OBJECTIVE:To investigate the number of insoluble particle in total parenteral nutrition(TPN)solutions and to pro-vide reference for clinical application. METHODS:6 kinds of commonly used TPN prescriptions were selected. After prepared ac-cording to sterile operation procedure,TPN at 25℃was investigated at 0,1,4,8 and 24 h in terms of appearance,pH value,os-motic pressure and the numbers of insoluble particles. RESULTS:The appearance and pH value of TPN had no significant change within 24 h after preparation,and osmotic pressures were all lower than 900 mOsm/L. Study results showed that the numbers of in-soluble particles quickly increased,and ≥10 μm and ≥25 μm insoluble particles exceeded the limitation of Chinese Pharmacopoe-ia after Lipid-soluble vitamin for injection were injected into TPN. Medium/long chain fat emulsion injection,water-soluble vita-min,electrolytes and trace elements also increased the numbers of insoluble particles. CONCLUSIONS:Medium/long chain fat emulsion injection,lipid-soluble/water-soluble vitamin,vitamin C,electrolytes and trace elements have certain influence on the number of insoluble particle of TPN. To analyze the reason for the forming of insoluble particles has great meaning both for improv-ing the TPN quality and reducing the harm of particles for patients.

OBJECTIVE:Preparation of levofloxacin eyedrops METHODS:Levofloxacin eyedrops was prepared with benzalkonium as bacteriostat,NaCl as osmotic-pressure regulating agent and PVP as thickener The content was determined with HPLC and the stability was observed in the range of 60℃～90℃ with 5℃ as a gradient RESULTS:Both the within-day and between-day RSDs were less than 3% The expected period of validity would be 1 5 years Irritation test showed that this preparation was not irritant to rabbit's eyes The preparation met the criterion in Chinese Pharmacopeia CONCLUSION:The Levofloxacin eyedrops is stable in quality

Objective:To extract the effective components from medical materials using modern preparation technology and to stud-y the preparation process to obtain Qingwen Tuire granules, and establish the quality standard. Methods:The medical materials in the formula were extracted by a heating decoction method. The wet granulation process was used for the granule preparation. The compo-nents including bupleurum, paeoniae alba, scutellaria baicalensis and indigowoad leaf in the granules were identified by TLC and the contents of seutellarin in the preparation was determined by HPLC. Results:The characteristic spots in TLC were clear without any in-terference. The linear range of scutellarin was 0. 194-1. 164 μg with the correlation coefficient of 0. 999 5. The average recovery was 100. 89%(RSD=0. 74%, n=6). Conclusion:The methods used in the identification and quantification are sensitive, simple and ac-curate, which can be used in the quality control of Qingwen Tuire granules.

Objective:To investigate the compatibility stability of muscular amino acids and peptides and nucleosides for injection in different infusions to provide basis for clinical application .Methods: The compatibility stability of muscular amino acids and pep-tides and nucleosides for injection respectively in 0.9%sodium chloride injection , 5% glucose injection , 10%glucose injection and glucose and sodium chloride injection was studied , and the indices included the appearance , pH value , number of insoluble particles and contents of hypoxanthine and polypeptides .Results:All the solutions were transparent .The pH value and the contents of hypoxan-thine and polypeptides showed no significant changes .When muscular amino acids and peptides and nucleosides for injection was mixed with 10%glucose injection , the number of insoluble particles (≥10 μm) was the smallest , which met the requirement in Chi-nese pharmacopoeia (2015 edition,volume Ⅳ).When it was mixed with 0.9% sodium chloride injection, 5% glucose injection and glucose and sodium chloride injection , the number of insoluble particles (≥10 μm) was beyond the limits .The number of insoluble particles (≥25 μm) in all the solutions met the requirement .Conclusion: The most suitable solvent for muscular amino acids and peptides and nucleosides for injection is 10%glucose injection .

OBJECTIVE:To establish a method for determination of Edaravone cont en ts in injection METHODS:The Kromasil C18 column(4 6mm?200mm,5?m) was use d The mobile phase was consisted of 0 1mol/L NaH2PO4-methanol(45∶55) with detection at 242nm,flow rate was 1 0ml/min RESULTS:The linear range was 1 2 4?g/ml～24 8?g/ml(r=0 9 999),the mean recovery was 100 3% with RSD=0 9 5%(n=6) CONCLUSION:This method is simple,sensitive and accurate,and can b e used to control the quality of Edaravone injection

Objective To develop a method of quality control for fingerprints of Xinshu Oral Liquid. Methods Based on electrophoregram of ten batches of genuine Radix Angelicae Sinensis (RAS), ten batches of genuine Rhizoma Chuanxiong (RC), and ten batches of genuine Flos Carthami (FC) by high performance capillary electrophoresis (HPCE) to compare the fingerprints between Xinshu Oral Liquid and the genuine medicinal herbs, single herb decoction, nagetive control herb solution, respectively. The fingerprint assignment was made by comparing the UV spectra and relative migration time. Results To compare the fingerprints of ten samples from different batches and single herb, the correlation of peaks between fingerprings was found. Finally the standard fingerprints and the method of quality control were established. Conclusion Based on the fingerprints of ten batches of prearations, an average electro-phoregram was used as the standard fingerprint. There are 27 “common peaks” in the fingerprint, among them 14 from RAS, ten from RC (in which seven are commnon) and nine from FC.

Objective:To research the stability of Dazhu Hongjingtian injection combined with four different infusion solutions (0. 9% sodium chloride injection, 5% glucose injection, fructose injection, xylitol and sodium chloride injection) . Methods:The insolu-ble particles and pH value of Dazhu Hongjingtian injection in 0, 0. 5,1,2,4 and 8h after the combination were detected by the methods described in China Pharmacopeia ( 2010 edition ) . Results: Dazhu Hongjingtian injection combined with the four infusion solutions showed no significant changes in appearance and pH value in 8h. The number of insoluble particles in Dazhu Hongjingtian injection combined with 0. 9% sodium chloride injection and 5% glucose injection met the requirement in the pharmacopeia, and that in 0. 9%sodium chloride injection was lower than that in 5% glucose injection. The quantity of insoluble particles in Dazhu Hongjingtian injec-tion combined with fructose injection exceeded the standard level, and showed remarkable change in the fourth hour. The quantity of insoluble particles in xylitol and sodium chloride injection slightly exceeded the standard. Conclusion: Dazhu Hongjingtian injection can be mixed with 0. 9% sodium chloride injection and 5% glucose injection, and fructose injection and xylitol and sodium chloride in-jection are not suitable for the solvent of Dazhu Hongjingtian injection. Although there is no instruction indicating that 0. 9% sodium chloride injection can be used as the suitable solvent for Dazhu Hongjingtian injection, the results of the experiment can be reasonable reference for diabetes patients treated with Dazhu Hongjingtian injection.

AIM： On the basis of in vitro study， a preliminary survey of the stability of diclofenac lysine sustained-release tables(DLST) was carried out to identify the period of validity.METHODS： To observe the changes of DLST under high temperature， blaze， high humidity and room temperature(for long period) and to perform accelerating test for 3 months.RESULTS： The drug release was accelerated under high temperature， and the tablet was apt to absorb moisture because of its hydrophilic matrix and the drug release became faster at day 10 under blaze， and therefore DLST should be stored away from high temperature， high humidity and blaze.CONCLUSION： DLST is stable and the period of validity is tentatively fixed at 2 years.

OBJECTIVE:To presume the structures and determine the contents of two metabolites of omeprazole in human urine after extraction and purification.METHODS:24 healthy volunteers were assigned to receive single oral dose of 40mg omepazole capsules,whose urinary samples collected within 12 hours after administration were extracted and concentrated with diethyl ether,and separated by HPLC.The relative purified metabolites were detected by mass spectrum,the structures of which were presumed and the contents were computed.RESULTS: The isolated 2 metabolites of omeprazole were presumed to be pyridine 5'— or 3'— methyl oxidation-generated hydroxy sulfone metabolite and 5'—methy hydroxylation thioether metabolite in pyridine ring,and the contents of which were 96.54% and 97.26%,respectively.CONCLUSION:The metabolites of omeprazole isolated from urinary samples by the method mentioned above were of high purity.

OBJECTIVE:To evaluate the biological compatibility and clinical therapeutic effect of the medical sterilized bone wax.METHODS:Embedding test and pathological test as well as hemolytic test were performed by using rabbits as test animal.12531case-times were investigated in respect to the therapeutic effect,prognosis and satisfactory rate.RESULTS:The embedded bone wax was coated by connective tissue and has not been absorbed without surrounding inflammation,edema or necrosis.The bone wax could not be absorbed after stanching bleeding of the bone broken surface.No hemolytic phenomena were observed.The wound healing obtained a satisfactory rate of99.1%.CONCLUSION:The sterilized medical bone wax has good biological compatibility and is safe and effective to stanch bleeding.It is convenient to use due to its singer dose sterilized packaging.