摘要
OBJECTIVES@#To investigate the clinical characteristics and risk factors of delayed bleeding after intestinal polypectomy in children, and to provide a theoretical basis for clinical surgical intervention of intestinal polyps.@*METHODS@#A retrospective analysis was conducted on the clinical data of 2 456 children with intestinal polyps who underwent endoscopic high-frequency electrocoagulation loop resection in the Endoscopy Center of Children's Hospital Affiliated to Zhengzhou University from January 2014 to December 2021. According to the presence or absence of delayed bleeding after surgery, they were divided into bleeding group with 79 children and non-bleeding group with 2 377 children. A multivariate logistic regression analysis was used to investigate the risk factors for delayed bleeding. The receiver operating characteristic (ROC) curve was used to investigate the value of various indicators in predicting delayed bleeding.@*RESULTS@#Of all 2 456 children, 79 (3.22%) experienced delayed bleeding, among whom 5 children with severe delayed bleeding underwent emergency colonoscopy for hemostasis and 74 received conservative treatment, and successful hemostasis was achieved for all children. There were significant differences between the bleeding and non-bleeding groups in age, body mass index, constipation rate, location of lesion, time of endoscopic procedure, resection method (P<0.05). Children with a diameter of polyps of 6-10 mm and >20 mm were more likely to develop delayed bleeding after resection (P<0.05). The multivariate logistic regression analysis showed that endoscopic operation time, polyp diameter, and resection method were significantly associated with delayed bleeding (P<0.05). The ROC curve analysis showed that the endoscopic operation time, polyp diameter, and resection method had a good value in predicting delayed bleeding after intestinal polypectomy, with an area under the ROC curve of 0.706, 0.688, and 0.627, respectively.@*CONCLUSIONS@#Endoscopic high-frequency electrocoagulation loop resection has a lower incidence of delayed bleeding in children with intestinal polyps, and the endoscopic operation time, polyp diameter, and resection method are closely associated with the occurrence of postoperative delayed bleeding.
Subject(s)
Child , Humans , Retrospective Studies , Intestines , Hemorrhage , Intestinal Polyps/surgery , Risk Factors摘要
Objective:To establish the grade evaluation standard of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces combining traditional character evaluation and modern intrinsic quality analysis. Method:The appearance character parameters (thickness and weight) and contents of internal index components (tanshinones and salvianolic acid B) of 18 batches of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces were determined, and the relative quality constant was calculated. The maximum value of the percentage quality constants of the tested samples was assumed to be 100%, the value ≥80% was classified as the first-class, ≥50% and <80% as the second-class, <50% as the third-class. Result:The relative quality constants of 18 batches of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces ranged from 349 to 884. According to the percentage quality constant, 18 batches of samples were successfully divided into three grades. The relative quality constant of the first-class product was ≥707, including samples ds5, ds8 and ds14, accounting for about 17% of the total number of samples. The relative quality constant of the second-class product was ≥442 and <707, accounting for about 61% of the total number of samples. the other samples were of the third-class, and their relative quality constants were all <442. Conclusion:The method of relative quality constant overcomes the one-sidedness of the single method in the grade evaluation of Salviae Miltiorrhizae Radix et Rhizoma decoction pieces, and the evaluation results can objectively, reasonably and scientifically classify the grade of the decoction pieces, which can provide reference for the establishment of the grade standard of other decoction pieces.
摘要
Objective::To establish a scientific and reasonable grade evaluation standard for Polygoni Multiflori Caulis. Method::The quality constant method was used to conduct a grade evaluation study on Polygoni Multiflori Caulis. A total of 16 batches of samples were collected from Chinese herbal slices enterprises and medicinal materials markets. By measuring its appearance traits (average quality and average thickness of the decoction pieces) and the intrinsic quality indicators (content of 2, 3, 5, 4′-tetrahydroxystilbene-2-O-β-D-glucoside), then its quality constant and percentage quality constant were calculated comprehensively, finally, the grades of Polygoni Multiflori Caulis were classified by quality constant method. Result::The quality constant of 16 batches of the decoction pieces was 0.054-0.417, and the percentage quality constant was 12.98-100.00.If these samples were divided into three grades, the quality constant shall be ≥0.334 for the first-grade decoction pieces, the quality constant shall be <0.334 and ≥0.209 for the second-grade decoction pieces, while for the third-grade decoction pieces, the quality constant shall be <0.209. Conclusion::The grade evaluation method based on quality constant can overcome the shortcomings of traditional evaluation method for decoction pieces, and can realize scientific, objective and simple classification of Polygoni Multiflori Caulis. This study enriches the research data of modern grade evaluation of Polygoni Multiflori Caulis, and provides reference for grade evaluation and market circulation of other decoction pieces.
摘要
Objective::To investigate excretion of GK-A, a antitussive compound separated from Ginkgo Semen, in the urine and bile of rats. Method::UPLC-MS/MS was used to determine the concentration of GK-A in rat urine and bile samples. The separation was performed on a C18 column, the mobile phase consisted of 0.1%formic acid aqueous solution (A) and acetonitrile (B) for gradient elution (0-1 min, 95%A; 1-3 min, 95%-85%A; 3-7.5 min, 85%-40%A; 7.5-8 min, 40%A). The detection was carried out by a triple quadrupole mass spectrometer in the positive ion mode with an electrospray ionization (ESI). Multiple reaction monitoring (MRM) mode was employed. After intragastric administration of GK-A, the urine and bile samples were collected at different time points, and the contents of GK-A in the samples were determined, and the cumulative excretion and cumulative excretion rate were calculated. Result::After 72 h of administration, the cumulative excretion of GK-A in urine was (12.35±2.69) μg, and the cumulative excretion rate was (0.58±0.13)%. Meanwhile, after 24 h of administration, the cumulative excretion of GK-A in bile was (55.16±29.22) μg, and the cumulative excretion rate was (1.57±0.83)%. Only a small amount of GK-A was excreted from urine and bile of rats with a slow speed. Conclusion::After intragastric administration, the excretion of GK-A in rat urine and bile is not the main elimination pathway.
摘要
OBJECTIVE@#To study the complications of upper gastrointestinal foreign body in children and related risk factors.@*METHODS@#Clinical data were collected from 772 children with upper gastrointestinal foreign bodies who were treated at the outpatient service or were hospitalized from January 2014 to December 2018. A multivariate logistic regression analysis was used to investigate the risk factors for the development of complications in children with upper gastrointestinal foreign bodies.@*RESILTS@#The upper gastrointestinal foreign bodies were taken out by electronic endoscopy for the 772 children. There were 414 boys and 358 girls, with a median age of 2.8 years. Children under 3 years old accounted for 59.5%. The foreign bodies were mainly observed in the esophagus (57.5%) and the stomach (28.9%), with a retention time of ≤24 hours in 465 children (60.2%) and >24 hours in 307 children (39.8%). The types of upper gastrointestinal foreign bodies mainly included round metal foreign bodies (37.2%), long foreign bodies (24.7%), sharp foreign bodies (16.2%), batteries (14.4%), corrosive substances (4.8%), and magnets (2.7%). As for the severity of complications, 47.7% (368 children) had mild complications, 12.7% (98 children) had serious complications, and 39.6% (306 children) had no complications. The logistic regression analysis showed that an age of 24 hours were risk factors for the development of complications in these children (OR=2.141, 7.373, 6.658, 8.892, and 6.376 respectively, P<0.05).@*CONCLUSIONS@#An understanding of the above high-risk factors for the complications of upper gastrointestinal foreign bodies is helpful to choose appropriate intervention methods and thus reduce the incidence of serious complications.
Subject(s)
Child, Preschool , Female , Humans , Male , Endoscopy, Gastrointestinal , Esophagus , Foreign Bodies , Retrospective Studies , Risk Factors , Upper Gastrointestinal Tract摘要
The grade classification of Chinese herbal medicines and their decoction pieces has always been a hot issue in the industry. In the trading history of Chinese herbal medicine,buyers and sellers often determine the price according to quality,so the naturally formed specifications and grades are changing with the change of technology and the increasing demand of the public for medical care.The planting,processing and circulation methods of Chinese medicinal materials have also changed greatly. Under the mode of pursuing yield and short-term benefit,the traditional rating evaluation method has been difficult to be used in the current quality status of prepared slices. Aurantii Fructus Immaturus is a genuine medicinal material of Jiangxi province,which is widely used,but has different quality levels on the market. In this paper,the quality levels were evaluated by the mass constant method. A set of grading method of Aurantii Fructus Immaturus slices was established,laying a foundation for " high quality and high price" Aurantii Fructus Immaturus slices. The grading method of Chinese herbal slices with quality constant was applied to 16 batches of Aurantii Fructus Immaturus slices collected form the market,and the final assessment results were as follows for different piece shapes( hemispherical type and thin type)respectively. The hemispherical Aurantii Fructus Immaturus pieces: quality constant ≥1. 11 for the first grade,< 1. 11 but ≥0. 69 for the second grade,and <0. 69 for the third grade. The thin type Aurantii Fructus Immaturus pieces: quality constant ≥0. 024 for the first grade,<0. 024 but ≥0. 015 for the second grade,and <0. 015 for the third grade. This work indicated that the quality constants grading method can be used to objectively classify the grades of traditional Chinese medicine,providing basis for standardizing market behavior and providing useful reference for grading of hemispherical or thin Aurantii Fructus Immaturus pieces.
Subject(s)
Citrus , Chemistry , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Quality Control摘要
To build the quality standard of processed Cinnamomi Cortex standard decoction and provide quality reference for Cinnamomi Cortex formula granules. Fourteen batches of Cinnamomi Cortex standard decoction pieces were prepared according to the preparation requirements for standard decoction of Chinese herbal medicine containing volatile oil. With cinnamaldehyde as the quantitative index, the transfer rate and extraction rate were calculated; pH value was determined and HPLC fingerprint analysis method was established. By the measurement of 14 batches of standard decoction, the transfer rate ranged from 25.0% to 68.4%; the extraction rate was at a range of 3.7% to 10.1% and pH was 3.72 to 5.48. Then the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprints. Four common peaks were determined and three were identified including coumarin (peak 1), cinnamic acid (peak 2) and cinnamaldehyde (peak 3). Moreover, the similarity was 1.0. This study established an HPLC fingerprint analysis method of processed Cinnamomi Cortex standard decoction. The method showed good precision, stability and repeatability in fingerprint analysis, with significance in identification.
摘要
To build an evaluation standard for quality of Leonuri Herba standard decoction. 13 batches of Leonuri Herba standard decoction with different quality were prepared. The contents of leonurine hydrochloride and stachydrine hydrochloride were determined; then the transfer rate and the extract rate were calculated and pH value was measured; and HPLC fingerprint method was established for analysis. The results of 13 batches of samples revealed that the transfer rate of leonurine hydrochloride and stachydrine hydrochloride was 30.0%-53.4% and 67.0%-82.6%, respectively; the extract rate was 12.1%-18.3% and the pH value was 5.87-6.22. Moreover, 12 common chromatographic peaks were determined based on fingerprint by using Similarity Evaluation System for Chromatographic fingerprint of Traditional Chinese Medicine (2012A). The similarity of 13 batches of samples was analyzed and compared, and the results showed that the similarity was higher than 0.9. In this study, the preparation method for Leonuri Herba decoction was standard, with high similarity in fingerprint, showing high precision, stability and repeatability in fingerprint analysis. Thus, this study can provide a reference for the quality control of Leonuri Herba dispensing granules.
摘要
By measuring the morphological indexes and the marker components content of 22 batches of Scutellariae Radix slices as well as calculating the quality constant, this research was aimed to establish a new method of evaluating the specifications and grades of Scutellariae Radix slices. The quality constants of these samples were in the range of 0.04-0.49, which can be divided into several grades based on the real requirement. If they were divided into three grades, the quality constant was ≥0.39 for the first grade, <0.39 but ≥0.24 for the second grade, and <0.24 for the third grade. This work indicated that the quality constants characterizing both apparent parameters and intrinsic quality can be used as a comprehensive evaluation index to classify the grades of traditional Chinese medicine quantitatively, clearly and objectively. The research results in this paper would provide new ideas and references for evaluating the specifications and grades of traditional Chinese medicines.
摘要
It is urgent to establish the limit standard of toxic components of Chinese herbal medicine, since the safety of traditional Chinese medicine (TCM) has attracted more and more attention.This paper analyzes the present situation and problems in the study of the limit standard of toxic components of Chinese herbal medicine. In addition, the current methods for setting the limit standards of toxic ingredients of TCM are reviewed in this paper, and we also propose a theoretical calculation method for setting the limit standards of toxic ingredients of TCM. Employing aristolochic acid as a case study, we formulate the limit standard of toxic components of Chinese herbal medicine. We believe this paper would provide some useful suggesting for formulating limits standard of toxic components of TCM.
摘要
Quality constant evaluation is a comprehensive method for grades evaluation of traditional Chinese medicine pieces, but when it comes to Glycyrrizae Radix et Rhizome pieces, grades evaluation is diverged due to significant difference in contents of liquiritin and glycyrrhizic acid and unreasonable weight of index. To solve this problem, we have established a relative quality constant method in this paper to evaluate grades of Glycyrrizae Radix et Rhizome pieces. Twenty-nine batches of different quality samples were collected and tested, and finally, 17 batches of them were chosen as researcher objects. The results revealed that the range of the relative quality constant of these samples was from 1.78 to 11.49. When Glycyrrizae Radix et Rhizome pieces are divided into three grades: the relative quality constant of first grade is greater than or equal to 9.19; the second grade is greater than or equal to 5.75 but less than 9.19; while the third grade is less than 5.75. This research indicates that relative quality constant can divide the grades of herbal pieces in a scientific, reasonable, objective and specific way and remedy the shortage of quality constant perfectly. It provides a novel mode for grading pieces of Chinese medicine that contains multi-target ingredients.
摘要
The present study was designed to determine the relationships between the performance of ethanol precipitation and seven process parameters in the ethanol precipitation process of Re Du Ning Injections, including concentrate density, concentrate temperature, ethanol content, flow rate and stir rate in the addition of ethanol, precipitation time, and precipitation temperature. Under the experimental and simulated production conditions, a series of precipitated resultants were prepared by changing these variables one by one, and then examined by HPLC fingerprint analyses. Different from the traditional evaluation model based on single or a few constituents, the fingerprint data of every parameter fluctuation test was processed with Principal Component Analysis (PCA) to comprehensively assess the performance of ethanol precipitation. Our results showed that concentrate density, ethanol content, and precipitation time were the most important parameters that influence the recovery of active compounds in precipitation resultants. The present study would provide some reference for pharmaceutical scientists engaged in research on pharmaceutical process optimization and help pharmaceutical enterprises adapt a scientific and reasonable cost-effective approach to ensure the batch-to-batch quality consistency of the final products.
Subject(s)
Chemical Precipitation , Chromatography, High Pressure Liquid , Methods , Drugs, Chinese Herbal , Chemistry , Ethanol , Injections , Principal Component Analysis摘要
Sodium aescinate, which is produced from saponins of Chinese Buckeye Seed, is a prescription drug for treatment of brain edema and all kinds of swellings caused by surgery. In this article, high-performance liquid chromatography/ion trap (HPLC-IT) mass spectrometry was applied to study the characteristic ions of ten reference substances, namely escin Ⅰa, escin Ⅰb, isoescin Ⅰa, isoescin Ⅰb, aesculiside A, aesculiside B, aesculuside A, escin Ⅳc, escinⅡa and escin Ⅴ, which were isolated from aescinate. Furthermore, 19 saponin compounds were predicted in sodium aescinate, besides the above mentioned reference substances. The study showed that sapogenins in sodium aescinate had two structural types, namely protoaescigenin and barringenol C, and the substituent acetyl, tigloyl or angeloyl was usually located at C-21, C-22 or C-28 position. Among these predicted saponins, their sugar chains were all located at C-3 position consisting of glucose and glucuronide. This study provides experimental data for chemical constituents in sodium aescinate and scientific basis for quality and safety evaluation.
摘要
To discuss the synergistic mechanism of compatible use of two medicinal herbs,Panax notoginseng and Bletilla striata, an HPLC was established to determine two ginseng saponins (20S)-ginseng saponin Rg₃ and ginseng saponin Rh₄ contained in single decoction of Panax notoginseng as well as in compound decoction of Panax notoginseng and Bletillastriata in different compatibility ratio (1∶0.5, 1∶1, 1∶2), followed by analyzing the impact of amount of notoginsenosides after compatibility. As a result, compared with the single decoction of Panax notoginseng, the contents of ginseng saponin Rg₃ and ginseng saponin Rh₄ in the compound decoction of Panax notoginseng and Bletillastriata were on the rise as the increasement of the amount of Bletillastriata. The contents of the notoginsengsaponin R₁, ginseng saponin Rg₁ and ginseng saponin Rb₁ of Panax notoginseng single decoction were significantly decreased after compatibility. Therefore, after compatibility, it was more easy to produce (20S)-ginseng saponin Rg₃ and ginseng saponin Rh₄.This study can extend to a method of preparation of (20S)-ginseng saponin Rg₃ and ginseng saponin Rh₄. Furthermore, after compatibility, two ginseng saponins which had lipase inhibitory effect were both increased significantly, indicating that the compatibility of these two herb medicines may have effect on losing weight.
摘要
To establish a LC-MS/MS method to determine the concentrations of liquiritin, glycyrrhizin, glycyrrhetinic acid, amygdalin, amygdalin prunasin, ephedrine, pseudoephedrine and methylephedrine of Maxing Shigan decoction in rat plasma, and study the differences on their pharmacokinetic process in normal rats and RSV pneumonia model rats. After normal rats and RSV pneumonia model rats were orally administered with Maxing Shigan decoction, the blood was collected from retinal vein plexus of different time points. Specifically, tetrahydropalmatine was taken as internal standard for determining ephedrine, while chloramphenicol was taken as internal standard for determining other components. After plasma samples were pre-treated as the above, the supernatant was dried with nitrogen blowing concentrator and then redissolved with methylalcohol. The chromatography was eluted with mobile phase consisted of acetonitrile and 0.1% formic acid solution in a gradient manner. ESI sources were adopted to scan ingredients in ephedra in a positive ion scanning mode and other ingredientsin a negative ion scanning mode. The multiple-reaction monitoring (MRM) method was developed the plasma concentration of each active component. The pharmacokinetic parameters of each group were calculated by using Win-Nonlin 4.1 software and put into the statistical analysis. The result showed the plasma concentration of the eight active ingredients, i.e., liquiritin, glycyrrhizin, glycyrrhetinic acid, amygdalin, amygdalin prunasin, ephedrine, pseudoephedrine and methylephedrine within the ranges of 1.04-1040, 1.04-1040, 0.89-445, 1.05-4200, 1.25-2490, 0.3-480, 0.3-480, 0.3-480 microg x L(-1), with a good linearity and satisfactory precision, recovery and stability in the above ingredients. After modeling, except for glycyrrhetinic acid whose pharmacokinetic parameters were lacked due to the data missing, all of the rest components showed significant higher Cmax, AUC(0-1) and lower clearance rate (CL) than that of the normal group, indicating the increase in absorption in rats in the pathological state by reducing the clearance rate. The method is accurate and sensitive and so can be used to determine the plasma concentrations of the eight active ingredients in Maxing Shigan decoction. RSV pneumonia-infected rats absorbed more ingredients in Maxing Shigan decoction.
Subject(s)
Animals , Male , Rats , Chromatography, High Pressure Liquid , Disease Models, Animal , Drugs, Chinese Herbal , Pharmacokinetics , Pneumonia, Viral , Drug Therapy , Metabolism , Rats, Sprague-Dawley , Respiratory Syncytial Virus Infections , Drug Therapy , Metabolism , Tandem Mass Spectrometry摘要
This study focused on the intestinal absorption of traditional Chinese medicines (TCM) to reveal the scientific connotation of the compatibility of TCM pairs. The single pass intestinal perfusion (SPIP) was used in rats to compare the absorption of single extracts from Puerariae Lobatae Radix, single extracts from Ginseng Radix et Rhizoma, combined extracts from Puerariae Lobatae Radix and Ginseng Radix et Rhizoma and Puerariae Lobatae Radix and Ginseng Radix et Rhizoma mixture in rats. The content of puerarin, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1 in liquid were tested by HPLC. The speed constant (Ka) and apparent permeability coefficients (Papp) were calculated and compared. Specifically, the order of puerarin Ka and Papp values from high to low was Ginseng Radix et Rhizoma and Puerariae Lobatae Radix mixture > single extracts from Puerariae Lobatae Radix > combined extracts from Ginseng Radix et Rhizoma and Puerariae Lobatae Radix; the order of ginsenosides Ka and Papp values from high to low was Ginseng Radix et Rhizoma and Puerariae Lobatae Radix mixture > single extracts from Ginseng Radix et Rhizoma > combined extracts from Ginseng Radix et Rhizoma and Puerariae Lobatae Radix. The combined administration of Ginseng Radix et Rhizoma and Puerariae Lobatae Radix may improve the absorption in the intestinal tract.
Subject(s)
Animals , Male , Rats , Ginsenosides , Pharmacokinetics , Intestinal Absorption , Isoflavones , Pharmacokinetics , Medicine, Chinese Traditional , Panax , Chemistry , Plant Extracts , Pharmacokinetics , Pueraria , Chemistry , Rats, Sprague-Dawley , Rhizome摘要
The study established a UPLC-MS/MS method that is used for simultaneous determination nine major bioactive compounds of Dachengqi Tang in rat plasma. Using Aglient C18 column (2.1 mm x 50 mm,1.7 microm) was chromatographed, using methanol-5 mmol x L(-1) ammonium formate mobile phase gradient, elution 0.3 mL x min(-1). In the plasma pre-treatment process, not only the method of methanol and acetonitrile protein precipitation was investigated, and different factors extraction solvent, the type of the scroll time, the number and the type of extraction solvent, the extraction volume of the extraction solution of liquid-liquid extraction is investigated. Finally, with ibuprofen as an internal standard, using ethyl acetate liquid-liquid extraction method pretreatment blood, N2 dry reconstituted supernatant after centrifugation UPLC-MS/MS analysis, in electrospray ionization (ESI) negative mode, using multiple reaction monitoring mode for testing. The linear range of emodin, rhein, aloe-emodin, chrysophanol, magnolol, honokiol, hesperidin and hesperitin is 0.33-660, 0.40-792, 0.41-827, 0.34-680, 0.45-907, 0.46-927, 0.43-867, 0.34-683, 0.39-787 microg x L(-1) respectively, good linear relationship; and extraction recovery were greater than 69.39%, days after the day of the RSD is less than 15%. This method can be used to study the rat gastric large bearing gas after Dachengqi Tang, the simultaneous determination of nine components in plasma for its pharmacokinetics and efficacy material base to provide a theoretical basis.
Subject(s)
Animals , Female , Male , Rats , Chromatography, High Pressure Liquid , Methods , Drugs, Chinese Herbal , Chemistry , Plasma , Chemistry , Rats, Sprague-Dawley , Tandem Mass Spectrometry , Methods摘要
<p><b>OBJECTIVE</b>The traditional decoction method of Dachengqi Tang is that "First boiling Magnolia officinalis and Citrus aurantium with a pipeful of water, taking out five litres from the decoction, removing residues, adding rheum officinale, boiling again, taking out two litres from it, removing residues, adding mirabilite, boiling it with low fire". According to it, residues of M. officinalis and C. aurantium should be removed after decocting. This essay aims to study the content of anthraquinones, in order to proof whether the removal of residues of M. officinalis and C. aurantium is scientific.</p><p><b>METHOD</b>The traditional method was adopted to prepare Dachengqi Tang. Decoction A (original method) was obtained by removing residues of M. officinalis and C. aurantium, whereas decoction B was obtained without removing residues of M. officinalis and C. aurantium. The content of anthraquinones of both methods was determined with HPLC.</p><p><b>RESULT</b>The content of both combined and free anthraquinones in decoction A was higher than that of decoction B. The content of total anthraquinones in residues of decoction A was lower than that of residue B.</p><p><b>CONCLUSION</b>The traditional decoction method of removing residues of M. officinalis and C. aurantium from Dachengqi Tang is scientific, because it improves the dissolution rate of effective ingredients, which provides a theoretical basis for effective substances of the drug.</p>
Subject(s)
Anthraquinones , Chromatography, High Pressure Liquid , Citrus , Chemistry , Drug Compounding , Magnolia , Chemistry , Plant Extracts , Chemistry , Reproducibility of Results摘要
To establish kinetic assay method for the analysis of hemolysis and to investigate dynamic hemolytic process of polysorbate 80. The UV-VIS spectrum of heme changes when hemoglobin is released continuously during the hemolytic process. Therefore, dynamic hemolytic curve was determined as a new way to characterize the kinetic process of interaction between polysorbate 80 and red blood cells. The effect of polysorbate 80 on blood cells could be perfectly investigated by the hemolytic dynamics. Dynamic hemolytic parameters of polysorbate 80 were calculated according to the hemolytic curves. The constants of hemolytic rate and maximum hemolytic rate of polysorbate 80 had fine linear relationships at the range of 1-20 mg x mL(-1) and 5-20 mg x mL(-1), respectively. In comparison with the present official method such as macroscopic observation and static spectrophotometric methods, kinetic spectrophotometry has the advantages of real time, on-line determination, sensitive, objective, good reproducibility and 2-dimensional information acquired. Therefore, as a biological technique, kinetic spectrophotometry could be applied to evaluate the quality of polysorbate 80 and to screen other solubilizing excipients.
Subject(s)
Animals , Rabbits , Drug Stability , Erythrocytes , Chemistry , Excipients , Chemistry , Hemoglobins , Hemolysis , Kinetics , Polysorbates , Chemistry , Reproducibility of Results , Spectrophotometry, Ultraviolet , Methods摘要
<p><b>OBJECTIVE</b>To establish a method for HPLC fingerprint determination of different growing areas on Fructus Aurantii fried with bran.</p><p><b>METHOD</b>HPLC chromatographic experiment was carried out by ultrasonic distilment of acetacetic ester, gradient elution mode and the detection wavelength of 320 nm. The column temperature was set at 30 degrees C, and flow rate is 1.0 mL x min(-1). Naringin served as the reference standard. Ten batches of Fructus Aurantii fried with bran in the different places were analyzed. Similarity evaluation system for chromatographic fingerprint of TCM proceeded the evaluation, The correlation coefficients between ten batches were used to define the similarity.</p><p><b>RESULT</b>There were eleven characteristic peaks in Fructus Aurantii fried with bran by HPLC fingerprint which constituted fingerprint characters. Both the reproducibility and stability on HPLC fingerprint were proper.</p><p><b>CONCLUSION</b>The method was accurate and simple. It can be applied to the analysis on Fructus Aurantii fried with bran. The fingerprint spectrum can be used to distinguish Fructus Aurantii fried with bran and to be its quality control.</p>