Ureuqing granules as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to uremia clearing granules as well as a preparation method and application thereof. The preparation method of the ureaoqing granules comprises the following steps: extracting rhubarb, astragalus membranaceus, white mulberry root-bark, radix sophorae flavescentis, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, prepared fleece flower root, white paeony root, salvia miltiorrhiza, ligusticum wallichii, chrysanthemum, ginger processed pinellia, plantain herb, radix bupleuri and liquorice to obtain clear paste, uniformly mixing the clear paste with corn dextrin, and drying to obtain the ureaoqing granules. The corn dextrin with proper parameters is taken as an auxiliary material through a screening experiment, the dosage of the auxiliary material is limited, the auxiliary material is mixed with the clear paste, and a proper drying mode is combined, so that the prepared ureaoqing granule has good hygroscopicity, dissolubility, formability and stability.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a urea-clearing granule and a preparation method and application thereof. Background Art

[0002] In the prescription of Uremia Clearing Granules, Astragalus and Codonopsis are used to strengthen the spleen and replenish qi, and processed Polygonum multiflorum is used to nourish the kidney and replenish essence, which can play the role of strengthening the spleen and replenishing the kidney; raw rhubarb is used to clear the bowels and eliminate turbidity, so that dampness and turbidity can be discharged from the stool, Atractylodes macrocephala is used to strengthen the spleen and eliminate dampness, Poria cocos and Plantago are used to promote diuresis and eliminate dampness, and Pinellia ternata is used to dry dampness and harmonize the middle, reduce adverse reactions and stop vomiting, which can play the role of clearing the bowels and reducing turbidity; Chuanxiong and Salvia miltiorrhiza are used to promote blood circulation and remove blood stasis. Looking at the whole prescription, it has the functions of strengthening the spleen and removing dampness, clearing the bowels and reducing turbidity, and promoting blood circulation and removing blood stasis. Its formula is reasonable and its compatibility is accurate. It hits the pathogenesis of chronic renal failure with kidney qi deficiency as the root and dampness and turbidity and blood stasis as the target, so the clinical efficacy is significant. It can reduce creatinine and urea nitrogen, stabilize renal function, and delay dialysis time; it also has a certain effect on improving renal anemia, increasing blood calcium, and reducing blood phosphorus.

[0003] Chinese invention patent publication number CN1579514A discloses a drug for treating chronic renal failure, a preparation method and use thereof, wherein the drug is prepared from crude drugs including the following raw materials: rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared radix polygoni multiflori, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, ginger pinellia, plantain, bupleurum and liquorice, wherein the crude drug composition ratio of each raw material is as follows by weight: rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared radix polygoni multiflori, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, ginger pinellia, plantain, bupleurum and liquorice = 3-30:9-30:6-12; 4.5-9:9-30:6-12:9-15:6-12:6-15:9-15:3-9:5-9:3-9:9-30:3-9:1.5-9.

[0004] However, the prior art Urea Clearing Granules have the problem of poor stability, require special conditions for preservation, and are not suitable for industrial production. In view of this, the art urgently needs to develop a Urea Clearing Granule with good hygroscopicity, solubility, formability and stability. Summary of the invention

[0005] In view of the problems existing in the prior art, the present invention provides a urea-clearing granule and a preparation method and application thereof.

[0006] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0007] A method for preparing urea-clearing granules comprises the following steps:

[0008] The extract obtained by extracting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is mixed with corn dextrin and dried to obtain the product.

[0009] Preferably, the DE value of the corn dextrin is 3-6.

[0010] More preferably, the DE value of the corn dextrin is 4-6.

[0011] Preferably, the mass ratio of the clear paste to corn dextrin is 5-8:2-3.

[0012] Preferably, the mass ratio of the clear paste to corn dextrin is 6-7:2.5-3.

[0013] Preferably, the mass ratio of rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is 1:3-5:2-6:1-5:2-6:3-7:4-5:3-6:2-4:3-6:1-4:2-3:1-2:3-6:1-2:0.5-1.

[0015] More preferably, the mass ratio of rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared polygonum multiflorum, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and licorice is 1:4:3:2:3:5:5:5:3:5:3:2.5:2:5:1.5:0.9.

[0017] Preferably, the preparation method of the clear paste comprises the following steps: decocting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and licorice in water, filtering and concentrating to obtain the clear paste.

[0018] Preferably, the decoction process comprises decocting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and licorice with 2-10 times the weight of water for 2-4 times, each time for 1-3 hours, and filtering and combining the decoctions.

[0019] More preferably, the decoction process comprises decocting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and licorice with 2.5-6 times the weight of water for 2-3 times, each time for 2-3 hours, and filtering and combining the decoctions.

[0020] Preferably, the concentration adopts double-effect concentration until the relative density is 1.1-1.3 g / mL, and the process parameters of the double-effect concentration include a first-effect concentration temperature of 45-90°C and a first-effect concentration pressure of ~0.05-~0.08Mpa; a second-effect concentration temperature of 40-85°C and a second-effect concentration pressure of ~0.07-~0.10Mpa.

[0021] Preferably, the drying is vacuum drying, spray drying or freeze drying.

[0022] Preferably, the inlet air temperature of the spray drying is 80-150°C, the outlet air temperature of the spray drying is 40-80°C, the atomization pressure of the spray drying spray gun is 0.05-0.45Mpa, the infusion pressure is 0.04-0.4Mpa, and the spray drying time is 2-5h.

[0023] The present invention also provides the Urea Clearing Granules prepared by the above preparation method.

[0024] The present invention also provides the Urea Clearing Granules prepared by the above preparation method or the use of the Urea Clearing Granules in preparing a drug for treating chronic kidney disease.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The invention uses corn dextrin with suitable parameters as an auxiliary material through screening experiments, limits the amount of the auxiliary material, mixes it with the clear paste, and combines it with a suitable drying method to prepare the urea-clearing granules with good hygroscopicity, solubility, formability and stability. DETAILED DESCRIPTION

[0027] It is worth noting that the raw materials used in the present invention are all common commercially available products.

[0028] Example 1

[0029] A method for preparing urea-clearing granules, comprising the following steps:

[0030] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0031] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0032] (3) The clear paste and corn dextrin (DE=5) are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 mesh.

[0033] Example 2

[0034] A method for preparing urea-clearing granules, comprising the following steps:

[0035] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 6 times the weight of water, each time for 3 h, filter and combine the decoctions.

[0036] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 90°C and the concentration pressure being -0.05 MPa; the second-effect concentration temperature being 85°C and the concentration pressure being -0.10 MPa, until the relative density reaches 1.3 g / mL, thereby obtaining a clear paste.

[0037] (3) The clear paste and corn dextrin (DE=5) are mixed in a mass ratio of 8:3, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 120°C, outlet air temperature is 50°C, spray gun atomization pressure is 0.3Mpa, infusion pressure is 0.2Mpa, and drying time is 3h. The dried mixture is crushed into 60 meshes to obtain.

[0038] Example 3

[0039] A method for preparing urea-clearing granules, comprising the following steps:

[0040] (1) Weigh 50 g of rhubarb, 150 g of astragalus, 100 g of mulberry bark, 50 g of sophora flavescens, 100 g of codonopsis pilosula, 150 g of atractylodes macrocephala, 200 g of poria, 150 g of processed shouwu, 100 g of white peony root, 150 g of salvia miltiorrhiza, 50 g of chuanxiong, 100 g of chrysanthemum, 50 g of pinellia tuber, 150 g of plantain, 50 g of bupleurum, and 25 g of liquorice, mix them, and boil them three times with 3 times the weight of water, each time for 2 h. Filter and combine the decoctions.

[0041] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 45°C and the concentration pressure being -0.05 MPa; the second-effect concentration temperature being 40°C and the concentration pressure being -0.07 MPa, until the relative density reaches 1.3 g / mL, thereby obtaining a clear paste.

[0042] (3) The clear paste and corn dextrin (DE=6) are mixed in a mass ratio of 5:3, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 80°C, outlet air temperature is 40°C, spray gun atomization pressure is 0.05Mpa, infusion pressure is 0.04Mpa, and drying time is 2h. The dried mixture is crushed into 60 mesh.

[0043] Example 4

[0044] A method for preparing urea-clearing granules, comprising the following steps:

[0045] (1) Weigh 50 g of rhubarb, 250 g of astragalus, 300 g of mulberry bark, 250 g of sophora flavescens, 300 g of codonopsis pilosula, 350 g of atractylodes macrocephala, 250 g of poria, 300 g of processed shouwu, 200 g of white peony root, 300 g of salvia miltiorrhiza, 200 g of chuanxiong, 150 g of chrysanthemum, 100 g of pinellia tuber, 300 g of plantain, 100 g of bupleurum, and 50 g of liquorice, mix them, and decoct them four times with 4 times the weight of water, each time for 3 h. Filter and combine the decoctions.

[0046] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 80°C and the concentration pressure being -0.08 MPa; the second-effect concentration temperature being 60°C and the concentration pressure being -0.1 MPa, until the relative density reaches 1.1 g / mL, thereby obtaining a clear paste.

[0047] (3) The clear paste and corn dextrin (DE=3) are mixed in a mass ratio of 4:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 150°C, outlet air temperature is 80°C, spray gun atomization pressure is 0.45Mpa, infusion pressure is 0.4Mpa, and drying time is 5h. The dried mixture is crushed into 60 meshes to obtain.

[0048] Comparative Example 1

[0049] Same as Example 1, except that the DE of corn dextrin is 2.

[0050] A method for preparing urea-clearing granules, comprising the following steps:

[0051] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0052] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0053] (3) The clear paste and corn dextrin (DE=2) are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 meshes to obtain the product.

[0054] Comparative Example 2

[0055] Same as Example 1, except that the DE of corn dextrin is 10.

[0056] A method for preparing urea-clearing granules, comprising the following steps:

[0057] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0058] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0059] (3) The clear paste and corn dextrin (DE=10) are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 mesh.

[0060] Comparative Example 3

[0061] The same as Example 1, the only difference is that corn dextrin is replaced by wheat starch.

[0062] A method for preparing urea-clearing granules, comprising the following steps:

[0063] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0064] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0065] (3) The paste and wheat starch are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: air inlet temperature is 100°C, air outlet temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 mesh.

[0066] Comparative Example 4

[0067] Same as Example 1, except that corn dextrin is replaced by potato starch.

[0068] A method for preparing urea-clearing granules, comprising the following steps:

[0069] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0070] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0071] (3) The clear paste and potato starch are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 mesh.

[0072] Comparative Example 5

[0073] The same as Example 1, the only difference is that corn dextrin is replaced by maltodextrin.

[0074] A method for preparing urea-clearing granules, comprising the following steps:

[0075] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0076] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0077] (3) The clear paste and maltodextrin (DE=5) are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 meshes to obtain.

[0078] Comparative Example 6

[0079] The same as Example 1, the only difference is that the clear paste and corn dextrin (DE=5) are mixed in a mass ratio of 6:5.

[0080] A method for preparing urea-clearing granules, comprising the following steps:

[0081] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0082] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0083] (3) The clear paste and corn dextrin (DE=5) are mixed in a mass ratio of 6:5, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 100°C, outlet air temperature is 60°C, spray gun atomization pressure is 0.25Mpa, infusion pressure is 0.2Mpa, and drying time is 4h. The dried mixture is crushed into 60 mesh.

[0084] Comparative Example 7

[0085] The same as Example 1, the only difference is the spray drying conditions.

[0086] A method for preparing urea-clearing granules, comprising the following steps:

[0087] (1) Weigh 50 g of rhubarb, 200 g of astragalus, 150 g of mulberry bark, 100 g of sophora flavescens, 150 g of codonopsis pilosula, 250 g of atractylodes macrocephala, 250 g of poria, 250 g of processed shouwu, 150 g of white peony root, 250 g of salvia miltiorrhiza, 150 g of chuanxiong, 125 g of chrysanthemum, 100 g of pinellia tuber, 250 g of plantain, 75 g of bupleurum and 45 g of liquorice, mix them, decoct them three times with 2.5 times the weight of water, each time for 2 h, filter and combine the decoctions.

[0088] (2) The filtrate is placed in a double-effect vacuum concentrator for concentration, with the first-effect concentration temperature being 60°C and the concentration pressure being -0.06 MPa; the second-effect concentration temperature being 50°C and the concentration pressure being -0.08 MPa, until the relative density reaches 1.2 g / mL, thereby obtaining a clear paste.

[0089] (3) The clear paste and corn dextrin (DE=5) are mixed in a mass ratio of 2:1, and the mixture is dried by spray drying. The specific spray drying conditions are: inlet air temperature is 180°C, outlet air temperature is 30°C, spray gun atomization pressure is -0.05Mpa, infusion pressure is 0.6Mpa, and drying time is 4h. The dried mixture is crushed into 60 meshes to obtain.

[0090] Test Case

[0091] The urea-clearing granules prepared in Examples 1-4 and Comparative Examples 1-7 were subjected to hygroscopicity, solubility, formability, stability and effective ingredient content tests, respectively. The specific experimental methods are as follows:

[0092] Hygroscopicity experiment: Place about 2mm thick Urea Clearing Granules at the bottom of a weighing bottle with constant weight, weigh accurately and place in the above-mentioned glass desiccator (relative humidity 75%), weigh regularly at 1, 24, 72 and 120 hours, and calculate the moisture absorption rate.

[0093] Solubility test: According to the general rule 0104 Granules of the 2020 edition of the Chinese Pharmacopoeia, the Urea Clearance Granules were tested. Specifically, take 10g of the test sample, add 200mL of hot water, stir for 5 minutes, and immediately observe the dissolution state of the soluble granules.

[0094] Formability test: According to the particle size and particle size distribution determination method of the Chinese Pharmacopoeia 2020 edition General Chapter 0982, the Urea Clearance Granules were tested. Specifically, the formula granules that can pass through the No. 1 sieve and those that cannot pass through the No. 5 sieve were collected and weighed.

[0095] Forming rate (%) = mass of particles after sieving / mass of particles before sieving × 100%.

[0096] Stability test: Put the Urea Clearing Granules into capsules, use aluminum-plastic-aluminum as outer packaging and put them into a high-temperature (50°C) stability test box, and observe the dispersibility of the material every 10 days.

[0097] Test of active ingredient content: paeoniflorin and salvianolic acid B were selected as detection indicators, and the test method referred to the quality detection method of Chinese medicine composition in China's invention patent—CN115184500A, wherein the content of paeoniflorin was not less than 0.7 mg / g, and the content of salvianolic acid B was not less than 0.25 mg / g.

[0098] The test data results are shown in Table 1-Table 2.

[0099] Table 1 Moisture absorption rate and molding rate test data

[0100]

[0101] Table 2 Solubility, stability and active ingredient content test results

[0102]

[0103] As shown in Table 1-Table 2, the Uridine Clear Granules prepared in Examples 1-4 are superior to Comparative Examples 1-7 in terms of hygroscopicity, solubility, formability, stability and active ingredient content. It can be seen from Comparative Examples 1 and 2 that only a specific corn dextrin DE value can maintain the hygroscopicity, formability, solubility and stability of the Uridine Clear Granules at a good level. And it can be seen from Comparative Examples 3, 4 and 5 that maltodextrin is very necessary to maintain the physical properties of the Uridine Clear Granules. After replacing corn dextrin with wheat starch, potato starch or maltodextrin, the hygroscopicity, formability and stability of the Uridine Clear Granules all show varying degrees of reduction, and the prepared granules cannot be stored for a long time. Finally, it can be seen from Comparative Examples 6 and 7 that different corn dextrin additions and drying processes also have a greater impact on the hygroscopicity, formability and stability of the Uridine Clear Granules of the present invention, especially the drying process has a more obvious impact on the active ingredient content of the granules.

[0104] In summary, the present invention uses corn dextrin with suitable parameters as an auxiliary material through screening experiments, limits the amount of the auxiliary material, mixes it with the clear paste, and combines it with a suitable drying method to prepare the urea-clearing granules with good hygroscopicity, solubility, formability and stability.

[0105] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing Urea Clearing Granules, characterized in that: The steps include: The extract obtained by extracting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is mixed with corn dextrin and dried to obtain the product.

2. The preparation method according to claim 1, characterized in that: The DE value of the corn dextrin is 3-6.

3. The preparation method according to claim 1, characterized in that: The mass ratio of the clear paste to corn dextrin is 5-8:2-3.

4. The preparation method according to claim 1, characterized in that: The mass ratio of rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is 1:3-5:2-6:1-5:2-6:3-7:4-5:3-6:2-4:3-6:1-4:2-3:1-2:3-6:1-2:0.5-1.

5. The preparation method according to claim 1, characterized in that: The preparation method of the clear paste comprises the following steps: boiling rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice in water, filtering and concentrating to obtain the clear paste.

6. The preparation method according to claim 5, characterized in that: The decoction process comprises decocting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice for 2-4 times with 2-10 times the weight of water, each time for 1-3 hours, and filtering and combining the decoction.

7. The preparation method according to claim 5, characterized in that: The concentration adopts double-effect concentration until the relative density is 1.1-1.3g / mL. The process parameters of the double-effect concentration include a temperature of 45-90°C for the first-effect concentration and a pressure of 0.05-0.08Mpa for the first-effect concentration; a temperature of 40-85°C for the second-effect concentration and a pressure of 0.07-0.10Mpa for the second-effect concentration.

8. The preparation method according to claim 1, characterized in that: The drying is vacuum drying, spray drying or freeze drying, the inlet air temperature of the spray drying is 80-150°C, the outlet air temperature of the spray drying is 40-80°C, the atomization pressure of the spray drying spray gun is 0.05-0.45Mpa, the infusion pressure is 0.04-0.04Mpa, and the spray drying time is 2-5h.

9. Urea-clearing granules prepared by the preparation method according to any one of claims 1 to 8.

10. Use of the Urea Clearing Granules prepared by the preparation method according to any one of claims 1 to 8 or the Urea Clearing Granules according to claim 9 in the preparation of a drug for treating chronic kidney disease.

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