1.Preparation and Quality Standard Formulation of Compound Bupleurum Suppository
Zhizhen YU ; Zegan LIU ; Libo WANG ; Liangyong HUANG ; Fang YE ; Haitao ZHU ; Ziyan XU ; Shiming DU
Herald of Medicine 2025;44(9):1482-1489
Objective To explore the prescription and preparation technology of compound Bupleurum suppository and draft its quality standard.Methods The volatile oil of Bupleurum was extracted by steam distillation,and the compound Bupleurum-based suppository was prepared by mixing the volatile oil with taurine using the melting method.The quality standard of the preparation was formulated according to the quality inspection items of the general rule 0107 of the Pharmacopoeia of the People's Republic of China(2020 Edition,Volume IV);The contents of n-hexanoic acid and n-heptanoic acid in the preparation were determined by gas chromatography-mass spectrometry(GC-MS).The content of taurine in the preparation was determined by high-performance liquid chromatography(HPLC).Results The optimized distillation time of the volatile oil was 1.5 h,The linear ranges of n-hexanoic acid,n-heptanoic acid and taurine are 23.175 0-115.875 0 μg·mL-1(R2=0.999 4),4.590 0-68.850 0 μg·mL-1(R2=0.998 9)and 15-125 μg·mL-1(R2=0.999 6),respectively.The average recoveries are 99.83%,101.96%,98.89%with RSDs of 2.84%,1.36%,2.88%,respectively.The RSDs of precision,stability,and repeatability tests are less than 5%.The properties,mass difference,melting time,microbial limit,and stability assessment of the preparationwere all in accordance with the Pharmacopoeia of the People's Republic of China.Conclusion Compound Bupleurum suppository preparation technology is reasonable and feasible,which meets the quality standard.
2.Preparation and Quality Standard Formulation of Compound Bupleurum Suppository
Zhizhen YU ; Zegan LIU ; Libo WANG ; Liangyong HUANG ; Fang YE ; Haitao ZHU ; Ziyan XU ; Shiming DU
Herald of Medicine 2025;44(9):1482-1489
Objective To explore the prescription and preparation technology of compound Bupleurum suppository and draft its quality standard.Methods The volatile oil of Bupleurum was extracted by steam distillation,and the compound Bupleurum-based suppository was prepared by mixing the volatile oil with taurine using the melting method.The quality standard of the preparation was formulated according to the quality inspection items of the general rule 0107 of the Pharmacopoeia of the People's Republic of China(2020 Edition,Volume IV);The contents of n-hexanoic acid and n-heptanoic acid in the preparation were determined by gas chromatography-mass spectrometry(GC-MS).The content of taurine in the preparation was determined by high-performance liquid chromatography(HPLC).Results The optimized distillation time of the volatile oil was 1.5 h,The linear ranges of n-hexanoic acid,n-heptanoic acid and taurine are 23.175 0-115.875 0 μg·mL-1(R2=0.999 4),4.590 0-68.850 0 μg·mL-1(R2=0.998 9)and 15-125 μg·mL-1(R2=0.999 6),respectively.The average recoveries are 99.83%,101.96%,98.89%with RSDs of 2.84%,1.36%,2.88%,respectively.The RSDs of precision,stability,and repeatability tests are less than 5%.The properties,mass difference,melting time,microbial limit,and stability assessment of the preparationwere all in accordance with the Pharmacopoeia of the People's Republic of China.Conclusion Compound Bupleurum suppository preparation technology is reasonable and feasible,which meets the quality standard.
3.Construction and validation of clinical prediction model of tongue base collapse under drug-induced sleep endoscopy in OSA patients
Shiming WANG ; Yinü DONG ; Yamin LIU ; Yanqing YE ; Jingmeng ZHOU ; Xiaoxing HUANG ; Huaihong CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(8):837-843
Objective:To analyze the correlation between drug-induced sleep endoscopy (DISE), results, polysomnography (PSG) indicators, and clinical parameters in patients with obstructive sleep apnea (OSA), and to establish and validate a predictive model for tongue base plane obstruction.Methods:This retrospective study analyzed 117 OSA patients diagnosed via PSG and treated at the Department of Otolaryngology-Head and Neck Surgery, Nanfang Hospital, Southern Medical University, between October 2014 and March 2022. The cohort comprised of 114 males and 3 females, with an age range of 20 to 54 years (mean age 38.1±8.4 years). Data on DISE results, PSG results, and clinical indicators were collected for all 117 patients. Logistic regression analysis was performed to identify relevant indicators, and a predictive model for tongue base plane obstruction was constructed and internally validated using the R programming language.Results:Univariate logistic regression analysis identified four independent risk factors for predicting tongue root plane obstruction: tonsil grading, N2, N3, and rapid eye movement sleep(REM) stage [ OR:0.412(0.260~0.652),1.045(1.012~1.079),0.943(0.903~0.984),0.961(0.925~0.998), P <0.05]. Multivariate logistic regression analysis confirmed tonsil grading and N3 sleep stage (12.48±12.22%) as significant predictors. A nomogram model incorporating these factors demonstrated good predictive performance, with an area under curve(AUC) of 0.82 (95% CI: 0.548-1.000), an optimal cutoff of 0.519, a specificity of 80.0%, and a sensitivity of 86.7%. Internal validation of the model in the validation cohort yielded an AUC of 0.751 (95% CI: 0.625-0.876). Conclusions:Tongue base plane obstruction observed during DISE in OSA patients is associated with tonsil grading and N3 sleep stage duration. The predictive model developed for tongue base plane obstruction based on DISE demonstrates good efficacy, as evidenced by its internal validation.
4.Recent Advance in Extraction Technology of Dioscin Chemical Composition
Hua CAI ; Pan LEI ; Guangyi YANG ; Shiming DU ; Xiaona HUI ; Fang YE ; Chenning ZHANG ; Jingbao WEI
China Pharmacist 2016;19(7):1366-1369
Dioscin chemical compositions are the main effective components in clinical commonly used Chinese medicines such as Diaoxinxuekang capsules and Xinnaoshutong capsules etc , which show distinct curative effect on cardiovascular and cerebrovascular diseases.Meanwhile, they are the important raw materials for the synthesis of steroid hormone drugs .The studies on the extraction technology exhibit important significance in the exploration of pharmacological activities of the components , which also are the external requirements for the growing demand of steroid hormone drugs market .In this paper , the relatively mature extraction methods re-searched in recent years were summarized ,and the advantages and disadvantages of the different processes were discussed in order to provide reference for the further studies and application .
5.Technology of Diosgenin from Doscorea zingiberensis by Bio-enzyme Pretreatment-alcohol Extraction and Acid Hydrolysis Method
Pan LEI ; Guangyi YANG ; Shiming DU ; Fang YE ; Xiaona HUI ; Jinbao WEI ; Chenning ZHANG
Herald of Medicine 2016;35(4):389-393
Objective To explore a clean and efficient new method for extraction of Diosgenin. Methods Yield of the total saponins was evaluated to determine the optimal enzymolysis temperature,pH,solid to liquid ratio,dosage of enzyme and enzymolysis time.Using diosgenin yield as an index,solid to liquid ratio,concentration of sulfuric acid and hydrolysis time were optimized in the saponins hydrolysis process via orthogonal experiment. Results The best conditions for the enzyme pretreatment were as follows:the temperature for enzymolysis was 70℃,pH 5.5,solid to liquid ratio was 1:4,dosage of enzyme was 8 mL?kg-1,and extraction time was 24 h.The best conditions of total saponins hydrolysis were as follows:the solid to liquid ratio was 1:4,concentration of sulfuric acid was 2.0 mol?L-1 ,and hydrolysis time was 5 h. Conclusion The new method is environmental friendly and highly efficient,and expected to be applied in industrial production.
6.A Study of Universal Newborn Hearing Screening Combined with Deafness Predisposing Gene Screening in 965 Newborns
Ying WANG ; Bing GUAN ; Shiming YE ; Li XU ; Lingmei CHANG ; Aimin YU
Journal of Audiology and Speech Pathology 2015;(3):248-251
Objective To investigate the clinical significance of universal newborn hearing screening for deaf‐ness predisposing genes in newborns .Methods A total of 965 newborns at Subei Hospital in Yangzhou were taken blood samples at heel and received for deafness predisposing genes screening .The most common deafness genes were detected by gene sequencing ,including mt12SrRNA c .1555A > G ,c .1494C > T ,GJB2 35delG ,167delT ,176_191del16 ,235delC ,299_300delAT ,SLC26A4 281C> T ,589G>A ,IVS7 -2A>G ,1174A> T ,1226G> A ,1229C> T ,IVS15+5G> A ,1975G>C ,2027T > A ,2162C> T ,2168A> G ,GJB3538C> T ,547G> A .At the same time ,all infants received hearing screening .Otoacoustic emission(OAE) was used as the first step screening ,and OAE combined with auto-auditory brainstem response(AABR) detection were used as the second step screening . Results Fifty -three cases (5 .49% ) had partial gene mutation ,one case of 12SrRNA gene mutation ,33 cases of GJB2 gene mutation ,18 cases of SCL26A4 gene mutation ,one case of GJB3 gene mutation .Of 965 cases ,28 cases failed to pass hearing screening while 18 cases did not pass rescreening .There were 10 cases taking audiological di‐agnosis at the age of three months .Six cases were confirmed with hearing loss .There were 905 cases passed thehearing screening and genetic screening ,11 failed born hearing and gene screening .Conclusion That the newborn gene screening was added into the hearing screening can be helpful to find out the deafness predisposing genes and drug -induced or late-onset hearing loss .
7.Research Progress and Utilization of Radix Bupleuri Preparations
Hua CAI ; Pan LEI ; Shiming DU ; Guangyi YANG ; Fang YE
China Pharmacist 2015;(11):1963-1966
Radix bupleuri is mainly used to treat cold fever and liver disease, and the curative effect is remarkable. The prepara-tions previously explored including bupleurum injection, tablets and capsules all show their own characters and different applicable peo-ple. Recently, many researchers carried out extensive research on its dosage forms. The early formulations have been improved as well, and successively developed dropping pill, nasal sprays, transdermal patches and the other new dosage forms. In the paper, the recent research progress in bupieurum preparations were summarized in order to provide reference for the improvement and application.
8.Recent Advances in Extraction Methods, Pharmacology,Toxicology and Pharmacokinetics Studies of Phill-yrin
Jinbao WEI ; Guangyi YANG ; Huan CHEN ; Fang YE ; Chenning ZHANG ; Shiming DU
China Pharmacist 2015;18(12):2144-2148
Phillyrin is an important lignans compound from Forsythia. It is not only found in the raw medicinal material with high content, but also shows a variety of pharmacological activities. In the paper, the recent advances in extraction methods, pharmacology-toxicology, pharmacokinetics and the other studies of phillyrin were reviewed in order to provide reference and suggestions for the fur-ther research.
9.Condition Optimization of Semi-bionic Extraction for Gardenia Jasminoides Ellis by Uniform Design
Fang YE ; Xiangyan LIU ; Guangyi YANG ; Shiming DU ; Ting DU
China Pharmacist 2015;(1):46-48,79
Objective: To optimize the extraction conditions of semi-bionic extraction for Gardenia jasminoides Ellis. Methods:The best extraction conditions of the semi-bionic extraction for Gardenia jasminoides Ellis was screened by uniform design with yield of geniposide, total iridoid glycosides and dry extract as the indices. Results:The optimal conditions were as follows:the pH value of wa-ter for the lst, 2nd and 3rd decoction was 2. 0, 6. 5 and 9. 0, respectively, and the extraction time was 2. 0, 1. 0 and 1. 0h according-ly. Conclusion:The optimized extraction conditions by uniform design is scientific and reasonable.
10.Study on UPLC-MS Fingerprint of Bupleurum Marginatum in Northwest Hubei
Hua CAI ; Fang YE ; Guangyi YANG ; Ling XIAO ; Shiming DU
China Pharmacist 2014;(5):797-800
Objective: To study the UPLC-MS fingerprint of Bupleurum marginatum DC. in northwest Hubei and establish the quality evaluation system for the herb. Methods:A UPLC-MS method was used to analyze 10 samples of B. marginatum DC with the following chromatographic conditions:an ACQUITY UPLC? RBEH C18 column (100 mm × 2. 1 mm, 1. 7 μm) was used, the mobile phase consisted of acetonitrile-0. 3% formic acid water with gradient elution, the flow rate was 0. 2 ml·min-1, and the detection wavelength was 203nm with ESI(-). Results:There were 8 common peaks in the UPLC-MS fingerprint of B. marginatum DC. Through analyzing the information of mass spectrometry and combining the references, 6 peaks were identified. Conclusion:The UPLC-MS fin-gerprint method is simple,rapid and feasible. The acquired UPLC-MS fingerprint of B. marginatum DC. and the evaluation indices can provide the scientific quality assessment of B. marginatum DC.

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