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CN-122005744-A - Quality marker for preventing and treating kidney-yang deficiency by using medicinal and edible formula composition, and preparation method and application thereof

CN122005744ACN 122005744 ACN122005744 ACN 122005744ACN-122005744-A

Abstract

The invention relates to the technical field of traditional Chinese medicine research, in particular to a quality marker for preventing and treating kidney-yang deficiency by a medicinal and edible formula composition, and a preparation method and application thereof. The medicinal and edible formula composition comprises, by weight, 1-2 parts of cinnamon, 6-8 parts of momordica grosvenori, 2-4 parts of dried orange peel, 2-4 parts of dried ginger, 8-10 parts of ginseng, 29-31 parts of astragalus mongholicus, 4-6 parts of honey-fried licorice root and 14-16 parts of poria cocos, wherein the mass markers comprise [6] -shogaol, 3,5,6,7,8,3',4' -heptamethoxyflavone, 1-dehydro- [8] -gingenedione, 6-methyl Jiang Erchun, nobiletin, eupatorium Luo Lilin and the like. The ginseng middle-jiao nang is reasonably modified, is applied to the prevention and treatment of kidney-yang deficiency syndrome, and endows a new application prospect to classical prescriptions. Meanwhile, based on the 'spectrum-effect' correlation study, the quality marker group correlated with the kidney-yang deficiency efficacy is screened and established for the first time, which is beneficial to realizing the science, the accuracy, the stability and the controllability of the product quality of the medicinal and edible formula composition.

Inventors

  • LAI KEDAO
  • ZHOU HUANHUAN
  • LU GUOSHOU
  • ZHANG YING
  • CHEN FENG
  • ZHANG BINBIN
  • HU XIAOXI
  • LUO JINRONG
  • WEI
  • HUANG ZHOUFENG

Assignees

  • 广西壮族自治区中医药研究院

Dates

Publication Date
20260512
Application Date
20260413

Claims (8)

  1. 1. A medicinal and edible formula composition for preventing and treating kidney yang deficiency is characterized by comprising, by weight, 1-2 parts of cinnamon, 6-8 parts of Momordica grosvenori, 2-4 parts of dried orange peel, 2-4 parts of dried ginger, 8-10 parts of ginseng, 29-31 parts of astragalus membranaceus, 4-6 parts of honey-fried licorice root and 14-16 parts of poria cocos, wherein the medicinal and edible formula composition comprises [6] -shogaol, 3,5,6,7,8,3',4' -heptamethoxyflavone, 1-dehydro- [8] -gingenedione, 6-methyl Jiang Erchun, nobiletin, petiolus Luo Lilin, 1- (3, 4-dimethoxyphenyl) -5-hydroxydecane-3-one, dihydro- [6] -gingerol, isoliquiritigenin, 3-hydroxy-9, 10-dimethoxypterocarpan, astragalus isoflavane, hesperetin, naringenin, glycyrrhizin P, glycyrrhizin R, glycyrrhizin, lanetin, 8-gingerol and 8-dehydrogingerol.
  2. 2. A method for preparing a quality marker for preventing and treating kidney-yang deficiency by using the pharmaceutical and food homologous formula composition according to claim 1, comprising the following steps: (1) Decocting the raw materials in water for 2-3 times (each for 1-2 hr), and concentrating to obtain concentrated solution; (2) Separating the concentrated solution with macroporous resin column, washing with water until the eluate is nearly colorless, gradient eluting with 25-35%, 45-55% and 70-80% ethanol-water solution, and collecting ethanol eluates with different concentrations; (3) And (3) performing component identification on the eluent obtained in the step (2) by a high-resolution liquid chromatography-mass spectrometry method, combining eluates capable of identifying 20 chemical components of [6] -shogaol, 3,5,6,7,8,3',4' -heptamethoxyflavone, 1-dehydro- [8] -gingerol, 6-methyl Jiang Erchun, nobiletin, peter Luo Lilin, 1- (3, 4-dimethoxy phenyl) -5-hydroxydecane-3-one, dihydro- [6] -gingerol, isotrefoil aglycone, isoliquiritigenin, 3-hydroxy-9, 10-dimethoxy pterocarpan, astragalus isoflavan, hesperetin, naringenin, glycyrrhizic acid P, glycyrrhizic acid R, glycyrrhizin, pinocembrin, cassitin and 8-dehydrogingerol, concentrating and drying to obtain the quality marker for preventing and treating kidney yang deficiency.
  3. 3. The method for preparing the quality marker for preventing and treating kidney-yang deficiency by using the pharmaceutical and edible formula composition according to claim 2, wherein in the step (3), 100 mu L of eluent is taken, placed in a 1.5 mL centrifuge tube, 300 mu L of methanol is added, vortex mixing is carried out for 1: 1min, centrifugation is carried out for 5-10: 10 min under the conditions of 4 ℃ and 12000: 12000 rpm, 100 mu L of solution is taken, 100 mu L of ultrapure water is added, and after mixing, the mixture is placed in a sample injection bottle, and the sample is to be tested.
  4. 4. The method for preparing the quality marker for preventing and treating kidney-yang deficiency by using the pharmaceutical and edible formula composition according to claim 2, wherein in the step (3), chromatographic conditions are ACQUITY UPLC HSS T chromatographic columns, chromatographic column temperature is 40 ℃, sample injection amount is 5.0-8.0 mu L, flow rate is 0.3 mL/min, and mobile phase consists of phase A, water+0.1% formic acid and phase B, acetonitrile; The elution gradient of the chromatographic column is: 0-1min, and the volume fraction of the phase B is 2%; 1-14min, wherein the volume fraction of the phase B is 2-30%; 14-25min, and the volume fraction of the phase B is 30-100%; 25-28min, wherein the volume fraction of the phase B is 100%; 28-28.1min, and the volume fraction of the phase B is 100-2%; 28.1-29.5min, and the volume fraction of the B phase is 2%.
  5. 5. The preparation method of the medicine and food homologous formula composition for preventing and treating kidney yang deficiency effect according to claim 2 is characterized in that mass spectrum conditions are that ion source voltages of positive ions and negative ions are 3.7 kV and 3.5 kV respectively, capillary heating temperature is 320 ℃, sheath gas pressure is 30 psi, auxiliary gas pressure is 10 psi, solvent heating evaporation temperature is 300 ℃, sheath gas and auxiliary gas are nitrogen, collision gas is nitrogen, pressure is 1.5 mTorr, data are collected by using a Full scan/dd-MS 2 mode, full scan parameters are 1X 10 6 , maximum isolation time is 50 MS, mass-to-charge ratio scanning range is 100-1500, dd-MS 2 parameters are 1X 10 5 , and maximum isolation time is 50 MS.
  6. 6. The method for preparing a quality marker for preventing and treating kidney-yang deficiency by using a pharmaceutical and food homologous formula composition according to claim 2, wherein in the step (2), the composition is eluted by gradient of 30%, 50% and 75% ethanol-water solution respectively.
  7. 7. A method for analyzing quality markers of the effects of preventing and treating kidney-yang deficiency of a pharmaceutical and food homologous formula composition according to claim 1, comprising the steps of: S1, analyzing a medicinal and edible formula composition by using a pharmacological database and an analysis platform of a traditional Chinese medicine system to obtain effective components, sequentially importing the effective components into a SwissTargetPrediction database, and screening effective targets of the medicinal and edible formula composition by taking Probability >0.1 as screening conditions; S2, using GENECARDS database with ' kidney function ', endocrine disorder, metabolic sydrome ' as search key word to obtain relevant kidney-yang deficiency related disease target, using Venn drawing pharmaceutical and food homologous formula composition effective component target and Venn diagram of kidney-yang deficiency related target, obtaining intersection target which is target gene of pharmaceutical and food homologous formula composition effective component on kidney-yang deficiency disease; s3, uploading the combined action target genes obtained by the medicines and the diseases to a STRING database to draw a PPI network diagram, and performing topology parameter analysis in Cytoscape 3.10.10 software to obtain a traditional Chinese medicine-component-disease-target interaction network diagram of the medicine-food homologous formula composition and the kidney-yang deficiency related diseases, and obtaining the 20 active ingredients in the top ranking; S4, analyzing the collected combined action gene targets by utilizing DAVAD databases, carrying out enrichment analysis on GO functions and KEGG signal paths by using P <0.05, and selecting data which are ranked at the front to draw pictures on a microbial communication platform for visual analysis.
  8. 8. The use of a quality marker for preventing and treating kidney-yang deficiency of a pharmaceutical and food homologous formula composition according to claim 1 in the preparation of a medicament for preventing and treating kidney-yang deficiency.

Description

Quality marker for preventing and treating kidney-yang deficiency by using medicinal and edible formula composition, and preparation method and application thereof Technical Field The invention relates to the technical field of traditional Chinese medicine research, in particular to a quality marker for preventing and treating kidney-yang deficiency by a medicinal and edible formula composition, and a preparation method and application thereof. Background The kidney-yang deficiency syndrome is one of the common symptoms of traditional Chinese medicine, and clinically manifests as soreness and weakness of waist and knees, aversion to cold, cold limbs, listlessness, sexual hypofunction, clear urine and the like. The modern life rhythm is accelerated, the pressure is increased, the prevalence rate of kidney-yang deficiency syndrome is increased due to bad life habit, and the life quality is seriously affected. At present, aiming at the prevention and treatment of kidney-yang deficiency, western medicine mainly adopts hormone replacement therapy, but has certain side effects and risks in long-term application. The traditional Chinese medicine accumulates abundant experience in preventing and treating kidney-yang deficiency, wherein the warming and tonifying kidney-yang is a fundamental treatment method, and classical prescriptions such as the Jinkui kidney-qi pill, the Yougui pill and the like are widely applied, and the curative effect is definite. The ginseng middle-jiao regulating decoction is derived from a traditional Chinese medicine decoction of Ji Zao Liu Zhi Ding (Ji Zu Ding Fang) from the external table, mainly comprises ginseng, dried ginger, liquorice, poria cocos, cinnamon, orange peel, astragalus root and the like, has the core effects of warming middle-jiao to dispel cold, tonifying qi and strengthening spleen, and is mainly used for mainly treating umbilicus building symptoms caused by cholera hole leakage and kidney qi deficiency. The theory of traditional Chinese medicine holds that the spleen is the acquired root and the kidney is the congenital root, and the spleen and the kidney are mutually physiological and pathological influences. Spleen yang deficiency may involve kidney yang for a long time, and conversely, warming and invigorating kidney yang also helps to invigorate spleen yang. Therefore, based on the theory of 'tonifying fire and activating soil' and 'banking up earth and producing water', the representative prescription of Shang Zheyi in ginseng for warming middle-jiao and strengthening spleen is subjected to parallelization and cutting, is applied to the prevention and treatment of spleen-kidney yang deficiency syndrome, in particular kidney-yang deficiency syndrome, has theoretical basis and expansion potential, and has good application prospect. The traditional Chinese medicine prescription is developed into a medicine and food homologous product which is suitable for modern people and has definite quality standard and efficacy substance basis, and a plurality of challenges are faced, namely, quality markers (Q-markers) are not definite, the quality control of the traditional Chinese medicine prescription for the ginseng decoction in middle-jiao is mostly limited to the content measurement of individual index components (such as ginsenoside and glycyrrhizic acid) in single medicine, and the comprehensive quality Marker group which can integrally reflect the efficacy characteristics of the compound' warming and tonifying spleen and kidney (especially kidney yang) is lacking. This results in product quality uniformity, stability and efficacy correlation being difficult to guarantee scientifically, restricting industrialization and modernization development thereof. The medicinal and edible suitability is insufficient, the taste of the traditional decoction is poor, and the acceptance of the traditional decoction as a daily product can be influenced by direct application. The formulation needs to be scientifically optimized for the 'homology of medicine and food' attribute, and the palatability is improved while the core efficacy is maintained. Although the ginseng decoction is supported by the traditional Chinese medicine theory for treating kidney-yang deficiency, modern pharmacological researches of the system are lack to clarify the specific action mechanism of the ginseng decoction, and spectrum-effect correlation evidence between key quality markers and the efficacy of preventing and treating kidney-yang deficiency. Therefore, the core quality marker for preventing and treating kidney-yang deficiency is determined by rationalizing and matching according to the standard of the homology of medicine and food catalogue based on the theory and the compatibility essence of the classical formula ginseng decoction, and finally the homology of medicine and food formula composition with reliable quality and definite efficacy is formed. Disclosure of Invention Aiming at the defects, th