Holistic evaluation of San-Huang Tablets using a combination of multi-wavelength quantitative fingerprinting and radical-scavenging assays / 中国天然药物

The present study was designed to establish a multi-wavelength quantitative fingerprinting method for San-Huang Tablets (SHT), a widely used and commercially available herbal preparation, where high performance liquid chromatography (HPLC) with a diode array detector (DAD) was employed to obtain the fingerprint profiles. A simple linear quantitative fingerprint method (SLQFM) coupled with multi-ingredient simultaneous determination was developed to evaluate the quality consistency of the tested samples qualitatively and quantitatively. Additionally, the component-activity relationship between chromatographic fingerprints and total radical-scavenging capacity in vitro (as assessed using the 1, 1-diphenyl-2-picrylhydrazyl (DPPH) assay) was investigated by partial least squares regression (PLSR) analysis to predict the antioxidant capacity of new samples from the chromatographic fingerprints and identify the main active constituents that can be used as the target markers for the quality control of SHT. In conclusion, the strategy developed in the present study was effective and reliable, which can be employed for holistic evaluation and accurate discrimination for the quality consistency of SHT preparations and other traditional Chinese medicine (TCM) and herbal preparations as well.

Selection of Guanxin Suhe Pill reference preparation by internal standard quantified fingerprints method / 中草药

Objective: To establish the Guanxin Suhe Pill (GXSHP)-HPLC internal standard quantified fingerprints method (ISQFM) for selecting the reference preparation of GXSHP by ISQFM and providing the quality control method of reference preparation. Methods: Agilent Poroshell 120 SB C18 column (150 mm × 4.6 mm, 2.7 μm), 0.2% ethylic acid-water, and 0.2% ethylic acid-methanol were used as the mobile phases that were eluted with liner program. The flow rate was 0.5 mL/min, the UV absorbance was monitored at 275 nm by injecting 5 μL of the sample solution each time, and the column temperature was maintained at (25.00 ± 0.15)°C. The ISQFM was used to identify the quality and select the reference preparation. Results: The 36 common peaks were marked by choosing IS as the referential peaks and the quality of 12 batches of GXSHPs was identified by the ISQFM. The identification results were that the quality of five batches (S3, S5-S7, and S9) were best, four batches (S4, S8, S10, and S11) were better, two batches (S1 and S2) were good, and one batch (S12) was lower than good, according to the results of this method, S3, S5-S7, and S9 could be used as the reference preparation of GXSHPs. Conclusion: This method could reduce the use of reference substances and improve the accuracy of the measured results. The reference preparation of GXSHPs, which is selected by this method, could be used for the quality control of large quantities of GXSHPs with the great significance in practical production.

A comparison of applicability in three diagnostic criteria of metabolic syndrome in Jiangsu population / 中华预防医学杂志

<p><b>OBJECTIVE</b>To compare the applicability of the three diagnostic criteria for metabolic syndrome (MS) proposed by the International Diabetes Federation (IDF) in 2005, Adult Treatment Panel III of National Cholesterol Education Program (NCEP-ATP III) in 2005 and Chinese Diabetes Socie (CDS) in 2004.</p><p><b>METHODS</b>Based on the findings of cohort study of multiple metabolic disorders and metabolic syndrome (1971 cases) in Jiangsu province, MS was diagnosed according to these three definitions respectively, and by calculating the sensitivity, specificity, and ROC curve distance, those with lower false positive and false negative rates were identified as to detecting cardio vascular diseases (CVD) and type 2 diabetes mellitus (T2DM). While, through Cox regression analysis, to compare their relative risk (RR) and 95% confidential interval (CI) was wade.</p><p><b>RESULTS</b>Among three diagnostic criteria, the specificity by CDS of MS was higher than the other criteria (83.52%, 76.36%, 89.57%; 85.02%, 78.67%, 92.28%), however the sensitivity of CDS of MS was low (40.82%, 29.47%). When using CDS, over 50 percent of diagnosis might be missed. ATP III definition corresponded to the shortest distance in ROC curve, namely, at the diagnostic criteria, the rates of false positive and false negative for identifying clustering of CVD and T2DM were minimum (0.4369; 0.5777). The incidence of CVD [5.59 (2.62 - 11.92) vs 2.90 (1.41 - 5.93)], T2DM [3.36 (1.92 - 5.79) vs 1.97 (1.16 - 3.34)] was significantly higher in cases of ATP III+/IDF-than ATP III+/IDF+, as compared with ATP III-/IDF-.</p><p><b>CONCLUSION</b>Among three diagnostic criteria, the ATP III definition of the MS should be the most applicable diagnostic criteria for MS in Jiangsu population.</p>

Evaluating the quality of niuhuangjiedu tablets by the systematic quantified fingerprint method / 药学学报

The HPLC fingerprints of Niuhuangjiedu tablets (NHJDT) were established and assessed by systematic quantified fingerprint method. The chromatographic fingerprints (CFPs) were determined by reversed-phase HPLC, in which the CFPs containing 53 co-possessing peaks were marked by choosing baicalin peak as the referential peak. Fifteen batches of NHJDT were identified with hierarchical clustering analysis by using macro qualitative similarities and macro quantitative similarities as variables. According to the results of classification, the referential fingerprint (RFP) was synthesized from 10 batches of NHJDTs. Taking the RFP for the qualified model, the whole 15 batches of NHJDTs were evaluated by the systematic quantified fingerprint method. Among the 15 batches of NHJDT, 9 batches were completely qualified, the relative variance of leveling coefficient of 1 batch was obviously higher while the contents of other 5 batches were lower. The systematic quantified fingerprint method closely integrates the systematic fingerprints with the macro qualitative similarities and macro quantitative similarities to perform the entire qualification and quantitation analyses, which can briefly and effectively assess the quality of Chinese traditional medicine.

Determination of the fingerprint attribution ratio and process recovery of medicinal effectiveness components for TCM-compound prescription with quantified fingerprint method / 药学学报

By setting up the organic additive model of chemical fingerprints of TCM-compound, the quantified fingerprint method had been established to solve the qualitative and quantitative analyses problems for both the fingerprint attribution ratio and process recovery of medicinal effective components in TCM-compound prescription. The method firstly performs the qualitative analyses of the attribution ratios, and then the quantitative analyses, which can successfully disclose the results of attribution ratio and determine the process recovery of the medicinal effective components for TCM-compound prescription. Three optional methods were represented to assess the amount and distribution proportion of chemical compositions for single crude drug to compound prescription. In terms of components absorbed ultraviolet light, S5 (Radix Scutellariae) was assessed to be the most important crude drug containing much more effective components, and S7 (Radix Gentianae), S4 (Flos Lonicerae Japonica), S8 (Rhizome Anemarrhena) and S9 (Fructus Gardeniae) were second important crude drugs. The results showed lower process recovery of the medicinal effective components for eight batches of marketed preparations. Above all, the quantified fingerprint method can objectively and accurately reflect how high is the contribution of a single crude drug to the compound prescription, and quantitatively evaluate the process recovery of medicinal effectiveness components.

Comparison between the qualitative similarity and the quantitative similarity of chromatographic fingerprints of traditional Chinese medicines / 药学学报

To explore the differences between the qualitative similarity and the quantitative similarity of chromatographic fingerprints of traditional Chinese medicines, the quantitative similarity calculated by vector shadow C%, apparent quantitative similarity R%, quantitative similarity P%, etc. were firstly proposed to disclose the quantitative information characteristics of traditional Chinese medicines fingerprints. The HPLC fingerprints of both the standard Fructus gardeniae and the ten batches of Fructus gardeniae produced in different places were evaluated by the new parameters to obtain good results. The contrasted fingerprint contained 35 peaks while geniposide was selected as the reference peak. The HPLC fingerprint had good precision and reproducibility with the RSD of the relative retention time less than 1.5% and the RSD of the relative peak area within 5%. The qualitative similarity and quantitative similarity between each crude drug and the contrasted fingerprint were quantitatively calculated, the values of C%, P%, etc., were applied in the quality control practice, which had less errors. What is more, this method could be used for the overall quality control of Fructus gardeniae and especially suits for qualitative and quantitative evaluations of the chromatographic fingerprints both in chemical constituent distribution and in contents. The quantitative parameters such as C% and P% can be used to objectively, authentically and thoroughly display the content information characteristics. When they combined with the qualitative similarity, it will be the good method to evaluate the chromatographic fingerprints of traditional Chinese medicines.

Study on the comparison of three diagnostic criteria of metabolic syndrome in Jiangsu population / 中华流行病学杂志

<p><b>OBJECTIVE</b>To compare the significance of the application in Jiangsu population using the diagnostic criteria for metabolic syndrome(MS) proposed by the IDF in 2005, ATP III in 2005 and CDS in 2004.</p><p><b>METHODS</b>Based on the populations in Jiangsu province from a project of Multiple Metabolic Disorders and MS, the study was conducted including 5888 cases, with data of plasma glucose, lipid profile, blood pressure, serum insulin etc. MS was diagnosed and compared according to these three definitions respectively.</p><p><b>RESULTS</b>The age-adjusted MS prevalence rates were 17.48%, 21.95% and 9.59% according to the IDF(2005), ATP III (2005) and CDS (2004) respectively. The agreement in the diagnosis of MS using ATP III (2005) and CDS(2004) definitions was 85.11%, and the agreement in the diagnosis of MS using IDF(2005) and CDS definitions was 87.35%. The agreement in the diagnosis of MS using IDF (2005) and ATP III (2005) definitions was 95.14%. The MS subjects diagnosed by the ATP III (2005) was 1.26 higher than subjects diagnosed by the IDF(2005) definition. The ratios of prevalence rates of high waist circumference(WC), MS_IDF (2005) and MS_ATP III (2005) was 2.17, 1.99 and 1.54 in sex ratio (woman to man).</p><p><b>CONCLUSION</b>The agreement in the diagnosis of MS using the IDF(2005) and ATP III (2005) definition was higher than using CDS(2004) and other two definitions. For diagnosing MS, the cut off of WC in IDF(2005) and ATP III (2005) seemed not appropriate and the diagnostic criteria used for ATP III (2005) (waist circumference of man 85 cm, woman 80 cm) could identify more MS.</p>

Study on the prevalence of metabolic syndrome among 35-74 year-olds in Jiangsu province / 中华流行病学杂志

<p><b>OBJECTIVE</b>To describe the prevalence of metabolic syndrome (MS) in Jiangsu province, using IDF 2005 and ATP III 2005 definition.</p><p><b>METHODS</b>Multistage cluster sampling method was used and the participants were interviewed by trained health workers under a structured questionnaire. The number of research subjects was 5888. Fasting plasma glucose (FPG), blood lipids, body mass index, blood pressure (BP) of all sample population (5888 subjects) were measured.</p><p><b>RESULTS</b>The prevalence of MS was 17.48% by IDF 2005 definition and 21.95% by ATP lII 2005 definition. Women had higher prevalence than men (P < 0.01). The prevalence of MS increased with age. Abrupt increase of the prevalence started at age of 50 in women. The prevalence varied by education, marital status, occupation and income. People from the urban and the south had a higher prevalence than from the rural and from the northern part of the country. The most common combination of MS individual components were 1) central obesity, dislipidemia and high BP; 2) central obesity, dislipidemia, high BP and high FPG.</p><p><b>CONCLUSION</b>The prevalence of MS was high in Jiangsu province. Clustering of MS components was common. It is necessary to discuss the cut-off points of central obesity for the waist circumference diagnostic criteria of MS in Chinese population. The importance of prevention of MS should be strengthened both by health professionals and the government.</p>

The digital criterion of the potential information characteristics of the traditional Chinese medicine chromatographic fingerprints / 药学学报

<p><b>AIM</b>To exploit the characteristic digital criterion for the potential information characteristics of traditional Chinese medicine chromatographic fingerprints, the 37 parameters such as F and I were firstly proposed to disclose the potential information characteristics of traditional Chinese medicine fingerprints.</p><p><b>METHODS</b>The HPLC fingerprints of the Ginkgo biloba extract (GBE) , Ginkgo leaf extract and diphyridamole injection (GLEDI), Ixeris sonchifolia Hance (ISH) and Ixeris sonchifolia Hance injection (ISHI) were compared each other.</p><p><b>RESULTS</b>As far as the peak signal intensity, the uniform of peak signal, resolution and the fingerprint information were concerned. The GBE fingerprint was better than the GLEDI's, and the ISH fingerprint was also better than the ISHI's, then GBE fingerprint was close to the ISHI' s.</p><p><b>CONCLUSION</b>The 37 parameters such as F and I can be used to objectively, authentically and thoroughly display the potential information characteristics of the traditional Chinese medicine chromatographic fingerprints.</p>

Study on the metabolic health risks of body mass index and waist circumference / 中华流行病学杂志

<p><b>OBJECTIVE</b>To evaluate the effect of body mass index (BMI) and waist circumference (WC) on metabolic health risks (MHR).</p><p><b>METHODS</b>Based on data from two community populations (Suzhou city and Changshu city) derived from a project on 'multiple metabolic disorders and metabolic syndrome' in Jiangsu province. 1604 subjects were divided into groups as normal weight (BMI: 18-23.9), overweight (BMI: 24-27.9) and obesity (BMI > or = 28) according to BMI measurement. According to the results from WC measurement, they were grouped as abdominal obesity (male: > or = 85 cm; female: > or = 80 cm) and normal. Relative risks (RR) for hypertension, hyperglycemia, dyslipidemia were calculated.</p><p><b>RESULTS</b>In males and females, the mark values of hypertension, hyperglycemia, dyslipidemia as well as the prevalence of MS were related to BMI and WC. The relativity remained true when the confounding factors were under control. Among the overweight group, the aRR of all these metabolic health risks were basically lower than those when the overweight group and the abdominal obesity group were combined. Both in males and females, when groups combining normal weight with abdominal obesity group, the aRR of all these metabolic health risks were higher than overweight group combining with normal WC group in most of the cases.</p><p><b>CONCLUSION</b>As to the effect of BMI and WC on metabolic health risks, WC--the mark of abdominal obesity seemed to be more effective than BMI.</p>

The relation between blood pressure level in prehypertensives and multiple metabolic disorders / 中华流行病学杂志

<p><b>OBJECTIVE</b>To study the relation between blood pressure level in prehypertensives and multiple metabolic disorders.</p><p><b>METHODS</b>Based on the populations in Jiangsu province from the project of Multiple Metabolic Disorders and Metabolic Syndrome, a case-control study was conducted including 585 cases of isolated systolic prehypertensive,746 cases of diastolic-systolic prehypertensive, 340 cases of isolated diastolic prehypertensive and 1755 individuals with normal blood pressure.</p><p><b>RESULTS</b>The occurrence of triglyceride(TG), body mass index(BMI) and waist circumference(WC) disorders were significantly higher in the three case groups than in the normal blood pressare group. Among case groups, 50% of them had at least one more metabolic abnormalities as compared to 35% in the controls.</p><p><b>CONCLUSION</b>Among patients in prehypertensive stage, TG disorder was most popular in multiple metabolic disorders. Prehypertensive was associated with WC, BMI and age, indicating that there had already been collections of cardiovascular risk factors in the prehypertensive stage.</p>

Assessment and analysis on the risk and community treatment of hypertension in rural areas in Changshu city / 中华流行病学杂志

<p><b>OBJECTIVE</b>To assess and analyze the risk and community treatment of hypertension in rural population of Changshu city, Jiangsu province.</p><p><b>METHODS</b>A stratified cluster sampling technique was conducted to select a sample of 800 people, aged 35 - 74 years old, in a rural village according to the proportion of the national population in Changshu. Weight, height, blood pressure, serum lipid, blood glucose and other related factors were examined and analyzed.</p><p><b>RESULTS</b>The prevalence rate of hypertension in the rural area was 32.01%, and significantly higher with the increase of age (P < 0.01). The average systolic blood pressure of hypertension in females was significantly positively correlated while, the average diastolic blood pressure of male and female hypertensives was significantly negatively correlated to age. The proportions of risk factors of cardiovascular diseases (CVD) as senility, hyperlipemia, premature familial history of CVD and overweight of hypertension were significantly high than those without hypertension (P < 0.01). The percentage of medium-low risk on hypertension was 85.72%, but of high risk was 14.28%. The ratio of using medication, exclusive non-medication, comprehensive treatment or total cure were 42.05%, 2.84%, 14.20% and 59.09%, accordingly. The rates of blood pressure control under the above approaches were 35.14%, 40.00%, 36.00% and 39.77%.</p><p><b>CONCLUSION</b>Assessment on the risk of hypertension in the rural areas suggested that the priority should be given to medium-low risk groups, while the rate of medication and non-medicine intervention was at low level. It is necessary to strengthen a comprehensive intervention program for hypertension control.</p>

The index F and relative index Fr of chromatographic fingerprints / 药学学报

<p><b>AIM</b>The index F and relative index Fr of chromatographic fingerprints were firstly proposed to indicate how bountiful was the information in traditional Chinese medicines chromatographic fingerprints, how better was the separation effect, how high was the peak signal and how equal were the peak areas.</p><p><b>METHODS</b>The index F and relative index Fr of chromatographic fingerprints were firstly applied to evaluate the chromatographic fingerprints results of traditional Chinese medicines determined by the reversed-phase high performance liquid chromatographic method and high performance capillary electrophoresis.</p><p><b>RESULTS</b>The Shegan Kangbingdu injection and all its traditional Chinese medicines ingredients had been evaluated by F and Fr, so did for the HPLC fingerprints of Radix salviae miltiorrhizae reported in literature. As the same time, the F and Fr of the capillary electrophoresis fingerprints of Folium isatidis, Rhizoma belamcandae and compound liquorice tablets were successfully determined. As far as F was concerned, there was no evident difference between HPLC and capillary electrophoresis (CE), but the Fr values came from CE was usually a thousand times more than that from HPLC.</p><p><b>CONCLUSION</b>The F and Fr can be applied to evaluate objectively, simply and thoroughly the chromatographic fingerprints.</p>