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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.
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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.
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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.
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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.
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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.
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Objective: To prepare and evaluate bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules, composed of Epimedium flavonoids as drug, snail enzyme as hydrolase and common formulation accessories, which is in favor of in vivo real-time enzymolysis and real-time absorption of Epimedium flavonoids. Methods: The UV method and single factor experiment were applied to investigating the effects of key factors such as filling agents species and dosage, disintegrating agents species and dosage, wetting agents species and drying temperature on the cumulative release degree of Epimedium flavonoids. Response surface method was used to optimize the prescription for bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules, and the enzymatic process of the four Epimedium flavonoids (icariin and epimendin A, B, C) was also evaluated by HPLC. Results: The optimal formulation for the bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules was composed of 100 mg Epimedium flavonoids extract, 68 mg snail enzyme, 65 mg α-lactose, and 11.7 mg low-substituted hydroxypropyl cellulose. This enteric-coated capsules showed a cumulative Epimedium flavonoids release rate of 85.43% within 45 min in simulated intestinal fluid and a complete enzymolysis within the intestine emptying time (3-6 h). Conclusion: The bionic enzymatic Epimedium flavonoids-loaded enteric-coated capsules show an advantage in improving hydrolysis and anti-osteoporosis efficacy of Epimedium flavonoids, providing some research ideas for improving the oral bioavailability of other flavonoids.
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Objective To observe the curative effect of Zhengqingfengtongning release tablets and lumbroki-nase enteric -coated capsules and losartan potassium tablets joint for the treatment of chronic nephritis proteinuria, and explore its mechanism.Methods 42 patients with chronic nephritis were randomly divided into two groups. 20 cases in the control group were given losartan potassium tablets,50mg,1 ~2 times a day.22 cases in the treatment group received Zhengqingfengtongning release tablets 120mg,2 times a day,lumbrokinase enteric -coated capsules 600 000u,3 times a day on the basis of the control group.The 24h urine protein,liver and kidney function before and after the treatment were observed.Results 20 days after treatment,24h urinary protein in the treatment group decreased 57.08%,which in the control group decreased 41.59%,the difference was statistically significant (t =2.39,P <0.05).30 days after treatment,24h urinary protein in the treatment group decreased 81.28%,which in the control group decreased 52.34%,the difference was statistically significant (t =3.65,P <0.01 ).Renal function change had no significant difference between the two groups.Conclusion Zhengqingfengtongning release tablets and lumbrokinase enteric -coated capsules combined with losartan potassium tablets in the treatment of chronic nephritis proteinuria work fast,and has good curative effect,less side effects,and is worth to recommend.
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Objective:To establish a method for the determination of omeprazole delayed release capsules and investigate the be-havior of reference preparations to provide experimental basis for generic drugs quality consistency evaluation. Methods:According to the first dissolution method (basket method) stated in 0. 931 of Chinese Pharmacopeia (2015 edition), the type of release media, solu-bility and stability of omeprazole in different media, effect of different treatment methods on the drug adsorption in the solution, differ-ent rotation speed and the methodology of ultraviolet spectrophotometry were investigated. Results:The rotation speed was 75 r·min-1 with the dissolution medium volume of 900 ml. The dissolution profiles of omeprazole delayed release capsules in three different media ( pH 6. 0 phosphate buffer, pH 6. 8 phosphate buffer and water containing 3% Tween-80) were determined with online filteration. The solubility of omeprazole in the different media was 0. 123, 0. 078 and 0. 275 mg·ml-1 , respectively. The results showed that ome-prazole was degraded 44%, 8% and 14% in 2 h in the above three release media, and degraded up to 43% in 6 h in water containing 3% Tween-80. The linear of omeprazole was 0. 209 4-20. 94, 0. 204 8-20. 48 and 0. 2016-20. 16 μg·ml-1 with the average recovery of 99.3% (RSD=0.7%,n=12), 99.7% (RSD=0.9%,n=12) and 99.5% (RSD=0.6%,n=12) respectively in the three media. Conclusion:The method is accurate and reliable, which can be used to study the quality consistency of omeprazole delayed re-lease capsules.
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Objective:To discuss the influence of bifid triple viable enteric-coated capsules on liver function and inflammatory fac-tor in the patients with non-alcoholic steatohepatitis ( NASH) . Methods:Totally 70 cases of patients with NASH were selected and di-vided into the control group and the observation group at random. The patients in the two groups were all given routine hepatoprotective therapy. The patients in the observation group were additionally given 420mg bifid triple viable enteric-coated capsules, three times a day for 4 weeks. Except for bifid triple viable enteric-coated capsules, the patients in the control group were given the same medical treatment as that in the observation group. The changes of liver function index, serum high sensitivity C reaction protein ( hs-CRP) , IL-6 and IL-8 levels in the two groups before and after the medical treatment were observed and the security was compared. Results:After the 4-week medical treatment, ALT, GGT, serum hs-CRP, IL-6 and IL-8 levels in the two groups were obviously declined than those before the treatment (P0. 05). Conclusion:Bifid triple viable enteric-coated capsules in the treatment of NASH can obviously reduce the serum hs-CRP, IL-6 and IL-8 levels, inhibit the intrahepatic inflammation and immunologic injury, and improve the liver function index with high security.
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Objective To investigate the effect of deproteinised calf serum enteric-coated capsules (DCSECC) on cognitive function of patients with epilepsy.Methods Sixty-six patients were randomly divided into two groups including experimental group who received DCSECC 5 mg/d,3 times a day and antiepileptics,and control group who received antiepileptics.To detect the cognitive function by means of Wechlors memory scale (WMS),Montreal cognitive assessment (MoCA),event related potentials (P300) latency period and malondialdehyde (MDA) before treatment and after treatment for 1,2,3 months,and compared with 33 healthy subjects controls (healthy group).Results Compared with healthy group,the scores of memory quotient (MQ) and MoCA were signifiantly decreased in experimental group and control group [(80.4 ± 14.2),(79.6 ± 13.9) scores vs.(103.2 ± 30.1) scores; (13.5 ± 4.5),(12.9 ± 3.9) scores vs.(28.8 ±8.7) scores],in the mean time,P300 latency period and MDA were signifiantly prolonged [(380.8 ± 49.7),(389.5 ± 50.4) ms vs.(309.8 ± 44.7) ms ; (5.0 ± 1.8),(4.8 ± 1.7) μ mol/L vs.(2.2 ± 0.6) μ mol/L],there was significant difference (P ＜ 0.05).Compared with the control group after treatment for 3 months,the scores of MQ and MoCA in experimental group [(96.5 ± 18.3) scores,(26.8 ± 7.7) scores] were increased and P300 latency period [(321.3 ±36.1) ms] was shortened,there were significant differences (P ＜ 0.05).The level of MDA decreased significantly in experimental group after 2,3 months treatment[(3.02 ± 1.04),(2.99 ± 1.01) μ mol/L],there was significant difference(P＜ 0.05).The scores of MQ and MoCA in control group after treatment had no significant difference compared with before treatment (P ＜ 0.05).Conclusions The cognitive function in patients with epilepsy is decreased.DCSECC medical treatment can improve the cognitive function by means of antioxidant activity.
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OBJECTIVE:To compare the bioequivalence of 2 kinds of Omeprazole enteric-coated capsules. METHODS: A single dose of Omeprazole enteric-coated capsules was given to 18 healthy volunteers by randomized crossover method, and the plasma concentrations of omeprazole were determined by HPLC. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalence was evaluated. RESULTS: The plasma concentration-time curve of two preparations fitted to one-compartment model. The pharmacokinetic parameters of test preparation vs. reference preparation were as follows: Cmax(1.69?1.00) ?g?mL-1 vs. (1.71?1.02) ?g?mL-1; tmax(3.22?1.11)h vs. (3.06?1.00)h; AUC0～24(8.42?4.38) ?g?h?mL-1 vs. (8.87?5.32) ?g?h?mL-1; AUC0～∞(10.35?5.01) ?g?h?mL-1 vs. (10.81?5.86) ?g?h?mL-1. The relative bioavailability of Omeprazole enteric-coated capsules was(94.93?14.54)%.CONCLUSION:2 kinds of Omeprazole enteric-coated capsules are bioequivalent.
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OBJECTIVE: To observe clinical efficacy of Bifid tripie viable enteric-coated capsules in the treatment of children diarrhea after pneumonia. METHODS: 360 cases of children pneumonia were randomly divided into two groups. Treatment group were treated with antibiotics and Bifid triple viable enteric-coated capsules in duration of hospital stay(n=180). Control group were treated with antibiotics only (n=180). The incidence and severity of diarrhea in two groups were observed at the 3rd, 5th, 7th of therapy. RESULTS: The incidence of diarrhea at the 3rd, 5th, 7th of therapy in treatment group were 10.00%,16.67% and 13.33%, in control group 36.67%, 43.33% and 50.00%, with statistically significance(P
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Objective To explore a simple and convenient method of small intestine double contrast examination:small intestine double contrast radiography with air-barium by non-tube fast.Methods 130 cases were randomly divided into study group(67) and control group(63).In study group,the enteric-coated capsules to be full of aerogenic powder,barium and cisapride were taken orally by the patients,while in control group,only barium was given orally,and metoclopramide injected by muscle,then the small intestinal air-barium double contrast examinations were performed.Results In the study group,the effect of examinations was satisfactory,ordinary and no effect in 53,12 and 2 cases respectively,and one patients fell because of swallowing difficulty,the total efficiency was 97.02% and the average examination time was(34.63?16.66) minute.In the control group,the effect of examinations was all ordinary and lasted time was(77.12?32.98) minute.These two methods were of remarkable difference in effect and lasted time in statistics(P