Preparation method, application and product of Fule granules

Abstract

The invention provides a preparation method and application of Fule granules and a product, and belongs to the technical field of traditional Chinese medicine preparation. The preparation method comprises the following steps: S1, soaking cooked rhubarb powder in ethanol, percolating, collecting percolate, filtering to obtain filtrate, recovering rhubarb clear paste from the filtrate by using second-effect steam at the temperature of not more than 55-90 DEG C, and retaining medicine residues; s2, heating honeysuckle stem, sargentgloryvine stem, liquorice, folium isatidis, dandelion, moutan bark, red paeony root, szechwan chinaberry fruit, vinegar-processed corydalis tuber and the decoction dregs in the S1, extracting, filtering and concentrating to obtain ten-component clear paste, and drying to obtain dry paste powder; and S3, granulating. The fule granule product prepared by the invention has high chrysophanol content and good dissolution rate, and has a certain application prospect clinically.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparation, and specifically relates to a preparation method, application and product of Fule granules. Background Art

[0002] Pelvic inflammatory disease refers to inflammation of the female reproductive organs, connective tissue around the uterus, and pelvic peritoneum. Chronic pelvic inflammation is often caused by incomplete treatment of the acute phase. It has a long onset and is a stubborn disease. Bacteria retrogradely infect the pelvis through the uterus and fallopian tubes. Fule Granules are currently included in the 2020 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the Pharmacopoeia). It is a Chinese patent medicine made from 10 medicinal materials, including honeysuckle vine, Sargentophyllum reticulata, licorice, isatis indigotica, dandelion, peony bark, red peony root, Toosendan fruit, vinegar Corydalis and cooked rhubarb. It has the effects of clearing heat and cooling blood, removing blood stasis and relieving pain. It is clinically used for leucorrhea caused by stagnation of blood stasis and chronic pelvic inflammatory disease.

[0003] The prescription composition ratio of Fule Granules recorded in the pharmacopoeia is: 1126g of honeysuckle vine, 338g of dandelion, 1126g of Sargentodoxa chinensis, 338g of Toosendan fruit, 338g of Isatis indigotica, 113g of licorice, 338g of red peony root, 338g of peony bark, 338g of vinegar Corydalis yanhusuo, 225g of cooked rhubarb, made into 1000g. The process / preparation method recorded in the pharmacopoeia includes: the above ten flavors, take cooked rhubarb and crush it into coarse powder, use 60% ethanol as solvent, soak for 24 hours and then percolate, collect 1215mL of percolate, filter, and decompress the filtrate to a clear paste with a relative density of 1.20-1.22 (45-50℃), and set aside the residue; the remaining nine flavors such as honeysuckle vine are decocted twice with water, the first time for 2 hours, and the second time, after adding cooked rhubarb to percolate the residue, decocted for 1 hour, the decoction is filtered, the filtrate is combined, concentrated to a ten-flavor clear paste with a relative density of 1.06-1.08 (85-90℃), combined with the above clear paste, mixed, spray-dried into fine powder, added with appropriate amount of stevioside and dextrin, made into granules, dried, and made into 1000g. The current standard controls the content of chrysophanol and rhein in cooked rhubarb.

[0004] However, the chrysophanol content of the Fule Granules prepared using the method recorded in the pharmacopoeia is not ideal, the product failure rate is high, and the product solubility has certain shortcomings. Summary of the invention

[0005] In order to solve the above problems, the present invention provides a method for preparing Fule granules.

[0006] The preparation method of the present invention comprises the following steps:

[0007] S1. After the cooked rhubarb powder is impregnated with ethanol, the percolation liquid is collected and filtered to obtain a filtrate, and the filtrate is recovered by a second-effect steam at no more than 55-90 ℃ and the rhubarb paste is retained;

[0008] S2. The residues of honeysuckle vine, Sargentophyllum spatholobi, licorice, isatis indigo leaf, dandelion, peony bark, red peony root, Toosendan fruit, vinegar Corydalis and S1 were heated and extracted, filtered and concentrated to obtain a ten-flavor clear paste, which was dried to obtain a dry paste powder;

[0009] S3. Granulation.

[0010] Preferably, in step S1, the second-effect steam temperature does not exceed 55-80°C.

[0011] Further preferably, in step S1, the second-effect steam temperature does not exceed 55-70°C.

[0012] Furthermore, in step S1, the second-effect steam temperature does not exceed 55-60°C.

[0013] In some specific embodiments, in step S1, the second-effect steam temperature does not exceed 55°C.

[0014] The preparation method of the present invention may refer to the pharmacopoeia for some steps, and specifically may be:

[0015] In step S1, the concentration of ethanol is 60% (V / V).

[0016] The impregnation in step S1 includes impregnation for 20 minutes, and the impregnation time is 24 hours.

[0017] The recovered clear paste in step S1 is a clear paste having an ethanol relative density of 1.1.

[0018] The number of heating extractions in step S2 is 2 times.

[0019] The conditions for heating extraction in step S2 are: heating extraction of honeysuckle vine, Sargentodon sphagnum, licorice, isatis indigotica, dandelion, peony bark, red peony root, Toosendan fruit, and vinegar Corydalis yanhusuo for the first time, adding 5 times of water for the first time and decocting for 2 hours; adding 4 times of water for the second time, adding the residue of step S1, and decocting for 1 hour; combining the extracts.

[0020] The concentration in step S2 is to concentrate the drug solution until the relative density is 1.06-1.08.

[0021] The drying in step S2 is spray drying.

[0022] Step S3 includes mixing with auxiliary materials for granulation; the auxiliary materials include dextrin or stevioside.

[0023] The granulation in step S3 is performed by fluidized bed granulation.

[0024] In some specific implementations, the following steps may be included:

[0025] 1-1 Take cooked rhubarb and grind it into coarse powder. Use 60% ethanol as solvent and soak it for 20 minutes. After the powder is fully moistened and expanded, soak it for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter it and use two-effect steam (not exceeding 55-90℃) to recover the rhubarb paste with a relative density of 1.1 (45-50℃). The residue is reserved for later use.

[0026] 1-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, decoct for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, decoct for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), to obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0027] 1-3 Add the dry paste powder, dextrin and stevioside into a fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0028] On the other hand, the present invention provides application of the preparation method in preparing Fule granules.

[0029] Accordingly, the present invention also protects the Fule granule product prepared according to the preparation method.

[0030] Preferably, the Fule granule product comprises greater than 0.099 mg / g of chrysophanol, preferably greater than 0.102 mg / g, or greater than 0.107 mg / g, or greater than 0.12 mg / g, or greater than 0.19 mg / g of chrysophanol.

[0031] Preferably, the solubility of the Fule granule product is greater than 34, or greater than 51.4, or greater than 52, or greater than 57, or greater than 62, or greater than 79.

[0032] Beneficial effects of the present invention:

[0033] The present invention optimizes the preparation method of Fule granules in the pharmacopoeia, adds the step of extracting chrysophanol with double-effect steam, on the one hand, increases the content of chrysophanol in the product, which can reach up to 0.19 mg / g, far exceeding the product prepared by the method recorded in the pharmacopoeia; on the other hand, increases the solubility of the product, which is 51.4-79, both higher than the product prepared by the pharmacopoeia method. The product prepared by the method of the present invention has a small amount of use and a high solubility in actual application, and has a good clinical application prospect. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1-Figure 3This is the detection diagram of chrysophanol and rhamnosine in the sample.

[0035] Figure 1 This is the peak diagram of rhein and chrysophanol reference substances. Figure 2 This is the peak diagram of the pharmacopoeia sample Fule Granules. Figure 3 This is the peak diagram of the sample prepared in Example 1.

[0036] Figure 1 Middle: The marker value at the chrysophanol peak is 17.010.

[0037] The peak graph is obtained by taking a screenshot of the software, and some unclear details do not affect the determination of the technical effect. DETAILED DESCRIPTION

[0038] The present invention will be further described in detail below in conjunction with specific examples. The following examples are not intended to limit the present invention, but are only intended to illustrate the present invention. The experimental methods used in the following examples are generally conventional, unless otherwise specified, and the materials, reagents, etc. used in the following examples are commercially available, unless otherwise specified.

[0039] Example 1

[0040] The preparation method of Fule granules comprises the following steps:

[0041] 1-1 Take cooked rhubarb and grind it into coarse powder. Use 60% ethanol as solvent and soak it for 20 minutes. After the powder is fully moistened and expanded, soak it for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter it and use two-effect steam (not exceeding 55°C) to recover the rhubarb paste with a relative density of 1.1 (45-50°C). The residue is reserved for later use.

[0042] 1-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, decoct for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, decoct for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), to obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0043] 1-3 Add the dry paste powder, dextrin and stevioside into a fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0044] Compared with the method in the pharmacopoeia, this embodiment optimizes the filtrate recovery method and adopts two-effect steam for recovery.

[0045] Example 2

[0046] The preparation method of Fule granules comprises the following steps:

[0047] 2-1 Take cooked rhubarb and grind it into coarse powder. Use 60% ethanol as solution to soak for 20 minutes. After the powder is fully moistened and expanded, soak for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter and use two-effect steam (60℃) to recover the ethanol with a relative density of 1.1 (45-50℃) rhubarb paste. The residue is reserved for later use.

[0048] 2-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, and put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, decoct for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, decoct for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), to obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0049] 2-3 Add the dry paste powder, dextrin and stevioside into a fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0050] Example 3

[0051] The preparation method of Fule granules comprises the following steps:

[0052] 3-1 Take cooked rhubarb and grind it into coarse powder. Use 60% ethanol as solution to soak for 20 minutes. After the powder is fully moistened and expanded, soak for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter and use two-effect steam (70℃) to recover the ethanol with a relative density of 1.1 (45-50℃) rhubarb paste. The residue is reserved for later use.

[0053] 3-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, boil for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, boil for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), and obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0054] 3-3 Add the dry paste powder, dextrin and stevioside into the fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0055] Example 4

[0056] The preparation method of Fule granules comprises the following steps:

[0057] 4-1 Take cooked rhubarb and crush it into coarse powder. Use 60% ethanol as solution to soak for 20 minutes. After the powder is fully moistened and expanded, soak for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter and use two-effect steam (not exceeding 80°C) to recover the ethanol with a relative density of 1.1 (45-50°C) to make rhubarb paste. The residue is reserved for later use.

[0058] 4-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, boil for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, boil for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), and obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0059] 4-3 Add the dry paste powder, dextrin and stevioside into the fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0060] Example 5

[0061] The preparation method of Fule granules comprises the following steps:

[0062] 5-1 Take cooked rhubarb and crush it into coarse powder. Use 60% ethanol as solution to soak for 20 minutes. After the powder is fully moistened and expanded, soak for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter and use two-effect steam (not exceeding 90°C) to recover the ethanol with a relative density of 1.1 (45-50°C) to make rhubarb paste. The residue is reserved for later use.

[0063] 5-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar corydalis, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, boil for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, boil for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90°C), to obtain ten-flavor clear paste, spray dry to obtain dry paste powder, and set aside.

[0064] 5-3 Add the dry paste powder, dextrin and stevioside into the fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0065] Comparative Example 1

[0066] 6-1 Take cooked rhubarb and crush it into coarse powder. Use 60% ethanol as solvent and soak it for 20 minutes. After the powder is fully moistened and expanded, soak it for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter it and use two-effect steam (not exceeding 40℃) to recover the rhubarb paste with a relative density of 1.1 (45-50℃). The residue is reserved for later use.

[0067] 6-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar Corydalis yanhusuo, put them in a multi-functional extraction tank, heat and extract twice, add 5 times of water for the first time, boil for 2 hours, add 4 times of water for the second time, add rhubarb percolation residue, boil for 1 hour, combine the two extracts, filter, and enter the double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90℃), to obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0068] 6-3 Add the dry paste powder, dextrin and stevioside into the fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0069] Comparative Example 2

[0070] 7-1 Take cooked rhubarb and crush it into coarse powder. Use 60% ethanol as solvent and soak it for 20 minutes. After the powder is fully moistened and expanded, soak it for 24 hours and then perform percolation. Collect the percolation liquid with a volume of 5.4 times the weight of rhubarb. Filter it and use two-effect steam (not exceeding 55°C) to recover the rhubarb paste with a relative density of 1.1 (45-50°C). The residue is reserved for later use.

[0071] 7-2 Take 1126g of honeysuckle vine, 1126g of Sargentodoxae, 113g of liquorice, 338g of isatis indigotica, 338g of dandelion, 338g of peony bark, 338g of red peony root, 338g of toosendan fruit, and 338g of vinegar Corydalis yanhusuo, put them in a multi-functional extraction tank, heat and extract three times, add 5 times of water for the first time, and boil for 2 hours; add 4 times of water for the second time, add rhubarb percolation residue, and boil for 1 hour; add 2 times of water for the third time, boil for 1h, combine the three extracts, filter, and put them into a double-effect concentrator for concentration until the relative density of the liquid is 1.06-1.08 (85-90℃), to obtain Shiweiqing paste, spray dry to obtain dry paste powder, and set aside.

[0072] 7-3 Add the dry paste powder, dextrin and stevioside into the fluidized bed granulator, spray granulate the rhubarb paste, and dry it to obtain the product.

[0073] Effect experiment example

[0074] Test method: Take 10g of each of the granules prepared in the examples and comparative examples, and use the pharmacopoeia sample prepared by the preparation method of Fule Granules recorded in the Chinese Pharmacopoeia as a control, and perform the following tests:

[0075] (1) The dissolution test of the Fule Granules prepared according to the Chinese Pharmacopoeia was carried out to investigate the dissolution of the Fule Granules prepared according to the present invention and the Chinese Pharmacopoeia.

[0076] (2) Chrysophanol and rhamnosin were tested according to the content detection method of Fule Granules on page 949 of Volume 1 of the Chinese Pharmacopoeia 2020.

[0077] The test results are shown in Table 1:

[0078] Table 1

[0079] sample Dissolution Chrysophanol (mg / g) Rhein(mg / g) Pharmacopoeia samples 34 0.1 0.058 Example 1 79 0.19 0.096 Example 2 62 0.12 0.063 Example 3 57 0.107 0.056 Example 4 52 0.102 0.052 Example 5 51 0.099 0.049 Comparative Example 1 72 0.17 0.082 Comparative Example 2 76 0.184 0.09

[0080] Table 1 above shows:

[0081] 1. Due to the different extraction conditions of cooked rhubarb paste, the contents of chrysophanol and rhein in the prepared Fule granules are also different. The contents of chrysophanol and rhein in the Fule granules prepared in Example 1 are the best. In addition, the extraction temperature also affects the solubility of the Fule granules product in the context of the overall solution. It can be seen that the product solubility is the best under the conditions of Example 1, which has unexpected technical effects.

[0082] Some of the detection peaks are shown in Figure 1-Figure 3 ,in Figure 1 This is the peak diagram of rhein and chrysophanol reference substances. Figure 2 This is the peak diagram of the pharmacopoeia sample Fule Granules. Figure 3 This is the peak diagram of the sample prepared in Example 1.

[0083] 2. The product prepared by the method of the present invention reduces the loss of effective ingredients. For example, patients take 12 g of Fule Granules (pharmacopoeia sample) prepared according to the method of the Chinese Pharmacopoeia each time, while they only need to take 4-6 g of Fule Granules prepared by the present invention each time, thereby increasing the content of effective ingredients.

[0084] Example 6 Pilot Process Investigation

[0085] Step 1: Weigh 675g of cooked rhubarb powder, place it in a closed container according to the percolation method, add 60% ethanol to soak for 20 minutes, wait until the powder is fully moistened, evenly load it into the percolation cylinder, add 60% ethanol (6 times the amount of medicinal materials) 4050mL, soak for 24 hours, then perform percolation, adjust the percolation speed to 3-5mL / min / kg, collect 3013.0g of percolate for later use.

[0086] Step 2: Filter the percolate, and use the second-effect steam at a temperature not exceeding 55°C to recover the rhubarb paste, and keep the residue for later use.

[0087] Step 3: Weigh 3378.0g of honeysuckle vine, 1014.0g of dandelion, 3378.0g of safflower vine, 1014.0g of Chuanlianzi, 1014.0g of Isatis indigotica, 339.0g of licorice, 1014.0g of red peony root, 1014.0g of peony bark, and 1014.0g of vinegar corydalis, wash, moisten and chop. Put the above nine herbs in an extraction tank and boil them twice with water. For the first time, add 65895mL of water 5 times the amount of the herbs, soak for half an hour, boil with steam, boil, keep warm for 2 hours, and filter the decoction; the decoction is about 15602.5g.

[0088] Step 4: Add the cooked rhubarb residue for the second time, add 4 times the amount of water as the medicinal material (52716.0 mL), boil, keep warm for 1 hour, filter the decoction, and obtain about 37553.5 g of decoction.

[0089] Step 5: Combine the two decoctions, concentrate to a Shiweiqing paste with a relative density of 1.20 (85-90°C), and filter to obtain 4203.5 g of Shiweiqing paste.

[0090] Step 6: Concentrate the Shiweiqing Paste under reduced pressure until the medicinal liquid is concentrated to 679.5 g of Shiweiqing Paste with a relative density of 1.20 (45°C).

[0091] Step 7: Weigh 10.29g of stevia and add it to the hot ten-flavor extract, fully dissolve it, and stir it evenly. Weigh 1813.5g of dextrin and heat it in a hot bed for more than 30 minutes (80°C), then cool it to below 40°C. Take the ten-flavor extract (cool it to below 40°C) and add it to the rhubarb extract, and stir it evenly. Spray it into a fluidized bed for granulation, sieve it, and get 2072g of granules.

[0092] Step 8: Rhein and chrysophanol were tested according to the content test method of Fule Granules on page 896 of the 2020 edition of the Chinese Pharmacopoeia. The test results are as follows:

[0093] The granule batch number is S230302, and the content is: 0.096 mg / g of rhein, 0.19 mg / g of chrysophanol, and the moisture content is: 1.6%.

Claims

1. A method for preparing Fule granules, characterized in that: The following steps are involved: S1. After the cooked rhubarb powder is impregnated with ethanol, the percolation liquid is collected and filtered to obtain a filtrate, and the filtrate is recovered by a second-effect steam at no more than 55-90 ℃ and the rhubarb paste is retained; S2. The residues of honeysuckle vine, Sargentophyllum spatholobi, licorice, isatis indigo leaf, dandelion, peony bark, red peony root, Toosendan fruit, vinegar Corydalis and S1 were heated and extracted, filtered and concentrated to obtain a ten-flavor clear paste, which was dried to obtain a dry paste powder; S3. Granulation.

2. The preparation method according to claim 1, characterized in that: In step S1, the second-effect steam temperature is not more than 55-80°C; preferably not more than 55-70°C; more preferably not more than 55-60°C; further preferably not more than 55°C.

3. The preparation method according to claim 1, characterized in that: In step S1, the concentration of ethanol is 60% (V / V); the soaking before soaking includes soaking for 20 minutes, and the soaking time is 24 hours; the recovered clear paste is a clear paste with a relative density of ethanol of 1.

1.

4. The preparation method according to claim 3, characterized in that: The number of heating extractions in step S2 is 2 times; the conditions for heating extraction are: heating extraction is performed on honeysuckle vine, safflower vine, liquorice, isatis indigotica, dandelion, peony bark, red peony root, toosendan fruit, and vinegar corydalis for the first time, adding 5 times of water for the first time and decocting for 2 hours; adding 4 times of water for the second time, adding the residue of step S1, and decocting for 1 hour; and combining the extracts.

5. The preparation method according to claim 4, characterized in that: The concentration in step S2 is to concentrate the drug solution until the relative density is 1.06-1.

08.

6. The preparation method according to claim 5, characterized in that: The drying in step S2 is spray drying.

7. The preparation method according to claim 6, characterized in that: Step S3 includes mixing with auxiliary materials for granulation; the auxiliary materials include dextrin or stevioside.

8. The preparation method according to claim 7, characterized in that: The granulation is carried out by fluidized bed granulation.

9. Use of the preparation method according to any one of claims 1 to 8 in the preparation of Fule Granules.

10. The Fule granule product obtained according to the preparation method according to any one of claims 1 to 8.

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