Radix paeoniae alba extract as well as extraction method and application thereof

Abstract

The invention belongs to the technical field of medicinal material extraction, and relates to a radix paeoniae alba extract as well as an extraction method and application thereof. The radix paeoniae alba extract is prepared from the following components in percentage by mass: 40 percent to 50 percent of paeoniflorin, 9 percent to 20 percent of albiflorin and 7 percent to 15 percent of 1, 2, 3, 4, 6-pentagalloylglucose. The extraction method of the white paeony root extract comprises the following steps: extracting a white paeony root medicinal material with ethanol, diluting extracted concentrated paste with water, adjusting the pH value to 5.5-6.5, adding alkali liquor to an HPD-500 type macroporous resin column, washing with water, eluting with 60-70w / w% ethanol, and concentrating and drying eluent to obtain the white paeony root extract. The radix paeoniae alba extract is enriched with three components at the same time, the content of the three components is within the required range of the national pharmacopoeia commission, the composition of medicinal components is more balanced, the content of the medicinal components is higher, the radix paeoniae alba extract has better medicinal value, ethyl acetate and n-butyl alcohol are not left, and the radix paeoniae alba extract is safer and more effective.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicinal material extraction, and relates to a Paeonia lactiflora Pall. extract, an extraction method thereof, and an application thereof. Background Art

[0002] Total glucosides of Paeonia lactiflora Pall. are an extract of Paeonia lactiflora Pall. prepared by extracting from the traditional Chinese medicinal material Paeonia lactiflora Pall. The drug standard of total glucosides of Paeonia lactiflora Pall. was initially included in Volume 38 of the new drug standard, which clearly stipulates that calculated on the dried product, the content of paeoniflorin (C 23 H 28 O 11 ) shall not be less than 40.0%. In October 2020, the Pharmacopoeia Commission of the People's Republic of China publicized the draft drug standard of total glucosides of Paeonia lactiflora Pall., and it was proposed to stipulate that calculated on the dried product, the content of paeoniflorin (C 23 H 28 O 11 ) shall not be less than 40.0%, the content of albiflorin (C 23 H 28 O 11 ) shall not be less than 10.0%, and the content of 1,2,3,4,6-pentagalloylglucose (C 41 H 32 O 26 ) shall not be less than 8.0%. In December 2023, the Pharmacopoeia Commission of the People's Republic of China publicized the draft drug standard of total glucosides of Paeonia lactiflora Pall. again, and it was proposed to stipulate that calculated on the dried product, the content of paeoniflorin (C 23 H 28 O 11 ) shall not be less than 40.0%, the content of albiflorin (C23H28O11) shall not be less than 9.0%, and the content of 1,2,3,4,6-pentagalloylglucose (C23H28O11) shall not be less than 7.0%.

[0003] According to the draft quality standard publicly announced by the National Pharmacopoeia Commission, the common preparation methods of total glucosides of Paeonia lactiflora are as follows: Take Paeonia lactiflora, extract it with ethanol multiple times and concentrate to obtain an extract; then, add a saturated sodium bicarbonate solution to adjust the pH value to 5.9 - 6.1, extract twice with ethyl acetate, discard the ethyl acetate layer, and extract the mother liquor 3 times with a mixed solvent of ethyl acetate - n - butanol, and then combine the extracts of these 3 times. The combined extract is concentrated to a relative density of 1.13 - 1.20 (50 °C - 65 °C) and then spray - dried, pulverized, sieved, and mixed to obtain the product. Chinese Patent CN115844958A further discloses the preparation method of total glucosides of Paeonia lactiflora, and further discloses the dosage of ethyl acetate extraction, the ratio and dosage of the ethyl acetate - n - butanol mixed solvent, etc. However, in the preparation methods of total glucosides of Paeonia lactiflora disclosed by the National Pharmacopoeia Commission and Chinese Patent CN115844958A, a large amount of hazardous solvents such as ethyl acetate and ethyl acetate - n - butanol mixed solvent are used, which not only pollutes the environment, but also increases the harm to operators during the production process and the risk of the production process.

[0004] Chinese Patent CN102492005A discloses a preparation method of paeoniflorin and albiflorin, which uses macroporous resin to adsorb the vinegar extract and then elutes it with ethanol gradient to obtain a refined extract. However, there are no content indexes for the two components of paeonolide glycoside and 1,2,3,4,6 - pentagalloylglucose in this extract, and it cannot meet the requirements of the total glucosides of Paeonia lactiflora drug standard.

[0005] Based on the current national requirements for environmental protection and the national advocacy for the green transformation of pharmaceutical production processes, it is very necessary to develop a green production process for total glucosides of Paeonia lactiflora, which can not only avoid using hazardous solvents such as ethyl acetate and n - butanol to achieve clean and green production, but also enable components such as paeonolide glycoside and 1,2,3,4,6 - pentagalloylglucose in total glucosides of Paeonia lactiflora other than paeoniflorin to meet the new standard requirements. Summary of the Invention

[0006] To solve the above - mentioned problems existing in the prior art, the purpose of the present invention is to provide a Paeonia lactiflora extract, its extraction method and application, so as to overcome the deficiencies of the prior art.

[0007] One object of the present invention is achieved by the following technical solutions:

[0008] A Paeonia lactiflora extract, which comprises the following components in mass fractions: paeoniflorin 40% - 50%, paeonolide glycoside 9% - 20%, 1,2,3,4,6 - pentagalloylglucose 7% - 15%;

[0009] The extraction method of the Paeonia lactiflora extract comprises the following steps:

[0010] The white peony root medicinal material is extracted with ethanol. The extracted and concentrated paste is diluted with water, and the pH is adjusted to 5.5 - 6.5. The alkali-adjusted solution is loaded onto an HPD-500 macroporous resin column, washed with water, and then eluted with 60 - 70 w / w% ethanol. The eluate is concentrated and dried to obtain the white peony root extract.

[0011] The HPD-500 macroporous resin column refers to a chromatographic column filled with HPD-500 macroporous resin. The particle size range of HPD-500 macroporous resin is 0.3 - 1.5 mm, and the specific surface area is 700 - 800 m 2 / g.

[0012] Preferably, the white peony root extract comprises the following components in mass fractions: paeoniflorin 40% - 46%, albiflorin 12% - 18%, 1,2,3,4,6-pentagalloylglucose 7.5% - 12%.

[0013] The second object of the present invention is achieved by the following technical solution:

[0014] A method for extracting a white peony root extract, comprising the following steps:

[0015] (1) The white peony root medicinal material is extracted with 60 - 80 w / w% ethanol for 2 - 4 times, and the ethanol extracts are combined and concentrated to an ethanol content of ≤5% to obtain a concentrated paste;

[0016] (2) The concentrated paste is diluted with water, and the pH is adjusted to 5.5 - 6.5 to obtain an alkali-adjusted solution;

[0017] (3) The alkali-adjusted solution is loaded onto an HPD-500 macroporous resin column, first washed with water, and then eluted with 60 - 70 w / w% ethanol. The ethanol eluate is collected, and the eluate is concentrated and dried to obtain the white peony root extract.

[0018] The white peony root medicinal material is mainly derived from the dried roots of the Ranunculaceae plant Paeonia lactiflora Pall., including the original white peony root medicinal material without any processing or preparation, white peony root slices, etc.

[0019] When the white peony root medicinal material is the original white peony root, the original white peony root is crushed to a mesh number of ≥1; when the white peony root medicinal material is white peony root slices, the white peony root slices can be crushed to a mesh number of ≥1, or can be not crushed.

[0020] Preferably, in step (1), the white peony root medicinal material is first extracted with 4 - 6 times 60 - 80 w / w% ethanol for 1.5 - 3 hours, the second time with 3 - 5 times 60 - 80 w / w% ethanol for 1.5 - 3 hours, and the third time with 3 - 5 times 60 - 80 w / w% ethanol for 1 - 2 hours. The ethanol extracts are combined and concentrated to an ethanol content of ≤3%.

[0021] Further preferably, in step (1), the Paeonia lactiflora Pall. medicinal materials are first extracted with 4 - 5 times 70 - 80 w / w% ethanol for 1.5 - 2 hours, secondarily extracted with 3 - 4 times 70 - 80 w / w% ethanol for 1.5 - 2 hours, and thirdly extracted with 3 - 4 times 70 - 80 w / w% ethanol for 1 - 2 hours.

[0022] Even further preferably, in step (1), the Paeonia lactiflora Pall. medicinal materials are first extracted with 4 times 73 - 77 w / w% ethanol for 1.5 hours, secondarily extracted with 3 times 73 - 77 w / w% ethanol for 1.5 hours, and thirdly extracted with 3 times 73 - 77 w / w% ethanol for 1 hour.

[0023] Preferably, in step (2), the concentrated paste is diluted with water, and the volume ratio of water to the mass of the concentrated paste is 1 - 5 ml : 1 g. Even further preferably, it is 1.5 - 3 ml : 1 g. Even further preferably, it is 1.5 - 2.5 ml : 1 g. Even further preferably, it is 2 ml : 1 g.

[0024] Preferably, in step (2), the pH is adjusted using one or more of saturated sodium bicarbonate solution, sodium carbonate solution, and sodium hydroxide solution.

[0025] Preferably, in step (2), the pH is adjusted to 6.0 ± 0.1.

[0026] Preferably, in step (3), the alkali - adjusted solution is loaded onto an HPD500 macroporous resin column at a flow rate of 0.8 - 1.5 macroporous resin column volumes / h. Even further preferably, the flow rate is 0.9 - 1.2 macroporous resin column volumes / h.

[0027] Preferably, in step (3), first wash with 3 - 5 times the macroporous resin column volume of water, and then elute with 2.5 - 5 times the macroporous resin column volume of 60 - 70 w / w% ethanol. Even further preferably, first wash with 3 - 4 times the macroporous resin column volume of water, and then elute with 3 - 4 times the macroporous resin column volume of 65 ± 1 w / w% ethanol. Even further preferably, first wash with 3 times the macroporous resin column volume of water, and then elute with 3 times the macroporous resin column volume of 65 ± 1 w / w% ethanol.

[0028] Preferably, the extraction method of the Paeonia lactiflora Pall. extract comprises the following steps:

[0029] (1) The Paeonia lactiflora Pall. medicinal materials are first extracted with 4 times 73 - 77 w / w% ethanol for 1.5 hours, secondarily extracted with 3 times 73 - 77 w / w% ethanol for 1.5 hours, and thirdly extracted with 3 times 73 - 77 w / w% ethanol for 1 hour. The ethanol extraction solutions are combined and concentrated to an ethanol content of ≤3% to obtain a concentrated paste;

[0030] (2) Dilute the concentrated paste with water, with the volume ratio of water to the mass of the concentrated paste being 2 ml:1 g, and adjust the pH to 6.0 ± 0.1 using one or more of saturated sodium bicarbonate solution, sodium carbonate solution, and sodium hydroxide solution to obtain an alkali-adjusted solution.

[0031] (3) Apply the alkali-adjusted solution to an HPD-500 macroporous resin column, wash it with 3 times the volume of the macroporous resin column with water, and then elute it with 3 times the volume of the macroporous resin column of 65 ± 1 w / w% ethanol. Collect the ethanol eluate, concentrate and dry the eluate to obtain the Paeonia lactiflora extract.

[0032] The third object of the present invention is achieved by the following technical solutions:

[0033] The application of the Paeonia lactiflora extract in medicines, health foods, and cosmetics.

[0034] Preferably, the Paeonia lactiflora extract is prepared into a dosage form for use in medicines, health foods, and cosmetics. The dosage form includes one or more of pills, powders, pastes, creams, capsules, tablets, granules, film patches, plaster patches, suspensions, liniments, etc.

[0035] The Paeonia lactiflora extract can be directly prepared into a dosage form or can be mixed with excipients to prepare a dosage form.

[0036] Preferably, the application of the Paeonia lactiflora extract in medicines for treating various immune diseases such as autoimmune diseases and allergic reactions, primary Sjögren's syndrome, ulcerative colitis, Crohn's disease, gout, etc. Immune diseases can include arthritis, systemic lupus erythematosus, eczema, psoriasis, lupus nephritis, Sjögren's syndrome, ankylosing spondylitis, oral lichen planus, recurrent aphthous ulcer, inflammatory bowel disease, psoriasis, alopecia areata, vitiligo, etc.

[0037] Compared with the prior art, the present invention has the following beneficial effects:

[0038] 1. The existing macroporous resin technology only enriches a single component of paeoniflorin, and there is no process for simultaneously enriching three components. The Paeonia lactiflora extract prepared by the present invention relative to the existing macroporous resin process simultaneously enriches three components: paeoniflorin, albiflorin, and 1,2,3,4,6-pentagalloylglucose, which is not available in the prior art.

[0039] 2. The existing extraction process for simultaneously enriching three components is the organic solvent extraction technology. There will be residues of extraction solvents such as ethyl acetate and n-butanol in the white peony root extract, which is not safe or environmentally friendly. The present invention uses an HPD-500 macroporous resin column for adsorption and elution, which can simultaneously enrich three components without using harmful and dangerous chemical solvents such as ethyl acetate and n-butanol. The production process is green and environmentally friendly, and there will be no residues of ethyl acetate and n-butanol in the white peony root extract, improving the safety of the production of white peony root extract and the safety during its own use.

[0040] 3. The white peony root extract of the present invention simultaneously enriches three components, and the obtained white peony root extract composition includes paeoniflorin 40%-50%, albiflorin 9%-20%, and 1,2,3,4,6-pentagalloylglucose 7%-15%. The contents of the three components are all within the requirements of the National Pharmacopoeia Commission. The composition of the active pharmaceutical ingredients is more balanced, the content of the active pharmaceutical ingredients is higher, and it has better medicinal value. Moreover, there are no residues of ethyl acetate and n-butanol, making the white peony root extract safer and more effective.

[0041] 4. The present invention uses HPD-500 macroporous resin for adsorption, first washes with water (without using low-concentration ethanol for elution), and then directly elutes with 60-70 w / w% ethanol and collects the eluate. The losses of the three components, namely paeoniflorin, albiflorin, and 1,2,3,4,6-pentagalloylglucose, are extremely low, and the transfer rates of the three components relative to the white peony root are relatively high.

[0042] 5. The yield of the white peony root extract using the extraction process of the present invention is increased to more than 8%, making the utilization of white peony root more sufficient and enabling better resource conservation. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 shows the effect of the white peony root extract on the paw swelling degree of adjuvant-induced arthritis in rats;

[0044] Figure 2 shows the effect of the white peony root extract on the joint index of adjuvant-induced arthritis in rats. DETAILED DESCRIPTION OF THE INVENTION

[0045] The technical solutions of the present invention will be further described and illustrated below through specific examples and drawings. It should be understood that the specific examples described herein are only used to help understand the present invention and are not used for specific limitations of the present invention. Moreover, the drawings used herein are only for better illustrating the content disclosed by the present invention and do not have a limiting effect on the protection scope. If there is no special description, the raw materials used in the embodiments of the present invention are all commonly used raw materials in the art, and the methods used in the embodiments are all conventional methods in the art.

[0046] In the following examples and comparative examples, HPD-500 macroporous resin, D101, AB-8, and HPD750 macroporous resin were all purchased from Beijing Ruida Henghui Technology Development Co., Ltd.

[0047] The preparation method of the macroporous resin column includes the following steps:

[0048] Mix the macroporous resin with deionized water and pour it into a graduated cylinder to allow the resin to settle fully. By adding and removing, make the resin bed level with the scale (required resin volume) to complete the measurement of the resin.

[0049] Close the outlet valve at the lower end of the chromatography column, pour all the resin in the graduated cylinder into the chromatography column, then open the outlet valve of the chromatography column to allow the resin to settle and compact in the column, and then close the outlet valve of the exchange column.

[0050] Use water to wash the column forward at a flow rate of 1 BV / h for 2 BV. After the treatment, the resin column is ready for use.

[0051] Example 1

[0052] Take 500 g of Paeonia lactiflora Pall. slices and extract them three times with 75 w / w% ethanol. The first time, extract with 4 times 75 w / w% ethanol for 1.5 hours, the second time with 3 times 75 w / w% ethanol for 1.5 hours, and the third time with 3 times 75 w / w% ethanol for 1 hour. Combine the ethanol extracts, recover ethanol and concentrate to an ethanol content of ≤3%, to obtain a concentrated paste with a relative density of 1.2 (60 °C). Dilute the concentrated paste with water, and the volume ratio of water to the mass of the concentrated paste is 2 ml:1 g. Adjust the pH value of the diluted solution to 6.0 ± 0.1 with saturated sodium bicarbonate solution. Load the alkali-adjusted solution onto an HPD-500 macroporous resin column at a flow rate of about 1 BV / h. After loading, wash with 3 times the column volume (BV) of water. After the water wash, elute with 3 BV of 65 w / w% ethanol, and collect the ethanol eluate. After recovering ethanol from the ethanol eluate by rotary evaporation, dry it in vacuo at 60 °C to obtain Paeonia lactiflora Pall. extract.

[0053] Detect the contents of paeoniflorin, albiflorin, and 1,2,3,4,6-pentagalloylglucose in the Paeonia lactiflora Pall. extract of Example 1 by HPLC. The detection results are shown in Table 1.

[0054] Table 1 Component contents of Paeonia lactiflora Pall. extract in Example 1

[0055]

[0056] Table 2 Relative transfer rate of Paeonia lactiflora Pall. extract in Example 1 to the medicinal material

[0057]

[0058] Example 2

[0059] Example 2 is only different from Example 1 in that in Example 2, elution is carried out with 60 w / w% ethanol with a volume of 3 BV, and the others are the same as in Example 1.

[0060] Table 3 Component contents of the white peony root extract in Example 2

[0061]

[0062] Table 4 Relative transfer rate of the white peony root extract in Example 2 to the medicinal material

[0063]

[0064] Example 3

[0065] Example 3 is only different from Example 1 in that in Example 3, elution is carried out with 70 w / w% ethanol with a volume of 3 BV, and the others are the same as in Example 1.

[0066] Table 5 Component contents of the white peony root extract in Example 3

[0067]

[0068] Table 6 Relative transfer rate of the white peony root extract in Example 3 to the medicinal material

[0069]

[0070] Example 4

[0071] Example 4 is only different from Example 1 in that after sample loading in Example 4, washing is carried out with 5 times the column volume (BV) of water, and after the washing is completed, elution is carried out with 65 w / w% ethanol with a volume of 3 BV, and the others are the same as in Example 1.

[0072] Table 7 Component contents of the white peony root extract in Example 4

[0073]

[0074] Table 8 Relative transfer rate of the white peony root extract in Example 4 to the medicinal material

[0075]

[0076]

[0077] Example 5

[0078] Example 5 is only different from Example 1 in that after sample loading in Example 5, washing is carried out with 2 times the column volume (BV) of water, and after the washing is completed, elution is carried out with 65 w / w% ethanol with a volume of 3 BV, and the others are the same as in Example 1.

[0079] Table 9 Component contents of the white peony root extract in Example 5

[0080]

[0081] Table 10 Relative transfer rate of Paeonia lactiflora Pall. extract in Example 5 to the medicinal material

[0082]

[0083] As can be seen from Table 1 - 10, the contents of paeoniflorin, albiflorin, and 1,2,3,4,6 - pentagalloylglucose in the Paeonia lactiflora Pall. extracts obtained in Examples 1 - 5 are all within the standard range required by the Pharmacopoeia Commission of China. Among them, in Example 2, 60% ethanol was used for elution, and in Example 3, 70% ethanol was used for elution. The contents of paeoniflorin, albiflorin, and 1,2,3,4,6 - pentagalloylglucose in the Paeonia lactiflora Pall. extract were lower than those in Example 1 eluted with 65% ethanol; in Example 4, 5 - fold water washing was carried out first, and in Example 5, 2 - fold water washing was carried out first. The contents of paeoniflorin, albiflorin, and 1,2,3,4,6 - pentagalloylglucose in the Paeonia lactiflora Pall. extract were lower than those in Example 1 with 2 - fold water washing first. The extraction rate of Paeonia lactiflora Pall. in Example 1 was relatively high, the contents of paeoniflorin, albiflorin, and 1,2,3,4,6 - pentagalloylglucose in the Paeonia lactiflora Pall. extract were relatively high, and the losses of the three components during the extraction process were extremely low. The transfer rates of the three components of paeoniflorin, albiflorin, and 1,2,3,4,6 - pentagalloylglucose were the best. Therefore, the extraction process of Example 1 is the optimal extraction process of the present invention.

[0084] Comparative Example 1

[0085] The difference between Comparative Example 1 and Example 1 is that in Comparative Example 1, a D101 macroporous resin column was used, and the others were the same as in Example 1.

[0086] Comparative Example 2

[0087] The difference between Comparative Example 2 and Example 2 is that in Comparative Example 2, a D101 macroporous resin column was used, and the others were the same as in Example 2.

[0088] Comparative Example 3

[0089] The difference between Comparative Example 3 and Example 2 is that in Comparative Example 3, an AB - 8 macroporous resin column was used, and the others were the same as in Example 2.

[0090] Comparative Example 4

[0091] The difference between Comparative Example 4 and Example 3 is that in Comparative Example 4, an AB - 8 macroporous resin column was used, and the others were the same as in Example 3.

[0092] Comparative Example 5

[0093] The difference between Comparative Example 5 and Example 2 is that in Comparative Example 5, an HPD750 macroporous resin column was used, and the others were the same as in Example 2.

[0094] Comparative Example 6

[0095] The difference between Comparative Example 6 and Example 3 is that HPD750 macroporous resin column was used in Comparative Example 6, and the others were the same as those in Example 3.

[0096] Comparative Example 7

[0097] The difference between Comparative Example 7 and Example 1 is only that 50 w / w% ethanol with a volume of 3 BV was used for elution in Comparative Example 7, and the others were the same as those in Example 1.

[0098] Comparative Example 8

[0099] The difference between Comparative Example 8 and Example 1 is only that 80 w / w% ethanol with a volume of 3 BV was used for elution in Comparative Example 8, and the others were the same as those in Example 1.

[0100] Comparative Example 9

[0101] The difference between Comparative Example 9 and Example 1 is only that the alkali-adjusted solution in Comparative Example 9 was loaded onto an HPD-500 macroporous resin column at a flow rate of about 1 BV / h. After the loading was completed, it was washed with 3 column volumes (BV) of water. After the water washing was completed, it was eluted with 3 BV of 10 w / w% ethanol and then eluted with 3 BV of 65 w / w% ethanol, and the ethanol eluate was collected. The others were the same as those in Example 1.

[0102] Table 11 Component contents of the white peony root extracts in the comparative examples

[0103]

[0104]

[0105] In Comparative Examples 1-6, D101, AB-8, and HPD750 were used for adsorption and elution, resulting in a decrease in the yield of the white peony root extract, and a decrease in the contents of paeoniflorin and albiflorin in the white peony root extract. In particular, the content of paeoniflorin decreased to be lower than the requirements of the Pharmacopoeia Commission of the People's Republic of China.

[0106] The research of the present invention found that the extraction process has a very great influence on the component contents of the white peony root extract. Only by using a suitable macroporous resin and a precise elution process can an extract with appropriate ranges of the contents of the three components be obtained. Furthermore, by using a suitable process, the extraction rate of the white peony root and the component transfer rate can be increased.

[0107] When the contents of the three components in the white peony root extract are appropriate, it has very high medicinal value. The white peony root extract of Example 1 was used for animal experiments for verification.

[0108] The Freund's adjuvant (CFA) was injected intradermally into the paw of rats to induce an adjuvant arthritis (AA) model, and the effects of the extract of Paeonia lactiflora Pall. on paw swelling and joint index were observed, as well as its intensity of action.

[0109] 1. Effects on paw swelling

[0110] 1) 0.1 ml of Freund's adjuvant (CFA) (10 g / L) was injected intradermally into the paw of rats, and the paw volume measuring instrument was used to regularly detect the paw swelling of rats on days 12, 16, 20, 24, and 28 after inflammation induction. The results showed that the regularly detected values of paw swelling in the model group were significantly increased compared with those in the normal control group (P<0.05), as shown in Figure 1 .

[0111] 2) After intragastric administration (ig) of the positive control drug prednisone at 10 mg / kg, the paw volume was measured on day 3 (d3), d7, and d11. Compared with the model group, the paw swelling was significantly reduced (P<0.05 - 0.01), as shown in Figure 1 .

[0112] 3) After intragastric administration (ig) of the test drug, the extract of Paeonia lactiflora Pall. at 25, 50, and 100 mg / kg, the paw volume was measured on d3, d7, and d11. Compared with the model group, it was found that in the groups of 25 and 100 mg / kg of the extract of Paeonia lactiflora Pall., the paw swelling was significantly reduced on d7 (P<0.05); when administered at 25, 50, and 100 mg / kg on d11, the paw swelling was significantly reduced (P<0.01 - 0.05), as shown in Figure 1 .

[0113] 2. Effects on joint index

[0114] 1) 0.1 ml of Freund's adjuvant (CFA) (10 g / L) was injected intradermally into the paw of rats, and the joint index was regularly evaluated on d3, d7, and d11 after administration according to a five - level score of 0 - 4. The results showed that the evaluation scores of the joint index in the model group were significantly increased compared with those in the normal control group (P<0.01), as shown in Figure 2 .

[0115] 2) After intragastric administration (ig) of the positive control drug prednisone at 10 mg / kg, the joint index was evaluated on d3, d7, and d11. Compared with the model group, the evaluation scores of the joint index were significantly reduced (P<0.05 - 0.01), as shown in Figure 2 .

[0116] 3) After intragastric administration (ig) of the test drug, the extract of Paeonia lactiflora Pall. at 12.5, 25, 50, and 100 mg / kg, the joint index was evaluated on d3, d7, and d11. Compared with the model group, it was found that in the groups of 25, 50, and 100 mg / kg of the extract of Paeonia lactiflora Pall., the joint index scores showed a dose - dependent decrease (P<0.05 - 0.01), as shown in Figure 2 .

[0117] Aspects, embodiments, and features of the present invention should be considered illustrative in all respects and not limiting of the present invention, the scope of which is defined only by the claims. Without departing from the spirit and scope of the claimed invention, those skilled in the art will appreciate other embodiments, modifications, and uses.

[0118] In the preparation method of the present invention, the order of each step is not limited to the recited order. For those of ordinary skill in the art, without creative efforts, the sequence changes of each step are also within the protection scope of the present invention. In addition, two or more steps or actions can be carried out simultaneously.

[0119] Finally, it should be noted that the specific embodiments described herein are merely illustrative of the present invention and do not limit the implementation manners of the present invention. Those skilled in the technical field of the present invention can make various modifications or supplements to the described specific embodiments or use similar ways to replace them. It is not necessary and impossible to list all implementation manners here. And these obvious changes or variations derived from the essence of the present invention still fall within the protection scope of the present invention. Interpreting them as any additional limitation is contrary to the spirit of the present invention.

Claims

1. A white peony root extract, characterized in that The invention comprises the following components in mass fractions: 40%-50% of paeoniflorin, 9%-20% of paeoniflorin, and 7%-15% of 1,2,3,4,6-pentagalloylglucose; The extraction method of the white peony root extract comprises the following steps: The white peony root is extracted with ethanol, the concentrated extract is diluted with water, and the pH is adjusted to 5.5-6.5, the adjusted alkali solution is added to the HPD-500 macroporous resin column, washed with water, and then eluted with 60-70w / w% ethanol, and the eluate is concentrated and dried to obtain the white peony root extract.

2. The white peony root extract according to claim 1, characterized in that HPD-500 macroporous resin column is a chromatographic column filled with HPD-500 macroporous resin. The particle size of HPD-500 macroporous resin ranges from 0.3 to 1.5 mm and the specific surface area is 700 to 800 m 2 / g.

3. The white peony root extract according to claim 1, characterized in that The white peony root extract comprises the following components in mass fractions: 40%-46% of paeoniflorin, 12%-18% of paeoniflorin, and 7.5%-12% of 1,2,3,4,6-pentagalloylglucose.

4. The method for extracting white peony root extract according to claim 1, characterized in that: The following steps are involved: (1) extracting white peony root with 60-80w / w% ethanol for 2-4 times, combining the ethanol extracts, and concentrating the extracts to an ethanol content of ≤5% to obtain a concentrated paste; (2) diluting the concentrated paste with water and adjusting the pH to 5.5-6.5 to obtain an alkali solution; (3) The alkali solution is loaded onto a HPD-500 macroporous resin column, first washed with water, and then eluted with 60-70 w / w % ethanol, the ethanol eluate is collected, and the eluate is concentrated and dried to obtain the white peony root extract.

5. The preparation method according to claim 4, characterized in that: In step (1), the white peony root is extracted with 4-6 times 60-80w / w% ethanol for 1.5-3 hours for the first time, extracted with 3-5 times 60-80w / w% ethanol for 1.5-3 hours for the second time, and extracted with 3-5 times 60-80w / w% ethanol for 1-2 hours for the third time, and the ethanol extracts are combined and concentrated to an ethanol content of ≤3%; and / or, in step (2), the concentrated cream is diluted with water, and the ratio of the volume of water to the mass of the concentrated cream is 1-5 ml: 1 g; And / or, in step (2), one or more of saturated sodium bicarbonate solution, sodium carbonate solution, and sodium hydroxide solution are used to adjust the pH; and / or, in step (2), adjusting the pH to 6.0±0.1; And / or, in step (3), the alkali solution is loaded on a HPD-500 macroporous resin column at a flow rate of 0.8 to 1.5 macroporous resin column volumes / h; And / or, in step (3), first wash with 3-5 times the volume of the macroporous resin column with water, and then elute with 2.5-5 times the volume of the macroporous resin column with 60-70 w / w% ethanol.

6. The preparation method according to claim 4, characterized in that: In step (1), the peony material is first extracted with 4-5 times 70-80 w / w % ethanol for 1.5-2 hours, secondly extracted with 3-4 times 70-80 w / w % ethanol for 1.5-2 hours, and thirdly extracted with 3-4 times 70-80 w / w % ethanol for 1-2 hours; and / or, in step (2), the concentrated cream is diluted with water, and the ratio of the volume of water to the mass of the concentrated cream is 1.5-3 ml: 1 g; And / or, first wash with 3-4 times the volume of the macroporous resin column with water, and then elute with 3-4 times the volume of the macroporous resin column with 65±1w / w% ethanol.

7. The preparation method according to claim 4, characterized in that: The method for extracting the white peony root extract comprises the following steps: (1) extracting white peony root with 4 times 73-77 w / w % ethanol for 1.5 hours, extracting with 3 times 73-77 w / w % ethanol for 1.5 hours, and extracting with 3 times 73-77 w / w % ethanol for 1 hour. The ethanol extracts are combined and concentrated to an ethanol content of ≤3% to obtain a concentrated paste. (2) diluting the concentrated cream with water, with the volume of water and the mass of the concentrated cream being 2 ml:1 g, and adjusting the pH to 6.0±0.1 with one or more of a saturated sodium bicarbonate solution, a sodium carbonate solution, and a sodium hydroxide solution to obtain an adjusted alkali solution; (3) The alkali solution is loaded onto a HPD-500 macroporous resin column, washed with water (3 times the volume of the macroporous resin column), and then eluted with 65±1w / w% ethanol (3 times the volume of the macroporous resin column), the ethanol eluate is collected, and the eluate is concentrated and dried to obtain the white peony root extract.

8. Use of the white peony root extract according to claim 1 in medicines, health foods and cosmetics.

9. The use according to claim 8, characterized in that: The white peony root extract is prepared into dosage forms for use in medicines, health foods and cosmetics, and the dosage forms include one or more of pills, powders, ointments, creams, capsules, tablets, granules, patches, plasters, suspensions and liniments.

10. The use according to claim 8, characterized in that: The white peony root extract is used in medicines for treating immune diseases, primary Sjögren's syndrome, ulcerative colitis, Crohn's disease or gout.

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