Exploration on Shared Decision-making Mechanisms in Chinese Medicine Treatment / 中国医学伦理学

Traditional Chinese medicine(TCM) treatment models are rich and unique, including patient-led decision-making, doctor-led decision-making, and doctor-patient shared decision-making. However, doctor-led decision-making is more common. The connotation of TCM shared decision-making is rich, including not only the smooth flow of information and the encouragement and support of equal participation by patients, but also the discussions on various aspects of diet, exercise, emotions, daily life, physiology, psychology, society, and nature that affect health based on the unique holistic concept of TCM. Integrating "shared decision-making" into the treatment process of TCM can be divided into four steps according to the process of "diagnosis and treatment". TCM shared decision-making has advantages and limitations, requiring both doctors and patients to meet certain objective conditions, and there are also special situations in TCM treatment where shared decision-making cannot be applied. Multiple ways to enhance the decision-making ability of doctors and patients, scientific evaluation and matching treatment plans, development of decision-making aids, and smooth channels for information transmission can all enhance the shared decision-making ability of doctors and patients.

A Novel Single-arm Single-port Micro-traumatic Laparoscopic Robotic Surgical System / 中国医疗器械杂志

As the robotic assisted single port surgery arousing attention, a novel single-arm single-port micro-traumatic laparoscopic robotic surgical system is proposed in this study. From the perspective of the mechanics, joints with high rigidity and high reliability were utilized to realize the remote center of motion (RCM). Besides, the cost of consumables was reduced by adding the support of the rigid endoscope. From the perspective of the algorithm, high-precision motion control method and feedback force protection mechanism were implemented. The effectiveness of the aforementioned characteristics were verified by five clinical experiments of cholecystectomy. The results showed that the system is able to reduce the amount of bleeding, accelerate the patient recovery, reduce the infection risk and shorten the learning period. The robotic surgical system had significant clinical application value.

Application of minimally invasive technique in kidney transplantation / 器官移植

Since the 21st century, minimally invasive technique has become a main development direction of surgery, which has been widely applied in all branches of surgery. In the field of kidney transplantation, minimally invasive technique has been mainly applied in the procurement of living donor kidney, kidney transplantation and the management of complications after kidney transplantation. It not only increases the resource of donor kidney, but also reduces the incidence of postoperative complications and enhances the quality of life of the recipients. The application of minimally invasive technique has become one of the research hot spots in the field of kidney transplantation. In this article, research progresses on the application of minimally invasive technique in the procurement of living donor kidney, kidney transplantation and management of complications after kidney transplantation were reviewed, aiming to provide reference for increasing the resource of donor kidney, enhancing the success rate of kidney transplantation and improving clinical prognosis of kidney transplant recipients, thereby promoting the development of minimally invasive technique in surgery.

Validation of detection method for tributyl phosphate residue in human prothrombin complex / 中国输血杂志

【Objective】 To establish gas chromatography for the determination of tributyl phosphate(TBP) residues in human prothrombin complex and then verify it. 【Methods】 Acid modified polyethylene glycol(PEG)(20M) capillary column was used with n-hexane as solvent. The chromatographic parameters were as follows: gasification chamber temperature at 220 ℃, column temperature at 155 ℃, detector temperature at 220 ℃, column flow rate at 2.0 mL/min, carrier gas as N2, detector as FID, and collection time for 10min. The accuracy, repeatability, linearity, specificity, intermediate precision, detection limit, quantitative limit, range and durability were verified. 【Results】 The verification results showed that the method had good specificity. The linear regression correlation coefficient of standard curve was 0.999 90. The recovery rate were 98.4%, 97.5% and 95.7% when the concentration at 50%, 100%(30μg/mL) and 150%, respectively, with an average recovery of 97.2% and a relative deviation of 2.15%. When the concentration was 100%, the repeatability was 2.08%, and the relative deviation of intermediate precision was 1.63%. The detection limit was 0.255 μg/mL, and the quantitative limit was 0.511 μg/mL. After changing capillary chromatographic columns with different batch numbers but the same types and manufacturer, the applicability test of the system met the requirements, and the method had good durability. 【Conclusion】 This method can be used for the determination of TBP residues of human prothrombin complex in laboratory.

Establishment and verification of the tightness inspection method of blood products / 中国输血杂志

【Objective】 To establish and verify the vacuum decay method for the tightness inspection of blood products. 【Methods】 The method for inspecting the tightness of blood product was established, and the detection limit, linearity, range, accuracy, precision and durability were verified according to the requirements of methodological verification.The validated method was used to check the tightness of blood product packaging. 【Results】 The detection limit of this method was 2.5 μm, linear correlation coefficient was r=1, the differential pressure of positive sample was within the allowable range of accuracy, and the durability met the requirements.The RSD of results of 6 repeatability tests and 12 intermediate precision tests were both less than 10%, and all validation items met the verification standards. 【Conclusion】 Vacuum decay method can be used to check the tightness of blood products.

Determination of polymer content in human albumin production process / 中国输血杂志

【Objective】 To study the quality control of human albumin intermediates content in production process using High Performance Liquid chromatography (HPLC) method. 【Methods】 In accordance with the general principles of The Chinese Pharmacopoeia (2015 edition), 3121 human albumin polymer was used to determine the component V precipitation solution, human albumin stock solution, human albumin semi-finished products and human albumin products in the production process of human albumin. The chromatographic retention time and the chromatographic peak area percentage corresponding to the retention time were analyzed. 【Results】 The polymer content of component V precipitation solution, human albumin stock solution, human albumin semi-finished products, and human albumin products were was 0.2% vs 0.0% vs 1.9% vs 1.7%, 0.2% vs 0.0% vs1.8% vs1.5% and 0.1% vs 0.0% vs 1.6% vs 1.5%, respectively. 【Conclusion】 HPLC can be used as a monitoring method for human albumin production.

Verification of method for microbial limit test on diatomite and pearlite / 中国输血杂志

【Objective】 To establish a microbial limit test method for diatomite and pearlite, and verify its applicability. 【Methods】 According to the requirements of general rule 1105, Microbial Limit Test for Non Sterile Products of Pharmacopoeia of the People′s Republic of China (2020 Edition), the applicability test of microbial counting methods for three batches of perlite and diatomite was conducted before the microbial limit test of samples. The microbial growth of filter aid was analyzed and the recovery rate of each test bacterium was calculated. 【Results】 The ratio of the colony number of the test group minus the colony number of the test sample control group to the bacterial liquid control group was in the range of 0.5~2.0. 【Conclusion】 The method is accurate, reliable and can be used for microbial limit test of diatomite and perlite.

Clinical experience of surgical treatment in metastatic renal cell carcinoma with venous tumor thrombus / 中华泌尿外科杂志

Objective:To investigate the safety and effectiveness of cytoreductive nephrectomy and tumor thrombectomy in patients with metastatic renal cancer with renal vein or inferior vena cava tumor thrombus.Methods:From February 2015 to May 2019, 56 cases of metastatic renal cell carcinoma with venous tumor thrombus were analyzed retrospectively, including 44 male (78.6%) and 12 female (21.4%)cases, and the average age was (59.2±10.7)(22-82). The clinical presentations covered local symptoms in 26 cases (46.4%), systemic symptoms in 8 cases (14.3%), both local symptoms and systemic symptoms in 12 cases (21.4%), and asymptomatic in 10 cases (17.9%). Among them, renal tumors were located in 35 cases (62.5%) on the right and 21 cases (37.5%) on the left. The average tumor diameter was (10.1±3.8)(1.5-21.1) cm. Forty-five cases (80.4%) scored 2 points and 11 cases (19.6%) scored 3 points by the American Society of anesthesiologists(ASA). Preoperative hemoglobin was (118.2±23.1)(72-178) g/L, and albumin was (37.9±5.6)(23-50) g/L, total protein was (67.7±6.7)(43-81) g/L, serum creatinine was (111.3±119.6)(32-958) μmol/L. There were 16 cases of Mayo 0 (28.6%), 14 cases of Mayo Ⅰ(25.0%), 17 cases of Mayo Ⅱ(30.4%), 4 cases of Mayo Ⅲ(7.1%), and 5 cases of Mayo Ⅳ(8.9%). Fourteen cases (25.0%) were in the stage of cN 0 and 42 cases (75.0%) in the stage of cN 1. Five cases (8.9%) had simple bone metastasis, 16 cases (28.6%) had simple lung metastasis, 2 cases (3.6%) had simple adrenal metastasis, 6 cases (10.7%) had simple liver metastasis, and 27 cases (48.2%) had 2 or more multiple system metastasis. According to the location of the organ system, 91 metastatic lesions were found in 56 patients. Among them, 37 cases (40.7%) had lung metastasis, 18 cases (19.8%) had liver metastasis, 21 cases (23.1%) had bone metastasis and 15 cases (16.5%) had adrenal metastasis. All 56 patients belonged to IMDC prognosis score model medium risk group. The surgical treatment of Mayo grade 0 tumor thrombus was the same as that of routine radical nephrectomy. The tumor thrombus of Mayo grade Ⅰ was removed after IVC was partially blocked by Satinsky′s forceps. The Mayo Ⅱ tumor thrombus was removed, after blocking the distal vena cava, the contralateral renal vein and the proximal vena cava. Mayo grade Ⅲ tumor thrombus needed pringer's method to block the first porta hepatis. For grade Ⅳ tumor thrombus the diaphragm could be cut directly, or the thrombus could be removed by cardiopulmonary bypass. Laparoscopic surgery was performed in 22 cases (39.3%) and open surgery in 30 cases (53.6%). Six cases (10.7%) underwent IVC wall resection because of tumor invasion. 32 cases (57.1%) underwent ipsilateral adrenalectomy because of tumor invasion or adrenal metastasis, and 23 cases (41.1%) underwent ipsilateral lymphadenectomy. In this study, there were 11 cases of solitary metastasis, 8 cases of which were operated on and 3 cases of which were not operated on. Forty-three patients were treated with sunitinib after palliative nephrectomy, 9 patients were treated with pazopanib, 3 patients were treated with acitinib, and 1 patient was treated with sorafenib. Results:The operations were successfully completed in 56 patients. Four cases (7.1%) changed from laparoscopic surgery to open surgery. The operation time was (326.8±114.9)(108-589) min. Intraoperative hemorrhage was (1 435.2±1 513.4)(20-6 000) ml, intraoperative red blood cells transfusion was (1 456.7±832.8)(400-3 600) ml in 30 cases, and intraoperative plasma transfusion was (700.0±473.6)(200-1 800) ml in 15 cases. The postoperative hospital stay was (10.6±4.6)(5-26) days. The serum creatinine one week after operation was (109.5±98.7) (47-772) μmol/L. There were 46 cases (82.1%) of renal clear cell carcinoma, 7 cases (12.5%) of papillary renal cell carcinoma and 3 cases (5.4%) of unclassified renal cell carcinoma. One case was WHO/ISUP 2016 nuclear grade 1 (1.8%), 20 cases(36.4%) was grade 2, 18 cases(32.7%)was grade 3, and 16 cases(29.1%)was grade 4. Early postoperative complications occurred in 22 cases (39.3%). Among them, 1 case of Clavien gradeⅠ was wound infection. There were 16 cases with Clavien gradeⅡ, including 5 cases who received blood transfusion due to anemia, 3 cases with chylous fistula, 4 cases with postoperative pulmonary infection, 2 cases with postoperative lower extremity venous thrombosis, 1 case with atrial fibrillation and 1 case with epididymitis. Clavien gradeⅢ a was found in 1 case with pneumothorax. Clavien gradeⅣ was found in 2 cases, including 1 case of acute cerebral infarction and 1 case of renal insufficiency.There were 2 cases with Clavien gradeⅤ with perioperative death. Among the 56 patients, 5 lost the follow-up, 2 died during the perioperative period, and the other 49 patients were followed up for 1-39 months, with a median follow-up of 14 months. The mean survival time was (25.6±2.5) months, and the median survival time was 25 months.Conclusions:It was relatively safe and effective to perform cytoreductive nephrectomy and tumor thrombectomy in patients with metastatic renal cancer with tumor thrombus. For the patients with clinical symptoms, IMDC prognosis score model medium risk group, and strong desire for surgery, the combination of cytoreductive nephrectomy with tumor thrombectomy and postoperative targeted medical therapy was recommended.

Effects of ferritin heavy chain of Clonorchis sinensis on human hepatic stellate cell line LX-2 / 中华地方病学杂志

Objective To observe the effects of recombinant protein ferritin heavy chain of Clonorchis sinensis (CsFHC) on human hepatic stellate cell line LX-2. Methods LX-2 cells were cultured in vitro by the cell culture method . Cell proliferation/toxicity detection kit (CCK-8) was used to detect the cell proliferation activity of LX-2 cells stimulated with CsFHC recombinant protein [0 (control), 1, 2, 5, 10, 20 nmol/L] at 48 h and 72 h, respectively, and the effect of CsFHC recombinant protein on cell cycle was analyzed by flow cytometry; a semi quantitative RT-PCR was used to detect the mRNA expression of type I collagen (Collagen Ⅰ), type Ⅲ collagen (Collagen Ⅲ) and α smooth muscle actin (Αsma). Results The effects of CsFHC on proliferation of LX-2 cells (48 h: 0.987 ± 0.042, 1.315 ± 0.105, 1.298 ± 0.078, 1.432 ± 0.089, 1.781 ± 0.040, 1.581 ± 0.056; 72 h:1.050 ± 0.030, 1.503 ± 0.111, 1.671 ± 0.102, 1.769 ± 0.123, 1.927 ± 0.067, 1.492 ± 0.081) between groups were significantly different statistically (F = 1892.133, 534.136, P<0.05). The quiescent stage/DNA synthesis (G0/G1 ) cells in 1, 2, 5, 10, and 20 nmol/L CsFHC recombinant protein groups (74.93 ± 4.05, 75.87 ± 4.16, 76.73 ± 5.03, 78.57 ± 5.51, 74.90 ± 3.61) were significantly higher than that of control group (54.90 ± 3.61, P<0.05);the synthesis phase (S) + DNA synthesis late/mitotic (G2/M) cells (22.24 ± 3.06, 24.13 ± 2.00, 18.54 ± 1.53, 18.71 ± 1.53 and 21.17 ± 3.06) were lower than that of control group (33.26 ± 2.65,P < 0.05). In control and 1, 2, 5, 10, 20 nmol/L CsFHC recombinant protein groups, the differences of Mrna expression levels of Collagen Ⅰ, Collagen Ⅲ and α SMA were statistically significant (48 h:F=81.419, 14.417, 70.456;72 h:F=79.224, 50.461, 41.872, P<0.05). Conclusion The CsFHC recombinant protein can stimulate the proliferation and activation of LX-2 cells in vitro, the CsFHC involved in the process of hepatic fibrosis induced by Clonorchis sinensis.

A survey of epidemic status of principal human parasites in Guangdong Province in 2015 / 中华地方病学杂志

Objective To analyze the epidemic status of principal human parasites, so as to provide scientific evidence for making prevention countermeasures for Guangdong Province in the future. Methods In 2015, a survey was performed according to the scheme of "The 3rd National Survey of Principal Human Parasites"as well as the incidence of parasites disease in Guangdong Province,the residents at 48 investiation sites in counties were surveyed. The survey of the soil-transmitted nematodes (Ascariasis, Ancylostoma, Trichuris trichiura and Enterobius vermicularis) and intestinal protozoa were performed based on the ecological regions and stratified by economic and geographic situation.The survey of food borne Clonorchis sinensis was performed along with the soil-transmitted nematodes in rural areas, and it was performed by the sample method of random cluster in cities and towns.The residents in each investigation site as the object, the ovum of the soil-transmitted nematodes, Clonorchis sinensis and other helminths were examed by the modified Kato-Katz method, test tube filter paper was used to identify Hookwormspecies, and the intestinal protozoa was checked by direct smear method. The transparent tape anal swabs method for children aged 3 - 6 years to check Enterobius vermicularis. Results Totally 12 401 residents of 48 survey sites from 22 counties were surveyed, and the total infection rate of intestinal parasites was 8.29%(1 028/12 401). The infection rate of soil-transmitted nematodes was 3.39% (420/12 401),in which the infection rate of Ascariasis, Ancylostoma, Trichuris trichiura and Enterobius vermicularis were 0.52% (64/12 401), 1.89%(234/12 401),0.46%(57/12 401),and 0.52%(65/12 401),respectively.The infection rate of Clonorchis sinensis was 4.90%(608/12 401). Nine hundred and sixty-seven children were tested for eggs of Enterobius vermicularis with the infection rate of 12.41% (120/967). The number of hook larva culture was 153, among them, 140 were hookworm larvae of America and no duodenal hookworm larvae and other nematode species were found.Totally 9 309 residents were tested for intestinal protozoa infection,and the infection rate was 0.31%(29/9 309). Conclusion In Guangdong Province, the infection rate of soil-transmitted nematodes is decreasing while the infection rate of Clonorchis sinensis is still high, and the control work of parasites still should be strengthened especially for food borne parasitic diseases.

Progress in research on TLR7 gene single nucleotide polymorphisms and copy number variations in autoimmune diseases / 中华医学遗传学杂志

Autoimmune diseases (AID) are a group of complex disorders due to antibodies acting on self-antigens causing damage to the body. AID has long been considered as the outcome of genetic and environmental interactions. In recent years, studies have shown that increased susceptibility to AID may be associated with single nucleotide polymorphisms and copy number variations of Toll like receptor 7 (TLR7) gene, which provided a clue to further understanding of the pathogenesis of AID. This paper provides a review of the recent advances in understanding of the roles of TLR7 gene single nucleotide polymorphisms and copy number variations in AID.

Distribution and schistosomiasis transmission risks of Biomphalaria stra-minea in inland China / 中国血吸虫病防治杂志

Biomphalaria straminea,the intermediary host of Schistosoma mansoni,was found by survey in local areas of Shen-zhen City in 1981,which was the first finding of the snail in inland China. By 2013,the snail had spread in large range of Shen-zhen City and overspread to the surrounding regions,Dongguan City and Huizhou City. Due to the facts that Shenzhen City has many international communications and is a key area of labor export,with high population mobility,while the reports of S. manso-ni infection in the returnees of our country from Africa have been increasing recently,it must be paid a high attention to whether the epidemic or transmission of schistosomiasis mansoni may happen under the present circumstance. This paper initially discusses the finding,distribution,spreading and overspreading and transmission risk of B. straminea in inland China and puts forward some related control suggestions.

CD4+ cell count analysis on 1 056 cases of HIV/AIDS treated with TCM for half a year / 国际中医中药杂志

Objective To Analyze CD4+ cell count which embodies curative effect in HIV and patients with AIDS, who have treated with TCM for half a year. Methods According to CD4+cell count, the patients were divided into 4 phases. Their CD4+cell count were analyzed before and after the treatment. Results 1.Rank sun test showed that CD4+cell count were significantly improved in people who used TCM treatment. On the whole, CD4+cell count was(317.76±175.61) in 1 cu mm before treatment, which was(350.60±175.92) in 1 cu mm after treatment, P<0.01. 2. Ridit showed that patients whose CD4+cell count more than 500 were in phase I. Their R=0.614, and the 95%confidence interval was 0.5702 to 0.6579. Patients whose CD4+cell count more than 350 and less than 500 were in phase II. Their R=0.575, and the 95%confidence interval was 0.5439 to 0.6062. Patients whose CD4+cell count more than 200 and less than 350 were inphase III. Their R=0.460 and the 95%confidence interval was 0.4347 to 0.4849. Patients whose CD4+cell count less than 200 were in phase IV. Their R=0.428, and the 95%confidence interval was 0.3971 to 0.4589. There was no overlap between phase III, phase IV and phase I, phase II in 95% confidence interval. Conclusion TCM has the advantages in strengthening vital qi, but that is worse than western medicine in effort of expelling pathogen.

Observation of sweating rate and temperature variation in arteriosclerosis obliterans patients / 国际生物医学工程杂志

Objective To investigate the evaluative meaning of the traditional Chinese medicine (TCM)sweat detector and temperature detector to atheriosclerosis obliterans (ASO).Methods 68 limb plantar of ASO patients and 20 left plantar of healthy subjects were tested by TCM sweat detector and temperature detector to observe the differences of sweating rate and temperature between the two groups.Results ①Sweating rate and temperature of ASO patients' limb plantar showed different graphic morphology from that of healthy control group.The sweating rate of patients was worse than that of healthy subjects in responding to external stimuli.②ASO patients'limb plantar baseline values of the sweating rate and temperature were lower than that of healthy subjects,and the result was statistical significant (P＜0.01).Conclusion Data obtained from TCM sweat detector and temperature detector can be used to distinguish ASO patients from healthy people.

Analysis of common syndrome elements of chronic viral hepatitis / 国际中医中药杂志

Objective Determine the common syndrome elements of viral hepatitis.Methods Refering to the syndrome elements hypothesis proposed by Zhang Zhibin,syndrome elements from the collection of 19,341 cases of Viral Hepatitis were extracted which were diagnosed by National Science and Technology Major Project of AIDS and Viral Hepatitis and Other Major Infectious Diseases Prevention and Control.And the results were compared with industry standards.Results There were 27 involved syndrome elements of viral hepatitis.Common syndrome elements were Qi stagnation,internal dampness,internal fire,blood stasis,yin deficiency,Qi deficiency,toxin,pathogenic water,and yang deficiency; The main excessive syndromes were Qi stagnation,internal dampness,internal fire,and blood stasis.The main deficiency syndromes were yin deficiency and Qi deficiency.Conclusion Excessive syndromes were the main syndromes of viral hepatitis.Dampness,heat,blood stasis,and toxin played key roles in the development of viral hepatitis.In addition to this,Qi stagnation,pathogenic water and phlegm were also important syndrome elements.

High performance liquid chromatographic separation of thirteen drugs collected in Chinese Pharmacopoeia 2010(Ch.P2010) on cellulose ramification chiral stationary phase / 药物分析学报

The enantiomers separation of thirteen drugs collected in Ch.P2010 was performed on chiral stationary phase of cellulose ramification (chiralpak OD and chiralpak OJ) by high performance liquid chromatographic (HPLC) methods,which included ibuprofen (Cl),ketoprofen (C2),nitrendipine (C3),nimodipine (C4),felodipine (C5),omeprazole (C6),praziquantel (C7),propranolol hydrochloride (C8),atenolol (C9),sulpiride (C10),clenbuterol hydrochloride (C11),verapamil hydrochloride (C12),and chlorphenamine maleate (C13).The mobile phase consisted of isopropanol and n-hexane.The detection wavelength was set at 254 nm and the flow rate was 0.7 mL/min.The enantiomers separation of these thirteen racemates on chiralpak OD column and chiralpak OJ column was studied,while the effects of proportion of organic additives,alcohol displacer and temperature on the separation were studied.And the mechanism of some of racemates was discussed.The results indicated that thirteen chiral drugs could be separated on chiral stationary phase of cellulose ramification in normal phase chromatographic system.The chromatographic retention and resolution of enantiomers could be adjusted by factors including column temperature and the concentration of alcohol displacer and organic alkaline modifier in mobile phase.It was shown that the resolution was improved with reducing concentration of alcohol displacer.When concentration of organic alkaline modifier was 0.2％ (v/v),the resolution and the peak shape were fairly good.Most racemates mentioned above had better resolution at column temperature of 25 ℃.When racemates were separated,the temperature should be kept so as to obtain stable separation results.

Methods for grain size analysis of nanomedicines / 药学学报

As nanomedicines are developing fast in both academic and market areas, building up suitable methods for nanomedicine analysis with proper techniques is an important subject, requiring further research. The techniques, which could be employed for grain size analysis of nanomedicines, were reviewed. Several key techniques were discussed with their principles, scope of applications, advantages and defects. Their applications to nanomedine analysis were discussed according to the properties of different nanomedicines, with the purpose of providing some suggestions for the control and administration of nanomedicines.

Analysis and evaluation of the impurity of felodipine and its tablets / 药学学报

The paper reports the systematic study on felodipine and its impurities in tablets, to improve its quality standards for the control of the related substances. HPLC-DAD, UPLC-MS, IR and NMR methods were used for the isolation of felodipine and its impurities in tablets, their identification and the zebrafish animal model was used for the analysis of the toxic impurities. In felodipine material and its tablets, three impurities are isolated and identified. They are impurity 1 [dimethyl 4-(2, 3-dichlorophenyl)-2, 6-dimethyl-1, 4-dihydropyridine-3, 5-dicarboxylate], impurity 2 [ethyl methyl 4-(2, 3-dichlorophenyl)-2, 6-dimethylpyridine-3, 5-dicarboxylate] and impurity 3 [diethyl 4-(2, 3-dichlorophenyl)-2, 6-dimethyl-1, 4-dihydropyridine-3, 5-dicarboxylate], separately. The result of zebrafish animal model analysis showed that the teratogenic effects of four compounds were: impurity 3 > or = felodipine > impurity 1 > impurity 2, lethal effects were as follows: impurity 2 = impurity 3 > felodipine > or = impurity 1. This study confirmed the toxicity of three impurities in felodipine. According to the results, the paper suggested the amendments to the standard of the medicine and provided the support to the control of impurities in the manufacturing process.

HPLC determination of six components in zedoary turmeric oil and its related injections / 中国中药杂志

<p><b>OBJECTIVE</b>To establish an HPLC method to simultaneously determine six ingredients in zedoary turmeric oil and its related injections.</p><p><b>METHOD</b>HPLC analysis was performed on Waters Symmetry C18 (4.6 mm x 250 mm, 5 microm). The mobile phase was composed of methanol and water solution in gradient elution mode with at a flow rate of 1.0 mL x min(-1). The column temperature was 30 degrees C and the UV detection wavelength was 215 nm.</p><p><b>RESULT</b>The six ingredients were separated well. The linear ranges of curdione, curcumol, germacrone, curzerene, furanodiene and beta-elemene were 1.74-347.00, 2.38-475.00, 2.49-497.00, 2.07-826.00, 5.05-1009.00, 4.78-955.00 mg x L(-1) (r > or = 0.9996), respectively. The average recoveries were above 95% (RSD <3.0%, n=9).</p><p><b>CONCLUSION</b>The method is accurate, reliable and reproducible, it can be used for the quality control of zedoary turmeric oil and its related injections.</p>

Development and validation of HPLC-UV-MS method for the control of four anti-diabetic drugs in suspected counterfeit products / 药学学报

An HPLC-UV method has been developed for the determination of valibose, miglitol, voglibose and acarbose, the four anti-diabetic drugs. The separation was accomplished successfully by using reversed phase chromatography (Prevail carbohydrate column, 250 mm x 4.6 mm, 5 microm) with a gradient acetonitrile-phosphate buffer solution (pH 8.0) at a wavelength of 210 nm. Furthermore, the method of a high-performance liquid chromatography coupled with ESI-MS in positive ionization mode has been established. These two methods were successfully applied to the assay and qualitative detection of four alpha-glucosidase inhibitors in the potential counterfeit anti-diabetic drugs.