Determination method of flatstem milkvetch seed extract and related application thereof

Abstract

The invention relates to the field of quality control of medicinal materials, and discloses a determination method of flatstem milkvetch seed extract and related application thereof. The determination method comprises the following steps: mixing flow paste obtained by soaking, decocting, filtering and concentrating a flatstem milkvetch seed test sample with beta-cyclodextrin, so that the structure of dried and crushed powder is looser, the dissolution of alcohol-soluble components in dry powder during the determination of the extract is facilitated, and the determination method has the advantages of simplicity, high efficiency, easiness in implementation and the like, and is suitable for popularization and application. The extract of the astragalus complanatus medicinal material can be more accurately and effectively measured. According to the embodiment of the invention, the screening standard of the flatstem milkvetch seed medicinal material is established, the quality and the qualified rate of the finished product medicine can be obviously improved, and a way is provided for large-scale high-quality production of the flatstem milkvetch seed formula granules.

Description

Technical Field

[0001] The invention relates to the field of quality control of medicinal materials, and in particular to a method for determining an extract of Astragalus complanatus and related applications thereof. Background Art

[0002] Astragalus complanatus R.Br. is the dried mature seed of the leguminous plant Astragalus complanatus R.Br., which has the functions of tonifying the kidney and strengthening yang, consolidating essence and reducing urine, nourishing the liver and improving eyesight. It is mainly used to treat kidney deficiency and low back pain, spermatorrhea and premature ejaculation, enuresis and frequent urination, leucorrhea, dizziness, and blurred vision.

[0003] Chinese medicine formula granules are made from single Chinese medicine slices, which are processed into decoction-free Chinese medicine granules through extraction, separation, concentration, drying, granulation and other production processes. In the preparation process of Chinese medicine formula granules, the preparation of intermediates is a key link, and the formulation of the limit range of indicators such as extract, content, paste yield and transfer rate is the focus and difficulty in the process of process research. In the production and preparation of Chinese medicine formula granules, it is necessary to conduct a comprehensive quantitative transfer study on indicators such as extract, content, paste yield, transfer rate and characteristic spectrum of slices, intermediates and finished products, determine various process parameters, and ensure the consistency of the finished product with the standard soup.

[0004] Astragalus complanatus has been announced as a national standard variety, with a prescription of 6g of crude drug per 1g, a paste rate of 10% to 16.5%, and an extract of 18.0%. After the test of the decoction pieces of Astragalus complanatus formula granules, more than 70% of the extracts did not meet the standard requirements, resulting in difficulties in purchasing medicinal materials and waste of medicinal material resources. Therefore, it is necessary to control the extract standards of the medicinal materials entering the factory. The traditional determination of medicinal material extracts is to directly determine the medicinal materials by crushing and sieving them, but during the research of Astragalus complanatus, it was found that the medicinal material extract data obtained by this operation had a poor correlation with the extract of the extract. Therefore, it is necessary to simulate the extract obtained in the production extraction process and establish a determination method for the extract of Astragalus complanatus medicinal materials. In addition, since the inspection of medicinal materials entering the factory is generally carried out in the laboratory, considering the lack of spray drying equipment and the complexity of the operation in most laboratories, it is necessary to establish a simpler method to detect the extracts of the medicinal materials entering the factory.

[0005] In view of this, the present invention is proposed. Summary of the invention

[0006] The purpose of the present invention is to provide a method for determining an extract of Astragalus complanatus and related applications thereof.

[0007] The present invention is achieved in that:

[0008] In a first aspect, an embodiment of the present invention provides a method for determining an extract of Astragalus complanatus, comprising the following steps:

[0009] After mixing the test sample and water, heat and filter to obtain a filtrate;

[0010] Concentrating the filtrate to obtain a fluid paste;

[0011] The fluid paste is mixed with β-cyclodextrin and then dried to obtain a dry product;

[0012] The extract of Astragalus membranaceus medicinal material was calculated based on the extract of the original powder measured after the dry product was crushed and sieved.

[0013] In a second aspect, an embodiment of the present invention provides a screening method or quality control method for Astragalus complanatus medicinal material, which comprises: using the determination method described in the aforementioned embodiment to determine the extract of Astragalus complanatus medicinal material, and judging whether the quality of the medicinal material is qualified based on the determination result.

[0014] In a third aspect, embodiments of the present invention provide application of the determination method described in the preceding embodiments or the screening method or quality control method described in the preceding embodiments in the preparation of Complanatae Astragali extract or Complanatae Astragali formula granules.

[0015] The present invention has the following beneficial effects:

[0016] The embodiment of the present invention provides a method for determining the extract of Astragalus Complanatus medicinal material, wherein the fluid paste of Astragalus Complanatus test sample after soaking, decocting, filtering and concentrating is mixed with β-cyclodextrin, so that the powder structure after drying and crushing is looser, which is conducive to the dissolution of alcohol-soluble components in the dry powder when determining the extract. The determination method has the advantages of low cost, simplicity, high efficiency and easy implementation, and can more accurately and effectively determine the extract of Astragalus Complanatus medicinal material. The embodiment of the present invention establishes the screening standard of Astragalus Complanatus medicinal material according to the determination method, which can significantly improve the quality and qualified rate of the intermediate products of Astragalus Complanatus formula granules, and provides a way for large-scale high-quality production of Astragalus Complanatus formula granules. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0018] Figure 1 This is the correlation result between the medicinal material alcohol extract and the extract extract of Comparative Example 2. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0020] In response to the problems existing in the prior art, the inventors of the present application discovered that, for the Astragalus membranaceus medicinal material, the fluid paste obtained after soaking, decocting, filtering and concentrating the Astragalus membranaceus test sample can be mixed with β-cyclodextrin to make the powder structure after drying and crushing more loose, which is more conducive to the dissolution of alcohol-soluble components in the dry powder when determining the extract, and can better simulate the loose state of mass-produced dry powder. The determination method has the advantages of simplicity, high efficiency and easy implementation. There is no need to purchase additional spray drying equipment, and the extract of the Astragalus membranaceus medicinal material can be determined more accurately and effectively, which solves the problems of difficulty in purchasing Astragalus membranaceus medicinal materials and waste of medicinal material resources, thereby reducing costs from the medicinal material end.

[0021] Establishing screening criteria for Astragalus membranaceus medicinal materials based on the extract determination method provided in the embodiments of the present application can significantly improve the quality and qualified rate of the intermediate product (Astragalus membranaceus extract) of Astragalus membranaceus formula granules (for example, significantly improve the qualified rate of the intermediate extract of Astragalus membranaceus formula granules), and provide a way for large-scale high-quality production of Astragalus membranaceus formula granules.

[0022] On the one hand, an embodiment of the present invention provides a method for determining an extract of Astragalus complanatus, comprising the following steps:

[0023] After mixing the test sample and water, heat and filter to obtain a filtrate;

[0024] Concentrating the filtrate to obtain a fluid paste;

[0025] The fluid paste is mixed with β-cyclodextrin and then dried to obtain a dry product;

[0026] The content of Astragalus membranaceus medicinal material extract was calculated based on the original powder extract measured after the dry product was crushed and sieved.

[0027] In some embodiments, the mixing ratio of the fluid paste and β-cyclodextrin is: for every 100g of the sample, 10 to 30g of the β-cyclodextrin is added. The amount of β-cyclodextrin added within this set range is more conducive to accurate determination of the extract. Specifically, for every 100g of the sample, the amount of β-cyclodextrin added can be any one of 10, 15, 20, 25, 30g or a range between any two.

[0028] In some embodiments, the drying method includes: drying in an oven or vacuum drying.

[0029] In some embodiments, the oven is a common oven (laboratory oven, specifically an electric heated blast drying oven).

[0030] In some embodiments, when the drying method is drying in an oven, the measuring method further comprises stirring the mixture of the fluid paste and β-cyclodextrin evenly, pouring the mixture into a container, spreading the mixture evenly, and drying the mixture in an oven.

[0031] In some embodiments, the drying temperature is 50-70° C. The temperature may be any one of 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70° C. or a range between any two thereof.

[0032] In some embodiments, the mass ratio of the sample to water is 1:10 to 20. The mass ratio can be any one of 1:10, 1:12, 1:14, 1:16, 1:18, 1:20 or a range between any two of them.

[0033] In some embodiments, before the heating, the assay method further comprises: soaking the mixture of the test sample and water for 30 to 60 minutes. The soaking time can be any one of 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60 minutes or a range between any two of them.

[0034] In some embodiments, the heating method is boiling, the heating time is 20 to 120 minutes, and the temperature is 98 to 100° C. The heating time can be any one of 20, 40, 60, 80, 100, and 120 minutes, or a range between any two of them. The temperature can be any one of 98, 99, and 100° C., or a range between any two of them.

[0035] In some embodiments, the filtration uses a filter cloth with a mesh size of 200 to 400, which can be any one of 200, 250, 300, 350, and 400, or a range between any two of them.

[0036] In some embodiments, the concentration method includes concentration under reduced pressure.

[0037] In some embodiments, the pressure of the reduced pressure concentration is 0.057-0.085 MPa. The pressure can be any one of 0.057, 0.06, 0.065, 0.07, 0.075, 0.08, 0.085 MPa or a range between any two of the pressures.

[0038] In some embodiments, the concentration includes: concentrating the filtrate to a specific gravity of 1.02 to 1.10 at 75 to 90° C. The temperature may be any one of 75, 78, 80, 82, 84, 86, 88, and 90° C. or a range between any two thereof. The specific gravity may be any one of 1.02, 1.04, 1.06, 1.08, and 1.10 or a range between any two thereof.

[0039] In some embodiments, the mesh number of the sieve used for sieving is 24 to 100 meshes, and the mesh number can be any one of 24, 30, 40, 50, 55, 60, 65, 70, 75, 80, 90, 100 meshes or a range between any two of them.

[0040] In some embodiments, the calculation formula of the extract is:

[0041] Extract of Astragalus complanatus medicinal material = extract of original powder × (extraction rate + proportion of added β-cyclodextrin) / extraction rate;

[0042] The raw powder extract is the alcohol-soluble extract content in the raw powder measured according to the alcohol-soluble extract measurement method.

[0043] Specifically, the steps of the alcohol-soluble extract determination method may include: taking about 2 g (m 原粉取样量 ), add 100 ml (V 溶剂 ), weigh the mixture, let it stand for 1 hour, connect a reflux condenser, heat to boiling, and keep it boiling for 1 hour. After cooling, weigh it again, make up the lost weight with ethanol, shake well, filter with a dry filter, and accurately measure 25 ml of the filtrate (V 所取滤液 ), put it in an evaporating dish that has been dried to constant weight, evaporate it on a water bath, dry it at 105℃ for 3 hours, cool it in a desiccator for 30 minutes, and quickly weigh it accurately (m 浸出液中可溶性物质 ).

[0044] Extract of original powder = m 浸出液中可溶性物质 / V 所取滤液 ×V 溶剂 / m 原粉取样量 ; Among them, m 浸出液中可溶性物质 is the mass of soluble matter in the leachate, V 所取滤液 is the volume of the filtrate taken, V 溶剂 The volume of solvent used to determine the extract, m 原粉取样量 The quality of the raw powder sample is taken.

[0045] The cream yield is the cream yield of the flowing cream, and the proportion of the added β-cyclodextrin is the percentage of β-cyclodextrin in the weight of the test sample.

[0046] On the other hand, an embodiment of the present invention further provides a screening method or quality control method for Astragalus complanatus medicinal materials, which comprises: using the determination method described in any of the aforementioned embodiments to determine the extract of Astragalus complanatus medicinal materials, and judging whether the quality of the medicinal materials is qualified based on the determination results.

[0047] In some embodiments, the judgment criteria include: if the result of the extract is ≥18%, the medicinal material is judged to be qualified, otherwise it is unqualified.

[0048] On the other hand, an embodiment of the present invention further provides a method for preparing an extract of Astragalus complanatus, which comprises the following steps described in any of the above embodiments:

[0049] After mixing the test sample and water, heat and filter to obtain a filtrate;

[0050] Concentrating the filtrate to obtain a fluid paste;

[0051] The paste is mixed with β-cyclodextrin and then dried to obtain a dry product as the Astragalus complanatus seed extract.

[0052] In addition, the embodiments of the present invention also provide the use of the determination method described in any of the above embodiments or the screening method or quality control method described in any of the above embodiments in the preparation of Complanatae Astragali extract or Complanatae Astragali formula granules.

[0053] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0054] Example 1

[0055] A method for determining an extract of Astragalus complanatus medicinal material comprises the following steps.

[0056] 1. Weigh 50g (m 供试品 ) as the test article;

[0057] 2. Heating and filtration: add 10 times the amount of drinking water, soak for 30 minutes, heat and boil (98-100°C) for 60 minutes, filter through a 200-mesh filter cloth to obtain the filtrate;

[0058] 3. Concentration under reduced pressure: The filtrate was concentrated under reduced pressure (75°C) at a pressure of -0.06 MPa until the specific gravity at 75°C was 1.03 to obtain a paste. The total weight of the paste was recorded as m 流膏 ;

[0059] 4. Drying: Mix the flow paste and β-cyclodextrin, with the amount of β-cyclodextrin added being 20% ​​of the mass of the test drug material, stir evenly, pour into a white disk covered with plastic wrap, spread evenly, and place in an oven to dry (50°C).

[0060] 5. Grinding: Grind the dried product through a 50-mesh sieve, weigh and record m 粉碎后的产物 .

[0061] 6. Calculate the extract of Astragalus membranaceus according to the following formula:

[0062] Extract of Astragalus complanatus medicinal material = extract of original powder × (extraction rate + proportion of added β-cyclodextrin) / extraction rate;

[0063] The raw powder extract is the alcohol-soluble extract content in the raw powder measured by the alcohol-soluble extract determination method;

[0064] The alcohol-soluble extract determination method includes: taking about 2g (m 原粉取样量 ), add 95% ethanol (solvent) 100ml (V 溶剂 ), weigh the mixture, let it stand for 1 hour, connect a reflux condenser, heat to boiling, and keep it boiling for 1 hour. After cooling, weigh it again, make up the lost weight with ethanol, shake well, filter with a dry filter, and accurately measure 25 ml of the filtrate (V 所取滤液 ), put it in an evaporating dish that has been dried to constant weight, evaporate it on a water bath, dry it at 105℃ for 3 hours, cool it in a desiccator for 30 minutes, and quickly weigh it accurately (m 浸出液中可溶性物质 ).

[0065] Extract of original powder = m 浸出液中可溶性物质 / V 所取滤液 ×V 溶剂 / m 原粉取样量 ; Among them, m 浸出液中可溶性物质 is the mass of soluble matter in the leachate, V 所取滤液 is the volume of the filtrate taken, V 溶剂 The volume of solvent used to determine the extract, m 原粉取样量 The quality of the raw powder sample is taken.

[0066] Paste yield: Take 20g of paste (sampling amount of paste), weigh accurately, place in an evaporating dish with constant weight, evaporate to dryness in a water bath, dry in a 105℃ electric heating blast drying oven until dry (3 hours), move to a desiccator, cool for 30 minutes, weigh, and calculate the solid content of the paste;

[0067] Solid content of paste (%) = (total weight of paste and evaporating dish after drying - weight of evaporating dish) / sample amount of paste × 100%;

[0068] Paste yield (%) = solid content of paste × total weight of paste / m 供试品 ×100%;

[0069] The ratio of the added β-cyclodextrin is the percentage of β-cyclodextrin in the weight of the test sample.

[0070] Example 2

[0071] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that in Example 1, except that:

[0072] Step 4 Drying: The amount of β-cyclodextrin added is 25% of the mass of the test drug material.

[0073] Example 3

[0074] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that in Example 1, except that:

[0075] Step 2. Heating and filtering: the heating and boiling time is 120 minutes, and the filter cloth is 300 mesh;

[0076] Step 3. Concentration under reduced pressure: the temperature for concentration under reduced pressure is 90°C; the pressure for concentration under reduced pressure is -0.068MPa, and the specific gravity is 1.02 at 90°C;

[0077] Step 4. Drying: The amount of β-cyclodextrin added is 15% of the mass of the test drug material;

[0078] Step 5. Grinding: Grind the dried product through an 80-mesh sieve.

[0079] Example 4

[0080] A method for determining the extract of Astragalus Complanatus medicinal material is substantially the same as that of Example 3, except that:

[0081] Step 2. Heating and filtering: Add 15 times the amount of drinking water.

[0082] Example 5

[0083] A method for determining the extract of Astragalus Complanatus medicinal material is substantially the same as that of Example 3, except that:

[0084] Step 2. Heating and filtering: Add 20 times the amount of drinking water.

[0085] Example 6

[0086] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that in Example 1, except that:

[0087] Step 2. Heating and filtering: Add 15 times the amount of drinking water and heat and boil for 20 minutes;

[0088] Step 3. Concentration under reduced pressure: the temperature for concentration under reduced pressure is 80°C; the pressure for concentration under reduced pressure is -0.07MPa, and the specific gravity is 1.04 at 80°C;

[0089] Step 4. Drying: The amount of β-cyclodextrin added is 15% of the mass of the test drug material; the drying temperature in the oven is 60°C;

[0090] Step 5. Grinding: Grind the dried product through a 65-mesh sieve.

[0091] Example 7

[0092] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that of Example 6, except that:

[0093] Step 2. Heating and filtering: The heating and boiling time is 60 minutes.

[0094] Example 8

[0095] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that of Example 6, except that:

[0096] Step 2. Heating and filtering: The heating and boiling time is 120 minutes.

[0097] Example 9

[0098] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that in Example 1, except that:

[0099] Step 2. Heating and filtering: add 20 times the amount of drinking water, heat and boil for 80 minutes; filter with a 300-mesh filter cloth;

[0100] Step 3. Concentration under reduced pressure: the temperature for concentration under reduced pressure is 85°C; the pressure for concentration under reduced pressure is -0.073MPa, and the specific gravity is 1.04 at 85°C;

[0101] Step 4. Drying: The amount of β-cyclodextrin added is 15% of the mass of the test drug material; the drying temperature in the oven is 55°C;

[0102] Step 5. Grinding: Grind the dried product through a 24-mesh sieve.

[0103] Example 10

[0104] A method for determining the extract of Astragalus Complanatus medicinal material is substantially the same as that of Example 9, except that:

[0105] Step 5. Grinding: Grind the dried product through a 65-mesh sieve.

[0106] Embodiment 11

[0107] A method for determining the extract of Astragalus Complanatus medicinal material is substantially the same as that of Example 9, except that:

[0108] Step 5. Grinding: Grind the dried product through a 100 mesh sieve.

[0109] Comparative Example 1

[0110] A method for determining the extract of Astragalus complanatus medicinal material is substantially the same as that in Example 1, except that:

[0111] Step 4 Drying: No β-cyclodextrin is added.

[0112] Complanatus Astragali medicinal material extract = original powder extract.

[0113] Test Example 1

[0114] The extracts of 4 batches of Astragalus complanatus medicinal materials were measured by the determination method provided in Examples 1 to 11 and Comparative Example 1, and the quality of the 4 batches of medicinal materials was evaluated based on the extracts of the medicinal materials. If the result (content) of the extract is ≥18%, the medicinal materials are judged to be qualified, otherwise they are unqualified. The results are as follows.

[0115] Table 1 Measurement results

[0116]

[0117] Note: The extract of beta-cyclodextrin is only 0.2%, which can be ignored.

[0118] Test Example 2

[0119] After preparing the formula granules with the medicinal materials verified by the method provided in Example 1 of the present application, the production data of the formula granules of Astragalus membranaceus were tested (the testing method was determined with reference to the alcohol-soluble extract determination in the pharmacopoeia), and the results were as follows.

[0120] Table 2 Measurement results

[0121]

[0122] It can be seen from the results that the extracts of the Astragalus complanatus medicinal materials tested by the method of the present invention are qualified, and the extracts of the Astragalus complanatus formula granules produced in the corresponding batches are also qualified.

[0123] Comparative Example 2

[0124] A method for determining an extract of Astragalus complanatus medicinal material, comprising the following steps:

[0125] The medicinal material of Astragalus complanatus is directly powdered and tested by the alcohol-soluble extract determination method (hot soaking method), and the determination method comprises the following steps:

[0126] Grind the product, take about 2g, weigh accurately, put it in a 100-250ml conical flask, add 100ml of ethanol accurately, plug it, weigh it, let it stand for 1 hour, connect the reflux condenser, heat it to boiling, and keep it boiling for 1 hour. After cooling, remove the conical flask, plug it, weigh it again, make up the lost weight with ethanol, shake it well, filter it with a drying filter, accurately measure 25ml of the filtrate, put it in an evaporating dish that has been dried to constant weight, evaporate it on a water bath, dry it at 105℃ for 3 hours, cool it in a desiccator for 30 minutes, and quickly weigh it accurately.

[0127] The correlation analysis was performed between the prepared ethanol extract and the extract of Astragalus membranaceus medicinal material.

[0128] Depend on Figure 1 It can be seen that the correlation between the extract and the alcohol extract of the medicinal material is poor, so the method of direct alcohol extraction of the medicinal material is not advisable. And only half of the extracts produced from these six batches of Astragalus complanatus medicinal materials meet the standards (the standard for Astragalus complanatus formula granules requires that the extract should be ≥18%). Therefore, the Astragalus complanatus extract is obtained by simulating production (decoction → concentration → drying) in the manner provided in the embodiment of the present application, and the extract of Astragalus complanatus medicinal materials is determined by this method to ensure that the extract obtained from the medicinal materials that are qualified by this method can also be qualified when used in production.

[0129] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for determining the extract of Astragalus complanatus, characterized in that: It includes the following steps: After mixing the test sample and water, heat and filter to obtain a filtrate; Concentrating the filtrate to obtain a fluid paste; The fluid paste is mixed with β-cyclodextrin and then dried to obtain a dry product; The extract of Astragalus membranaceus medicinal material was calculated based on the extract of the original powder measured after the dry product was crushed and sieved.

2. The measuring method according to claim 1, characterized in that The mixing ratio of the fluid paste and β-cyclodextrin is: for every 100g of the test sample, 10 to 30g of the β-cyclodextrin is added.

3. The measuring method according to claim 1, characterized in that The drying method includes: drying in an oven or vacuum drying; Optionally, the drying temperature is 50-70°C.

4. The measuring method according to claim 1, characterized in that The mixing mass ratio of the test sample to water is 1:10-20; Optionally, before the heating, the determination method further comprises: soaking the mixture of the test sample and water for 30 to 60 minutes; Optionally, the heating time is 20 to 120 minutes and the temperature is 98 to 100° C.; Optionally, the filtration uses a filter cloth with a mesh size of 200 to 400.

5. The measuring method according to claim 1, characterized in that The concentration method includes reduced pressure concentration; Optionally, the pressure of the reduced pressure concentration is 0.057-0.085 MPa; Optionally, the concentration includes: concentrating the filtrate until the specific gravity of the slurry at 75-90° C. is 1.02-1.

10.

6. The measuring method according to claim 1, characterized in that The mesh number of the sieve used for the sieving is 50 to 80 meshes.

7. The measuring method according to any one of claims 1 to 6, characterized in that The calculation formula of the extract of Astragalus complanatus is: Extract of Astragalus complanatus medicinal material = extract of original powder × (extraction rate + proportion of added β-cyclodextrin) / extraction rate; Wherein, the raw powder extract is the alcohol-soluble extract content in the raw powder measured according to the alcohol-soluble extract determination method; The cream yield is the cream yield of the flowing cream, and the proportion of the added β-cyclodextrin is the percentage of β-cyclodextrin in the weight of the test sample.

8. A screening method or quality control method for Astragalus complanatus medicinal material, characterized in that: The method comprises: using the determination method described in any one of claims 1 to 7 to determine the extract of the Astragalus complanatus medicinal material, and judging whether the quality of the medicinal material is qualified based on the determination result; Optionally, the judgment standard includes: if the result of the extract is ≥18%, the medicinal material is judged to be qualified, otherwise it is unqualified.

9. A method for preparing an extract of Astragalus complanatus, characterized in that: It comprises the following steps as described in any one of claims 1 to 7: After mixing the test sample and water, heat and filter to obtain a filtrate; Concentrating the filtrate to obtain a fluid paste; The paste is mixed with β-cyclodextrin and then dried to obtain a dry product as the Astragalus complanatus seed extract.

10. Use of the determination method according to any one of claims 1 to 7 or the screening method or quality control method according to claim 8 or 9 in the preparation of Astragalus complanatus extract or Astragalus complanatus formula granules.

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