纯化技术、超临界萃取技术、分子蒸馏技术等，并在制药工业中推广应用，以加快中药产业现代化进程。     

统一编制制药装备产品型号的思考

我国制药产业近年来迅猛发展,药品剂型、种类迅速增加,整体产量提高很快。尤其是一些新工艺的引进,不仅提高了医药产品的质量,而且节约了能源。这些优势的显现与制药装备制造水平的提升是分不开的。制药装备制造业的高速发展对制药产业的发展可谓功不可没。尤其是制药装备制造企业在引进消化吸收方面、创新方面和仿制方面有了长足的发展。制造企业打造名牌意识的增强,造就了一批知名的制药企业。虽然国家颁布了制药装备的制造标准,但是同种同类的制药装备、制造企业不同,产品型号的编制也就不一样,或不完全统一。同种同类制药装备统一型号的…     

浅谈院内自制制剂质量控制存在的问题及问题分析

目的探讨院内自制制剂质量控制中存在的问题及问题的分析思考。方法回顾分析我院近一年内自制药品检验时遇到的问题并进行分析。结果经过分析发现,硬件设施、剂型、制作工艺对自制制剂质量的影响最为重要,原材料、储存环境和人员对自制制剂的质量也有影响,为了控制自制制剂质量,必须严格处方配比,规范制药工艺,保证原材料质量以及加强人员专业水平培训。结论影响自制制剂质量的因素主要是硬件设施,剂型,制药工艺和原材料等,在制药和药品管理的过程中要加强针对性和规范性,保证药品质量,提高治疗效果。     

国外中药制剂进展概况

近数十年来,中药制剂的研究、生产和应用,不仅在国内取得了巨大进展,而且在世界各地引起普遍关注,不少国家和地区将现代技术和先进设备应用于中药制剂的研究和生产,使得中成药的剂型品种不断发展,工艺技术不断优化,成品质量不断提高,为中药制剂的进一步发展开拓了广阔前景。一、中药制药在亚洲、欧洲及美国简况在亚洲,日本的中成药生产水平堪称世界一流。自76年汉方药被政府承认后,日本再次掀起了     

京帮传统中药制药技术流派特点及在甘肃的发展状况

从京帮传统中药制药工具、制剂工艺及在甘肃的发展3个方面对传统中药制药技术流派的特点进行了总结与分析,并介绍了甘肃庆阳一带水泛丸制剂工艺的应用与发展,以期促进京帮传统中药制药技术的传承与发展。     

基于工作过程的中药固体制剂成型课程改革探讨

中药固体制剂成型是我校中药制药专业的一门专业课程,也是我校的重点改革课程。该课程以中药固体制剂生产岗位的工作任务为主线,整合了中药制剂技术、中药制药设备、药事管理学、药品生产质量管理规范等多门学科的知识,以中药固体制剂生产为工作过程,要求学生掌握中药固体制剂的成型技术、剂型特点、制备方法、质量要求和检查方法,     

HPLC法测定中药成方制剂中有效成分

中药制剂成分复杂定量困难,一直是影响中药制药发展的重要问题之一。本课题通过对穿山龙注射液、当归寄生注射液、复方丹参片、元胡止痛片等中药制剂中有效成分含量测定的研究,确定了一套采用HPLC法测定中药成方制剂中有效成分含量     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.     

Expression of OPGmRNA and ODFmRNA in the patients of hip fracture due to osteoporosis

Objective：To investigate the gene expression of osteoprotegerin（OPG） and osteoclast differentiation factor（ODF） in the bone tissue of patients with hip fracture due to osteoporosis. Methods：OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers（over 50 years old） with hip fracture（Observer Group） and 30 cases of hip facture sufferers with no osteoporosis（Control group） were analyzed with the Semi-Quantitative RT-PCR method. Results：The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion：Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption.     

Dynamic Changes in Serum Estradiol and Progesterone levels in Patients of Premenstrual Syndrome with Adverse Flow of Liver-qi

Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.     

Real-time Three-dimensional Echocardiography in Assessment of Left Ventricular and Right Ventricular Volumes

Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.     

SCREENING FOR A 21-CHROMOSOME ABNORMALITY IN PREIMPLANTED EMBRYOS OF ELDERLY WOMEN

Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.     

Scientific principles and rigorous processes should be followed in developing clinical guidelines for therapeutic interventions of integrative medicine

A clinical guideline for the therapeutic interventions of integrative medicine may be defined as a written document which states a series of recommendations on therapeutic interventions of integrative medicine for a special disease or condition. The guideline may provide assistance to medical professionals in making clinical decisions aimed at improving the clinical outcome of patients and reducing the costs of medical care（~＇4~. Recommendations issued by a guideline should be based on the best available evidence in both Western and Chinese medicine. For fulfilling this purpose, the development of clinical guidelines for therapeutic interventions in the field of integrative medicine should follow scientific principles and undergo a rigorous processes.