L—malic acidIt is a form that can be used by organisms. It is often combined withamino acidInjection (an important nutritional drug after surgery) to improve the utilization rate of amino acidsLiver dysfunctionPatients are particularly important.L—Potassium malateIt is a good potassium supplement, which can keep the body'swater balance, treatment of edemahypertensionAnd fat accumulation.L-Malic acid is a treatmenthepatopathy, especially caused by liver dysfunctionHyperammonemiaGood medicine.L—Sodium malateIt has 1/3 salty taste of salt and can be used as a substitute for salt for kidney patients.
L-malic acid is used in food, medicine, daily chemical industry and other sectors as follows: (1)food industry: It is used for processing and preparing drinks, liqueur, fruit juice, and also forcandy、JamIt has antibacterial and antiseptic effects on food.Can also be used forYoghurtfermentationPHAdjustment,Wine makingMiddle divisionTartrateEtc.(2) Tobacco industry: Malic acid derivatives (such as esters) can improve the aroma of tobacco.（3）Pharmaceutical industry: Various tablets and syrups can be mixed with malic acid to form a fruit flavor, which is conducive to absorption and diffusion in the body.(4) Daily chemical industry: goodcomplexing agent, ester agent, used in toothpaste formulaDental filmCooperationSynthetic perfumeIt can also be used as an ingredient of deodorant and detergent.
Specific curlTake this product, weigh it precisely, add water to dissolve it and dilute it quantitatively to make a solution containing 0.085g per 1ml, and measure it according to the law (Appendix VI E, Volume II, Chinese Pharmacopoeia, 2010 Edition). The specific rotation is - 1.6 ° - 2.6 °.
[Identification] (1)Take about 0.5g of this product, add 10ml of water to dissolve it, and useammoniaAdjust pH value to neutral, add 1%P-aminobenzenesulfonic acid1ml solution, heated in boiling water bath for 5 minutes, 20% addedSodium nitrite5ml solution, placewater bathMedium heating for 3 minutes, add 4%sodium hydroxide5ml of solution, the solution should be red immediately.
(2) Of this productinfrared lightThe absorption spectrum should be consistent with the spectrum of L-malic acid reference substance (Appendix IVC of Chinese Pharmacopoeia, Volume II, 2010 Edition)
chemical property
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Paul Walden discoveredConfiguration inversionThe compound used is malic acid.another usePhosphorus trichloride(+) - chloromalic acid was obtained by treating (-) - malic acid in ether, and thenSilver hydroxide(Newly madeSilver oxide）(+) - malic acid was obtained by treatment;Similarly, he found that (-) - chloromalic acid can also be obtained by treating (+) - malic acid with phosphorus trichloride, and (-) - malic acid can be obtained by treating it with silver hydroxide.From then on, he found an experimental method for configuration reversal of malic acid.
Related substancesIt shall be determined by high performance liquid chromatography (Appendix V D, Volume II, Chinese Pharmacopoeia, 2010 Edition).
Chromatographic conditions and system suitability testUse sulfonated cation exchange resin toFillerWith 0.005mol/Lsulphuric acidThe solution ismobile phase；The detection wavelength is 210nm;The column temperature is 37 ℃;takeFumaric acid、Maleic acid、L-malic acidReference substanceAppropriate amount, dissolved in mobile phase and diluted to produce fumaric acid 10% per 1mlμg, Maleic acid 4 μ g, malic acid 1mg solution, as system suitability solution, accurately measure 20 μ l, and injectLiquid chromatograph，Theoretical plate numberCalculated as malic acid, it is not less than 2000, and the peak value of fumaric acid, maleic acid and L-malic acidResolutionAll shall comply with the regulations.
Determination method Take an appropriate amount of this product, weigh it precisely, add mobile phase to dissolve and dilute it to make a solution containing about 1mg per 1m asTest solution；In addition, take appropriate amount of fumaric acid and maleic acid reference substance, weigh precisely, dissolve and dilute with mobile phase to prepare a solution containing 5 μ g fumaric acid and 2 μ g maleic acid per 1ml as the reference solution.Precisely measure 20 μ l of each of the above two solutions for injectionLiquid chromatograph, recordChromatogramTo main peakretention time 4.5 times.If there is a peak in the chromatogram of the test solution that is consistent with the retention time of fumaric acid and maleic acid peak, pressExternal standard methodwithpeak areaCalculated, the content shall not exceed 1.0% and 0.05% respectively.The peak area of other single impurities shall not exceed 0.5 times (0.1%) of the peak area of maleic acid in the reference solution;The total amount of other impurities shall not exceed 2.5 times (0.5%) of the peak area of maleic acid in the reference solution.
Clarity of solutionTake 5.0g of this product, add 25ml of water, shake fully to dissolve it, and the solution should be clear (Appendix IX B, Volume II, Chinese Pharmacopoeia, 2010 Edition).
water contentTake some of this product and measure it according to the moisture determination method (Appendix Ⅷ M, Part II, Chinese Pharmacopoeia, 2010 Edition). The moisture content should not exceed 2.0%.
Insoluble matter in waterTake 25.0g of this product, add 100ml of water to dissolve it, and vertically melt it with No. 4 with constant weight at 100 ℃crucibleFilter and wash repeatedly with hot waterFilterAfter drying at 100 ℃ to constant weight, the residual residue shall not exceed 0.1%.
Easy oxideTake 0.10g of this product and place 100mlEvaporation panAdd 25ml of water and 25ml of sulfuric acid (1 → 20) to dissolve and shake up, and place at 20 ± 1 ℃water bathIntermediate cooling, add 0.02mol/Lpotassium permanganateTitrant5ml, the color of the solution should not disappear within 3 minutes.
chlorideTake 1.0g of this product and check it according to the law (Appendix VIII A, Part II, Chinese Pharmacopoeia, 2010 Edition), andStandard sodium chloride solutionThe control solution made of 5.0ml shall not be more concentrated (0.005%).
sulfateTake 1.0g of this product and check it according to law (Appendix Ⅷ B, Part II, Chinese Pharmacopoeia, 2010 Edition), andStandard potassium sulfate solutionThe 3.0ml control solution shall not be more concentrated (0.03%).
ArseniteTake 1.0g of this product and addhydrochloric acid5ml and 23ml of water, according to the law (the first method in Appendix VIII J of Chinese Pharmacopoeia, Part II, 2010 Edition), should meet the requirements (0.0002%).
Ignition residueNot more than 0.1% (Appendix Ⅷ N of Chinese Pharmacopoeia, Volume II, 2010 Edition).
heavy metalTake 1.0g of this product, addsodium hydroxideTest solutionDissolve 5ml and 20ml of water, and check according to the law (the third method in Appendix VIII H of Chinese Pharmacopoeia, Volume II, 2010 Edition). The content of heavy metals shall not exceed 20 parts per million.
[Content determination]Take about 1.5g of this product, precisely weigh it, and place it in 250mlMeasuring flaskMedium, add water to dissolve and dilute to the scale, shake well, measure 25ml accurately, placeConical flaskMedium, plusPhenolphthalein2 drops of indicator solution, titrate with sodium hydroxide titrant (0.1mol/L) to a reddish color and keep it for 30 seconds without fading.Every 1ml of sodium hydroxide titrant (0.1mol/L) is equivalent to 6.704mgC4H6O5。
