Effect of Yunkang Oral Solution on pregnant mice with spleen deficiency syndrome / 中国中药杂志

This study aimed to investigate the therapeutic effect of Yunkang Oral Solution on the improvement of spleen deficiency and pregnancy outcomes in pregnant mice with spleen deficiency syndrome induced by irregular diet and over consumption of cold and bitter foods. To simulate human irregular diet and over consumption of cold and bitter foods leading to spleen deficiency, the pregnant mice with spleen deficiency syndrome were prepared using an alternate-day fasting and high-fat diet combined with oral administration of Sennae Folium. During the experiment, spleen deficiency-related indicators and diarrhea-related parameters were measured. Gastric and intestinal motility(gastric emptying rate and intestinal propulsion rate) were evaluated. The levels of serum ghrelin, growth hormone(GH), gastrin(Gas), total cholesterol(TC), low-density lipoprotein cholesterol(LDL-c), chorionic gonadotropin β(β-CG), progesterone(P), and estradiol(E_2) were measured. Intestinal barrier function in pregnant mice with spleen deficiency syndrome was assessed. Conception rate, ovarian coefficient, litter-bearing uterine coefficient, number of live fetuses, average fetal weight, and fetal length were calculated. The results showed that Yunkang Oral Solution significantly improved spleen deficiency-related indicators and diarrhea in pregnant mice with spleen deficiency syndrome, increased gastric emptying rate and intestinal propulsion rate, elevated the levels of gastrointestinal hormones(ghrelin, GH, and Gas) in the serum, and reduced lipid levels(TC and LDL-c), thereby improving lipid metabolism disorders. It also improved colonic tissue morphology, increased the number of goblet cells, and promoted the mRNA and protein expression of occludin and claudin-1 in colonic tissues, thereby alleviating intestinal barrier damage. Yunkang Oral Solution also regulated the levels of pregnancy hormones(β-CG, P, and E_2) in the serum of pregnant mice with spleen deficiency syndrome. Moreover, it increased the conception rate, ovarian coefficient, litter-bearing uterine coefficient, number of live fetuses, average fetal weight, and fetal length. These findings suggest that Yunkang Oral Solution can improve spleen deficiency-related symptoms in pregnant mice before and during pregnancy, regulate pregnancy-related hormones, and improve pregnancy outcomes.

Study on formulation screening of chloral hydrate oral solution / 药学学报

Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.

Effect of Yinxing Mihuan Oral Solutionon P2RX7/NLRP3 Signaling Pathway in Depression Model Rats Induced by Isolation Combined with Chronic Unpredictable Mild Stress / 中国实验方剂学杂志

Objective:To explore the antidepressant mechanism of Yinxing Mihuan oral solution （YMO） by investigating its effect on depression model rats. Method:The depression rats were induced by isolation combined with chronic unpredictable mild stress （CUMS） and then randomly divided into model group， fluoxetine group （10 mg·kg^-1） and high-dose （618 mg·kg^-1） and low-dose （309 mg·kg^-1） YMO groups. A blank control group was also set up and ten rats were included in each group. Modeling lasted for 21 consecutive days， and rats were administered the 8th day after stimulation at a dose of 10 mL·kg^-1 for 14 days， except those in the blank control and model groups which were given distilled water. Afterward， the sucrose preference test， open field test， tail suspension test were carried out. The pathological changes of hippocampus in depression rats were observed after hematoxylin-eosin （HE） staining. The content of interleukin-1<italic>β </italic>（IL-1<italic>β</italic>）， interleukin-6 （IL-6） and tumor necrosis factor-<italic>α </italic>（TNF-<italic>α</italic>） in the hippocampus of rats in each group and the expression of NOD-like receptor 3 （NLRP3） and other proteins in its related activation signaling pathways were detected with multi-factor detection （Luminex） and Western blot. Result:After 14 days of continuous administration， compared with the blank control group， the model group witnessed significantly reduced sugar water consumption rate and the times of rearing and significantly prolonged cumulative time of immobility during tail suspension （<italic>P</italic><0.05， <italic>P</italic><0.01）. Compared with the model group， the fluoxetine group and the high-dose YMO group saw increases in the times of rearing， times of crossing and sugar water consumption rate and a significant decrease in the cumulative time of immobility during tail suspension （<italic>P</italic><0.05， <italic>P</italic><0.01）. The results of HE staining showed that the neurons in the hippocampus of rats in the high-dose YMO group were arranged in order and slightly loosened， without obvious microglia infiltration observed. The levels of IL-1<italic>β</italic>， IL-6 and TNF-<italic>α</italic> in the hippocampus of the model group increased significantly as compared with the blank control group （<italic>P</italic><0.05， <italic>P</italic><0.01）， and their content in the high-dose YMO group was significantly lowered in the comparison with the model group （<italic>P</italic><0.05， <italic>P</italic><0.01）. Molecular biology experiments demonstrated that compared with the results of blank group， the expression of purinergic receptor P2X7 （P2RX7）， NLRP3， apoptosis-associated speck-like protein （ASC）， Caspase-1 and IL-1<italic>β</italic> remarkably increased in the model group （<italic>P</italic><0.05， <italic>P</italic><0.01）. Additionally， the expression of P2RX7， NLRP3， ASC， Caspase-1 and IL-1<italic>β </italic>was significantly inhibited in the fluoxetine group and the high-dose YMO group compared with the model group （<italic>P</italic><0.05， <italic>P</italic><0.01）. Conclusion:YMO can improve the depression-like behaviors of rats induced by isolation combined with CUMS， and its mechanism of action is related to the regulation of the P2RX7/NLRP3 signaling pathway.

Application of capability sixpack in quality analysis of hospital preparation magnesium sulfate oral solution / 药学实践杂志

Objective To analyze the quality of the hospital preparation magnesium sulfate oral solution by using capability sixpack. Methods By using the capability sixpack of Minitab, the content of magnesium sulfate in the magnesium sulfate oral solution was used as an indicator to determine whether the magnesium sulfate composition reached a controlled state during the production process and whether the production process of magnesium sulfate oral solution was stable. Results The content of magnesium sulfate and the production process of magnesium sulfate oral solution was under control, but there were potential disadvantages. Based on the concept of risk management philosophy, The failure model and effect analysis (FMEA) were applied to the prospective management of potential risks. Conclusion The application of the capability sixpack in the quality analysis of the hospital preparation of magnesium sulfate oral solution is helpful for us to discover the potential risks under the controlled state of the production process, which is beneficial to the improvement of the preparation production process and the assurance of the quality of the preparation.

Safety on Chloral Hydrate Oral Solution for Sedative and Hypnotic in Children ：A Systematic Review / 中国药房

OBJECTIVE：To systematically evaluate the safety of Chloral hydr ate（CH）oral solution for sedative and hypnotic in children，and to provide evidence-based reference for clinical use. METHODS ：Retrieved from 9 electronic databases （PubMed， Cochrane Library ，Embase，CINAHL，International Pharmaceuticals ，CNKI，CBM，Wanfang Database ，VIP），3 clinical trial registry platforms （Clinical Trials ，Cochrane Clinical Trial Database ，WHO Clinical Trial Database ）and 18 adverse drug reaction （ADR）monitoring systems （ADR monitoring websites of WHO ，USA，Switzerland，China and other countries/areas/international organizations），during the date of database establishment to March 2019，the reports of randomized controlled trials ，cohort studies，case-control studies ，case series studies ，case reports ， cross-sectional studies and adverse reactions monitoring network of chloral hydrate versus other interventions （blank 85503205。E-mail：chenzhehx@163.com control，placebo or other sedative hypnotics ）for children ’s sedative and hypnotic safety were collected. After data extraction of included literatures met inclusion criteria ，quality mail：zhanglingli@scu.edu.cn evaluation of included s tudies with Cochrane bias risk evaluation manual （RCT），Newcastle-Ottawa scale evaluation tool （Cohort study and case control study ），Australian JBI quality assessment tool （case series study and case report study ），Meta-analysis was performed by Rev Man 5.3 software，or descriptive analysis was conducted. RESULTS ：A total of 54 studies were included ，among which there were 13 RCTs，9 cohort studies ，17 case series studies ，13 case reports ，and 2 reports from ADR monitoring network. Based on the results of RCT and cohort studies ， the incidence of Chloral hydrate oral solution adverse events was 7.25％. There was no statistical significance in the incidence of digestive system [RR ＝0.87，95％ CI（0.14，5.42），P＝0.88]，nervous system [RR ＝0.13，95％ CI（0.01，2.41），P＝0.17]， cardiovascular system [RR ＝2.12，95％ CI（0.08，56.57），P＝0.65] adverse event between Chloral hydrate oral solution and midazolam. The incidence of respiratory system adverse events induced by Chloral hydrate oral solution was higher than that of midazolam [RR ＝3.07，95％CI（1.94，4.86），P＜0.01]. There was no statistical significance in the incidence of digestive system adverse events between Chloral hydrate oral solution and diazepam [RR ＝0.71，95％CI（0.47，1.10），P＝0.13]. There was no statistical significance in the incidence of digestive system ，nervous system and cardiovascular system adverse events between Chloral hydrate oral solution and barbiturates （P＞0.05）. CONCLUSIONS ：Chloral hydrate oral solution is similar to midazolam ， diazepam and barbiturates in terms of digestive ，nervous and cardiovascular systems adverse events ，but the incidence of respiratory system adverse events is higher than midazolam.

Study on the Effects of Biyuanshu Oral Solution on mRNA Expression of IFN-γ and Immune Checkpoint B7-H1/ PD-1 of Nasal Sinus Mucosa in CRS Model Mice / 中国药房

OBJECTIVE：To investigate the effects of Biyuanshu （BYS）oral solution on IFN-γ of chronic rhinosinusitis （CRS）model mice ，and to investigate its potential mechanism on the basis of B 7-H1/PD-1 immune checkpoint. METHODS ：Male C57 mice were randomly divided into normal group ，sham operation group ，chemical medicine control group （clarithromycin，103 mg/kg），BYS low-dose ，medium-dose and high-dose groups （BYS oral solution ，3.1，6.2，12.4 mL/kg），with 20 mice in each group. Except for normal group without any treatment ，other mice were all open maxillary sinus ，sham operation group was not filled with sponge with bacteria ，while model group and administration groups were filled with sponge with bacteria to induce CRS model. Since 8th week after modeling ，normal group ，sham operation group and model group were given normal saline 0.2 mL intragastrically，administration groups were given relevant medicine intragastrically ，once a day ，for consecutive 14 d. The nasal symptoms and general condition of mice were observed ，and the pathological changes of mice ’s nasal sinus mucosa were observed by HE staining ；qRT-PCR was used to measure the mRNA expression of IFN-γ，B7-H1 and PD- 1 in nasal sinus mucosa of mice. RESULTS：The normal group and sham operation group had no abnormal in nose ，and the epithelium and cilia of the nasal sinus mucosa were intact ；there was no significant difference f8y3j0127@163.com in the relative mRNA expression of IFN-γ，B7-H1 and PD- 1 between 2 groups（P＞0.05）. In model group ，the mice were found to have runny n ose，frequent scratching and sneezing ，a small amount of yellow secretion in the nasal cavity ，and serious depilation ；the nasal sinus mucosa was seriously damaged ，cilia was exfoliated ，and the gland in the submucosa was hyperplasia ，lymphocyte infiltration was also found ；the relative mRNA expression of IFN-γ，B7-H1 and PD- 1 were significantly increased compared with normal group （P＜0.01）. Compared with model group，the nasal symptoms ，general condition and pathological changes of the nasal sinuses in each administration group were improved in varying degrees ；the relative mRNA expression of IFN-γ and B7-H1 in chemical medicine control group ，BYS medium-dose and high-dose groups ，as well as the relative mRNA expression of PD- 1 in administration groups were decreased significantly；above indexes of BYS medium-dose and high-dose groups were significantly lower than BYS low-dose group ，while relative mRNA expression of IFN-γ in BYS high-dose group were significantly higher than BYS medium-dose group. The relative mRNA expression of IFN-γ in BYS low-dose and medium-dose groups，the relative mRNA expression of B 7-H1 in BYS low-dose group，the relative mRNA expression of PD- 1 in BYS groups were significantly higher than chemical medicine control group ； mRNA expression of IFN-γ in BYS high-dose group was significantly higher than chemical medicine control group（P＜0.05 or P＜ 0.01）. Above indexes of BYS medium-dose group were similar to those of chemical medicine control group （P＞0.05）. CONCLUSIONS：BYS oral solution can improve chronic inflammation in nasal sinus mucosa of mice ，the mechanism of which may be associated with intervening mRNA overexpression of B 7-H1/PD-1 by inhibiting mRNA expression of IFN-γ.

Relative oral bioavailability of three formulations of vitamin D3: An open-label, three-treatment study

Background: Supplementation of vitamin D2 or vitamin D3 is recommended for vitamin D deficiency. Weekly supplementation of 60,000 IU of vitamin D3 increases serum 25(OH) D to optimal values. Various marketed forms of vitamin D3 include tablets, capsule, granules and oral solution. The main objective of this study is to compare the relative bioavailability of vitamin D3 oral solution with vitamin D3 tablet and capsule.Methods: This is an open-label, randomized, single-dose, three-treatment study to compare the relative bioavailability of vitamin D3 oral solution with capsule and tablet. Subjects (n=70) were supplemented with single dose of one of these formulations and their blood sample were assessed for Cmax, AUC0-28d and Tmax.Results: The logarithmic transformed data of pharmacokinetic parameters were analyzed for 90% Confidence Intervals (CI) using ANOVA. The mean (90% CI) values of vitamin D3 oral solution against tablet for the ratio of Cmax and AUC0-28d were 113.00 (105.32-121.23) and 105.54 (97.95-113.72) respectively. The mean (90% CI) values of vitamin D3 oral solution against capsule for the ratio of Cmax and AUC0-28d were 115.02 (106.38 - 124.37) and 112.33 (104.44 - 120.81) respectively. These values were within the bioequivalence range of 80-125%.Conclusions: It is concluded that vitamin D3 Oral Solution formulated with nanotechnology is bioequivalent to vitamin D3 tablet and capsule. However, oral solution of vitamin D3 shows higher Cmax and AUC when compared to tablet and capsule formulations.

Determination of Potassium Sorbate in Xiao'er Kechuanling Oral Solution by HPLC / 中国药师

Objective:To develop a method for the determination of potassium sorbate in Xiao 'er Kechuanling oral solution by HPLC.Methods:A Phenomenex Gemini C18 column (250 mm ×4.6 mm, 5 μm) was used, and the mobile phase was 0.02 mol· L-1 sodium dihydrogen phosphate (adjusting pH to 4.0 with phosphoric acid)-acetonitrile (80:20).The flow rate was 1.0 ml· min-1 and the detection wavelength was set at 262 nm.The column temperature was 30℃and the injection volume was 20μl.Results:The linear range of potassium sorbate was 8.584-85.840μg· ml-1(r=0.9999).The recovery of potassium sorbate was 100.0％and the RSD was 0.47％(n=9).The limit of detection was 0.43 ng and the limit of quantitation was 1.29 ng.Conclusion:After the valida-tion, the method can be used for the assay of potassium sorbate in Xiao'er Kechuanling oral solution .

Protective effect of Yinxing Mihuan oral solution on acute myocardial ischemia injury in rats / 药学学报

This study was designed to investigate the effect of Yinxing Mihuan oral solution on rats with myocardial ischemia injury. Left anterior descending (LAD) coronary artery was occluded in rats to establish the model. Yinxing Mihuan oral solution was given by intragastric administration daily for one week at dosage of 309 and 618 mg·kg-1. Cardiac ultrasound function, pathologic change and serum myocardial enzymes were determined to evaluate the effect of Yinxing Mihuan oral solution. The heart function was significantly reduced in the model group compared with sham operation group, and the pathologic damage was clear. The changes were significantly improved by Diltiazem hydrochloride tablets in heart function and ejection fraction (P -1) (P P < 0.01). In addition, Yinxing Mihuan oral solution decreased the myocardial damage and inhibited inflammatory reaction, and inhibited platelet activation factor. Yinxing Mihuan oral solution can protect against myocardial ischemia injury, inflammation and platelet activation in the rat model.

Clinical analysis of ampheturine oral liquid in respiratory symptoms in Children with bronchitis / 中国生化药物杂志

Objective To analyze the clinical effect of amitriptyline oral solution on respiratory symptoms in children with bronchitis. Methods A total of 234 patients were selected from the clinical treatment materials of children with bronchial disease aged 9 months to 9 years in Longyou People's Hospital from 2015 to 2016 and divided into two groups according to the differences in administration. The patients in the observation group were treated with ambrotenol oral solution and the control group was treated with ambroxol syrup. The clinical manifestations of the two groups were compared before and after treatment, including cough, sputum sticky, expectoration difficulties, wheeze and so on. Results After treatment the two groups of children with relevant diseases were all reduced than before treatment, respectively. After one day, three days and five days treatment, the observation group children cough, sputum viscous, expectoration difficulties, wheezing and other symptoms of the degree of relief and duration of symptoms and other aspects of the effect were higher than the control group, the data were statistically significant. (P<0.05). Conclusion Ampheturazole oral solution can effectively improve the respiratory symptoms of children with bronchitis, the treatment effect is remarkable.

Clinical analysis of ampheturine oral liquid in respiratory symptoms in Children with bronchitis / 中国生化药物杂志

Objective To analyze the clinical effect of amitriptyline oral solution on respiratory symptoms in children with bronchitis. Methods A total of 234 patients were selected from the clinical treatment materials of children with bronchial disease aged 9 months to 9 years in Longyou People's Hospital from 2015 to 2016 and divided into two groups according to the differences in administration. The patients in the observation group were treated with ambrotenol oral solution and the control group was treated with ambroxol syrup. The clinical manifestations of the two groups were compared before and after treatment, including cough, sputum sticky, expectoration difficulties, wheeze and so on. Results After treatment the two groups of children with relevant diseases were all reduced than before treatment, respectively. After one day, three days and five days treatment, the observation group children cough, sputum viscous, expectoration difficulties, wheezing and other symptoms of the degree of relief and duration of symptoms and other aspects of the effect were higher than the control group, the data were statistically significant. (P<0.05). Conclusion Ampheturazole oral solution can effectively improve the respiratory symptoms of children with bronchitis, the treatment effect is remarkable.

Observation on the effect of calcium gluconate oral solution combined with psychological intervention on preventing the advertise reaction in blood donation by plateletpheresis / 中国生化药物杂志

Objective To study the effect of calcium gluconate oral solution combined with psychological intervention on preventing the advertise reaction in blood donation by plateletpheresis.Methods From February 2015 to February 2016, 114 cases were collected in Shaoxing downtown blood bank, and were divided into the control group and the experimental group 57 cases in each group.In the blood collection process, the control group were not given any treatment, the experimental group was given calcium gluconate oral liquid combined with psychological intervention.The total incidence adverse reactions and SAS scores in the two groups was compared.Results Before blood donation, Before blood donation, SAS scores in the two groups has no statistically significance.After blood donation, the SAS scores and the total incidence of adverse reactions in the experimental group were significantly lower than those in the control group, the differences in the two groups were statistically significant.(P<0.05).Conclusion Calcium gluconate oral liquid combined with psychological intervention can prevent the adverse reactions in the process of blood donation by plateletpheresis, which is worthy of promotion in the process of plateletpheresis.

Effect of Reduning Injection combined with spleen aminopeptide oral solution on children with hand-foot-and-mouth disease and its regulative effect on myocardial enzyme and inflammatory level / 药物评价研究

Objective To investigate the effect of Reduning Injection (RI) combined with spleen aminopeptide oral solution on children with hand-foot-and-mouth disease and its regulative effect on myocardial enzyme and inflammatory level.Methods Totally 184 cases treated in Children's Hospital of Kaifeng City from September,2014 to September,2016 were randomly divided into observation group and control group with each group of 92 cases.Control group was given conventional therapy,on the basis of which,observation group was given RI combined with spleen aminopeptide oral solution.Clinical effect and levels of inflammatory cytokine and myocardial enzyme were compared between the two groups.Results The total effective rate in observation group was 93.48％,which was significantly higher than that in control group (80.43％) (P ＜ 0.05).After therapy,the levels ofhs-cTnT,CK-MB,CK,TNF-α,IL-6,CRP,CD3+,CD4+,CD8+,IgA,IgM,and IgG in observation group showed no statistical difference compared with healthy group.Index mentioned above of control group were significantly improved,however there were still statistical difference compared with healthy group (P ＜ 0.05).Conclusion RI combined with spleen aminopeptide oral solution could effectively decrease the levels of inflammatory cytokine as well as myocardial enzyme,which deserves clinical expansion.

Improvement of preparing technique for compound glycyrrhiza oral solution / 国际药学研究杂志

Objective To obtain a clear and qualified compound glycyrrhiza oral solution by using NaSO3 and EDTA as stabi-lizers and Tween80 as solubilizer so as to solve the problem of morphine content instability. Methods NaSO34g and EDTA 0.6 g as stabilizers,and Tween803 g as solubilizer were added in the traditional method. The pH of the solution was adjusted to 8.0. Then the solution was obtained and filled in the brown polyester bottle. Results The preparation was clear,qualified and the content of mor-phine was steady. Conclusion The improved method is feasible,simple,stabilized and suitable for manufacturing.

Lactulose Oral Solution on the Treatment of 61 Cases of Postpartum Constipation / 医药导报

Objective To study the effect and adverse reaction of lactulose oral solution on the treatment of postpartum constipation.Methods A total of 120 patients with postpartum constipation were randomly divided into treatment group (n=61) and control group (n=59).The treatment group received 15 mL lactulose oral solution,twice a day.The control group received wheat cellulose particles 3.5 g,twice a day.After the improvement of symptoms,the patient''s medication frequency was changed to 1 time a day,the course of treatment was 2 weeks long.The curative effect(including before treatment,period during the treatment,and the first week after finish the whole treatment) and the recurrence of constipation after treatment were observed.Results The frequency of defecation per week in the treatment group was(3.83±1.61)times,that in the control group was(3.09±1.53)times at the first week after treatment(P0.05) after follow-up to 60 d.The degree of drug acceptance in two groups was 100.00% and 76.27% respectively(P<0.01).There was no obvious adverse reaction in both two groups.Conclusion The effect of lactulose oral solution on the treatment of postpartum constipation is definite and with low recurrence rate.Lactulose oral solution has a good taste,easily to be taken and to be accepted,it is worthy of clinical application.

Analysis and Countermeasures of Microbial Contamination in Methadone Hydrochloride Oral Solution / 中国药师

Objective:To analyze the causes of microbial contamination in methadone hydrochloride oral solution used for the ma-intenance treatment of heroin addict in Guangxi and propose the relative countermeasures. Methods:The samples of methadone hydro-chloride oral solution were obtained from 10 maintenance treatment clinics, and then the microbial limit test and identification were per-formed,the content of preservative was detected and the relationship between the preservative content and microbial contamination was studied. Results:The total number of aerobe in the samples of methadone hydrochloride oral solution from the 10 clinics was all over the standard limit value of 100 cfu·ml-1 ,and the main contaminating germ was Burkholderia cepacia. The contents of sorbic acid were 78. 2％-98. 3％,the four batches with the lowest concentration of preservative were detected with higher total number of aerobe. Con-clusion:The microbial contamination in methadone hydrochloride oral solution from the 10 maintenance treatment clinics is severe,and the environment of medicine packaging, content of preservatives, packaging machine and storage conditions are the primary causes for the microbial contamination. To ensure drug quality safety, it is suggested that the environment cleanliness of medicine packaging be improved, suitable content of preservatives be added, packaging machine be clean, the products be stored in shade and the quality be tested regularly.

Untargeted Urinary Metabolomic Study on Toxicity-alleviation Effect of Huangqi Oral Solution in Cisplatin-exposed Rats / 分析化学

A liquid chromatography-quadrupole-time-of-flight mass spectrometer(LC-Q/TOF-MS) based urinary metabolomic approach was employed to assess the toxicity-alleviation effect of Huangqi oral solution(HOs) on cisplatin-exposed rats and explore its possible mechanisms. Rat toxicity model was developed by multiple intraperitoneal injection of low-dose cisplatin, while HOs was orally administrated to rats simultaneously for 16 consecutive days to attenuate or reduce the cisplatin-induced toxicity. 24-hour urine samples on day 18 were collected and analyzed using LC-Q/TOF-MS to obtain the dataset of urinary metabolites. Principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were employed to assess the quality of the dataset and screen the potential toxicity-alleviation biomarkers. The serum level of rat creatinine and urea nitrogen on day 20 was determined, and the results showed that successive administration of HOs significantly reduced the cisplatin-induced increase of creatinine and urea nitrogen. PCA cluster analysis clearly demonstrated that HOs could partly improve the CDDP-induced abnormality of metabolic profiling. 35 urinary metabolites were finally screened as the potential biomarkers associated with the toxicity-attenuation effect of HOs, according to the combination of the analysis results of OPLS-DA, t-test and fold change analysis. Further metabolic pathway analysis revealed that HOs could restore the metabolic disorders of amino acid, energy and nucleotide, thereby exerted its toxicity-alleviation effect.

Improvement in Quality Control Methods for Belladonna Oral Solution / 中国药师

Objective:To improve the identification and determination methods in the original quality standard for belladonna oral solution.Methods:Belladonna oral solution was identified by a specific chromatogram of HPLC,and scopoletin and hyoscyamine sulfate in belladonna oral solution were detected by dual wavelength spectrophotometry.The detection of fingerprints was performed on a Waters SunFire C18 (250 mm×4.6mm,5 μm) column.The mobile phase was methanol-0.05% phosphoric acid solution at a flow rate of 1.0 ml·min-1.The detection wavelength was 344 nm and the column temperature was 30℃.The detection of scopoletin and hyoscyamine sulfate was performed on the same C18 column.The mobile phase was 10 mmol·L-1 heptanesulfonate sodiumat (pH value was 3.3 adjusted by glacial acetic acid)-absolute ethanol-acetonitrile (68.75∶6.25∶25) at a flow rate of 1.0 ml·min-1.The detection wavelengths were 344 nm and 210 nm,and the column temperature was 30℃.Results:The specific chromatogram of belladonna oral solution was accordance with that of belladonna tincture raw material.The retention time and relative peak area of each characteristic peak and reference peak all met requirements of Chinese Pharmacopoeia.Scopoletin and hyoscyamine sulfate were completely separated from the other compositions under the above mentioned conditions.The calibration curves were linear within the range of 5.168-103.360 μg·ml-1 (r=1.000 0) for scopoletin and 50.560-758.400 μg·ml-1 (r=0.999 9) for hyoscyamine sulfate.The average recovery was 101.79% (RSD=1.05%,n=6) and 100.92% (RSD=0.97%,n=6),respectively.Conclusion:After the quality control method improvement,the identification shows high specificity and the quality of belladonna oral solution can be better controlled by the two selected index components.The method is easy and accurate,which can provide a reliable way to control the quality.

Rat Toxicological Study of Shuanghuanglian Oral Solution (Only for Children) / 中国中医药信息杂志

Objective To study the effects of Shuanghuanglian Oral Solution (only for children) on general condition, body weight, food intake, growth and development, blood routine and pathologic changes of SD weanling rats; To provide experimental references for clinical safe medication.Methods SD weanling rats were randomly divided into control group,Shuanghuanglian (only for children) Oral Solution low-, medium- and high-dose group according to body mass, with 30 rats in each group. Each administration group was given corresponding amount of Shuanghuanglian Oral Solution (only for children) concentrated ointment for gavage, once a day, for 33 d. The toxicity of the rats during dosing period and recovery period (medicine withdrawal 25 d) was observed.Results There were no significant differences in general condition, individual development, organ mass and coefficient, and internal fixation and pathological findings of rats in administration groups during dosing period and recovery period. The body mass and food intake of female and male rats in the Shuanghuanglian Oral Solution high-dose group were lower than those in the control group. The blood routine test during dosing period showed that the lymphocyte ratio of female rats and male rats in Shuanghuanglian Oral Solution high-dose group decreased significantly, neutrophil ratio increased significantly, and then returned to normal level in recovery period.Conclusion Shuanghuanglian Oral Solution (only for children) concentrated ointment has no toxic effect on the whole body organs and tissues of juvenile rats, and the safety is good.

Research on quality standard of Santeng oral solution / 药学实践杂志

Objective To establish the quality standard of Santeng oral solution.Method Sargentodoxa Caulis and Spatholobi Caulis were identified by thin layer chromatography.Chlorogenic acid was assayed by high performance liquid chromatography.The chromatographic column is Agilent Zorbax SB C18 (4.6 mm×250 mm, 5 μm) with a stable temperature of 35 ℃.The mobile phase in isocratic elution consists of acetonitrile and 0.1% folic acid aqueous solution with a preliminary volume ratio of 9∶91.The flow rate is 1.0 ml/min with an injection volume of 20 μl.Results Thin layer chromatography showed distinct spots of Sargentodoxa Caulis and Spatholobi Caulis with a great specificity.A regression formula Y=60.14X-6.37(r>0.999 9) was obtained with a good linearity in concentration range of 2.70~202.50 μg/ml.Conclusion A simple, stable and repeatable method was established for the quality control of Santeng oral solution.