Objective: To improve the quality standard for Zengguang tablets.Methods: Instead of the microscopic identification, Acorus tatarinowii rhizoma,Lycii Fructus and Polygalae radix were indentified by TLC.The content of schisandrin in Schisandrae Chinensis Fructus was determined by HPLC.The HPLC system consisted of a Hypersil BDS C18(250 mm×4.6 mm,5 μm)column, methanol-water (1∶1) was used as the mobile phase at a flow rate of 1.0 ml·min-1, and the detection wavelength was at 250 nm.The column temperature was 35℃ and the sample size was 10 μl.Results: The microscopic images were with strong specificity.The developed TLC spots were quite clear, and the method of TLC was simple with strong specificity and good reproducibility.The linear range of schisandrin was 21.17-423.40 ng(r=0.999 9).The average recovery was 99.7% and the RSD was 1.4%(n=6).Conclusion: The method for the quality control of Zengguang tablets is comprehensive and perfect.

Objective: To determine the impurities in pharmaceutical adjuvant sodium bisulfite. Methods: An IC method was used with a Dionex IonPac AS17-C RFIC analytical column. ECD was used as the detector by gradient elution and the temperature of column was 30℃. Results:Sulfate radical was detected out in all samples. Conclusion:The method is simple and fast with high sensi-tivity, which is suitable for the determination of related substances in sodium bisulfite.

Objective:To determine the related substances in benzalkonium chloride used as a pharmaceutical adjuvant, and com-pare the quality at home and abroad. Methods:An HPLC method was used with an ODS-HYPERSIL C18 column(250 mm × 4. 6 mm, 5 μm). The detection wavelength was 210 nm and 257 nm. The flow rate was 1. 0 ml· min-1 and the column temperature was 30℃. The injection volume was 20 ml. The mobile phase was A ( dissolving 1. 09 g sodium1-hexanesulfonate and 6. 9 g sodium dihydrogen phosphate in water, adjusting pH to 3. 5 with phosphoric acid and diluting to 1 000. 0 ml) and B ( methanol) with gradient elution. Results:The content of benzaldehyde in the samples at home and abroad was low. The content of benzyl alcohol in the samples from a-broad was qualified, which was significantly higher than that in the domestic samples. The content of benzyl chloride in the domestic samples was higher than that in the samples from abroad. Conclusion:The method is simple and fast, which is suitable for comparing the related substances of domastic and imported samples. At the same time, the study provides basis for enterprises to choose benzalko-nium chloride rationally.

OBJECTIVE:To establish a method to determine and compare the contents of sodium benzoate in medicinal(phar-maceutical excipients and active pharmaceutical ingredients) and non-medicinal (chemical reagents and food additives) grade. METHODS:HPLC was conducted for content determination,SPSS 18.0 software was adopted to compare the results. The column was Purospher STAR LP RP-18 endcapped with mobile phase of acetotrile-0.02% formic acid(adjusted pH to 4.0 with aqua ammo-nia)(30∶70,V/V)at a flow rate was 1.0 ml/min,the detection wavelength was 230 nm,column temperature was 35 ℃,and vol-ume injection was 20 μl. RESULTS:The linear range of sodium benzoate was 10.5-525.3 μg/ml(r=0.999 9);RSDs of precision, stability,reproducibility and durability tests were lower than 0.5%;recovery was 99.38%-101.26%(RSD=0.56%,n=9). The av-erage contents of sodium benzoate in medicinal and non-medicinal grade were between 99.400%-99.875%,but the average content of non-medicinal grade is lower than the medical grade. CONCLUSIONS:The method is accurate and simple with high specificity and good reproducibility,and can be used to determine and compare the content of sodium benzoate in medicinal and non-medici-nal grade.

To establish a GC method to determine the related substances in pharmaceutical excipient benzyl alcohol. Methods:A GC method was used with an Agilent DB-wax eapillary column(0. 32 mm × 30 m,1. 8 μm)and programming temperature. The initial temperature was 50℃, and then raised to 220℃ with a rate of 5℃·min-1 and maintained for 35min. The detector was FID. The temperature of the injection port was 200℃,and the detector temperature was 310℃. The results were confirmed by GC-MS. Results:Within a certain range,the peak area and concentration of every impurity had a good linear relationship (r≥0. 999 9). The recovery was between 96. 1% and 102. 7%. The quantitative limit was between 1. 37-3. 63 ng. Toluene, benzyl chloride, benzalde-hyde and benzyl ether were found out in the samples. Conclusion:The method is accurate and convenient, and suitable for the quanti-tative determination of related substances in pharmaceutical excipient benzyl alcohol.

Objective:To compare the quality differences in benzalkonium chloride samples from domestic and abroad to provide references for the quality standard revision for benzalkonium chloride in Chinese pharmacopoeia. Methods: The ratio of alkyl compo-nents was determined according to the method described in USP 38, and the total content of benzalkonium chloride was determined ac-cording to the method recorded in Chinese Pharmacopoeia (2015 edition) and USP 38, respectively. Results:According to the results of composition ratio of alkyl, the fraction defective of domestic samples and imported samples was 100% and 50%, respectively. The content difference between the values calculated by the methods in the two pharmacopoeias showed that the total content of domestic samples changed from 3. 86% to 4. 15%, and that of imported samples changed from 1. 15% to 3. 90%. Conclusion:There are sig-nificant differences in the quality of benzalkonium chloride between domestic samples and imported samples. It is recommended that the ratio of alkyl components should be supplemented in our pharmacopoeia referring to the method in USP 38 and the total content calcula-tion formula for benzalkonium chloride should be revised to improve the quality standard for benzalkonium chloride.

Objective:To establish the method for determining the related substances in lansoprazole for injection and qualitatively study the impurities. Methods:An HPLC method and an HPLC-MS method were used with isocratic elution and DAD as the detector. Results:The priciple impurity in all samples was impurity B. Conclusion:The method is fast, simple and sensitive, and suitable for the determination of the related substances in lansoprazole for injection.

Objective: To establish an ion chromatography (IC) method to determine the content of chloride ion and sulfate ion in ethylparaben, and evaluate the quality status of chloride ion and sulfate ion in ethylparaben at different levels.Methods: Ion chromatograph was used.The column was Dionex IonPac AS 18 (250 mm ×4 mm,5 μm) using potassium hydroxide as the mobile phase with gradient elution, the flow rate was 1.0 ml·min-1 , the injection volume was 25 μl, and the quantitative method was standard curve.Results: The method showed good linear relationship within the range of 0.02-4.00 μg·ml-1 for chloride ion (r=0.999 9) and 0.10-10.00μg·ml-1 for sulfate ion (r=0.999 5).The average recovery was 90.12% (RSD=3.4%) and 85.54% (RSD=6.2%) for chloride ion and sulfate ion, respectively (n =9).The content range of chloride ion and sulfate ion was 0.000 3%-0.015 7% and 0.000 9%-0.024 4% in 63 batches of samples, respectively.Conclusion: The established method is simple, fast and accurate, which can be used to determine the contents of chloride ion and sulfate ion in ethylparaben and is helpful to its quality control.

Objective: The objectives were to explore the optimal concentration of drinking water in Eastern Guangdong and to provide information for the health administrative department to set up the criteria for fluoride concentration. Methods: Totally 1237 9～ 17 and 35～44 years old residents in Eastern Guangdong who drinking water containing 0.1～2.5mg/L fluoride were recruited to investigate the occurrences of dental caries and dental fluorosis. Their background information and perceived appearances of teeth were also recorded. Results: The major factor influencing dental fluorosis was fluoride concentration in drinking water. Dental caries decreased when the fluoride concentration increased but dental fluorosis also increased at the same time. It was showed by calculation that the Dental Fluorosis Index would be 0.4 and 0.6 when the fluoride concentration was 0.57 mg/L and 0.7 mg/L respectively. The acceptation to the severity of dental fluorosis among the study subjects was in accordance with the Dean's criteria. Conclusion: It suggests that the optimal fluoride concentration in Eastern Guangdong is 0.57 mg/L and should not exceed the upper limit of 0.7 mg/L.

OBJECTIVETo establish a high-quality method for detecting short tandem repeats(STR) using denaturing high performance liquid chromatography(DHPLC) in order to exclude maternal contamination and improve the accuracy of prenatal diagnosis.

METHODSTwo families were recruited. DNA was extracted from blood samples from the parents as well as amniotic fluid. Sixteen STR sites were amplified and analyzed based on the range of allele length reported by a STR database. Maternal DNA was mixed with DNA derived from amniotic fluid samples with the ratio 1:1, 1:4, 1:9, 1:19 and 1:99. vWA STR site was detected with DHPLC to confirm the sensitivity of detection.

RESULTSSixteen STR sites were analyzed by DHPLC, for which at least 10 were found to be different between the mothers and fetuses. The detection rate, with maternal contamination excluded, was 66.7%. And the sensitivity of detection was 1-10%.

CONCLUSIONMaternal contamination of amniotic fluid can be rapidly excluded with accuracy with DHPLC, which features a high sensitivity and good quality control, and can meet the European standards and provide a reliable quality control platform for prenatal diagnosis.

Chromatography, High Pressure Liquid ; methods ; DNA ; analysis ; chemistry ; genetics ; DNA Contamination ; Female ; Humans ; Microsatellite Repeats ; Pedigree ; Pregnancy ; Prenatal Diagnosis ; methods