Meta-analysis of the efficacy and safety of Ilaprazole Enteric-Coated Tablets on reflux esophagitis / 药学实践杂志

Objective To evaluate the efficacy and safety of Ilaprazole Enteric-Coated Tablets in the treatment of RE. Methods The databases of CNKI, VIP, Wanfang Data, PubMed, Embase, and The Cochrane Library were searched to collect all the randomized controlled trials (RCTs) of Ilaprazole in the treatment of RE published before April 2021. After data extraction and quality evaluation, the RCTs meeting the inclusion criteria were performed, and the meta-analysis was conducted by RevMan 5.4. Results Nine RCTs were included, with a total of 1115 patients of RE. The results of the meta-analysis showed that Ilaprazole Enteric-Coated Tablets were comparable to Esomeprazole Enteric-Coated Tablets in both endoscopic efficiency (90.08% vs. 90.00%, P > 0.05) and symptom relief rates (91.79% vs. 91.23%, P > 0.05), and there was no statistically significant difference in the incidence of adverse reactions (7.99% vs. 8.66%, P > 0.05). Conclusion Ilaprazole Enteric-Coated Tablets with lower doses were comparable to Esomeprazole Enteric-Coated Tablets which showed good efficacy and safety in the treatment of reflux esophagitis.

Bridging the structure gap between pellets in artificial dissolution media and in gastro-intestinal tract in rats

Changes in structure of oral solid dosage forms (OSDF) elementally determine the drug release and its therapeutic effects. In this research, synchrotron radiation X-ray micro-computed tomography was utilized to visualize the 3D structure of enteric coated pellets recovered from the gastrointestinal tract of rats. The structures of pellets in solid state and in vitro compendium media were measured. Pellets in vivo underwent morphological and structural changes which differed significantly from those in vitro compendium media. Thus, optimizations of the dissolution media were performed to mimic the appropriate in vivo conditions by introducing pepsin and glass microspheres in media. The sphericity, pellet volume, pore volume and porosity of the in vivo esomeprazole magnesium pellets in stomach for 2 h were recorded 0.47, 1.55 × 108 μm3, 0.44 × 108 μm3 and 27.6%, respectively. After adding pepsin and glass microspheres, the above parameters in vitro reached to 0.44, 1.64 × 108 μm3, 0.38 × 108 μm3 and 23.0%, respectively. Omeprazole magnesium pellets behaved similarly. The structural features of pellets between in vitro media and in vivo condition were bridged successfully in terms of 3D structures to ensure better design, characterization and quality control of advanced OSDF.

Exposure difference of various dosage forms of mycophenolic acid in different age groups of pediatric kidney transplantation / 器官移植

Objective To investigate the exposure difference of different dosage forms of mycophenolic acid (MPA) between children aged ≤12 and > 12 years old after kidney transplantation. Methods Clinical data of 73 children undergoing kidney transplantation from donation after cardiac death (DCD) were retrospectively analyzed. Postoperative immunosuppressive regimen was MPA+ tacrolimus+glucocorticoid. According to different dosage forms of MPA, all recipients were divided into group A (n=37, mycophenolate mofetil capsules), group B (n=28, enteric-coated mycophenolate sodium) and group C (n=8, mycophenolate mofetil dispersible tablets). All children were divided into ≤12 and > 12 years old groups according to the age of kidney transplantation. The daily dosage of different dosage forms was calculated. The blood concentration (C) of MPA and the area under the curve (AUC) were detected by enzyme-multiplied immunoassay technique. The MPA blood concentration was statistically compared between two age groups at different time points. The recovery of renal function and postoperative complications were assessed. Results No significant differences were observed in the dosage and blood concentration of drug at different time points among groups A, B and C (all P > 0.05). The MPA-C4 h and AUC in the ≤12 years old group were significantly higher than those in the > 12 years old group (both P < 0.05). In group B, the MPA-C4 h of children aged ≤12 years old was significantly higher compared with that in those aged > 12 years old (P=0.016). The MPA-C4 h of children aged ≤12 years old in group B was higher than those in group A and group C, but the differences were not statistically significant (P=0.080). There was no significant difference in the incidence of acute rejection and infection among three groups (both P > 0.05). Conclusions Children of different ages who are given with different dosage forms of MPA after kidney transplantation obtain different exposure rates. The exposure rate of kidney transplant recipients aged ≤12 years old tends to be higher than that of their counterparts aged > 12 years old, mainly seen in the recipients treated with enteric-coated mycophenolate sodium. Therefore, it is necessary to monitor the exposure level of MPA, which provides significant guidance for adjusting the drug dosage of different dosage forms.

Effect of Weikang Capsule () on Aspirin-Related Gastric and Small Intestinal Mucosal Injury / 中国结合医学杂志

OBJECTIVE@#To investigate the effects of Weikang Capsule (, WKC) on aspirin-related gastric and small intestinal mucosal injury by magnetically controlled capsule endoscopy (MCCE).@*METHODS@#Patients taking enteric-coated aspirin aged 40-75 years were enrolled in Beijing Anzhen Hospital, Capital Medical University from January 2019 to December 2019. The patients continued taking aspirin Tablet (100 mg per day) and underwent MCCE before and after 1-month combined treatment with WKC (0.9 g per time orally, 3 times per day). The gastrointestinal symptom score, gastric Lanza score, the duodenal, jejunal and ileal mucosal injury scores were used to evaluate the gastrointestinal injury before and after treatment. Adverse events including nausea, vomiting, abdominal pain, abdominal distension, abdominal discomfort, dizziness, or headache during MCCE and combined treatment were observed and recorded.@*RESULTS@#Twenty-two patients (male/female, 13/9) taking enteric-coated aspirin aged 59.5 ± 11.3 years with a duration of aspirin use of 28.0 (1.0, 48.0) months were recruited. Compared with pre-treatment, the gastrointestinal symptom rating scale scores, gastric Lanza scores, and duodenal mucosal injury scores were significantly reduced after 1-month WKC treatment (P<0.05), and jejunal and ileal mucosal injury scores showed no obvious change. No adverse events occurred during the trial.@*CONCLUSIONS@#WKC can alleviate gastrointestinal symptoms, as well as gastric and duodenal mucosal injuries, in patients taking enteric-coated aspirin; it does not aggravate jejunal or ileal mucosal injury, which may be an effective alternative for these patients (Clinical trial registry No. ChiCTR1900025451).

Clinical Effect of Changyanqing Mixture Combined with Mesalazine Enteric-coated Tablets for Maintenance Treatment of Ulcerative Colitis in Remission Period / 中国实验方剂学杂志

Objective:This study aims to evaluate the clinical effect of Changyanqing mixture combined with mesalazine enteric-coated tablets in the maintenance treatment of ulcerative colitis（UC） in remission period. Method:The 140 patients with UC in remission period were randomly divided into control group （70 cases） and observation group （70 cases）. The 61 patients in control group completed the therapy （6 cases lost or lost to follow-up and 3 were eliminated）， 63 patients in observation group completed the therapy （5 cases lost or lost to follow-up and 2 were eliminated）. Both groups′ patients got treatment of lifestyle adjustment， and they also took mesalazine enteric-coated tablets orally， 0.5 g/time， 3 times/day. Patients in observation group took Changyanqing mixture orally for a month in the morning and evening every day， 150 mL/time， and then changed to 150 mL/time， 1 time/day， for 3 consecutive months， finally changed to once every other day for 8 months. Patients in control group took simulated medicine of Changyanqing mixture orally in the same way as observation group. The treatment was continued for 12 months. When UC recurred during the treatment， patients took mesalazine enteric-coated tablets orally at 1 g/time， 3 times/day until remission， when the above intervention plan was continued to be adopted. The recurrence rate， first recurrence time within 12 months （duration from remission to Mayo≥3） and the degree of disease activity at recurrence were recorded. Scores of traditional Chinese medicine（TCM）syndrome and inflammatory bowel disease questionnaire （IBDQ） were evaluated once every 2 months. Before treatment， and at the 6^th and 12^th month after treatment， colonoscopy and mucosal histology were performed once， enteroscopic mucosal scores， Geboes index of mucosal histology were evaluated， and fecal calprotectin（FC） levels were detected. Also， safety evaluation was conducted. Result:During 12 months， the recurrence rate in observation group was 20.63% （13/63）， lower than 39.34% （24/61） in control group（<italic>P</italic><0.05）， the frequency of recurrence and the first recurrence duration in observation group were all less than those in control group（<italic>P</italic><0.01）. All these meant the disease activity of patients in observation group was lighter than that in control group （<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/444CE72A-DE9D-4013-BB0B-F487F60C8DC8-M003.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/444CE72A-DE9D-4013-BB0B-F487F60C8DC8-M003c.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic></alternatives></inline-formula>=5.947， <italic>P</italic><0.05）. After repeated measurements of variance analysis， scores of TCM syndrome， enteroscopic mucosal scores， Geboes index and FC levels in two groups gradually increased（<italic>P</italic><0.05）， and scores of IBDQ gradually decreased （<italic>P</italic><0.05） during the 12-month period. At the second， fourth， sixth， eighth， tenth and twelfth month， scores of TCM syndromes in observation group were lower than those in control group （<italic>P</italic><0.01）， and scores of IBDQ were higher than those in control group （<italic>P</italic><0.01）. At the sixth and twelfth month after treatment， intestinal endoscopic mucosal scores， Geboes index and FC levels in observation group were all lower than those in control group （<italic>P</italic><0.01）. And there were no adverse reactions related to Changyanqing mixture. Conclusion:Changyanqing mixture combined with mesalazine enteric-coated tablets in the maintenance treatment of patients with UC in remission can control the FC level， further reduce the recurrence rate， delay the recrudescence-time， reduce the frequency of UC and the disease activity， maintain the good remission state of UC， stabilize the quality of life of patients， and ensure the safety of clinical use.

Simultaneous Determination of 7 Constituents in Xiaoshuan Enteric-coated Capsules by HPLC-wavelength Switching Method / 中国药房

OBJECTIVE： To establish a method for simultaneous determination of 7 active constituents in Xiaoshuan enteric-coated capsules， such as chlorogenic acid， amygdalin， paeoniflorin， ferulic acid， senkyunolide Ⅰ， calycosin glycoside and ligustilide. METHODS： HPLC method was adopted. The determination was performed on Agilent Eclipse Plus C18 column with mobile phase consisted of acetonitrile-0.1％ phosphoric acid （gradient elution）. The detection wavelengths were set at 326 nm for chlorogenic acid， 210 nm for amygdalin， 230 nm for paeoniflorin， 321 nm for ferulic acid， 334 nm for senkyunolideⅠ， 274 nm for calycosin glycoside and 260 nm for ligustilide. The flow rate was set at 1.0 mL/min， and the column temperature was 35 ℃. The sample size was 10 μL. RESULTS： The linear range was 1.16-34.81 μg/mL for chlorogenic acid， 1.85-55.48 μg/mL for amygdalin， 13.22-396.50 μg/mL for paeoniflorin， 13.50-405.09 μg/mL for ferulic acid， 1.75-52.51 μg/mL for senkyunolideⅠ， 2.74-82.18 μg/mL for calycosin glycoside， 7.67-230.07 μg/mL for ligustilide （r＝0.999 1-0.999 7）， respectively. The limit of quantity were 0.056， 0.103， 0.085， 0.013， 0.136， 0.184 and 0.276 μg. RSDs of precision， stability （24 h） and reproducibility tests were lower than 2.0％ （n＝6）. Average recoveries were 99.3％，98.6％，98.8％，99.7％，97.1％，97.6％ and 99.2％ （RSD＜2.0％， n＝6）. CONCLUSIONS： Established method is accurate and simple. It can be used for simultaneous determination of 7 constituents in Xiaoshuan enteric-coated capsules.

Efficacy of herb-separated moxibustion combined with sulfasalazine enteric-coated tablets for ankylosing spondylitis with cold-dampness obstruction type / 中国针灸

OBJECTIVE@#To compare the clinical efficacy between herb-separated moxibustion and conventional moxibustion on ankylosing spondylitis (AS) based on oral administration of sulfasalazine enteric-coated tablets.@*METHODS@#A total of 64 patients with AS of cold-dampness obstruction type were randomly divided into an herb-separated moxibustion group and a conventional moxibustion group, 32 cases in each one. Based on oral administration of sulfasalazine enteric-coated tablets, the patients in the conventional moxibustion group were treated with moxibustion at the area with Dazhui (GV 14) to Changqiang (GV 1) as center and about 10 cm in width; the moxibustion was given for 1 hour. In the herb-separated moxibustion group, the gauze was soaked in the medicinal liquor and ginger juice, and placed on the same moxibustion area as the conventional moxibustion group, followed by moxibustion for 1 hour. The treatment in the two groups was given once a week, three treatments constituted a course and totally three courses were given. The symptom quantification score, occipital-wall distance, Schober test, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels were observed before and after treatment in the two groups, and the clinical efficacy was evaluated.@*RESULTS@#Compared before treatment, the symptom quantification score, occipital-wall distance, CRP and ESR levels were lower but the Schober test was higher after treatment in the two groups (all 0.05). The total effective rate was 90.0% (27/30) in the herb-separated moxibustion group, which was higher than 73.3% (22/30) in the conventional moxibustion group (<0.05).@*CONCLUSION@#The herb-separated moxibustion combined with sulfasalazine enteric-coated tablets has significant efficacy for AS with cold-dampness obstruction type, which could obviously relieve pain symptoms, improve occipital-wall distance, Schober test and other physical signs, and improve the quality of life.

In Vitro Dissolution Behaviors of Diclofenac Sodium Enteric-Coated Tablets / 中国药学杂志

OBJECTIVE: To investigate and compare the dissolution behaviors of diclofenac sodium enteric-coated tablets from Beijing Novartis, Turkey Novartis and German Novartis respectively. METHODS: According to the dissolution test METHODS: in Chinese Pharmacopoeia, the dissolution curves of the preparations in various media were investigated. Whether the dissolution stage in acidic medium has influence on the dissolution behavior as well as the influence of the ionic strength of buffer medium were investigated. RESULTS: The dissolution curves of diclofenac sodium enteric-coated tablets in media of pH 1.0, 5.5, 6.0 and 6.8 could be used as the characteristic dissolution curves of the preparation. The dissolution behaviors of the three preparations after being dissolved in acidic medium for 2 h were similar; the dissolution behaviors were quite different without the dissoulution stage in acid medium; the larger the ionic strength of the buffer medium was, the faster the dissolution rate of the enteric coated tablets was. CONCLUSION: The dissolution behavior of diclofenac sodium enteric-coated tablets depends on the dissolution rates of the enteric coating and the tablet core. The RSD of the dissolution rate just after the formulation starts to dissolute is large; the dissolution phase in acidic medium and the ionic strength of the buffer medium has influence on the dissolution behavior. There is difference in the in vitro dissolution behaviors of diclofenac sodium enteric-coated tablets from manufacturers in different areas of the same group. This study may provide data support for the selection of multi-source reference preparations in the evaluation of generic drug conformance, and plays an important role in guiding the prescription screening and bioequivalence risk assessment.

Dissolution and Permeability Behavior of Diclofenac Sodiumenteric-Coated Tablets In-Vitro / 中国药学杂志

OBJECTIVE: To investigate the permeability of diclofenac sodium(DS)through parallel artificial membrane, and compare the differences in the dissolution rates and fluxes of diclofenac sodium enteric-coated tablets from Novartis in Beijing, Turkey and Germany.METHODS :The permeation of diclofenac sodium in different pH media was studied and determined.The effects of excipients on the permeability of diclofenac sodium were investigated by comparing the differences in the permeability of diclofenac sodium enteric-coated tablets.After being placed in acidic media of pH 6.0 and pH 6.8 for 2 h, the difference in the dissolution profiles and membrane fluxes of three sources diclofenac sodium enteric-coated tablets were determined and compared. RESULTS: The permeability of diclofenac sodium in pH 5.0-6.8 medium increased with the decrease of pH value, which was the smallest in pH 6.8 medium (1.08×10-4 cm•s-1). The excipients did not affect the permeability of the main component. The dissolution rate of the sample from Turkey Novartis was slightly faster than those from Beijing and Germany Novartis. CONCLUSION: The permeability of diclofenac sodium depends on the pH of the medium. The biopharmaceutics classification system(BCS) of diclofenac sodium is classified as class Ⅱ, a drug of low solubility and high permeability. The dissolution of diclofenac sodium enteric-coated tablets depends on the dissolving rate of the enteric-coating and the dissolution rate of the tablet core.The dissolution behaviors of diclofenac sodium enteric-coated tablets from different regions of the same company in pH 6.0 and pH 6.8 media are difference but the membrane fluxes are similar. This study may provide data support for the selection of multi-source reference preparations in the evaluation of generic drug conformance, and plays an important guiding role in prescription screening and bioequivalence risk assessment.

Early Immunosuppressive Exposure of Enteric-Coated-Mycophenolate Sodium Plus Tacrolimus Associated with Acute Rejection in Expanded Criteria Donor Kidney Transplantation / 中华医学杂志(英文版)

<p><b>Background</b>Immunosuppressive agents are still inefficient in preventing biopsy-proven acute rejection (BPAR) after expanded criteria donor (ECD) kidney transplantation. The aim of this study was to investigate the relationships between early immunosuppressive exposure and the development of BPAR.</p><p><b>Methods</b>We performed a retrospective study of 58 recipients of ECD kidney transplantation treated with enteric-coated-mycophenolate sodium, tacrolimus (Tac), and prednisone. The levels of mycophenolic acid-area under the curve (MPA-AUC) and Tac Cwere measured at the 1 week and the 1 month posttransplant, respectively. The correlation was assessed by multivariate logistic regression.</p><p><b>Results</b>The occurrence rates of BPAR and antibody-mediated rejection were 24.1% and 10.3%, respectively. A low level of MPA-AUC at the 1 week posttransplant was found in BPAR recipients (38.42 ± 8.37 vs. 50.64 ± 13.22, P < 0.01). In addition, the incidence of BPAR was significantly high (P < 0.05) when the MPA-AUClevel was <30 mg·h·L at the 1 week (15.0% vs. 44.4%) or the Tac Cwas <4 ng/ml at the 1 month posttransplant (33.3% vs. 21.6%). Multivariable logistic regression analysis showed that the MPA-AUC at the 1 week (OR: 0.842, 95% CI: 0.784-0.903) and the Tac Cat the 1 month (OR: 0.904, 95% CI: 0.822-0.986) had significant inverse correlation with BPAR (P < 0.05).</p><p><b>Conclusions</b>Low-level exposure of MPA and Tac Cin the early weeks posttransplant reflects an increased acute rejection risk, which suggested that MPA-AUC <30 mg·h·L and Tac C <4 ng/ml should be avoided in the first few weeks after transplantation.</p>

Effects of endovascular stent implantation and medical treatment on symptomatic vertebral artery stenosis / 中国综合临床

Objective To investigate the clinical effect of endovascular stent implantation and medical treatment in the treatment of symptomatic vertebral artery stenosis. Methods Eighty patients with symptomatic vertebral artery stenosis admitted from January 2013 to May 2015 in the Department of Neurology of Wuhan Puren Hospital were selected. The patients were randomly divided into the observation group and the control group,with 40 cases in each group. The control group was given aspirin enteric?coated tablets 100 mg/ time,1 time /d,clopidogrel bisulfate bablets 75 mg/ time,1 time /d,atorvastatin calcium 10 mg/ time,1 time/d. The observation group was treated with intravascular stent implantation. After 1 years of follow?up, the degree of vascular stenosis,the occurrence of ischemic cerebrovascular time and the clinical effect of the two groups were compared. Results (1) The stenosis degree of the observation group and the control group before treatment was (72. 81±11. 99)％ and (68. 31±12. 35)％ respectively,after treatment,it was (24. 58±1. 24)％ and (56. 01 ±3. 30)％ respectively. There was no significant difference between the two groups before treatment (t=0. 121,P>0. 05). After treatment,vascular stenosis degree in two groups were significantly improved,compared with that before treatment,the differences were statistically significant (t=0. 790,P<0. 05; t=0. 457,P<0. 05); the degree of vascular stenosis after treatment in the observation group was significantly lower than that in the control group ( t=0. 842,P<0. 05);( 2) during follow?up,the total occurrence rate of ischemic cerebrovascular events in the observation group was 17. 5％ (7/40),compared to 37. 5％ (15/40) in the control group,the difference between the two groups was statistically significant (χ2=4. 065,P<0. 05) . ( 3) At 1 years of follow?up,the total effective rate of the observation group was 97. 5％ ( 39/40) ,while that of the control group was 60％ ( 24/40) , and the difference between the two groups was statistically significant ( P=0. 017) . Conclusion Endovascular stent implantation can effectively improve the clinical efficacy of symptomatic vertebral artery, reduce the incidence of ischemic cerebrovascular time,and improve the degree of vascular stenosis.

Study on the Preparation of Lansoprazole Enteric-coated Pellets Orally Disintegrating Tablets / 中国药师

Objective:To prepare lansoprazole enteric-coated pellets and compress them into orally disintegrating tablets , and e-valuate the acid resistance in the acid stage and the in vitro dissolution in the buffer stage .Methods:Lansoprazole enteric-coated pel-lets were prepared by fluid bed coating technology , and the effects of the ratio of methacrylic acid copolymer dispersion to ethyl acrylate–methyl methacrylate copolymer dispersion , the concentration of triethyl citrate and the main pressure on the acid resistance in the acid stage and the in vitro dissolution in the buffer stage were evaluated .The similarity of the self-prepared orally disintegrating tablets and the reference preparation was evaluated by using f 2 similarity factor method .Results:The average particle size of microcrystalline cellulose core was 150-180 μm, the ratio of methacrylic acid copolymer dispersion to ethyl acrylate –methyl methacrylate copolymer dispersion was adjusted to 8:2, the enteric-coated weight was 30％, 20％triethyl citrate was used and the main pressure was controlled within the range of 10-16 kN.Lansoprazole enteric-coated pellets had sufficiently flexibility and stability against the compression force . The enteric coating did not break , showing good acid resistance .The dissolution similarity factor of the self-prepared orally disintegra-ting tablets and the reference preparation was greater than 50.Conclusion: Lansoprazole enteric-coated pellets orally disintegrating tablets have good acid resistance and high similarity for the in vitro dissolution, which can be further amplified .

Efficacy and safety of psychological intervention combined with Metformin Hydrochloride Enteric-Coated Capsules in the treatment of type 2 diabetes mellitus / 中国生化药物杂志

Objective To investigate the effectiveness and safety of psychological intervention combined with Metformin Hydrochloride Enteric-Coated Capsules in the treatment of type 2 diabetes mellitus. Methods A total of 80 patients with type 2 diabetes mellitus were selected from May 2015 to October 2016 in our hospital. The subjects were randomly divided into control group and experimental group, with 40 patients in each group. The control group was given repaglinide treatment, given metformin treatment of Metformin Hydrochloride Enteric-Coated Capsules on the basis of the experimental group, psychological intervention on the mental status of patients and patients, strengthen communication and exchanges, increase confidence in the treatment and the treatment compliance of patients. Results After the corresponding treatment, the patients in the experimental group and the control group had no serious adverse reactions, and the safety was better. The probability of hypoglycemia in the experimental group (15%) was significantly higher than that in the control group (5%), with statistical difference (P<0.05). Before treatment, the fasting blood glucose levels of the experimental group and the control group were (9.21±2.31) and (9.38±2.28) nmol / L, and there was no significant difference between the two groups, and there was no statistical significance The fasting blood glucose level (7.31±1.02), nmol / L in the experimental group was significantly lower than that in the control group (7.90±0.82) nmol / L. The effect of diabetes treatment in the experimental group was significantly better than that in the control group, with statistical difference (P<0.05). Conclusion Psychological intervention combined with Metformin Hydrochloride Enteric-Coated Capsules in the treatment of type 2 diabetes mellitus has high efficacy and low incidence of adverse reactions. It has clinical significance.

Application value of methacetin enteric-coated tablets in patients with steroid resistant severe ulcerative colitis / 中国生化药物杂志

Objective To study the application value of methadazine enteric-coated tablets in the treatment of steroid resistant severe ulcerative colitis.Methods 110 cases of patients with steroid resistance severe ulcerative colitis in our hospital from June 2015 to December 2016 were randomly divided into experimental group and control group (n=55).The control group was given bacillus subtilis duplex living bacterium enteric capsules,the experimental group was given methadazine enteric-coated tablets.The total effective rate, Mayo score, cytokine levels change, C-reactive protein and erythrocyte sedimentation rate were Compared between two groups.Results The total effective rate of the experimental group was 96.36% higher than that of the control group 85.45%(P< 0.05).The Mayo score of the experimental group was (3.17±2.03)and the control group was (3.69±1.97), the difference was not statistically significant.The levels of IL-8、TNF-α in the experimental group were(17.33±2.18) pg/mL ,(18.33±2.23) ng/mL,which were significantly lower than the those of the control group (25.33±2.18) pg/mL, (25.93±1.54) ng/mL (P<0.05).The C-reactive protein in the experimental group was (10.33±2.11) mg/L the ESR (22.39±5.33) mm/h,which was significantly lower than that of the control group (27.27±3.97) mg/L, (33.17±4.93)mm/h (P<0.05).Conclusion Mesalazine is effective in the treatment of steroid resistant severe ulcerative colitis,which can effectively control the inflammation,,reduce the level of IL-8 and TNF-α, worthy of clinical promotion.

Content Determination of Ketoprofen in Ketoprofen Enteric-coated Capsules by Improving HPLC / 中国药房

OBJECTIVE:To improve HPLC for content determination of ketoprofen in Ketoprofen enteric-coated capsules. METHODS:HPLC method was adopted. The determination was performed on Chiralpak IC column with mobile phase consisted of n-hexane (0.1% TFA)-isopropanol(90:10,V/V)at a flow rate of 0.8 mL/min. The detection wavelength was set at 268 nm,and column temperature was 25 ℃. The sample size was 10 μL. RESULTS:The linear range of ketoprofen were 0.025-0.5 mg/mL(r=0.9998). The limit of quantitation was 1.0 mg/L,and limit of detection was 0.2 mg/L. RSDs of precision,stability and reproduc-ibility tests were lower than 2%;recoveries were 96.36%-100.32%(RSD=1.87%,n=6). CONCLUSIONS:The method is sim-ple,accurate and rapid,and can be used for the content determination of ketoprofen in Ketoprofen enteric-coated capsules.

Observation of clinical curative effect of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules combined with trimebutine maleate and psychological intervention in the treatment of functional diarrhea / 中国生化药物杂志

Objective To study the clinical efficacy of live combined bacillus subtilis and enterococcus faecium enteric-coated capsules combined with trimebutine maleate and psychological intervention in the treatment of functional diarrhea. Methods 100 patients with functional diarrhea treated in our hospital from May 2015 to August 2016 were selected and randomly divided into the control group and the experimental group, with 50 patients in each group. The control group were treated with trimebutine maleate treatment, the experimental group were treated with live combined bacillus subtilis and enterococcus faecium enteric-coated capsules trimebutine therapy and psychological intervention, pay attention to the psychological status of patients and patients, strengthen communication and exchanges, increase confidence in the treatment and the treatment compliance of patients. The therapeutic effects of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, the effective rate was 92.0％ in the experimental group and 84.0％ in the control group. The difference was statistically significant (P<0.05). There was no obvious adverse reaction in the experimental group and the control group. After treatment, the number of diarrhea in the experimental group was (3.0±0.3), significantly less than that of the control group (4.3±0.3), the difference was statistically significant (P<0.05). Conclusion The clinical effect of live combined bacillus subtilis and enterococcus faecium enteric-coated capsules combined with trimebutine maleate and psychological intervention in the treatment of functional diarrhea is good, can improve clinical symptoms in a large extent, has the meaning of promotion.

Clinical efficacy of anti-helicobacter pylori in treatment of type 2 diabetes mellitus with helicobacter pylori infection / 中国综合临床

Objective To explore the clinical efficacy of anti-helicobacter pylori (HP) treatment on patients with type 2 diabetes mellitus and HP infection.Methods A total of 112 type 2 Diabetes patients were diagnosed with HP infection in Combine Traditional Chinese and Western Medicine Hospital of Taizhou from April 2012 to June 2016.These patients were divided into control and treatment group based on the preprandial blood glucose averages from lower to higher hierarchy.Thus,there were 56 patients in each of the two groups.The control group was given Motilium and Talcid for gastric symptoms in addition to anti-diabetes treatment,while the treatment was administered the same treatments as well as the quadruple anti-HP therapy (omeprazole,amoxicillin,clarithromycin and colloidal-bismuth-subcitrate,with Talcid stopped while colloidal-bismuth-subcitrate was administered).The anti-HP lasted for 14 days.The two groups were compared the gastric symptoms,the blood glucose levels,and the HbA1c one month after treatment.Half a year and one year post treatment,the two groups were compared the gastric mucus signs under gastroscopy.Results The improvement rates after treatment with the treatment group in abdominal pain,bloating,regurgitation,belching and diarrhea/constipation were 88.5％ (23/26),83.3％ (25/30),74.1％ (20/27),83.9％ (26/31),82.6％ (19/23),respectively,and with the control group being 29.2％(7/24),32.1％(9/28),28％(7/25),30.3％(10/33),18.2％ (4/22),respectively.The differences between the two groups were significant (x2=8.06,6.62,3.92,7.65,6.66,P＜0.05 or P＜0.01).The control group did not show significant changes in preprandial glucose levels,the glucose levels two hours post meals and the HbA1c(P＞0.05) while the treatment group showed statistically significant changes(P＜0.05 or P＜0.01).The differences in the three indicators after treatment between the two groups were significant (t =4.07,7.85,4.16,P＜ 0.05).The Gastric mucus signs under gastroscopy showed improvements in both groups after treatment.The improvement rates with the treatment group were 86.2％(25/29),86.7％ (13/15),77.8％ (14/18),72.7％ (8/11) respectively,with the control group being 36％ (9/16),27.3％ (3/11),13.3％ (2/15),14.3％ (1/7),respectively.The differences between the two groups were significant (x2 =6.71,4.12,4.38,3.85,P ＜ 0.05 or P＜ 0.01).The effectiveness rate,which was based on combined improvements in gastric symptoms,glucose levels and gastric mucus signs,was 76.8％ with the treatment group and 32.1％ with the control group.The difference was statistically significant (x2 =6.78,P＜0.01).Conclusion Anti-HP treatment can relieve the gastric symptoms,stabilize the glucose levels,and help to reverse the changed gastric mucus.All these can reduce the complications of the diabetes and improve the prognosis of the patients.

Efficacy and safety of esomeprazole enteric coated capsules in the treatment of duodenal ulcer / 中国生化药物杂志

Objective To observe the efficacy and safety of esomeprazole enteric coated capsules in the treatment of duodenal ulcer.Methods52 cases of duodenal ulcer were selected and randomly divided into the observation group and the control group, 26 cases in each group.The control group was treated with omeprazole, the observation group was treated with esomeprazole enteric coated capsules, and the therapeutic effects of the two groups were evaluated.ResultsThe eradication rate of Helicobacter pylori in the observation group was 96.15% (25/26),which was significantly higher than the control group 80.76%(21/26)(P<0.05), and the clinical efficacy was better, had no serious adverse reactions.ConclusionEsomeprazole enteric coated capsules, can effectively help improve the symptoms of patients with duodenal ulcer, remove the Helicobacter pylori, and no serious adverse reaction, high safety.

Characterization of Indomethacin Enteric-coated Dropping Pills / 中国药师

Objective: To study the status of indomethacin (IDM) in IDM enteric-coated dropping pills and its interaction with PEG 6000.Methods: IDM, PEG 6000, their physical mixture and IDM enteric-coated dropping pills were respectively studied by DSC, IR, X-ray diffraction and SEM.Results: In the map of DSC, the endothermic peak of IDM enteric-coated dropping pills disappeared at 164℃, and the endothermic peak of PEG 6000 at 57℃ shifted forward.In the map of IR, the carbonyl stretching vibration peak of IDM in IDM enteric-coated dropping pills disappeared, and a new peak appeared at 1 680 cm-1.In the map of X-ray diffraction, there was no diffraction peak in IDM enteric-coated dropping pills.SEM showed the morphology of IDM in the base was much smaller than that of IDM raw material.Conclusion: IDM in IDM enteric-coated dropping pills is dispersed in the matrix with an amorphous or molecular form, and there is hydrogen bond between IDM and PEG 6000.

Similarity Evaluation of Dissolution Curves for Generic Preparation and Reference Preparation of Bisaco-dyl Enteric-coated Tablets / 中国药房

OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.