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Objective To obtain a clear and qualified compound glycyrrhiza oral solution by using NaSO3 and EDTA as stabi-lizers and Tween80 as solubilizer so as to solve the problem of morphine content instability. Methods NaSO34g and EDTA 0.6 g as stabilizers,and Tween803 g as solubilizer were added in the traditional method. The pH of the solution was adjusted to 8.0. Then the solution was obtained and filled in the brown polyester bottle. Results The preparation was clear,qualified and the content of mor-phine was steady. Conclusion The improved method is feasible,simple,stabilized and suitable for manufacturing.
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Objective: To obtain a clear, well-tasted and qualified compound glycyrrhiza oral solution by improving the addi-tion method of compound camphor tincture. Methods: Pulvis Talci instead of 56% alcohol was used to improve the solubility of camphor and anise oil. Firstly, camphor and benzoic acid were dissolved in 95% alcohol. Then the anise oil was mixed with Pulvis Talci and triturated sufficiently. After that, camphor solution and water were mixed with Pulvis Talci and agitated sufficiently. The im-proved compound camphor tincture was obtained after filtration. At last, a new compound glycyrrhiza oral solution was obtained by the pharmacopeial method. Results: The preparation was clear, well-tasted and qualified. Conclusion: The improved method is fea-sible, simple, stabilized and economical.
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OBJECTIVE:To validate the determination method of the content of Morphine in Compound Glycyrrhiza oral solution. METHODS: Samples were detected by solid phase extraction-HPLC on Kromasil C8 column (250 mm?4.6 mm,5 ?m) with mobile phase consisted of 0.05 mol?L-1 KH2PO4-0.0 025 mol?L-1 C14H15NaO3S?2H2O-acetonitrile using gradient elution.The detection wavelength was 220 nm and the flow rate was 1.0ml.min-1.RESULTS:The linear range of morphine was 2.02～20.2 ?g?mL-1(r=0.999 7),and the average recovery was 99.0%(RSD=0.40%,n=9).CONCLUSION: The method is accurate,sensitive and stable,and accurate and reliable in determination results.
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OBJECTIVE:To investigate the internal quality of 31 batches of Compound Glycyrrhiza oral solutions from different manufacturers.METHODS:The contents of Morphine and Guaifenesin in Compound Glycyrrhiza oral solutions were determined by HPLC,and the pH value of the solution was detected as well.RESULTS:Of the total 31 batches of samples,13 was unqualified in Morphine content,1 was unqualified in Guaifenesin content,and 1 was unqualified in pH value.CONCLUSION:The manufacturers should strictly obey the standards recorded in China Pharmacopoeia in respect of quality control to ensure the safety and efficacy of clinical medication.