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In this paper, the low-field nuclear magnetic resonance technology CPMG (Carr-Purcell-Meiboom-Gill) echo method was used to determine the cross-linking degree and cross-linking density of crospovidone (PVPP) from different manufacturers. Based on the seven physical properties of PVPP, a fingerprint spectrum (radar chart) of twenty secondary quality indicators were obtained, and three compressibility evaluation indicators, index of the parameter (IP), index of parametric profile (IPP), index of good compression (IGC) were calculated by the fingerprint spectrum. It was found that the cross-linking degree and compressibility index IP of PVPP showed a strong correlation (r = 0.816) by the correlation analysis, indicating that the cross-linking degree is one of the key quality attributes for evaluating the compressibility of PVPP.
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The quality difference of pharmaceutical excipients from different sources affects the molding properties of the powder, resulting in changes in the properties of the final product. In this study, the critical quality attributes of hydroxypropyl methylcellulose (HPMC) with different specifications from two manufacturers (manufacturer A and manufacturer B) were characterized including particle size, physical morphology, viscosity and powder physical quality attributes. Aminophylline, diclofenac sodium, and metformin hydrochloride were utilized as model drugs with different solubility to prepare sustained-release tablets, and the effect of HPMC from different sources on drug release of sustained-release tablets in vitro was investigated. The results showed that HPMC with the same viscosity specification from different sources had outstanding differences in the physicochemical properties (including particle size, physical morphology, viscosity, dimension, compressibility and powder flow), which could change the hardness and friability of the sustained-release tablets. The differences in the physicochemical properties of HPMC had different effects on the dissolution of different sustained-release tablets in vitro. It had no significant effect on the release of easily soluble aminophylline and metformin hydrochloride, but had a greater impact on the release of poorly soluble diclofenac sodium. Compared with manufacturer A, the sustained-release effect of matrix tablets prepared by HPMC from manufacturer B was more excellent. The results of this study will provide a theoretical reference on selecting the appropriate excipients for formulation design.
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OBJECTIVE@#To analyze the prognostic value of R-ISS staging combined with "Multiple-Hits" in patients with multiple myeloma (MM), and to detected the effect of different "Multiple- Hits" combinations to the prognosis of the patients.@*METHODS@#The 220 MM patients treated in the hematology department of People's Hospital of Xinjiang Uygur Autonomous Region from April 2013 to October 2019 were enrolled and retrospective analyzed. All the patients were detected by FISH. The effects of R-ISS staging combined with "Multiple-Hits" and different "Multiple-Hits" combinations to the prognosis of the patients were compared.@*RESULTS@#For the patients at R-ISS stage II and III, the median progression-free survival (PFS) time, overall survival (OS) time and duration of response (DOR) time in "Multiple-Hits" patients were all shorter than those without high-risk cytogenetic abnormality (HRCA) and those with only one type of HRCA (P<0.05), while the TTR (time to response) was significantly prolonged (P<0.05). For the prognosis of the patients among the three different "Multiple-Hits" combinations(1q21+ combined with del(17p), 1q21+ combined with t(14;16) and combined 1q21+ combined with t(4;14)), 1q21+ combined with del(17p) showed the worst prognosis.@*CONCLUSION@#The patients with Different "Multiple-Hits" combinations shows different prognosis. The R-ISS staging combination with "Multiple-Hits" is more conducive to accurately judging the prognosis of MM patients.
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Humanos , Aberrações Cromossômicas , Mieloma Múltiplo/patologia , Estadiamento de Neoplasias , Prognóstico , Estudos RetrospectivosRESUMO
Objective:To evaluate the clinical efficacy and safety of traditional Chinese medicine Lianhua Qingke granule （LH granule）in the treatment of coronavirus disease 2019（COVID-19）. Method:A randomized controlled method was used in this clinical study. The subjects were confirmed COVID-19 patients over 18 years old with cough symptoms，and the diagnosis is based on Diagnosis and Treatment Protocol for COVID-19 （Trial Version 6）. The subjects were randomized to usual treatment （control group） or in combination with LH granule （1 bag，thrice daily） for 14 days. The primary endpoint was the rate of cough recovery. Result:57 subjects were included in this study， including 25 in the control group and 32 in the observation group. The recovery rate of cough in observation group was 90.6%（29/32）， which was significantly higher than 64.0%（16/25）in the control group （P<0.05）. The effective time of cough treatment was significantly earlier than that of the control group （P<0.05）， the median time to cough recovery was markedly shorter in treatment group （P<0.05）. The recovery rate of expectoration in observation group was 94.7% （18/19）， which was significantly higher than 57.1%（8/14）in the control group （P<0.05）. The effective time of expectoration treatment was significantly earlier than that of the control group （P<0.05）， and the median time to expectoration recovery was markedly shorter in treatment group （P<0.05）. The improvement rate of CT in the observation group was 96.9% （31/32）， which was significantly higher than 72% （18/25） in the control group （P<0.05）. After treatment， the oxygenation index of the two groups increased in varying degrees， and the increase rate of the observation group was significantly higher than that of the control group （P<0.05）. There was no significant difference in the recovery rate of fever， fatigue， dry pharynx and sore throat between the observation group and the control group， and it showed that LH had a better improvement trend on the basis of usual treatment. Conclusion:On the basis of routine treatment，LH can significantly improve the symptoms of cough and expectoration of COVID-19 patients， shorten the duration of cough and expectoration symptoms， reduce lung pathological damage， improve respiratory function， and improve the symptoms of fever， fatigue， dry pharynx and sore throat.
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italic>K-values of 56 batches of 7 types of povidone were measured by microfluidic rheometry and with a Ubbelohde capillary viscometer. The K-values of the two methods were tested by SPSS software and the results showed that there was no significant difference between the two methods (P > 0.05). Taking K-values measured with the Ubbelohde capillary viscometer (Ku) as the abscissa and K-values measured by microfluidic rheometry (Km) as the ordinate a linear equation was calculated: Km = 0.893 9Ku + 4.617 6, R2 = 0.986 2, with good linearity, indicating that the microfluidic rheometer method can replace the Ubbelohde capillary viscometer in determining K-values of povidone. The microfluidic rheometer method has the benefits of less sample consumption, faster determination, and is more accurate, and it can be used with high-throughput automatic acquisition, which provides a more convenient method for the determination of K-values of different types of povidone. The weight-average molecular weights (Mw) of each type of povidone were measured by gel permeation chromatography-multi angle laser light scattering (GPC-MALLS), and the relationship between Mw and Km was lgMw = -0.000 4 Km2 + 0.072 7 Km + 2.791, R2 = 0.990 1. The fitting relationship was good, and Mw could be calculated by Km by the equation.
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A UPCC-Q-TOF-MS method was established to analyze the components of polyoxyethylene 35 castor oil. The separation was performed at 50 ℃ on a Waters Acquity UPCC system by an Torus Diol column (3.0 mm × 100 mm, 1.7 μm) with gradient elution of CO2 and methanol - acetonitrile (50∶50); the flow rate was 1.0 mL·min-1, the back pressure was 2 000 psi, and methanol containing 2.5 mmol·L-1 ammonium formate was used as ionization reagent, whose flow rate was 0.2 mL·min-1. Positive ion electrospray ionization (ESI) mode and MSE technology were used. The qualitative analyses were carried out by using precise mass information of the parent and product ions and a PCA model was established by UPCC-Q-TOF-MS. L-02 cells and RBL-2H3 cells were used to study the cytotoxicity and histamine release of CrEL samples in vitro. A total of 13 kinds of CrEL components were obtained and their structures were identified by UPCC-Q-TOF-MS, with 255 compounds in total. The percentage content of 13 types of components was calculated by the normalization method. The content of polyoxyethylene glycerol tri-ricinoleate (PGTri-ricinoleate) in all samples was 0.36% - 2.80% and the main components were polyethylene glycol, polyethylene glycerol and polyoxyethylene glycerol mono-ricinoleate. All samples have different degrees of cytotoxicity and histamine release, which is negatively correlated with the content of PGTri-ricinoleate and positively correlated with the content of polyoxyethylene glycol fatty acid esters. The UPCC-Q-TOF-MS method is simple and rapid, has strong separation ability and high accuracy. It is suitable for the analysis of CrEL components. It is suggested that the fatty acid composition should be included in the monograph of CrEL for injection to increase the content of PGTri-ricinoleate and decrease the content of polyoxyethylene glycol fatty acid esters, so as to improve the product safety.
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In this study, physical fingerprint and multivariate statistical analysis was applied to characterize the quality consistency of different sources of carboxymethylcellulose sodium, and the visualization of R language was used to explore the intrinsic correlation on its performances, and we drew contour maps between independent variables and flowability of powder to find the design space. Through the physical fingerprint and multivariate statistical analysis, it was found that there were differences in the powder properties of carboxymethylcellulose sodium from different sources, and its moisture content, bulk density and tapped density have a great influence on the fluidity. The fillibility was positively correlated with flowability, both negatively correlated with compressibility by R intelligent visualization analysis, which was statistically significant (P < 0.01). When the angle of repose is 30° - 40°, the appropriate design space was found as 5.092 2% < moisture content < 7.006 7%, 0.560 2 g·cm-3 < bulk density < 0.579 9 g·cm-3, and 0.646 3 g·cm-3 < tapped density < 0.816 5 g·cm-3. The results show that it is scientific and feasible to evaluate the quality consistency of pharmaceutical excipients by using the physical fingerprint, multivariate statistical analysis and visualization methods, which provides new ideas for the production and quality evaluation of excipients and the development of generic prescriptions.
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During the process of consistency evaluation, it was found that the consistency of drug release between generic and original brands in vitro was not sufficient to demonstrate their same release in vivo. The disintegration of tablets, as a premise for the release of tablet drugs, greatly affects the release of drugs, depending on the structure and properties of disintegrants. Hence the systematic research on disintegrants would be very important for the evaluation of generic consistency. In this experiment, the physicochemical properties and application of 11 different sodium carboxymethyl starch (CMS-Na) from 9 manufacturers were investigated. This provides the reference for selection of excipients for consistency evaluation. The particle morphology of CMS-Na was observed by scanning electron microscope. The particle size distribution was determined by dry particle size analyzer. The determination of pH and loss on drying was carried out according to the 2015 edition of Chinese pharmacopoeia method. The powder fluidity was evaluated with Carr's index, Hausner ratio and angle of repose. The disintegration performance of CMS-Na was evaluated through determining the water absorption and swelling. The disintegration effect of CMS-Na tablets was studied using lactose and microcrystalline cellulose as fillers. The results showed that pH values and weight loss on drying of all samples met the requirements, whereas the particle morphology, fluidity, water swell-ability and disintegration time had a large variation, which leads to the large differences the properties of CMS-Na depending on the sources. Therefore in order to ensure that the reproducibility of generic drugs from their name brand, our studies indicate that only a sizable choice of disintegrants could ensure good inter batch reproducibility.
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Pharmaceutical excipients are important ingredients of drugs, and the quality of it directly related to the safety of drug. Compared to the 2010 edition, one of the most significant improvement of the 2015 edition of Chinese pharmacopoeia is the monographs of pharmaceutical excipients will be available in an individual book (Chinese Pharmacopoeia Book IV). And also, some new features will be found in the new edition: the doubled varieties of chronicled pharmaceutical excipients, the application of new techniques, the strict standards of the excipients for injection, the establishment of functionality-related characteristics. This article will interpret the developing trend of the standards of pharmaceutical excipients and the effect of the trend on the entire pharmaceutical industry in the future via the improvement of Chinese Pharmacopoeia.
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1H NMR metabonomics approach was used to reveal the chemical difference of urine between patients with Xiao-Chaihu Tang syndrome (XCHTS) and healthy participants (HP). The partial least square method was used to establish a model to distinguish the patients with Xiao-Chaihu-Tang syndrome from the healthy controls. Thirty-four endogenous metabolites were identified in the 1H NMR spectrum, and orthogonal partial least squares discriminant analysis showed the urine of patients with Xiao-Chaihu Tang syndrome and healthy participants could be separated clearly. It is indicated that the metabolic profiling of patients with Xiao-Chaihu Tang syndrome was changed obviously. Fifteen metabolites were found by S-pot of OPLS-DA and VIP value. The contents of leucine, formic acid, glycine, hippuric acid and uracil increased in the urine of patients, while threonine, 2-hydroxyisobutyrate, acetamide, 2-oxoglutarate, citric acid, dimethylamine, malonic acid, betaine, trimethylamine oxide, phenylacetyl glycine, and uridine decreased. These metabolites involve the intestinal microbial balance, energy metabolism and amino acid metabolism pathways, which is related with the major symptom of Xiao-Chaihu Tang syndrome. The patients with Xiao-Chaihu Tang syndrome could be identified and predicted correctly using the established partial least squares model. This study could be served as the basis for the accurate diagnostic and reasonable administration of Xiao-Chaihu-Tang syndrome.
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Humanos , Análise dos Mínimos Quadrados , Medicina Tradicional Chinesa , Metaboloma , Metabolômica , Espectroscopia de Prótons por Ressonância Magnética , Síndrome , UrináliseRESUMO
Objective: Bupleuri Radix is a kind of medicinal material derived from many sources, and Bupleurum chinense and B. scorzonerifolium are described in Chinese Pharmacopoeia. In this study, the chemical constituents in Chaige Jieji Decoction (CJD) composed of B. scorzonerifolium or B. chinense were compared to elucidate the influence of different Bupleuri Radix on other components in CJD. Methods: Firstly, an HPLC method for the simultaneous determination of seven constituents (puerarin, albiflorin, paeoniflorin, liquiritin, baicalin, wogonoside, and baicalein) in CJD was developed. Then CJD composed of B. scorzonerifolium or B. chinense was compared by the established method. Results: Good linearity for the seven compounds was obtained, and the average recoveries ranged from 94.1% to 106.6%. The RSD values of all the precision and repeatability of the compounds were less than 2%, and the test sample was stable within 12 h. No significant differences were observed between the two different CJD. Conclusion: The developed HPLC method is simple and repeatable, which is helpful for the quality control of CJD. The effects of different Bupleuri Radix compatibility on other ingredients in CJD and pharmacological activity of CJD deserve further study.
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Molecular methods and fluoroscopic techniques suggest that rich microbial diversity exist in the marine environment, but less than 1% of these microbes can be cultured in the laboratory conditions, and that the cultivable dominant species were even less. This limitation has long been a barrier to the development of environmental microbiology and the utilization of marine resources. In the past decade, novel methods for culture and detection of these uncultured marine microbes have successfully applied to obtain several conventionally-uncultured microbes including those from extreme environments. Those progresses have inspired researchers greatly. Developments in the research of marine microbial resources are an important basis for the study of the micro-world and deserve increasing scientific attention.
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<p><b>OBJECTIVE</b>To evaluate total antioxidant capacity (TAC) of seminal plasma in fertile and infertile men and understand the relation between seminal plasma TAC and male fertility.</p><p><b>METHODS</b>Two hundred and twenty-five infertile men were divided into 10 cases of obstructive azoospermic men, 42 cases of non-obstructive azoospermic men,20 cases of oligozoospermic men, 78 cases of asthenozoospermic men, 57 cases of oligoasthenozoospermic men, and 18 cases of normozoospermic men, then 28 fertile men were taken as the control. The seminal parameter analysis was performed by computer-assisted semen analysis (CASA) system. Seminal plasma TAC was measured using spectroscopic analysis.</p><p><b>RESULTS</b>Seminal plasma TAC were (1.71 +/- 1.33) U in obstructive azoospermic men, (12.73 +/- 9.44) U in non-obstructive azoospermic men, (10.85 +/- 6.64) U in oligozoospermic men, (13.88 +/- 8.24) U in asthenozoospermic men, (11.20 +/- 7.02) U in oligoasthenozoospermic men, (18.07 +/- 8.73) U in normozoospermic men, and (19.82 +/- 6.33) U in fertile men. There was no significant difference in TAC between normozoospermic men and fertile men (P > 0.05). Compared with fertile men, seminal plasma TAC in other infertile groups was significantly lower (P < 0.01). There were significantly made positive correlation between seminal plasma TAC and sperm density (r = 0.182, P < 0.05), as well as sperm with grade a (r = 0.150, P < 0.05).</p><p><b>CONCLUSION</b>Seminal plasma TAC is closely related to male fertility, and the decreased level of TAC in seminal plasma may be one of the causes of male infertility.</p>
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Adulto , Humanos , Masculino , Estudos de Casos e Controles , Fertilidade , Fisiologia , Infertilidade Masculina , Oxirredução , Espécies Reativas de Oxigênio , Metabolismo , Sêmen , QuímicaRESUMO
<p><b>OBJECTIVE</b>To identify the genetic defect causing autosomal dominant congenital cataract (ADCC) in a five-generation family in the northeast of China.</p><p><b>METHODS</b>Linkage analysis was carried out with polymorphic microsatellites on the Human MapPairs marker set, special known loci. Mutation analysis of the candidate gene in the critical region was performed to detect the potential mutation.</p><p><b>RESULTS</b>The maximum Lod score (2.44 at recombination fraction theta=0) was obtained for markers D1S498,D1S305, and D1S2844. The cataract locus in this family constellation was mapped to 1q21.1 and 21.44 cM interval between D1S2344 and D1S2844, which were known to flank the gene coding Connexin 50 (Cx50) or gap junction protein alpha-8 (GJA8). Sequencing of the coding region of GJA8 gene showed a heterozygous transversion T>G in exon 2, which resulted in the substitution of glycine for valine at amino acid 64, and this position was in the first connexin signature region that characterized this protein.</p><p><b>CONCLUSION</b>This is the first report on a mutation in the first connexin signature region of the GJA8 and a different mutation within Cx50 revealed in this family, which might account for the phenotypic differences observed. Furthermore, this study confirmed that GJA8 plays a vital role in the maintenance of human lens transparency.</p>