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ObjectiveTo observe the effect of Jiangzhi Tongluo soft capsule on the protein levels of silent mating-type information regulation 2 homolog 1 （SIRT1） and forkhead transcription factor FoxO3 and podocyte apoptosis in the renal tissue of rats with membranous nephropathy and to reveal the underlying molecular mechanisms for the treatment of MN. MethodSixty male SD rats were randomly assigned into 6 groups with 10 rats each. The six groups included a normal group， a model group， benazepril hydrochloride group， and Jiangzhi Tongluo soft capsule groups of low， medium and high doses （25， 50， 100 mg·kg-1， respectively）. The model rats were established by injection with cationized bovine serum albumin into the tail vein. After modeling， the rats were administrated with corresponding agents by gavage for 4 weeks. At the end of the 4th week， an electron microscope was used to observe the pathological changes in the kidney. Western blot was employed to detect the protein levels of SIRT1 and FoxO3 protein in rat kidney， and immunohistochemistry to detect the expression of B lymphocytoma-2 （Bcl-2）， Bcl-2-associated X protein （Bax）， Bcl-2-associated death promoter （Bad）， and podocyte split diaphragm proteins nephrin and podocin. ResultCompared with normal group， the expression of pro-apoptotic factors Bax， Bad， and FoxO3 in the kidney was up-regulated （P<0.05）， while that of anti-apoptotic factors Bcl-2， SIRT1， nephrin， and podocin was down-regulated （P<0.05） after modeling. Compared with the model group， the treatments down-regulated the expression of Bax， Bad， and FoxO3 （P<0.05） and up-regulated that of Bcl-2， SIRT1， nephrin， and podocin （P<0.05）. ConclusionJiangzhi Tongluo soft capsule may regulate the SIRT1/FoxO3 pathway to reduce podocyte apoptosis and maintain podocyte structure stability， thereby exerting the renal protection effect.
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OBJECTIVE To observe the effects of Xuesaitong soft capsule on the complement-inflammatory receptor system in patients with type 2 diabetic nephropathy. METHODS A total of 92 patients with type 2 diabetic nephropathy were divided into control group and observation group by random number table method ，with 46 cases in each group. Patients in the control group were given basic treatment programs （including low-salt and low-protein diet ，quitting smoking and alcohol ，appropriate exercise ， lowering blood pressure ，blood sugar and lipid ，etc.）. The patients in the observation group took Xuesaitong soft capsules orally on the basis of the treatment of the control group ，0.55 g each time ，3 times a day. The treatment course of both groups was 4 weeks. Compare the renal function of the two groups of patients [24 h urine protein quantification ，serum creatinine （Scr），blood urea nitrogen，glomerular filtration rate （GFR）]，fasting blood glucose ，glycosylated hemoglobin ，complement factors [C3，C5， complement factor H （CFH），C5b-9]，inflammatory factors [interleukin 1（IL-1），tumor necrosis factor α（TNF-α），IL-6，monocyte chemoattractant protein- 1（MCP-1）]，renal tubular injury markers [β2-microglobulin（β2-MG），retinol binding protein 4（RBP4）， neutrophil gelatinase associated lipocalin] levels；correlation between renal tubular damage and complement-inflammatory receptor system was analyzed in the observation group before and after treatment. RESULTS Compared with before treatment ，24 h urine protein quantity ，Scr，C3，IL-1，TNF-α，MCP-1，β2-MG and RBP 4 of 2 groups were reduced significantly after treatment ，while GFR and CFH were significantly increased ；except for C 3，the observation group was significantly better than the control group （P＜ 0.05）. C 5 of the observation group was significantly decreased after treatment and was significantly lower than the control group （P＜0.05）. There were no statistically significant 60979837。E-mail：shanght126@126.com differences in other indicators of the two groups before and after treatment and between groups （P＞0.05）. C 3，MCP-1 and TNF-α were significantly correlated with renal tubular com damage （P＜0.05），and esp ecially C 3. CONCLUSIONS Xuesaitong soft capsule can reduce renal tubular damage in patients with type 2 diabetic nephropathy and improve renal function by acting on the complement system and reducing inflammation.
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Enteric-soluble soft capsule is a kind of new preparation that does not disintegrate in the stomach ，but releases rapidly in the intestinal tract to play a pharmacodynamic role. It has the unique advantages of improving drug stability ，reducing drug irritation ，delivering drugs directionally to the intestinal tract ，and prolonging drug action time. In this paper ，the decomposition and release mechanism ，application advantages ，classification of enteric-soluble coating materials and preparation methods of enteric-soluble soft capsule are sorted and summarized ，in order to provide reference for further development of this type of preparation.
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OBJECTIVE To analyze quality maker （Q-marker） of Ka nggongyan soft capsule （KSC）. METHODS The fingerprints of 20 batches of KSC were established by ultra high performance liquid chromatography （UPLC）method. Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）were used to evaluate the similarity and confirm common peaks. The contents of norisoboldine ，leonurine hydrochloride ，forsythoside B ，acteoside，poliumoside and isoacteoside were determined by the same UPLC method. Targets and pathways related to KSC in the treatment of cervicitis were screened and analyzed by network pharmacology and molecular docking method to construct a “component-target-pathway”network，and analyze its potential Q-marker. RESULTS Twelve common peaks were identified in the fingerprints of 20 batches of KSC ，and the similarity was greater than 0.99. Six common peaks were identified ，including norisoboldine ，leonurine hydrochloride ，forsythoside B，acteoside，poliumoside and isoacteoside. The contents of the above 6 components were 1.336-1.774，0.093-0.143，4.970-5.888， 0.505-0.623，5.206-6.226 and 0.785-0.895 mg/g，respectively. By network pharmacology analysis ，14 key targets and 94 pathways were obtained ，and their binding energies to the core targets （protein kinase B 1，tumor necrosis factor ）were all less than －6.4 kJ/cal. CONCLUSIONS Six components such as norisoboldine and leonurine hydrochloride are potential Q-marker of KSC.
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Objective: In order to establish a rapid and efficient analysis method for identification of the complex components in Jingzhi Guanxin Soft Capsule, and provide the basic research data for the systematic elaboration of its chemical constituents. Methods: An ultra-high performance liquid chromatography-quadrupole/Orbitrap high resolution mass spectrometry (UHPLC-Q-Orbitrap HRMS) was used for the identification analysis of the components in Jingzhi Guanxin Soft Capsule, and the multistage fragments ions data was compared with the standard substance and literature consulting. Results: Forty-three compounds were identified in this study, including flavones, phthalides, organic acids, quinones and other categories. Conclusion: The chemical constituents of Jingzhi Guanxin Soft Capsule are identified systematically, accurately and efficiently, which provide the theory basis for the further research of its pharmacodynamic material basis and quality control.
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It is difficult to directly observe the structural transformation inside of soft capsules if their shells are opaque. This study was designed to noninvasively in situ measure the structural characteristics of the soft capsules and internal particle distributions to reveal the intrinsic quality of the soft capsules and develop a new technique for reverse engineering and the physical stability evaluation of the soft capsules. In this research, the CT projection images of soft capsules, namely, propolis soft capsules, were collected via synchrotron radiation X-ray micro computed tomography (SR-μCT). After three-dimensional reconstruction, the structural differences of the soft capsules under long-term test and accelerated test for 6 months were quantitatively analyzed by calculating the three-dimensional structure parameters such as volume, number and distribution of the particles inside and the thickness for the wall of the capsules. There were only a small number of particles evenly distributed in the soft capsules stored under common storage condition without layering. On the other hand, the shell wall of the soft capsule turned thinner locally at the occlusal portion and the particles with strong X-ray absorption were densely distributed at the edge of the capsule wall after the accelerated test. This study revealed that the structural parameters of soft capsules obtained by SR-μCT could be used to evaluate the influence of storage environment on the physical stability of soft capsules. The technology provides a new method for quality control and evaluation for the soft capsules.
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Objective To establish a simultaneous detection of diclofenac sodium, fenbufen and rotundine hydrochloride illegally added in Yinhuang soft capsules by TLC-SERS. Methods The samples to be measured were placed on the silica gel plate, and the thin layer was developed with petroleum ether-ethyl acetate (3:5). Location detection was carried out under 254 nm ultraviolet lamp. Nano-silver colloidal solution was sprayed at each spot of separation according to the optimum conditions, and then qualitative identification was done by TLC-SERS. Results A method for simultaneous determination of diclofenac sodium, fenbufen and rotundine hydrochloride illegally added in Yinhuang soft capsule by TLC-SERS was established. And the minimum detection limits of three chemical constituents were determined. Conclusion TLC-SERS was a rapid, accurate and sensitive method for the simultaneous and rapid detection of diclofenac sodium, fenbufen and rotundine hydrochloride illegally added into Yinhuang soft capsule.
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Objective To develop a method for the determination and impurity analysis of vitamin D3 soft capsules with soybean oil matrix in reverse phase high performance liquid chromatography (RP-HPLC) system.Methods RP-HPLC system had Agilent Zorbax Eclipse XDB-C18 column (4.6 mm × 250 mm,5 ttm) with detection wavelength of 265 nm,column temperature of 25 ℃ and flow rate of 1 mL/min.Retention behaviors of vitamin D3 and its 3 isomers were studied by altering the mobile phase.Firstly,acetonitrile was mixed with different proportions of methanol,water and ethanol as the mobile phase to investigate the effects of these 4 mobile phase components on the retention behavior of vitamin D3 and its 3 main related substances (isomers) on a C18 column.Then,a suitable mobile phase was selected for content determination and impurity analysis according to the retention behavior study.Results The recovery was only 80.55％-84.37％ with 100％ acetonitrile as the mobile phase.The addition of ethanol in acetonitrile was found to make remarkably significant improvement.Recovery rate was achieved between 98.07 ％ and 103.23 ％ with V (acetonitrile) ∶V (ethanol) =90∶10 as the mobile phase,while improving pealk shape.The method showed good linearity [(0.52-5.2) x 10-4 t mol/L,R2＞0.999] and fine density (RSD＜2.32％) which can be used for determination.For impurities profile,it could be achieved using V (acetonitrile):V (water) =95:5 as the mobile phase which can obviate interference from soybean oil matrix.Conclusions The method established in this experiment can easily and accurately determine the content and impurity analysis of vitamin D3 soft capsules with soybean oil matrix in a RP-HPLC system.
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OBJECTIVE： To study the effects of Wuzhi soft capsule and imatinib mesylate tablet on the pharmacokinetics of imatinib in rats. METHODS： The rats were divided into single administration group and consecutive administration group. The single administration group was divided into imatinib group one （ig administration of blank soybean oil+imatinib suspension 10 mg/kg）， low-dose， medium-dose and high-dose of Wuzhi soft capsule+imatinib group （ig administration of Wuzhi soft capsule solution 134， 268， 536 mg/kg+imatinib suspension 10 mg/kg）， with 6 rats in each group. Each group was given imatinib suspension intragastrically 30 min after intragastric administration of blank soybean oil/Wuzhi soft capsule solution. The consecutive administration group was divided into imatinib group two （ig administration of blank soybean oil+imatinib suspension 10 mg/kg）， Wuzhi soft capsule low-dose+imatinib group （ig administration of Wuzhi soft capsule solution 134 mg/kg+imatinib suspension 10 mg/kg）， with 6 rats in each group. Each group was given blank soybean oil/Wuzhi soft capsule solution intragastrically for consecutive 14 d， once a day； 30 min after last administration， ig imatinib suspension. About 100 μL blood was collected before imatinib， 0.5， 1， 2， 2.5， 3， 4， 5， 6， 8， 12， 24 and 36 h after medication. The plasma concentration of imatinib was determined by HPLC-MS/MS. The pharmacokinetic parameters were fitted by using DAS 2.0 software. RESULTS： After single administration， compared with imatinib group one， cmax， t1/2， AUC0-36 h and AUMC0-36 h in low-dose， medium-dose and high-dose of Wuzhi soft capsule+imatinib group were increased significantly （P＜0.05 or P＜0.01）. After consecutive administration， compared with imatinib group two， cmax， t1/2 and AUMC0-36 h of imatinib+low-dose of Wuzhi soft capsule group were increased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS： Single administration and consecutive administration of Wuzhi soft capsule influence the pharmacokinetics of imatinib， increase plasma concentration of imatinib and prolong half-time.
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OBJECTIVE:To establish GC-MS fingerprints of liposoluble constituents from Danqi soft capsule. METHODS:GC-MS method was adopted. GC chromatogram column was DB-5 ms capillary column with high purity helium (99.999%)as carrier gas at the flow rate of 1.0 mL/min,with temperature programming. The injector temperature was 250 ℃. The sample size was 1 μL. The shunt ratio was 1:40,with distributary injection. Ionization mode was as follows as electron bombardment ion source,ion source temperature of 280 ℃,injector temperature of 300 ℃,electronic energy of 70 eV, solvent delay time of 3 min,mass charge ratio(m/z)of 50-550. Using ethyl palmitate as reference,MS spectrums of 11 batches of samples were determined. Similarity evaluation was conducted by using TCM Fingerprint Chromatogram Similarity Evaluation System(2004 A edition)to determine common peak. The common peaks were determined by LC Solution 2 workstation standard mass spectrometry Library(NIST05.LIB or NIST05s.LIB). RESULTS:The similarity of 11 batches of samples was higher than 0.90. After validation,GC-MS chromatograms of 11 batches of samples were in good agreement with control fingerprint. There were 49 common peaks in GC-MS chromatogram,and 38 chemical constituents were identified, accounting for 94.94% of total peak areas. CONCLUSIONS:Established fingerprint can provide evidence for quality evaluation of Danqi soft capsule.
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OBJECTIVE: To provide references for effective quality control of soft capsules and discuss the applicability of method for dissolution test of soft capsules. METHODS: Based on analyzing dissolution requirements of soft capsules, we were compared the differences of methods for dissolution test in the pharmacopoeias of several countries with current correlative research from home and abord. RESULTS: The dissolution characteristics of soft capsules are more complex than common oral solid dosage forms, and the requirments are different in the pharmacopoeias of several countries. The formula of contents, hydrophilicity, rupture test and crossliking have impacts on the dissolution characteristics as well as dissolution device and so on. CONCLUSION: In order to develop the method for dissolution test of soft capsules, the dissolution device and medium, rupture test and in vitro-in vivo correlation etc. should be studied.
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OBJECTIVE:To observe the antiviral effects of Qingre jiedu soft capsule(ADSC)against influenza A H1N1 virus in vivo,and to provide a experimental support for clinical therapy of influenza A H1N1 virus. METHODS:BALB/c mice were ran-domly divided into normal control group,model control group,positive drug high-dose,medium-dose and low-dose groups [oselta-mivir phosphate capsule,0.04,0.02,0.01 g/(kg·d)] and ADSC high-dose,medium-dose and low-dose groups [1.5,0.75,0.375 g/(kg·d)].Except for normal control group,others groups were given influenza A H1N1 virus with titer 1.6×10-5.2 via nasal cavity to induce poisoned mice model;6-8 h after modeling,they were given relevant medicine intragastrically,once a day,for 5 days. After medication,the change of body weight within 7 d were observed in mice;the mortality and death prevention rate within 15 d,mean survival days(MSDs)were calculated in mice.Other mice were selected and grouped,and they were given same drugs as above. 8 h after last medication,lung index and inhibition rate of lung index were determined in mice.RESULTS:In model control group,the body weight of mice decreased significantly since 5th day,and mice death was beginning to occur since 8th day(mortal-ity of 85.7% within 15 d);the lung index was increased significantly compared to normal control group (P<0.01). Both ADSC and oseltamivir phosphate capsule could slow down the decrease of body weight in mice,decreased the mortality and lung index of mice,and prolonged MSDs;the MSDs of mice in ADSC high-dose,positive drug high-dose and medium-dose groups were signifi-cantly higher than model control group(P<0.05),and lung index was significantly lower than model control group except that of ADSC low-dose group(P<0.05). CONCLUSIONS:ADSC has certain antiviral effect against influenza A H1N1 virus in vivo.
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Objective To observe the effect of Maren capsule with walking exercise for the patients with senile habitual constipation in community. Methods A total of 112 patients were randomly divided into three groups (control group A and the intervention group B,C). All the three groups took Maren capsule, and group A did not do the walking exercise, group B and C, walked for 30 min and 60 min after dinner, respectively. Two weeks were one course of treatment, all the groups took two courses. Results After treatment, the constipation symptoms and signs scores (4.1 ± 2.0, 4.8 ± 2.1 vs. 5.3 ± 1.5, F=3.886) in the group B and C were significantly lower than those in the control group A (P<0.05) ); and the scores in the group C was lower than that in the group B (P=0.041). Two weeks after the treatment, total effective rates were 36.8%(14/38), 63.2% (24/38), and 77.8% (28/36) in group A, B, C; and the difference was statistically significant (χ2=12.741, P=0.005). Four weeks later, total effective rates were 47.4%(18/38), 76.3%(29/38), 86.1%(31/36) in group A, B, C; and the difference was statistically significant (χ2=13.103, P=0.005). In the following 2 weeks after the end of treatment, total effective rates were 23.7% (9/38), 60.6% (23/38), 75.0% (27/36) in group A, B, C; and the difference was statistically significant (χ2=12.904, P=0.015). Conclusions The Maren capsule with 60 min walking exersice showed significant effect for the senile habitual constipation.
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Objective To evaluate the efficacy and safety of Modified Huoxiang Zhengqi Soft Capsule in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome.Methods A multi-center and double-blind double-dummy randomized controlled trial was conducted.440 patients of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome were enrolled from Januarary to July 2013.They were randomly divided into two groups,the trial group of 330 cases and the control group of 110 cases.The trial group was given Modified Huoxiang Zhengqi Soft Capsule and Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.The control group received Huoxiang Zhengqi Soft Capsule and Modified Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days.Clinical symptoms,signs and symptoms and adverse effect were observed and blood test,routine urine and stool test,feces occult blood,hepatorenal function and electrocardiogram were examined before and after treatment.Results In terms of traditional Chinese medicine syndrome and efficacy after treatment,the clinical healing rates of the trial group and the control group were 50.000％,35.455％ for full analysis set and50.464％,35.780％ for per protocol set.The overall effective rates were 94.848％,76.364％ for full analysis set and 96.285％,77.064％ for per protocol set.There were significant differences between the two groups (P ＜ 0.05).In addition,there were significant differences in clinical healing rates and overall effective rates of symptoms including diarrhea,nausea and vomiting,rhinobyon and rhinorrhea,fullness and oppression in the chest and diaphragm and abdominal swelling and pain between two groups (P ＜ 0.05).However,the difference in overall effective rates of headache and lightheadedness symptom were significant (P ＜ 0.05) except for clinical healing rate.No adverse effects were found in the trial.Conclusion Modified Huoxiang Zhengqi Soft Capsule is effective and safe in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome and its effect is better than that of Huoxiang Zhengqi Soft Capsule.
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OBJECTIVE:To investigate the improvement effect of Eucalyptol enteric soft capsule on mice with lipopolysaccha-ride(LPS)-induced acute lung injury(ALI). METHODS:60 mice were randomly divided into blank control group,model control group,Eucalyptol enteric soft capsule low-dose,medium-dose,high-dose groups(100,300,900 mg/kg),12 in each group. Mice in administration groups were intragastrically given relevant medicines,mice in blank control group and model control group were intragastrically given equal volume of normal saline(0.1 mL/10 g). After 2 h of administration,except for the blank control group, ALI was induced in other groups by atomized LPS. After 6 h of modeling,the mice were sacrificed,alveolar lavage fluid(BALF) and lung tissue were taken. Morphological changes of lung tissue were observed under microscope;number of total cells,neutro-phils in BALF were calculated by blood cell count plate and staining by wright-giemsa respectively. Total protein concentration in BALF supernatant was detected by BCA method;TNF-α,IL-6 contents in BALF supernatant were determined by enzyme-linked immunosorbent assay. RESULTS:Compared with blank control group,lung tissue of mice in model control group showed obvious pathological damage and severe pulmonary edema;number of total cells,neutrophils in BALF,total protein concentration and TNF-α,IL-6 contents in BALF supernatant were significantly increased(P0.05). CONCLUSIONS:High-dose Eucalyptol enteric soft capsule can obviously improve LPS-induced ALI of mice.
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OBJECTIVE:To observe the efficacy and safety of Huanglian shangqing soft capsule in the adjuvant treatment of in-flammation around the implant. METHODS:40 patients(72 implants)with inflammation around the implant were randomly divid-ed into control group (20 cases) and observation group (20 cases). Control group received full mouth supragingival scaling tech-nique,subgingival curettage,root planing,occlusal adjustment,loose teeth fixation or removal can not be reserved teeth using ul-trasonic scaler row scaling postoperative with 3% hydrogen peroxide,0.9% Sodium chloride injection alternately flushing periodon-tal pocket,removing residue until the inflammation control after the break-adjusted+appropriate amount of Minocycline hydrochlo-ride ointment,along with fine needles inserted into the periodontal pocket wall slowly until bag after pushed into the bottom of Mi-nocycline hydrochloride ointment,slow retreated the drug overflow until the gingival margin,no gargle and drinking water within half an hour,once a week. Observation group additionally received 1.2 g Huanglian shangqing soft capsules,twice a day. 4-week was regarded as 1 course,and it last 2 courses. Clinical efficacy,PLI,PD,SBI,IL-1β,IL-6,IL-2 and IL-17 levels before and af-ter treatment,and the incidence of adverse reactions in 2 groups were observed. RESULTS:The total effective rate in observation group was significantly higher than control group,the difference was statistically significant (P<0.05). After treatment,the PLI, PD,SBI,IL-1β,IL-6,IL-2 and IL-17 levels in 2 groups were significantly lower than before,and observation group was lower than control group,the differences were statistically significant(P<0.05). The incidence of adverse reactions in observation group was significantly higher than control group,the difference was statistically significant (P<0.05),but the symptoms were mild. CONCLUSIONS:Based on conventional treatment,Huanglian shangqing soft capsule shows significant efficacy in the adjuvant treatment of inflammation around the implant,it can reduce inflammatory cytokine levels in gingival sulcus fluid,but with more ad-verse reactions.
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OBJECTIVE:To establish a method for the simultaneous determination of costunolide and dehydrocostus lactone in Haoweilai soft capsule. METHODS:HPLC was performed on the column of Dikma C18 with mobile phase of acetonitrile- water (V/V,55∶45) at a flow rate of 1.0 ml/min,detection wavelength was 225 nm,column temperature was 25 ℃,and the injection volume was 10 μl. RESULTS:The linear range were 24.00-108.00 μg/ml(r=0.999 7) for costunolide and 20.88-93.98 μg/ml for dehydrocostus lactone (r=0.999 8);RSDs of precision,stability and reproducibility tests were lower than 1%;recoveries were 98.71%-100.00%(RSD=0.25%,n=6)and 96.88%-99.18%(RSD=0.40%,n=6). CONCLUSIONS:The method is simple with good stability and reproducibility,and can be used for the simultaneous determination of costunolide and dehydrocostus lactone in Haoweilai soft capsule.
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OBJECTIVE:To investigate the effect of Wuzhi soft capsule on the pharmacokinetics of sirolimus in rats. METH-ODS:Wistar rats were randomly divided into 5 groups,with 6 rats in each group. They were given very low-dose,low-dose,me-dium-dose and high-dose of Wuzhi soft capsule(67,134,268 and 536 mg/kg)ig or blank solvent,respectively;and then given si-rolimus 0.4 mg/kg. The blood 100 μl was sampled by capillary eyes before giving sirolimus(0 h)and 0.5,0.75,1,1.5,2,2.5, 3,4,6,8,12,24 and 36 h after giving sirolimus and put into edetic acid anticoagulation tube. Blood concentration of sirolimus was assayed by LC-MS/MS. The pharmacokinetic parameter was calculated by DAS 2.0 software using non-compartment model. RESULTS:The pharmacokinetic parameters of sirolimus in very low-dose,low-dose,medium-dose and high-dose groups and blank solvent group were cmax of(6.79±1.15),(17.40±3.13),(21.24±3.14),(22.06±4.82),(2.80±0.72)ng/ml;t1/2 of(11.01± 0.82),(12.20±2.02),(12.28±2.38),(12.36±0.73),(10.59±0.69)h;AUC0-∞ of(85.79±15.26),(162.18±41.75),(273.12± 73.69),(268.79±28.46),(36.72±3.01)ng·h/ml,respectively. Compared with blank solvent group,cmax and AUC0-∞ of sirolimus were all increased in very low-dose,low-dose,medium-dose and high-dose groups,but t1/2 changed slightly. CONCLUSIONS:Wu-zhi soft capsule can substantially enhance the absorption of sirolimus in rats.
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OBJECTIVE:To establish a method for the contents determination of phospholipid and γ-linolenic acid in Com-pound linolenic acid soft capsule. METHODS:HPLC was conducted to determine the content of soybean lecithin;the column was Agilent TC-C18 with mobile phase of methanol-water(84:16,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 219 nm,the column temperature was 30 ℃,and the injection volume was 10 μl.Gas chromatography was conducted to determine the content of γ-linolenic acid in the preparation;the column was DB WAX,injector temperature was 210 ℃ by temperature pro-grammed,carrier gas was helium at a flow rate of 1 ml/min by split injection(split ratio of 1:30),and the injection volume was 0.02μl. RESULTS:The linear range was 4.64-16.24μg/ml for phospholipid(r=0.999 6)and 0.093 44-0.327 04μg/ml forγ-linole-nic acid methy ester(r=0.999 6);RSDs of precision,stability and reproducibility tests were lower than 3%;recoveries were 97.44%-99.36%(RSD=0.93%,n=6) and 97.22%-99.07%(RSD=1.01%,n=6),respectively. CONCLUSIONS:The method is simple,stable with good separation,and can be use for the contents determination of phospholipid and γ-linolenic acid in Com-pound linolenic acid soft capsule.
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Objective: To observe the clinical efficacy of Maren Soft Capsule on treating constipation in stroke patients. Methods: Patients (104) suffered from constipation were randomly divided into the treatment group (n = 52) and the control group (n = 52). Patients in the treatment group were given Maren Soft Capsule and Maren Boluses were used to the patients in the control group. Results: In two weeks after treatment, the defecation frequency and stool consistency were observed and compared between the two groups. Compared with the control group, defecation frequency and stool consistency scores were higher in the observation group, the differences were statistically significant (P < 0.05). The total efficacies in the control group and observation group were 69.23% and 96.15%, respectively, the differences were statistically significant (P < 0.001). No serious adverse reactions were found in the two groups. Conclusion: Maren Soft Capsule could solve the constipation in stroke patients.