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Mannitol nicotinate quality control method
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A technology of mannohexanicotinate and detection method, which is applied in the field of analytical chemistry, can solve the problems of complex metabolites and cannot be qualitative and quantitative, and achieves the effects of high purity, improved accuracy and simple operation.
Inactive Publication Date: 2014-06-11
QINGDAO SHOUHEJINHAI PHARMA
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At the same time, Yikang metabolizes quickly in the body. In the process of establishing the separation method, it was found that the metabolites of Yikang were complex. Because there was no standard for metabolites, it was impossible to qualitatively quantify them, but it suggested that the active components might be metabolites.
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Embodiment 1
[0044] Embodiment 1 Utilizes the quality control method of Mannopenta Nicotinate to carry out Mannohexanicotinate
[0045] The quality control method that utilizes mannopentanicotinate to carry out mannohexanicotinate comprises the following four steps:
[0046] 1) Solution preparation:
[0047] Take 10mg of mannohexonicotinate, weigh it accurately, put it in a 50ml volumetric flask, add 5ml of 0.5mol / l hydrochloric acid to dissolve it, dilute it to the mark with methanol-water (60:40), shake well; use it as the test solution; Precisely measure 1ml, put it in a 100ml volumetric flask, dilute to the mark with methanol-water (60:40), shake well, and use it as a control solution;
[0048] Accurately weigh 10 mg of mannose pentanicotinate reference substance, put it in a 50ml volumetric flask, add anhydrous methanol to dissolve to volume, and shake well; then accurately measure 1ml, put it in a 100ml volumetric flask, dilute with mobile phase to volume, shake well, As a referenc...
Embodiment 2
[0052] The preparation method of embodiment 2 mannopentanoic acid ester
[0053] 2.1 The synthetic method preparation method of mannopentanoic acid ester
[0054] The chemical reaction formula of the reaction is
[0055] 1) Chloroesterification of nicotinic acid: nicotinic acid reacts with phosphorus oxychloride to generate chloroesterification of nicotinic acid.
[0056]
[0057] 2) Mannitol esterification: Mannitol reacts with chloro-esterified niacin, and the molar ratio of mannitol and chloro-esterified niacin is controlled to be 1:5 to generate mannitol pentanicotinate.
[0058]
[0059] In a 250ml three-necked bottle that has been dried beforehand and cooled to below 20°C, add 20.00g of nicotinic acid and 55ml of pyridine at one time, stir, and cool down. 10-60°C. After the dropwise addition, the temperature was controlled at 55-60° C., and the reaction was carried out for 1 hour. After the reaction is over, add 5.92 g of mannitol that has been pulverized in ad...
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Abstract
The invention relates to a mannitol nicotinate quality control method, and belongs to the chemical analysis field. The contents of related substances of the mannitol nicotinate are obviously increased in the storage and production processes of the mannitol nicotinate, HPLC (High Performance Liquid Chromatography) is adopted to detect the contents of important impurities in the mannitol nicotinate for inspection and control in the mannitol nicotinate detecting and control processes, the content of mannitol pentanicotinate is the highest, and the contents of mannitol binicotinate and mannitol mononicotinate take the second place. The method has the accuracy in inspection and simplicity in operation by use of the compounds such as the mannityl pentanicotinate, mannitol tetranicotinate, mannitol trinicotinate, the mannitol binicotinate and the mannitol mononicotinate for quality inspection and control, and is beneficial to quality control and standard formulation of the mannitol nicotinate industrially.
Description
technical field [0001] The invention belongs to the field of analytical chemistry, and relates to a quality control method of mannohexonicotinate. Background technique [0002] Impurities refer to substances introduced during the production or storage of drugs, which have no therapeutic effect or affect the stability and curative effect of drugs, and may even be harmful to human health. With the progress of the times and the improvement of the level of science and technology, people have a fuller understanding of the importance of scientific evaluation of the quality, safety and efficacy of drugs before they go on the market. Closely related to the quality of medicines is the control of impurities contained in medicines. Impurities are often associated with drug safety and, in a few cases, efficacy, so controlling impurity levels is gaining more and more attention during drug development research. At present, there are special general rules for impurity inspection in the p...
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