Objective: To compare the differences in pharmacokinetic behavior of six ingredients in Qikui Sustained-release Tablets in rabbit plasma. Qikui Granules was taken as reference. Methods: Diazepam was used as internal standard. LC-MS/MS detection methods of astragaloside, hyperin, isoquercitrin, rutin, morroniside, and loganin in rabbit plasma were established, and pharmacokinetic parameters of six components were calculated. Results: Six active ingredients’ equation of linear regressions were: astragaloside Y = 1.0 × 10-4 X - 0.009 9 (r = 0.999 7), morroniside Y = 1.0 × 10-4 X + 0.038 7 (r = 0.999 4), loganin Y = 3.0 × 10-5 X + 0.008 7 (r = 0.999 3), hyperin Y = 1.0 × 10-3 X - 0.016 1 (r = 0.999 0), rutin Y = 5.0 × 10-4 X - 0.011 5 (r = 0.999 4), isoquercitrin Y = 1.7 × 10-3X - 0.307 5(r = 0.999 2). Intra-day and inter-day precision and accuracy and recovery rate were up to the mustard. After Qikui Sustained-release Tablets and Qikui Granules being given by gavege, the maximal concentration (Cmax) of morroniside, loganin, astragaloside, rutin, hyperin, and isoquerctirin in Qikui Granules were (1.333 ± 0.051), (1.238 ± 0.164), (0.83 ± 0.079), (0.127 ± 0.017),(0.444 ± 0.048), and (0.223 ± 0.048) mg/L, t1/2 were (3.848 ± 0.311), (3.822 ± 0.757), (4.982 ± 1.14), (3.73 ± 0.298), (4.732 ± 0.642), and (5.132 ± 0.901) h, respectively, AUC(0-t) were (3.069 ± 0.307), (2.891 ± 0.943), (2.079 ± 0.306), (0.313 ± 0.068), (1.087 ± 0.177), (0.496 ± 0.129) mg∙h/L, respectively, Cmax of morroniside, loganin, astragaloside, rutin, hyperin, and isoquerctirin in Qikui Sustained-release Tablets were (0.985 ± 0.13), (0.961 ± 0.175), (0.693 ± 0.101), (0.094 ± 0.012), (0.354 ± 0.045), (0.201 ± 0.037) mg/L, t1/2 were (4.691 ± 0.337), (5.62 ± 1.64), (6.408 ± 0.707), (4.103 ± 0.341), (6.048 ± 0.882), (5.803 ± 0.59) h, AUC(0-t) were (5.191 ± 1.046), (6.168 ± 1.25), (4.293 ± 0.823), (0.485 ± 0.103), (1.84 ± 0.432), (0.924 ± 0.19) mg∙h/L. Contrast with Qikui Granules, relative bioavailability of morroniside, loganin, astragaloside, rutin, hyperin, and isoquerctirin in Qikui Sustained-release Tablets were 169.1%, 213.3%, 206.5%, 156.0%, 169.3%, and 186.3%, respectively. Conclusion: Qikui Sustained-release Tablets can significantly improve the bioavailability of each active ingredient in rabbit.

OBJECTIVETo observe the effect of Draconis Sanguis-containing serum on the expressions of NGF, BDNF, CNTF, LNG-FR, TrkA, GDNF, GAP-43 and NF-H in Schwann cells, and investigate the possible mechanism of Draconis Sanguis to promote peripheral nerve regeneration.

METHODSD rats were randomly divided into 2 groups: the Draconis Sanguis group (orally administered with Draconis Sanguis-containing balm solution) and the blank group (equivoluminal balm) to prepare Draconis Sanguis-containing serum and blank control serum. Schwann cells were extracted from double sciatic nerves of three-day-old SD rats, divided into 2 groups: the Draconis Sanguis group and the blank control group, and respectively cultured with 10% Draconis Sanguis-containing serum or blank control serum. The mRNA expressions of NGF, BDNF, CNTF and other genes in Schwann cells were measured by RT-PCR analysis 48 hours later.

RESULTMost of the Schwann cells were bipolar spindle and arranged shoulder to shoulder or end to end under the microscope and identified to be positive with the immunocytochemical method. To compare with the blank group, mRNA expressions of NGF, LNGFR, GDNF and GAP-43 significantly increased (P < 0.01). Whereas that of BDNF decreased significantly (P < 0.05), and so did that of TrkA, CNTF (P < 0.01), with no remarkable difference in NF-H-mRNA.

CONCLUSIONTraditional Chinese medicine Draconis Sanguis may show effect in nerve regeneration by up-regulating mRNA expressions of NGF, LNGFR, GDNF and GAP-43 and down-regulating mRNA expressions of TrkA, BDNF and CNTF.

Animals ; Arecaceae ; chemistry ; Brain-Derived Neurotrophic Factor ; genetics ; metabolism ; Cells, Cultured ; Ciliary Neurotrophic Factor ; genetics ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; GAP-43 Protein ; genetics ; metabolism ; Gene Expression ; drug effects ; Glial Cell Line-Derived Neurotrophic Factor ; genetics ; metabolism ; Male ; Nerve Growth Factor ; genetics ; metabolism ; Nerve Regeneration ; drug effects ; Neurofilament Proteins ; genetics ; metabolism ; Rats ; Rats, Sprague-Dawley ; Receptor, trkA ; genetics ; metabolism ; Schwann Cells ; drug effects ; physiology ; Serum ; chemistry

Objective To evaluate acute toxicity and genotoxicity of sapindus saponin and to provide toxicological basis for sapindus saponin ’s daily applications. Methods Acute oral toxicity test,mammalian erythocyte micronucleus test, bacterial reverse mutation test and in vitro mammalian chromosome aberration test were used to investigate the effect of the sapindus saponin on gene mutation and chromosome aberration in both prokaryotic and eukaryotic cells. Results The acute toxicity test showed that the LD50 of sapindus saponin was 4640 mg/kg for both male and female mice. Toxic symptoms were observed including salivation,mucus and other toxic manifestations. There was no significant difference between the each dose group and the negative control group in the results of mammalian erythocyte micronucleus test( P>0. 05). The results of bacterial reverse mutation test were also negative. In each dose group and strain with or without S9,the number of revertant colonies did not exceed 2 times than that of spontaneous revertant colonies( negative control). No dose-response relationship was observed. The vitro mammalian chromosome aberration test showed that the IC50 of sapindus saponin on CHL was 75 μg/ml,and the differences between each dose group and the negative control group were not statistically significant( P >0. 05 ). However,the positive control group differed from the negative control group in all tests( P <0. 01). Conclusion Under this experimental condition,sapindus saponin has no genotoxicity.

The possibility of using a subunit or fragment of human chorionic gonadotropin (hCG) as an immunogen for birth control has been actively explored for many years. This protein homone is produced by the fertilized egg and is required for implantation of the blastocyst into the maternal uterus and the maitenance of pregnancy. In previous studies, several bio-synthesized hCG chimeric peptides (CP) that contain three linear B-cell epitopes (beta5, beta9 and beta8) of beta-hCG subunit together with various foreign 'promiscuous' T-cell epitopes were constructed and expressed as potential new hCG vaccine immunogens. In order to detect antibodies to each of the individual B-cell epitopes present in the animal antiserum raised against the hCG CPs, we decided to construct three recombinant proteins, each contains a single target B-cell epitope (betaE) of beta-hCG. Two sets of DNA fragments were chemically synthesized encoding the beta5, beta9 and beta8 epitopes (betaE) 45 approximately 52, 113 approximately 116 or 133 approximately 144 of beta-hCG subunit and were inserted into the downstream of streptavidin (Stv) gene in pTSA18 separately, with or without an extra TAA codon at the 3'-terminals of the genes. SDS-PAGE analysis revealed that only Stv-betaE (-beta5, -beta9 or -beta8) fusion genes set with the TAA codon can be expressed in E. coli BL21 (DE3) pLysS strain at high level after 1mM IPTG induction for 4 hours. Additionally, these fusion proteins can all be recognized by specific polyclonal antiserum (RS-4157) generated upon immunization with the loop peptide 38 approximately 57 of beta-hCG, monoclonal antibody (mAb) FB12 to beta9 epitope and mAb OT3A that specially recognizes reporter sequence 133 approximately 139 of beta8 epitope 137 approximately 144. Each of the proteins can be purified to 95% relative homogeneity using an improved method of preparative gel polyacrylamide gel electrophoresis. The yields were 5 mg per 1 L culture. The three target Stv-betaE fusion proteins will be useful in determining the immunogenicity of designed hCG CPs and hCG vaccines, including hCG DNA vaccines.
Chorionic Gonadotropin, beta Subunit, Human ; genetics ; immunology ; Epitopes, B-Lymphocyte ; genetics ; Humans ; Recombinant Fusion Proteins ; biosynthesis ; immunology ; isolation & purification ; Streptavidin ; genetics ; Vaccines, Synthetic ; immunology

Objective To compare the pharmacokinetic behavior of two captopril tablets in Chinese healthy subjects,and evaluate the bioequivalence and safety of the tested and reference preparations.Methods This study was a single-center,random,open,double-cycle,double-cross design scheme.Twenty-four healthy subjects were randomized divided two groups and took single dose of 25 mg captopril of test tablet or reference tablet under fasting condition during each period.Plasma concentrations of captopril were determined by liquid chromatography-mass spectroscopy(LC-MS/MS)following administration of the oral single captopril tablet.The pharmacokinetic parameters were calculated by using non-atrioventricular model with WinNonlin 8.0 software to evaluate bioequivalence.The safety of clinical observation indexes of the subjects was evaluated during the trail.Results Main pharmacokinetic parameters of test preparation and reference preparation captopril in fasting group test:Cmax were(803.22±196.81)and(844.75±163.43)ng·mL-1;AUC0-t were(3 118.06±642.05)and(3 353.53±597.94)h·ng·mL-1;AUC0-∞ were(3 347.35±712.07)and(3 594.15±654.39)h·ng·mL-1.The 90％confidence intervals(CI)of geornetric mean ratio of Cmax,AUC0-t and AUC0-∞ were 87.15％-99.97％,89.54％-96.14％and 89.55％-96.26％,all in the range of 80.00％-125.00％,indicating that the bioequivalence of the two preparations could be determined.During the trial,the incidence rates of adverse events for the test preparation and the reference preparation were 30.43％and 33.33％,respectively,without any serious adverse events occurring.Conclusion The test tablet and reference tablet of captopril were equivalent and safe during the trial.

Objective To observe the clinical efficacy and safety of insulin glargine injection combined with glimepiride tablets in the treatment of type 2 diabetes mellitus (T2DM).Methods Forty-five patients with T2DM were randomly divided into control group (n =22 cases) and treatment group (n =23 cases).Control group was given insulin glargine with the starting dose of 0.2 U · kg-1,qd,subcutaneous injection.Treatment group was given glimepiride 2-4 mg,qd,orally,on the basis of the control group.Two groups were treated for 12 weeks.The blood glucose compliance rates and adverse drug reactions were compared between two groups.Results At 4,8,12 weeks after treatment,the blood glucose compliance rates in treatment group were 91.30％ (21 cases/23 cases),100.00％ (23 cases/23 cases) and 100.00％ (23 cases/23 cases),which in control group were 54.54％ (12 cases/22 cases),72.72％ (16 cases/22 cases) and 81.81％ (18 cases/22 cases),the differences were statistically significant (all P ＜ 0.05).The adverse drug reactions in treatment group were palpitation,which in control group were dizziness,palpitation,discomfort and sweating.The incidences of adverse drug reactions in treatment and control groups were 4.35％ and 31.82％ with significant difference (P ＜ O.05).Conclusion Insulin glargine injection combined with glimepiride tablets has a definitive clinical efficacy and safety in the treatment of T2DM,which can significantly improve the blood sugar compliance rate.

Purpose::To investigate the accuracy and efficiency of bedside ultrasonography application performed by certified sonographer in emergency patients with blunt abdominal trauma.Methods::The study was carried out from 2017 to 2019. Findings in operations or on computed tomography (CT) were used as references to evaluate the accuracy of bedside abdominal ultrasonography. The time needed for bedside abdominal ultrasonography or CT examination was collected separately to evaluate the efficiency of bedside abdominal ultrasonography application.Results::Bedside abdominal ultrasonography was performed in 106 patients with blunt abdominal trauma, of which 71 critical patients received surgery. The overall diagnostic accordance rate was 88.68%. The diagnostic accordance rate for liver injury, spleen injury, kidney injury, gut perforation, retroperitoneal hematoma and multiple abdominal organ injury were 100%, 94.73%, 94.12%, 20.00%, 100% and 81.48%, respectively. Among the 71 critical patients, the diagnostic accordance rate was 94.37%, in which the diagnostic accordance rate for liver injury, spleen injury, kidney injury, gut perforation and multiple abdominal organ injury were 100%, 100%, 100%, 20.00% and 100%. The mean time for imaging examination of bedside abdominal ultrasonography was longer than that for CT scan (4.45 ± 1.63 vs. 2.38 ± 1.19) min; however, the mean waiting time before examination (7.37 ± 2.01 vs. 16.42 ± 6.37) min, the time to make a diagnostic report (6.42 ± 3.35 vs. 36.26 ± 13.33) min, and the overall time (17.24 ± 2.33 vs. 55.06 ± 6.96) min were shorter for bedside abdominal ultrasonography than for CT scan. Conclusion::Bedside ultrasonography application provides both efficiency and reliability for the assessment of blunt abdominal trauma. Especially for patients with free peritoneal effusion and critical patients, bedside ultrasonography has been proved obvious advantageous. However, for negative bedside ultrasonography patients with blunt abdominal trauma, we recommend further abdominal CT scan or serial ultrasonography scans subsequently.

Objective To test the efficacy of multifactor intensive intervention for post percutaneous transluminal coronary intervention (post-PCI) outpatients on self management,risk factor control and outcome.Methods A total of 263 patients with coronary heart disease (CAD) discharged from our cardiac center were randomized into usual care (4 CAD lectures focusing on the 2nd CAD prevention and patientsoriented outpatient visit) and intensive intervention (4 CAD lectures focusing on the 2nd CAD prevention,CAD outpatient visit twice a month,monthly telephone instructions on risk factor control and optimal medication).Patients were followed for 12 months and 250 patients completed follow-up.Results There were more patients achieved a LDL-C level of less than 2.6 mmol/L in intensive intervention group than in usual care group (71.2％ vs.48.3％,P ＜ 0.01).The percentages of patients taking dietary control (55.3％ vs.26.2％,P ＜0.01) and physical exercises (64.4％ vs.39.0％,P ＜0.01),receiving betaadrenergic receptor blocker (75.0％ vs.50.8％,P ＜0.01) and statins (72.0％ vs.54.2％,P ＜0.01)were significantly higher while cardiovascular event rate (5.9％ vs.0％,P =0.005)was significantly lower in intensive intervention group than in usual care group.Conclusion Muhifactor intensive intervention is helpful on improving the second prevention for post-PCI coronary heart disease patients.

Hyperuricemia/gout is a common metabolic disease in China, which is a serious threat to people′s health. In clinical practice, the standardization of prevention and diagnosis and the rate of treat-to-target need to be improved. There is still a lack of education for the patients about the understanding of clinical guidelines, the disease knowledge and the importance of cooperating with doctors to carry out diagnosis and treatment. From the most concerned issues of the patients, we established the hyperuricemia/gout patient practice guideline working group with multidisciplinary physicians and patients. Seventeen opinions, as the hyperuricemia/gout patient practice guidelines, are proposed in accordance with the relevant principles of the "WHO guidelines development manual" , and with the international normative process, aiming to improve the patients compliance, improve the level of health management of the disease.

In recent years, the clinical guidelines for the diagnosis and treatment of rheumatoid arthritis (RA) have been constantly updated. Among the general principles, it is particularly emphasized that, in order to improve the ratio of treat to target(T2T) of RA, doctors and patients should work together to negotiate the details of the guidelines. Therefore, it is important for patients to further understand the disease and clinical guidelines of RA, and to better cooperate with doctors. This study was based on the most concerned issues of RA patients and international standard procedure of guideline study, we organized the working group and introduce the following 16 recommendations constituting the RA patients′ practice guidelines.