Qualitative and Quantitative Characterization of Monosaccharide Components of Salvia miltiorrhiza, Liguspyragine Hydrochloride, and Glucose Injection.

Salvia miltiorrhiza, liguspyragine hydrochloride, and glucose injection (SLGI) was made of Salvia miltiorrhiza Bge., liguspyragine hydrochloride, glucose, and glycerin. There were many kinds of monosaccharide components in SLGI, which might be from the raw material and Salvia miltiorrhiza Bge. Separation was performed on a Phenomenex Luna C18 analytical column (250 mm × 4.6 mm i.d., 5 µm, AccuStandard Inc., USA) at 30°C. The mobile phase consisted of two solvents: 0.1 mol/L phosphate-buffered saline (pH 6.7) (solvent A) and acetonitrile (solvent B) with gradient elution. The flow rate was maintained at 1.0 mL/min. Five kinds of monosaccharide components, glucose, D-mannose, L-rhamnose monohydrate, galactose, and xylose, were detected by precolumn derivatization HPLC, and their contents were compared with each other. And finally, concentrations of glucose in SLGI were determined and they were higher than the values of marked amount, which showed that one source of glucose might be from Salvia miltiorrhiza Bge. in SLGI. The average concentration of glucose was 5.18 g/100 mL, which was near the average value at 5.25 g/100 mL detected by ultraviolet spectrophotometry and also close to the marked amount (5.00 g/100 mL) on the label.

[Fingerprint and Simultaneous Determination of Multi-components in Water-soluble Components of Salvia miltiorrhiza in Miao Autonomous County of Songtao, Guizhou].

OBJECTIVE: To establish the HPLC fingerprint of water-soluble components of Salvia miltiorrhiza in Songtao, Guizhou, and to perform simultaneous determination of six components in it, so as to provide analytical method for its quality control. METHODS: The analyses were performed on a Phenomenex Luna C18 (2) (250 mm x 4. 6 mm, 5µm) column eluted with 0. 4% formic acid(A) - acetonitrile(B) in a gradient mode. The flow rate was 1. 0 mL/min, column temperature was set at 30 °C. RESULTS: Eleven common peaks were identified form the HPLC fingerprint of Salvia miltiorrhiza from 10 batches, the HPLC fingerprint similarities of 10 batches were not less than 0. 999. The linear ranges of danshensu, protocatechuic aldehyde, caffeic acid, rosmarinic acid, lithospermic acid and salvianolic acid B were 0. 0680 ~ 1. 3583 mg/mL, 0. 0008 ~ 0. 3967 mg/mL, 0. 0005 ~ 0. 2660 mg/mL, 0. 0020 ~ 0. 3992 mg/mL, 0. 0063 ~ 0. 6311 mg/mL and 0. 0097 ~ 1. 9306 mg/mL with r ≥ 0. 9999, respectively. The recovery rates were 100. 84%,102. 44%, 100. 53% ,100. 63%, 100. 83% and 100. 35% with RSD <2. 3%, respectively. CONCLUSION: The established method is simple, accurate and can provide reference for quality control of Salvia miltiorrhiza.

Phase I study of N(1),N(11)-diethylnorspermine in patients with non-small cell lung cancer.

PURPOSE: Polyamines are essential for tumor growth; consequently, agents that interfere with their metabolisms have been developed as antineoplastic agents. Diethylnorspermine (DENSPM) is one such agent. A focused Phase I clinical trial in patients with advanced non-small cell lung cancer was undertaken. EXPERIMENTAL DESIGN: Twenty-nine patients were treated with DENSPM using a dosing schedule of once daily for 5 days. Doses ranged from 25 mg/m(2)/day to 231 mg/m(2)/day. RESULTS: The dose-limiting toxicity was determined to be gastrointestinal including asthenia, abdominal cramps, diarrhea, and nausea. The maximal tolerated dose was 185 mg/m(2)/day for 5 days. At drug dosages for which it was possible to estimate, serum half-life ranged from 0.5 to 3.7 h without apparent dose dependence. Maximal serum concentrations increased with dosage. However, the increase was greater than the proportional increase of the administered dose. There were no objective disease responses observed during the Phase I trial. CONCLUSIONS: The results of the Phase I clinical trial suggest that DENSPM can safely be administered to patients with minimal toxicity. Furthermore, the observed dose-limiting toxicity is unique to DENSPM, thus underscoring the potential for DENSPM to be a suitable agent for chemotherapy in combination with agents possessing different spectrums of toxicities.