1.A novel method for testing sterility of injections based on biothermodynamics.
Dan GAO ; Dan GAO ; Yong-Shen REN ; Dan YAN ; Cong-En ZHANG ; Zhu-Yun YAN ; Yin XIONG ; Li-Na MA ; Le-Le ZHANG ; Xiao-He XIAO
Acta Pharmaceutica Sinica 2014;49(3):385-391
This study aims at trying to establish a novel method of sterility test for injections based on biothermodynamics, in order to overcome the deficiencies of routine sterility tests such as long detecting cycle, low sensitivity and prone to misjudgments. A biothermodynamics method was adopted to rapidly detect the microorganism contamination of injections by monitoring the heat metabolism during the growth of microbe. The growth rate equal to or greater than zero and the heat power difference of P(i) and P(0) with three folds higher than the noise of baseline were chosen as indexes to study the heat change rule of microbe. In this way, the effectiveness of the new method to detect strains required by conventional sterility test or in injection samples was also investigated. Results showed that the Gram-positive bacteria, Gram-negative bacteria and fungi demanded by sterility testing methodology could be detected by biothermodynamics method within 10 hours, with the sensitivity lower than 100 CFU x mL(-1). Meanwhile, this method was successfully applied to the sterility test of Compound Yinchen injection (FFYC), Shuanghuanglian powder injection (SHL) and Compound Triamcinolone injection (TAND) which were sterilized with different degrees. Therefore, the biothermodynamics method, with advantages of fast detection and high sensitivity, could be a complementary solution for conventional sterility tests.
Anti-Inflammatory Agents
;
administration & dosage
;
chemistry
;
Drug Contamination
;
Drugs, Chinese Herbal
;
administration & dosage
;
chemistry
;
Fungi
;
isolation & purification
;
Gram-Negative Bacteria
;
isolation & purification
;
Gram-Positive Bacteria
;
isolation & purification
;
Hot Temperature
;
Injections
;
Microbiological Techniques
;
methods
;
Sensitivity and Specificity
;
Sterilization
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Triamcinolone
;
administration & dosage
;
chemistry
2.A method of screening the antitumor lead compounds based on the dynamic bio-response profile of cells.
Lina MA ; Lele ZHANG ; Yin XIONG ; Yumei HAN ; Congen ZHANG ; Dan GAO ; Li MA ; Dan YAN ; Xiaohe XIAO
Acta Pharmaceutica Sinica 2014;49(5):695-700
The study is to report the establishment of a method of screening the antitumor compounds based on the dynamic bio-response profile of cells to make up for the shortages of conventional end-point tests such as tedious operation and low sensitivity. Based on the principle of electric impedance of cells, the real-time cell electronic sensing (RT-CES) system was used to monitor the effect of epirubicin (EPI), cisplatinum (DDP) and carboplatin (CBP) on the growth of HepG2 cells, with the cell index (CI), half maximal inhibitory concentration (IC50) and detachment curve as evaluation indexes. Meanwhile, cell counting kit-8 (CCK-8) and microscopy were applied for verification. The results showed that CI curve could sensitively real-time profile the inhibitory effect of model drugs on HepG2 cells. The IC50 of EPI, DDP and CBP were 0.53 +/- 0.04, 9.79 +/- 0.26 and 597.00 +/- 3.79 microg x mL(-1), respectively. What's more, the significant differences of detachment curves of the three drugs indicated that their functional mechanisms might be different, this is consistent with the literature. The RT-CES system with non-invasive, label-free and real-time characteristics could be used to monitor the bio-response profile of the three drugs to HepG2 cells, allowing to qualitatively and quantitatively distinguish the antitumor activities of the three drugs, and could be a complementary method for the present screening of antitumor compounds.
3.A novel method for testing sterility of injections based on biothermodynamics.
Dan GAO ; Yongshen REN ; Dan YAN ; Congen ZHANG ; Zhuyun YAN ; Yin XIONG ; Lina MA ; Lele ZHANG ; Xiaohe XIAO
Acta Pharmaceutica Sinica 2014;49(3):385-91
This study aims at trying to establish a novel method of sterility test for injections based on biothermodynamics, in order to overcome the deficiencies of routine sterility tests such as long detecting cycle, low sensitivity and prone to misjudgments. A biothermodynamics method was adopted to rapidly detect the microorganism contamination of injections by monitoring the heat metabolism during the growth of microbe. The growth rate equal to or greater than zero and the heat power difference of P(i) and P(0) with three folds higher than the noise of baseline were chosen as indexes to study the heat change rule of microbe. In this way, the effectiveness of the new method to detect strains required by conventional sterility test or in injection samples was also investigated. Results showed that the Gram-positive bacteria, Gram-negative bacteria and fungi demanded by sterility testing methodology could be detected by biothermodynamics method within 10 hours, with the sensitivity lower than 100 CFU x mL(-1). Meanwhile, this method was successfully applied to the sterility test of Compound Yinchen injection (FFYC), Shuanghuanglian powder injection (SHL) and Compound Triamcinolone injection (TAND) which were sterilized with different degrees. Therefore, the biothermodynamics method, with advantages of fast detection and high sensitivity, could be a complementary solution for conventional sterility tests.
4.Affordability Evaluation for 3 Kinds of Anti-tumor Targeted Drugs:Taking Hubei Province as an Example
Mengyuan TIAN ; Dan CUI ; Yuxiao ZHANG ; Xiao YIN ; Xin FANG ; Jianglin HU
China Pharmacy 2017;28(20):2746-2749
OBJECTIVE:To evaluate the affordability of 3 anti-tumor targeted drugs gefitinib,trastuzumab and sunitinib in ur-ban and rural residents of Hubei province,and to provide reference for medical insurance price admission of anti-malignant tumor targeted drugs in China. METHODS:Referring to the incidence of malignant tumor stated in statistical yearbook of Hubei province and income data of urban and rural residents in Hubei province,based on the policy of reducing the price of imported drugs by 50% mentioned in the national drug price negotiations,and assume the drugs are included in the medical insurance reimbursement list,WHO/HAI standard survey method,catastrophic expenditure evaluation method and poverty effect evaluation method were ad-opted to calculate the affordability of 3 drugs. RESULTS:According to WHO/HAI standard survey method,increment of payment for 3 drugs were 64.00%-74.00% before and after 50% discount and reimbursement. According to catastrophic expenditure evalua-tion method,50% discount of gefitinib and reimbursement gefitinib,trastuzumab and sunitinib in urban area would result in cata-strophic expenditures of 20.00%、59.28% and 35.48% patients;in rural area,would result in catastrophic expenditures of 50.63%、74.72% and 75.93% patients. According to poverty effect evaluation method,50% discount of 3 drugs and reimbursement caused less than 31.95% urban and rural patients falling to poverty. CONCLUSIONS:Fifty percentage discount of 3 anti-tumor targeted drugs mentioned in the national drug price negotiations cause the economic burden more serious for rural residents than urban resi-dents. In the formulation of policies,the corresponding reimbursement ratio should be adjusted according to urban and rural areas, drug price and disease types for a balance of patients with different economic burden.
5.Drugs administration and individual affordability under different medical insurance entry price:Example of Anti-tumor Targeted Medicare Drugs
Xin FANG ; Mengyuan TIAN ; Yuxiao ZHANG ; Xiao YIN ; Jianglin HU ; Dan CUI
Chinese Journal of Health Policy 2016;9(11):40-44
Objective: To analyze the New Cooperative Medical System ( NCMS ) funds and Individual afford-ability of anti-tumor targeted drugs under different medical insurance entry price, and to provide the basis for establis-hing the access price for medical insurance. Methods: Choosing Conmana or Kemer ( the lung cancer targeted drug) and Herceptin (breast cancer targeted drug) to analyze the Wuhan NRCMS operating status from 2012 to 2014, use tumor surveillance data from Hubei Province during the period from 2011 to 2015;consult clinical experts to form expert consensus price, refer to the Jiangsu Province Access Price and National Negotiation Price, and explore the fund bal-ance and individual affordability when the afore-mentioned two kinds of drugs can be compensated by medical insurance under different price. Results:The basic account balances of NRCMS in Wuhan from 2016 to 2018 are-11. 948 million Yuan, 2. 513 million Yuan and 82. 955 million Yuan when Kemer can be compensated by medical insurance under Na-tional Negotiation Price. Taking the compensation of Herceptin under National Price after the bargaining, the basic ac-count balances are -26. 901 million Yuan,-35. 962 million Yuan and 17. 542 million Yuan respectively. The rate of poverty caused by illness falls to 33. 40% from 45. 85% when Conmana can be compensated by Medical Insurance un-der National Negotiation Price, while this rate falls to 45. 42% from 46. 00% for Herceptin. Conclusion:The two kinds of drugs can be afforded by the Wuhan NRCMS after the medical insurance access price is negotiated by the govern-ment, but the individual affordability of Herceptin at the National Negotiation Price is worse.
6.Pyodermatitis-pyostomatitis vegetans
Hongmei WANG ; Shufang QIAO ; Chun LIU ; Dan CHEN ; Yin XIAO ; Huaan JI
Chinese Journal of Dermatology 2013;46(10):736-737
A 42-year-old woman was admitted to the hospital for an 11-month history of pustular lesions of the mouth and lips as well as a 5-month history of pustules,ulcer,proliferative plaques on the head,neck and trunk.She had suffered from 8 years of ulcerative colitis.Dermatological examination revealed mild erosion of eyelids,swelling of buccal mucosa and oral lips,as well as typical snail track lesions formed by pustules,exudates and mucilage.There was a large pitchy proliferative plaque sized 20 cm × 10 cm with an elevated margin in the neck as well as palm-to persian walnut-sized proliferative plaques in the prothorax,armpit,periumbilical area and left inguinal area.Histopathology revealed epitheliomatous hyperplasia of the epidermis with the formation of eosinophilic microabscesses,and superficial dermal infiltrate with numerous neutrophils and eosinophils.Direct immunofluorescence tests for IgA,IgG,and C3 were negative.A diagnosis of pyodermatitis-pyostomatitis vegetans was made.The patient was given intravenous methylprednisolone 40 mg/day and symptomatic treatment,which leaded to a gradual subsidence of skin lesions.
7.Clinical and pathological analysis of mesenchymal hamartoma of liver.
Dan LI ; Xiang-Hong YANG ; Xiao-Yin CHANG
Chinese Journal of Contemporary Pediatrics 2011;13(8):684-685
Child
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Child, Preschool
;
Female
;
Hamartoma
;
diagnosis
;
etiology
;
pathology
;
Humans
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Immunohistochemistry
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Infant
;
Liver Diseases
;
diagnosis
;
etiology
;
pathology
;
Male
8.A method of screening the antitumor lead compounds based on the dynamic bio-response profile of cells.
Li-Na MA ; Le-Le ZHANG ; Yin XIONG ; Yu-Mei HAN ; Cong-En ZHANG ; Dan GAO ; Li MA ; Dan YAN ; Xiao-He XIAO
Acta Pharmaceutica Sinica 2014;49(5):695-700
The study is to report the establishment of a method of screening the antitumor compounds based on the dynamic bio-response profile of cells to make up for the shortages of conventional end-point tests such as tedious operation and low sensitivity. Based on the principle of electric impedance of cells, the real-time cell electronic sensing (RT-CES) system was used to monitor the effect of epirubicin (EPI), cisplatinum (DDP) and carboplatin (CBP) on the growth of HepG2 cells, with the cell index (CI), half maximal inhibitory concentration (IC50) and detachment curve as evaluation indexes. Meanwhile, cell counting kit-8 (CCK-8) and microscopy were applied for verification. The results showed that CI curve could sensitively real-time profile the inhibitory effect of model drugs on HepG2 cells. The IC50 of EPI, DDP and CBP were 0.53 +/- 0.04, 9.79 +/- 0.26 and 597.00 +/- 3.79 microg x mL(-1), respectively. What's more, the significant differences of detachment curves of the three drugs indicated that their functional mechanisms might be different, this is consistent with the literature. The RT-CES system with non-invasive, label-free and real-time characteristics could be used to monitor the bio-response profile of the three drugs to HepG2 cells, allowing to qualitatively and quantitatively distinguish the antitumor activities of the three drugs, and could be a complementary method for the present screening of antitumor compounds.
Antineoplastic Agents
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pharmacology
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Biosensing Techniques
;
methods
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Cell Count
;
Cell Line, Tumor
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Cisplatin
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pharmacology
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Drug Screening Assays, Antitumor
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Electric Impedance
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Humans
9.Study on preventive and therapeutic effects of combined application of yindanxinnaotong soft capsule and exercise on atherosclerotic rats.
Jian-Lu WANG ; Lan WANG ; Long CHENG ; Xiao-Jie YIN ; Hai-Yu XU ; Wan-Dan WANG ; Ri-Xin LIANG
China Journal of Chinese Materia Medica 2014;39(13):2547-2552
To explore the prevention effect of the joint combination of Yindanxinnaotong soft capsule (YDXNT) and exercise (swimming) on atherosclerotic rats. The method of 3 x 3 factorial design, including two factors (YDXNT and swimming) and three levels (0, 1, 2 g x kg(-1) YDXNT; 0, 0.5, 1 h swimming), was mainly adopted. The atherosclerotic rat model was established by ligating their left common carotid arteries and feeding high-fat diet. After 8 weeks, blood samples were collected from their thoracic aorta to determine blood viscosity, plasma viscosity, fibrinogen (FIB), nitric oxide (NO), 6-keto-PGF(1alpha) endothelin (ET) and thromboxane B2 (TXB2). The tissues of left common carotid arteries of the rats were collected to detect the positive expression of SM22alpha and determine the semi-quantitation through the immunohistochemical staining. The result showed that the combination of YDXNT and swimming can significantly decrease the plasma viscosity (F = 3.241, P = 0.017), the high and low shear blood viscosity (F = 6.444, P = 0.001; F = 3.002, P = 0.024) and FIB (F = 4.046, P = 0.005). The increased NO and 6-keto-PGF(1alpha) and the decreased ET and TXB2 indicated a significant interaction (P < 0.05). The swimming showed an obvious main effect in the expression of up-regulated protein SM22alpha (F = 8.088, P = 0.001). The study suggested that the combined administration of YDXNT and swimming could improve the hemorheological parameters of atherosclerotic rats, protect the vascular endothelium, inhibit the vascular remodeling in atherosclerosis and positively prevent the atherosclerosis.
Animals
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Atherosclerosis
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drug therapy
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genetics
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metabolism
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prevention & control
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Blood Viscosity
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drug effects
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Combined Modality Therapy
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Drugs, Chinese Herbal
;
administration & dosage
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Exercise Therapy
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Humans
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Male
;
Microfilament Proteins
;
genetics
;
metabolism
;
Muscle Proteins
;
genetics
;
metabolism
;
Rats
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Rats, Sprague-Dawley
;
Swimming
10.Role of magnetic resonance imaging in the diagnosis of lesions in the sellar region.
Yue YIN ; Dan TONG ; Ting-ting YUAN ; Xiao-er ZHAO
Acta Academiae Medicinae Sinicae 2012;34(5):492-496
OBJECTIVETo evaluate the role of magnetic resonance imaging (MRI) in the diagnosis of lesions in the sellar region.
METHODSThe MRI data of 142 patients with surgically and pathologically proved lesions in the sellar region were retrospectively analyzed. Based on the MRI findings, the lesions were divided into pituitary adenoma and sellar region diseases except pituitary adenoma. According to the pathologic features, the sellar region diseases except pituitary adenoma were further divided into cystic lesions, parenchymatous lesions, and cystic and parenchymatous lesions.
RESULTSOf these 142 patients, pituitary adenoma was found in 30 cases, cystic lesions of sella region diseases except pituitary adenoma in 24. Further classification resulted in 66 cases of parenchymatous lesions and 22 cases of cystic and parenchymatous lesions.
CONCLUSIONMRI-based classification of lesions in the sellar region is useful for the diagnosis and differential diagnosis.
Adolescent ; Adult ; Aged ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Pituitary Diseases ; diagnosis ; Retrospective Studies ; Sella Turcica ; Young Adult