CN114460245A - Kaixisan quality marker group - Google Patents
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Abstract
The invention discloses a quality marker group for yippee powder, which comprises the following components: sibiricose A5, sibiricose A6, and cortex et radix Polygalae
Ketone III, 3,6' -disinapoyl sucrose, tenuifolin A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone. The invention also discloses application of the composition in preparing a medicament for treating the Alzheimer disease by equivalently replacing the kaixiong powder, wherein the components of the composition are the same as those of the quality marker group of the kaixiong powder, and the content proportion of each component is the same as that of the component in the kaixiong powder. The invention analyzes the yippee powder from the five aspects of 'transmission and traceability, uniqueness, effectiveness, testability and compound compatibility environment'; finally, the quality marker group of the yippee san is determined.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a quality marker group of yippee powder.
Background
The traditional Chinese medicine and the preparation thereof are a multi-component complex system, and the unclear basis of the drug effect substance becomes the bottleneck of the development process of the traditional Chinese medicine and the problem to be solved urgently. In recent years, with the rapid development of analysis technology and the cross fusion of various disciplines, the basic research level of the drug effect substances of the traditional Chinese medicine has all-round progress: from the measurement of a single index component to the measurement of multiple index components based on a fingerprint, from the content measurement based on a reference substance to the measurement of multiple scores and other methods, from the qualitative and quantitative quality control mode of the index components of the chemical drugs constructed in isolation to Liuchangxiaoling academy, Chinese medicine quality markers (Q-markers) ("Liuchangxiao"), Vaseline, Xiaoxiaohe, and the like which not only reflect the essential characteristics of the Chinese medicine for treating diseases, but also have specificity and pertinence are provided for the Liuchangxiao academy: chinese herbal medicine, 2016, 47 (9): 1443-.
The quality Marker of traditional Chinese medicine is a concept with integration and openness, is related to effectiveness and safety, is a chemical substance which is inherent in traditional Chinese medicines and traditional Chinese medicine products (such as traditional Chinese medicine decoction pieces, traditional Chinese medicine decoction, traditional Chinese medicine extracts and Chinese patent medicine preparations) or is formed in the processing and preparation process and is closely related to the functional attributes of the traditional Chinese medicines, and is a marking substance reflecting the safety and the effectiveness of the traditional Chinese medicines [ Zhenglei honor, peace, will, Liutao and Xuyu Ling ]. 2566, 2574). Through the research on the Chinese medicine quality markers, labeled substances capable of reflecting the safety, effectiveness and specificity of the Chinese medicine compound can be effectively found out, and a quality standard capable of reflecting the quality characteristics of the Chinese medicine compound is established.
The classic famous prescription, Kaixiyuan, was recorded at the earliest in the Stazest Qianjin Yao (prescription of Beiji Qianjin) by Sun Simiao, a medical scientist in Tang Dynasty. The yippee powder is prepared from four traditional Chinese medicines of ginseng, polygala root, calamus and tuckahoe, the prescription is simple and powerful, the formula is analyzed according to the basic theory of the traditional Chinese medicine, and the ginseng in the prescription can greatly tonify vitality, calm the nerves and benefit intelligence; poria has effects in invigorating spleen, calming heart, promoting diuresis, and eliminating dampness; the rhizoma acori graminei can resolve phlegm, induce resuscitation and refresh the mind; polygala root, radix polygalae, rhizoma acori graminei, poria cocos, fructus phyllanthi, polygala tenuifolia, rhizoma acori graminei, rhizoma atractylodis, radix polygalae, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, radix polygalae, rhizoma polygonati, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, radix polygalae, rhizoma polygonati, rhizoma pinellicis, radix polygalae, rhizoma pinelliae, and radix polygalae. Modern researches show that the yixin san has various pharmacological activities, has the effects of resisting dementia, improving learning and memory, resisting oxidation, depression, aging, fatigue, promoting nerve cell differentiation and regeneration and the like, and has obvious curative effects on diseases such as senile dementia, depression, anxiety and the like [ Wangxianxia, Jiangning, Lujing Wei, Liusi, Liuxin people, yinxian, Kaixian, Kaixuan, the action of resisting depression, improving learning and memory and the mechanism research progress [ J ] Chinese herbal medicines 2020,51(14): 3802-. At present, the pharmacological action of the yippee san is more researched, but substances exerting the pharmacological action are not clear, and the quality marker prediction research of the yippee san is blank.
Disclosure of Invention
Based on the technical problems in the background art, the invention provides a quality marker group for yingsan, which is analyzed in the aspects of five elements, namely 'transmission and traceability, uniqueness, effectiveness, testability and compound compatibility environment'; finally, the quality marker group of the yippee san is determined, and the quality control based on the pharmacodynamic ingredients is realized.
Because the components in the classic famous prescription, namely 'Kaixixiwan', are numerous, a plurality of components need to be analyzed so as to determine the quality marker group for treating the Alzheimer disease by the classic famous prescription, namely 'Kaixiwan'. The specific analysis comprises the following steps:
s1, collecting all known chemical components contained in the traditional Chinese medicines in the Kaixuan medicine through a database;
s2, collecting action targets of all known chemical components obtained by S1 through a database;
s3, searching targets of the Xinnao powder drug effect corresponding to the Alzheimer disease through a database;
s4, comparing the action target point obtained from S2 with the target point obtained from S3, and reserving a common target point;
s5, collecting all known chemical components entering the blood in the distraction through a database;
s6, comparing all the known chemical components obtained in the S1 with all the known chemical components obtained in the S5, and reserving common components;
s7, reserving a chemical component group acting on the S4 common target point in the S6 common component;
s8, determining whether the chemical component group obtained in S7 exists in the kaixin powder, and using the chemical component group which exists in the kaixin powder as a quality marker group of the kaixin powder.
The database may be CAS, Informix, Microsoft SQL Server, etc.
Finally, the invention provides a quality marker group of yippee san, which comprises the following components: sibiricose A5, sibiricose A6, and radix Polygalae
Ketone III, 3,6' -dibapigenin sucrose, senegaside A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone.
Preferably, the quality marker group is a quality marker group for treating alzheimer disease by yingxin san.
Preferably, the content ratio of each component is the same as that of the kaixing powder.
The invention also provides the application of the composition in preparing the medicament for treating the Alzheimer disease by equivalently replacing the kaixiong powder, the components of the composition are the same as those of the quality marker group of the kaixiong powder, and the content proportion of each component is the same as that of the kaixiong powder.
The yippee san was analyzed from "specificity":
ginseng radix is dried root and rhizome of Panax ginseng C.A.Mey. of Araliaceae (Araliaceae). Related documents show that ginseng mainly contains saponins, polysaccharides and volatile oil components, and also contains chemical components such as proteins, polypeptides, vitamins, organic acids, trace elements and the like. Saponins are widely considered as the most main bioactive components of ginseng, polysaccharides are the main active components of ginseng (Zhai soldiers, Xueyu, Huwenli, etc.. production, bioactive components and application status of ginseng adventitious roots J. food safety quality inspection, 2021,12(15): 6097-.
Poria cocos is a dry sclerotium of Wolf sclerotium of Poria cocos (Schw.) belonging to Polyporaceae, is listed as the superior product by Shen nong's herbal Jing, and mainly contains chemical components such as polysaccharides, triterpenes, steroids, volatile oils, proteins, amino acids, trace elements, and the like [ Du Xiao Yan, Wujiao, Poria cocos, research on chemical components and pharmacological action progress [ J ] proceedings of New rural college of medicine, 2021,38(05):496 + 500 ]. Polysaccharides and triterpenes are main effective components, have various pharmacological actions and are relatively characterized.
Cortex et radix Polygalae is dried root of Polygala tenuifolia Willd or Polygala sibirica L of Polygalaceae, and contains triterpenoid saponins, sugar and glycoside esters, flavonoids, alkaloids, etc. The triterpene saponins, the xanthones and the oligosaccharide esters are the main chemical components [ Wangweiyu, Liu Xin, Zhou Jia Li, and the like ] the research progress of the chemical components and the pharmacological action of the traditional Chinese medicine polygala tenuifolia and the prediction analysis of potential quality markers [ J ] the journal of international pharmaceutical research 2020,47(07):483-495+513 ], and have characteristics.
Acorus gramineus soland is the dried rhizome of Acortw tatarinowii Schott of Araceae, contains volatile oil, organic acid, flavonoid, terpenoid and other chemical components, and the volatile oil is the main active ingredient [ Zhuping, Liu Xiao Shuan, Wang hong Li, etc. ] the comparative research progress of three acorus calamus [ J ] Chinese national folk medicine, 2021,30(02):59-62 ], wherein the content of alpha-asarone and beta-asarone is higher and has more characteristics.
Analysis of the yippee powder from "effectiveness":
the effectiveness of the controlled traditional Chinese medicine is a key factor for determining the quality marker. The two pairs of drugs, ginseng and polygala tenuifolia, poria cocos and acorus gramineus, have a synergistic effect in stimulating the differentiation of neurons. In the formula, the ginseng can tonify primordial qi, soothe the nerves and benefit intelligence; poria has effects in invigorating spleen, calming heart, promoting diuresis, and eliminating dampness; the rhizoma acori graminei can resolve phlegm, induce resuscitation and refresh the mind; polygala root, radix polygalae, rhizoma acori graminei, poria cocos, fructus phyllanthi, polygala tenuifolia, rhizoma acori graminei, rhizoma atractylodis, radix polygalae, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, radix polygalae, rhizoma polygonati, rhizoma atractylodis, rhizoma polygonati, rhizoma atractylodis, radix polygalae, rhizoma polygonati, rhizoma pinellicis, radix polygalae, rhizoma pinelliae, and radix polygalae. Relevant researches show that the yippee powder can reduce brain tissue neuron necrosis and promote degradation of Abeta in PC12 cells by regulating the unbalanced state of monoamine neurotransmitter content, so that behavioral and mental symptoms of AD model mice are improved, and the yippee powder has good anti-AD effect.
Yippee san from testability analysis
The total amount of ginsenoside Rg1 and Re in Ginseng radix is not less than 0.27% and the total amount of ginsenoside Rb1 is not less than 0.18% specified in the Chinese pharmacopoeia 2020 edition; the total amount of tenuifolin in cortex et radix Polygalae should not be less than 2.0%, the total amount of xanthone III should not be less than 0.15%, and the total amount of 6' -digapinyl sucrose should not be less than 0.50%; the content of volatile oil in rhizoma Acori Graminei should not be less than 1.0% (mL/g) [ national pharmacopoeia Committee, pharmacopoeia of the people' S republic of China ]. Beijing, Chinese pharmaceutical science and technology Press, 2020 ]. HPLC profile studies of the kakkonensis serum from rats showed 24 blood-entering components, 14 of which were prototype components, 10 were metabolites, 15 peaks were derived from polygala tenuifolia, 7 peaks were derived from acorus gramineus, 2 peaks were derived from polygala tenuifolia and acorus gramineus, wherein the prototype components were sibiricose a5 derived from polygala tenuifolia, sibiricose a6, polygalanone iii and 3,6' -dimonoylsucrose and β -asarone derived from acorus gramineus.
Analysis of yippee powder from' Compound compatibility Environment
The prescription is simple and powerful, the formula is analyzed according to the basic theory of the traditional Chinese medicine, and the monarch drug is polygala tenuifolia, so that the effects of calming heart and tranquilizing mind, coordinating heart and kidney, eliminating phlegm and inducing resuscitation are achieved; the ministerial drug is ginseng, which greatly supplements vigor, promotes the production of body fluid, nourishes blood, soothes nerves and benefits intelligence; poria is added as an auxiliary material, so as to promote diuresis and eliminate dampness, invigorate spleen and calm heart; assisting with rhizoma acori graminei, inducing resuscitation and reducing phlegm, inducing resuscitation and improving intelligence [ Wangwei ], basic research on preparation of Chinese herbal compound Kaixinsan and Clary injection [ D ]. Beijing, university of cooperative medical science, 2010 ]; polygala root can be combined with acorus gramineus to enhance the effects of resolving phlegm and inducing resuscitation, and also can be combined with poria cocos to enhance the effect of communicating heart and kidney [ Jianwenxuan, Zhaozhao, Kaixinyao and Buyi in research progress of tonifying effect [ J ]. Neuropharmacology report, 2018,8(06):38 ].
The invention has the advantages that:
the quality marker group of the yingsan is analyzed in the aspects of five elements, namely 'transmission and traceability, uniqueness, effectiveness, testability and compound compatibility environment'; finally, the quality marker group of the yippee powder is determined, and the components of the quality marker group comprise: sibiricose A5, sibiricose A6, and radix Polygalae
Ketone III, 3,6' -dibapigenin sucrose, senegaside A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone. The components can be used as quality markers of the yixinsan for treating the Alzheimer disease for quality control, and the quality control based on the drug effect components is realized. And the quality marker group can be used for preparing a pharmaceutical composition for replacing the kaixiong powder and treating the Alzheimer disease.
Drawings
FIG. 1 is a super high liquid chromatogram of KAIXIN powder, wherein 1 is sibiricose A5, 2 is sibiricose A6, and 3 is cortex et radix Polygalae
Ketone III, 4 is 3,6' -dibapinyl sucrose, 5 is tenuifolin A, 6 is ginsenoside Rg1, 7 is ginsenoside Re, 8 is beta-asarone, and 9 is alpha-asarone.
Detailed Description
The technical solution of the present invention will be described in detail below with reference to specific examples.
Example 1
A quality marker group of yikaixing for treating Alzheimer disease comprises the following components: sibiricose A5, sibiricose A6, and radix Polygalae
Ketone III, 3,6' -dibapigenin sucrose, senegaside A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone.
The quality marker group of the yixinsan is obtained by analyzing the following steps:
s1, from the perspective of 'transmission and traceability, testability and uniqueness', all known chemical components contained in four Chinese medicinal materials in Xinxinsan are collected from CAS, Informix and Microsoft SQL Server databases, and 77 chemical components are identified in total, wherein the chemical components comprise 26 saponins, 13 triterpenic acids, 20 oligosaccharide esters and 5 oligosaccharide esters
Ketones and 13 other classes of ingredients; 25 of polygala tenuifolia, mainly oligosaccharide esters and
a ketone compound; 28 Ginseng radix extracts, mainly containing saponins; 17 are derived from Poria cocos, mainly triterpenic acids; 5 are derived from calamus and mainly are other compounds; analyzing chemical components of the rhizoma acori graminei by GC-MS according to literature records to obtain 56 volatile components, wherein the main characteristic components comprise beta-asarone, gamma-asarone, ether methyl eugenol and cis-methyl isoeugenol, the specific components in water are 41, the specific components in oil are 4, and the total components in oil and water are 11;
s2, from the perspective of 'transfer and tracing, testability, effectiveness, compound compatibility environment', constructing a 'component-target-path' network model based on network pharmacology, and collecting action targets of all known chemical components obtained from a CAS, an Informix and a Microsoft SQL Server database S1; obtaining 47 active chemical components from the yixinsan, and screening to obtain 443 potential drug targets;
s3, starting from the perspective of 'transfer and traceability, testability, effectiveness and compound compatibility environment', and collecting targets of the Xin san drug effect corresponding to the Alzheimer disease from the databases of CAS, Informix and Microsoft SQL Server based on the network pharmacology research mode of 'active ingredient-target-path';
s4, comparing the action target point obtained from S2 with the target point obtained from S3, and reserving a common target point; the potential 25 medicinal active ingredients in the Kaixuan powder are found, wherein the ginsenoside which is the main ingredient of ginseng can improve the depression behavior of rats caused by chronic stress, the prescription can mainly exert curative effect through ginseng, and saponins in the prescription can be the main ingredient for exerting curative effect;
s5, from the perspective of "delivery and traceability, testability, specificity", the discovery of all known chemical components entering the blood in the distraction from CAS, Informix, Microsoft SQL Server database: liuyang, etc. utilizes serum HPLC characteristic fingerprint spectrum to analyze and identify blood-entering components in the Kaixuan powder body, 24 blood-entering components appear in the medicine-containing serum, 14 components are external components and are directly inserted into the blood, and comprise siberian polygala tenuifolia saccharides in polygala tenuifolia,
Ketones, oligosaccharide esters and 3,6' -erucyl sucrose as well as β -asarone from Acorus tatarinowii, the other 10 being nascent metabolites. The serum medicinal chemistry research shows that the blood-entering components of the prototype polygala tenuifolia mainly comprise oligosaccharide esters and polygala tenuifolia saponins. Liu Ji Wei and the like found 6 tenuigenin prototypes and 3 tenuigenin metabolites in blood when studying components migrating in blood in yingxin san. The research of the drug-containing serum of Kaoxing powder of rats such as Bayin Yingying and the like shows 24 blood-entering components, wherein 14 of the blood-entering components are prototype components, 10 are metabolites, 15 peaks are derived from polygala tenuifolia, 7 peaks are derived from acorus gramineus, and 2 peaks are derived from polygala tenuifolia and acorus gramineus, wherein the prototype components comprise siberian polygalactose A5 derived from polygala tenuifolia, siberian polygalactose A6, polygalanone III, 3,6' -dibapinyl sucrose and beta-asarone derived from acorus gramineus;
s6, comparing all the known chemical components obtained in the S1 with all the known chemical components obtained in the S5, and reserving common components;
s7, reserving a chemical component group acting on the S4 common target point in the S6 common component; finally, 9 ingredients are determined, and the ingredients comprise: sibiricose A5, sibiricose A6, and radix Polygalae
Ketone III, 3,6' -dibapigenin sucrose, senegaside A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone;
s8, determining whether the 9 components obtained in the step S7 really exist in the Kaixiwan, and using the chemical component group really existing in the Kaixiwan as a quality marker group for treating the Alzheimer disease by the Kaixiwan;
wherein the identification process of S8 is as follows:
preparing a Kaixuan powder sample: pulverizing cortex et radix Polygalae, rhizoma Acori Graminei, Ginseng radix, and Poria (cortex et radix Polygalae 13.8g, Ginseng radix 13.8g, rhizoma Acori Graminei 13.8g, and Poria 37.6g) into fine powder respectively; mixing the fine powders gradually according to a multiplication chromatography method to obtain KAIXIN powder; wherein, the fine powder of the Kaixiong powder can completely pass through a 80-mesh sieve, and the weight of the fine powder passing through a 100-mesh sieve is more than or equal to 95 percent.
Pretreatment of Kaixuan powder samples: adding 2-4 ml of pure water into 200mg of Kaixin powder, placing the powder in hot water at 80-100 ℃ for standing for 10 minutes, taking 1-2 ml of supernate, and adding methanol until the volume fraction of the methanol is 75% to obtain a solution to be detected.
Detecting the solution to be detected by using a super-high liquid phase system, and positioning and contrasting by adopting the reference substance of the 9 components, wherein the specific chromatographic conditions are as follows: ultimate 3000rs flying by Saimer; the chromatographic column is an ACQUITY UPLC BEHC18 column (2.1X 100mm,1.7 μm); the mobile phase A is acetonitrile, and the mobile phase B is a phosphoric acid aqueous solution with the volume fraction of 0.05 percent; carrying out gradient elution to the mixture,
the specific procedure for gradient elution was: 0-9 min, wherein the volume fraction of the mobile phase A is 7-14%; 9-13 min, wherein the volume fraction of the mobile phase A is 14% -16%; 13-19 min, wherein the volume fraction of the mobile phase A is 16-19%; 19-23 min, wherein the volume fraction of the mobile phase A is 19-23%; 23-32 min, wherein the volume fraction of the mobile phase A is 23-36%; 32-37 min, wherein the volume fraction of the mobile phase A is 36-38%; 37-41 min, wherein the volume fraction of the mobile phase A is 38% -42%;
after the gradient elution program is finished, continuously running for 10min by taking the volume fraction of the mobile phase A as 7%, and then carrying out next detection;
the volume flow is 0.3 mL/min; the column temperature is 30 ℃; the sample injection volume is 2 mu L; the detection wavelength was 203 nm.
The results are shown in FIG. 1 and Table 1. FIG. 1 is a super high liquid chromatogram of KAIXIN powder, wherein 1 is sibiricose A5, 2 is sibiricose A6, and 3 is cortex et radix Polygalae
Ketone III, 4 is 3,6' -dibapinyl sucrose, 5 is tenuifolin A, 6 is ginsenoside Rg1, 7 is ginsenoside Re, 8 is beta-asarone, and 9 is alpha-asarone.
TABLE 1 Retention time of each component of the mass marker population in FIG. 1
As can be seen from FIG. 1 and Table 1, the Kaixiong powder contains the above 9 substances, so the quality marker group for treating Alzheimer's disease comprises sibiricose A5, sibiricose A6, and polygala tenuifolia
Ketone III, 3,6' -dibapigenin sucrose, senegaside A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (4)
1. A quality marker group for yippee san, which is characterized by comprising the following components: sibiricose A5, sibiricose A6, and cortex et radix Polygalae
Keton III, 3,6' -Disinapoyl sucrose, Leptospira meticulosaZhigan A, ginsenoside Rg1, ginsenoside Re, beta-asarone and alpha-asarone.
2. The kaixuan quality marker group according to claim 1, wherein the quality marker group is used for treating Alzheimer disease.
3. The kaixuan quality marker group according to claim 1 or 2, wherein the content ratio of each component is the same as the content thereof in kaixuan powder.
4. The use of a composition in the preparation of a medicament for treating alzheimer's disease in an equivalent replacement of kaixuan powder, wherein the components of the composition are the same as those of the quality marker group of kaixuan powder in claim 1, and the content ratio of each component is the same as that in kaixuan powder.
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| CN115267005A (en) * | 2022-08-09 | 2022-11-01 | 上海和黄药业有限公司 | Method for detecting content of multi-index components in Kaixiong powder |
| CN115267005B (en) * | 2022-08-09 | 2023-12-26 | 上海和黄药业有限公司 | Method for detecting content of multi-index components in yippee powder |
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