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A kind of detection method of residual petroleum ether in Ginkgo biloba dropping pills
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A technology of petroleum ether and leaf drop pills, applied in the detection field of residual petroleum ether, which can solve the problems of slow disintegration speed of solid oral preparations, low release speed of active ingredients, monitoring of petroleum ether, etc.
Active Publication Date: 2020-11-03
ZHEJIANG WANBANG PHARMA
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Problems solved by technology
Due to the reasons of the dosage form itself, they have the following problems: ①The disintegration rate of solid oral preparations (such as tablets, capsules, etc.) is slow, and the release rate of active ingredients is low
②First-pass effect problem
The current version of the quality standard for Ginkgo Leaf Dropping Pills is only the 2015 edition of the Chinese Pharmacopoeia, but the standard does not monitor the possible residual petroleum ether
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Embodiment 1
[0235] The preparation of embodiment 1 ginkgo leaf dripping pill
[0236] The preparation process of ginkgo biloba dripping pills is as follows: take ginkgo biloba extract, polyethylene glycol and other medicinal and inactive components, heat the chemical material, move it into the drip irrigation of the dropping pill machine, and drip the medicine liquid into the low-temperature liquid paraffin through the dripper Zhongcheng pills, then wash the liquid paraffin oil with petroleum ether, finally dry the petroleum ether, and select the pills to get the finished product.
[0237] Include the following steps:
[0238] ① Prepare the following raw materials: Ginkgo biloba extract, excipients and other medicinal and inactive components;
[0239] ②Mix the above raw and auxiliary materials evenly;
[0240] ③Heat the chemical material, move it into the drip irrigation of the dripping pill machine, drop the medicinal liquid into the low-temperature liquid paraffin through the dripper,...
Embodiment 2
[0243] The mensuration of residual sherwood oil in the ginkgo biloba dripping pill of embodiment 2
[0244] Step 1 Prepare the solution:
[0245] Solvent: N, N-dimethylformamide (DMF);
[0246] Need testing solution: take about 4g of Ginkgo biloba dripping pills need testing, accurately weighed, put in 20ml measuring bottle, add solvent to dissolve and dilute to the scale, shake up;
[0247] Reference substance solution: Take about 96mg of n-hexane, weigh it accurately, put it in a 100ml measuring bottle, dilute to the mark with a solvent, shake well, take 5ml accurately, put it in a 200ml measuring bottle, dilute to the mark with a solvent, and shake evenly;
[0248] Petroleum ether solution: Take about 96mg of petroleum ether, weigh it accurately, put it in a 100ml measuring bottle, dilute to the mark with solvent, shake well, take 5ml precisely, put it in a 200ml measuring bottle, dilute to the mark with solvent, and shake well;
[0249] Petroleum ether positioning soluti...
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Abstract
The invention relates to a method for detecting residual petroleum ether in folium ginkgo dropping pills. The method comprises the steps that step 1, solution preparation, using DMF as solvents to prepare following solutions: test solutions, reference solutions, petroleum ether solutions, petroleum ether positioning solutions and positioning solutions; step 2, precisely measuring out the DMF, thetest solutions and the petroleum ether positioning solutions, injecting 5ml of the positioning solutions and the reference solutions respectively through headspace injection into a gas chromatograph,recording chromatogram, calculating peak areas according to chromatographic peaks, and calculating the content of 7 main components of the petroleum ether through an external standard method by takingnormal hexane as reference substances. The method can be used for controlling the product quality of the folium ginkgo dropping pills and improving medication safety for patients.
Description
technical field [0001] The invention relates to a detection method of a traditional Chinese medicine preparation, in particular to a detection method of residual petroleum ether in the traditional Chinese medicine preparation Ginkgo biloba dripping pills. Background technique [0002] Ginkgo biloba is the leaf of Ginkgo biloba L. Contains flavonoids (about 20 kinds), terpenoids, phenols, beneficial trace elements and 17 kinds of amino acids and other active ingredients, which can reduce serum cholesterol, increase coronary blood flow, improve blood circulation, relieve smooth muscle spasm, relax bronchi and Antibacterial and other pharmacological effects. Clinically, it is not only used in the treatment of cardiovascular and cerebrovascular diseases, but also has good effects on the nervous system and respiratory system. Scientists such as France and Germany have confirmed that Ginkgo biloba extract has significant curative effects in the treatment of cerebral ischemia, se...
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