Analysis of 30 IU of total blood, in which 15 IU of professional blood donors and 15 IU of voluntary blood donors. 20 IU of erythrocyte volume, of them 10 IU were preserved in CPD/S, A, G, M2 (terumor) solutions and 10 IU were preserved in S, Na, G (glucoza 5%, NaCl 9%o with rate of 1:2). The results showed that: the erythrocyte indexes in the blood IU of the volutary blood donors were significantly higher compared to that of the professional blood donors. There was no significant differences of the erythrocyte indexes in blood IU preserved in the international standard solutions until the date of 10, 15, 20 and 30th and in S, Na, G solutions after producing and at the date of 10th at 4  2oC. However, erythrocyte indexes were found to be different in blood IU preserved in S, Na, G at the date of 15th and the following time
Blood ; Solutions/standards ; Blood Donors

During the routine tests, it's found that the testing method related to Hemodialysis mentioned in the industry standard YY0598-2006 cannot reflect the real bicarbonate concentration in Hemodialysis. To discuss the reaction principle and its interference factors deeply by studying the assay determination of bicarbonate in Hemodialysis, and it could be cited as reference for amending the quality standard or troubleshooting. The improved way of determining bicarbonate concentration in Hemodialysis is also put up.
Bicarbonates ; analysis ; Dialysis Solutions ; analysis ; standards ; Renal Dialysis ; methods ; standards

OBJECTIVETo determine the enantiomeric impurity contents of domestic timolol maleate in bulk drugs and eye drops.

METHODSEnantiomer impurity of timolol was assayed by chiral high performance liquid chromatography. The chromatographic conditions were as follows:chiralcel OD chiral column (4.6 mm ×150 mm, 5μm), detection wavelength:297 nm, mobile phase:hexane-isopropanol-diethylamine (480:20:1), column temperature:25 ℃, flow rate:1.0 ml/min, sample injection volume:5 μl.

RESULTSThe resolution between R- and S-timolol was more than 4. The enantiomeric impurity contents were less than 0.67% on average in two batches of timolol maleate bulk drugs, and 0.31% on average in three batches of timolol maleate eye drops.

CONCLUSIONEnantiomeric impurity contents in each batch of products all meet European Pharmacopoeia criteria, which can be used as references in Chinese Pharmacopoeia criteria.

Chromatography, High Pressure Liquid ; methods ; Drug Contamination ; Ophthalmic Solutions ; analysis ; standards ; Stereoisomerism ; Timolol ; analysis ; standards

OBJECTIVETo suggest a method for discriminating quality control indicators of concentrated solution before traditional Chinese medicine ethanol precipitation.

METHODThe second ethanol precipitation (SEP) of Guanxinning was taken as an example, with the concentrated supernatant of first ethanol precipitation (CSFEP) prepared with same dry matter content and the same amount of ethanol as raw materials, to conduct the ethanol precipitation test under the same conditions. The experimental data was analyzed by stepwise regression and partial least squares regression. Both of them selected the parameters which affect phenolic compounds retention ratios in SEP supernatant as the key indicators.

RESULTPhenolic compounds contents in SEP supernatant were mainly affected by the contents of danshensu, caffeic acid and salvianolic acid B in CSFEP.

CONCLUSIONThe discrimination method can be used to discover key quality control indicators of concentrated solution before ethanol precipitation.

Chemical Precipitation ; Ethanol ; chemistry ; Medicine, Chinese Traditional ; standards ; Quality Control ; Solutions

OBJECTIVETo evaluate the changes in the concentrations of five components in Fructus Evodiae used in Chinese medicine, including evodiamine and glycyrrhizic acid, during processing of Fructus Evodiae with Radix Glycyrrhizae extract by using high performance liquid chromatography (HPLC) and to provide a scientific basis for different clinical uses of processed and unprocessed Fructus Evodiae.

METHODSThe concentrations of the Fructus Evodiae components in processed or unprocessed Fructus Evodiae were evaluated by HPLC using a YMC J'sphere ODS-H80 column (4.6 mm×250 mm, 5 μm) with acetonitrile-water-tetrahydrofuran-acetic acid (41:59:1:0.2, v/v/v/v) as the mobile phase. The detection wavelength was 225 nm, the column temperature was 35°C, the flow rate was 1.0 mL/min, and the injection volume was 10 μL. The concentrations of the Radix Glycyrrhizae components were determined by HPLC with a Kromasil-C₁₈ column (4.6 mm×250 mm, 4 μm) and a gradient elution of acetonitrile (A) and 0.05% aqueous phosphoric acid (B) as the mobile phase. The detection wavelength was 237 nm, the column temperature was 35 °C, the flow rate was 1.0 mL/min, and the injection volume was 10 μL.

RESULTSThe calibration curves of evodia lactone, evodiamine, rutaecarpine, liquiritin, and glycyrrhizin showed good linear relationships (r>0.99). The recoveries of evodia lactone, evodiamine, rutaecarpine, liquiritin, and glycyrrhizin were 96.59%, 104.18%, 101.91%, 97.75%, and 97.95%, respectively. The concentrations of the components in processed Fructus Evodiae were obviously different to those in unprocessed Fructus Evodiae.

CONCLUSIONSThe developed method is rapid and accurate. The results provide a reference for processed Fructus Evodiae and the changes that could be expected in its effects compared to unprocessed Fructus Evodiae.

Calibration ; Chromatography, High Pressure Liquid ; Cooking ; Drugs, Chinese Herbal ; analysis ; Evodia ; chemistry ; Glycyrrhiza uralensis ; Plant Extracts ; analysis ; Reference Standards ; Solutions

OBJECTIVETo establish a HPLC method with the relative correction factors (RCFs) for quantification of five critical related substances (A, B, C, D and E) in puerarin and its injection.

METHODTaking puerarin as the internal standard, corresponding RCFs of the critical related substances were determined respectively. According to their RCFs, simultaneous determination of five related substances in puerarin and its injection was performed. The method was evaluated by comparison the quantitative results of external standard method and the method with RCFs correction.

RESULTThere were no significant differences in the results of five critical related substances in 38 batches of puerarin and its injection by external standard method and the method with RCFs correction.

CONCLUSIONThe HPLC method with RCFs was validated to be accurate and can be successfully applied to determine the critical related substances in puerarin and its injection.

Chromatography, High Pressure Liquid ; methods ; standards ; Drug Contamination ; Drug Stability ; Humans ; Hydrogen-Ion Concentration ; Injections ; Isoflavones ; analysis ; Pharmaceutical Solutions ; analysis ; Plant Extracts ; chemistry ; Plants, Medicinal ; chemistry ; Pueraria ; chemistry ; Quality Control ; Reproducibility of Results ; Temperature ; Vasodilator Agents ; analysis

To establish a quality control method of Dendrobium aurantiacum eye drops, in order to evaluate acute toxicity, irritation and irritability and lay a foundation for its development and utilization in the future. The content of gigantol and SA in D. aurantiacum eye drops were determined by high-performance liquid chromatography (HPLC). The linear ranges of gigantol and SA were 0.040 8-1.530 0 g x L(-1) (r = 0.999 9) and 0.100 8-0.504 0 g x L(-1) (r = 0.999 9), with the average recoveries being 100.8%, 99.84%, and RSD being 1.4%, 1.8% (n = 9) respectively. The sample solution was stable at room temperature within 72 h. The acute toxicity test showed no toxic reaction of D. aurantiacum eye drops in mice. The irritating test for single-dose and multiple-dose administrations of D. aurantiacum eye drops and physiological saline in rabbit eyes and skin, as well as the allergic test in guinea pigs showed no eye irritation and skin irritation and irritability. These findings indicated that D. aurantiacum eye drops are safe and stable, with a good druggability.
Animals ; Cataract ; drug therapy ; Dendrobium ; chemistry ; Diabetes Complications ; drug therapy ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; standards ; Eye ; drug effects ; Female ; Guinea Pigs ; Humans ; Male ; Mice ; Ophthalmic Solutions ; administration & dosage ; adverse effects ; standards ; Quality Control ; Rabbits ; Skin ; drug effects

PURPOSE: To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. METHODS: This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 +/- 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. RESULTS: Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. CONCLUSIONS: Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.
Adult ; Aged ; Aged, 80 and over ; Diagnostic Techniques, Ophthalmological/*standards ; *Disease Management ; Dry Eye Syndromes/*diagnosis/*drug therapy/epidemiology ; Female ; Follow-Up Studies ; Humans ; Immunosuppressive Agents/*administration & dosage ; Male ; Middle Aged ; Morbidity/trends ; Ophthalmic Solutions ; *Practice Guidelines as Topic ; Republic of Korea/epidemiology ; Retrospective Studies ; Young Adult