Method for preparing a composition of zhi-tu qu-shi granules

Abstract

The application discloses a preparation method of a shuidi granule composition, and belongs to the technical field of traditional Chinese medicine preparations. The technical problems to be solved are to improve the preparation efficiency, the transfer rate of active ingredients and the extract rate. The technical solution is as follows: medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include Astragalus membranaceus, salted Cuscuta chinensis, Bitter Orange Kernel, Atractylodes lancea, dried orange peel, Centella asiatica and Cicada Slough; the extract is concentrated and sieved to obtain a clear extract; a first part of malt dextrin is mixed with the clear extract, dried and sieved to obtain a dry powder; the dry powder is mixed with a flow aid, a second part of malt dextrin is added, and the mixture is uniformly mixed to obtain a shuidi granule intermediate; the shuidi granule intermediate is granulated and sieved to obtain the shuidi granule; the addition amount of the first part of malt dextrin is 3-8% of the mass of the medicinal materials; and the addition amount of the second part of malt dextrin is adjusted according to the actual yield of the dry powder, so that the first part of malt dextrin and the second part of malt dextrin account for 30-35% of the mass of the shuidi granule.

Description

Technical Field

[0001] The present invention provides a preparation method of Qitu Qushi Granule composition, belonging to the technical field of traditional Chinese medicine preparations. Background Art

[0002] For understanding the technical content of the present invention:

[0003] The Tangshen Qushi Prescription can significantly increase the glomerular filtration rate eGFR of diabetic nephropathy patients and significantly decrease the serum creatinine Cr, and has a definite renal function protection effect on patients with mild urinary protein (1202.15±784.85) and above stage 3 of CKD (eGFR 25 75 mL / min / 1.73 m2). However, the Tangshen Qushi Prescription is a traditional Chinese medicine decoction, which needs to be decocted before taking, and is not conducive to maintaining the compliance of patients.

[0004] Relevant patent documents retrieved: The country of publication is China, the publication number is CN113041300B, and the publication date is June 29, 2021. This document discloses: A Tangshen Qushi Prescription and its application, and its main active ingredients include, by weight: 9-30 parts of Astragalus membranaceus, 6-15 parts of Cuscuta chinensis, 5-10 parts of Prunus persica, 3-10 parts of Atractylodes lancea, 3-10 parts of Citrus reticulata Blanco, 15-30 parts of Centella asiatica, 3-10 parts of Cordyceps cicadae. The present invention also provides the application of the Tangshen Qushi Prescription. However, this prescription adopts the form of decoction, which is not convenient to take.

[0005] Relevant non-patent documents retrieved: The research on the preparation process and quality control of Tangshen Qingdu Granule (Chengdu University of Traditional Chinese Medicine, 2018) discloses: In the research on the extraction process of Tangshen Qingdu Granule, add 7 times the amount of water and decoct for 3 times, each time for 40 min. In the research on the purification process, the water extract of the whole prescription is concentrated under reduced pressure until the concentration of the medicinal liquid is 0.75 g·mL

[0002] , , centrifuge for 20 min (8000 r / min). In the research on the forming process, by observing the state of the clear paste, determine that the relative density of the thick paste is about 1.25-1.30, vacuum dry, pulverize to obtain the extract powder. The auxiliary material is dextrin (extract powder: dextrin 1:1), mix evenly, then add 0.4% of steviol glycoside, use 75% ethanol as the wetting agent, granulate, dry, size, and package.

[0006] The prior art represented by the foregoing documents at least has the following unsolved technical problems or defects: The Tangshen Qushi Prescription is a traditional Chinese medicine decoction, which needs to be decocted before taking, and is not conducive to maintaining the compliance of patients. Summary of the Invention​​​​The preparation method of the Astragalus and Cuscuta Dehumidifying Granules Composition and related technologies, in order to solve technical problems such as improving preparation efficiency, increasing the transfer rate of active ingredients, and increasing the yield of ointment, or combinations thereof.

[0008] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0009] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0010] Definitions of standard chemical terms can be found in the reference "Chinese Pharmacopoeia 2020 Edition".

[0011] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0012] The terms “optional / arbitrary” or “optionally / arbitrarily” mean that the event or situation described below may or may not occur, including both the occurrence and non-occurrence of the event or situation.

[0013] In a first aspect, the present invention provides a method for preparing a composition of Astragalus and Cuscuta chinensis dehumidifying granules, comprising the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus and Cuscuta chinensis. Cuscuta chinensis, roasted peach kernel, Atractylodes lancea, dried tangerine peel, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidin, then add the second part of maltodextrin, and mix well to obtain stilbene. Intermediate components of the Tu Qu Shi Fang formula; (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula to obtain Astragalus and Cuscuta Dehumidifying Granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

[0014] The extraction in step (1) is performed at an extraction temperature of 95-100℃ for 0.5-1.5 hours, and 2-3 times.

[0015] The amount of water added in step (1) is 6-10 times the weight of the medicinal material.

[0016] The preferred medicinal materials are, by weight: 600-700 parts Astragalus membranaceus, 450-550 parts Cuscuta chinensis, 300-400 parts Prunus persica, 300-400 parts Atractylodes lancea, 300-400 parts Citrus reticulata, 450-550 parts Centella asiatica, and 200-300 parts Cordyceps sinensis.

[0017] The concentration in step (2) is: concentrating the extract to a relative specific gravity of 1.04-1.06.

[0018] The concentration temperature in step (2) is 60-70℃.

[0019] The amount of maltodextrin added in step (3) is 3-8% of the weight of the medicinal material.

[0020] The maltodextrin in step (3) includes at least one of maltodextrin MD15 and maltodextrin MD20.

[0021] The drying process described in step (3) is spray drying.

[0022] The spray drying process includes: inlet air temperature of 165-185℃ and outlet air temperature of 90-100℃.

[0023] Wherein, the moisture content of the dry powder in step (3) is <6.0wt%.

[0024] The flow aid in step (4) is at least one of magnesium stearate and silicon dioxide.

[0025] The amount of the glidant added in step (4) is 0.3-0.8% of the mass of the Astragalus and Cuscuta Dehumidifying Granules.

[0026] In step (5), the granulation mesh size is 12-15 mesh.

[0027] The preferred amount of maltodextrin added in the first part is 3%, 4%, 5%, 6%, 7%, 8% of the weight of the medicinal material, or any combination thereof.

[0028] The preferred proportions of the first and second maltodextrin components are 30%, 31%, 31.4%, 32%, 33%, 34%, 35% or any combination thereof, which together constitute 30% of the mass of the Astragalus and Cuscuta Dehumidifying Granules.

[0029] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: The first preferred option is spray drying. This technical solution, in addition to solving the technical problems of "improving the transfer rate of hesperidin and astragaloside A and increasing the yield of extract", further solves the technical problem of "improving preparation efficiency".

[0030] Secondly, the present invention provides: the Astragalus and Cuscuta Dehumidifying Granules Composition prepared by the above preparation method.

[0031] Thirdly, the present invention provides: a method for improving the stability of a composition of Astragalus and Cuscuta Dehumidifying Granules, comprising the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus and Cuscuta chinensis. Cuscuta chinensis, roasted peach kernel, Atractylodes lancea, dried tangerine peel, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidin, then add the second part of maltodextrin, and mix well to obtain stilbene. Intermediate components of the Tu Qu Shi Fang formula; (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula to obtain Astragalus and Cuscuta Dehumidifying Granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

[0032] Fourthly, the present invention provides the application of maltodextrin in improving the stability of the Astragalus and Cuscuta Dehumidifying Granules composition, comprising the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus and Cuscuta chinensis. Cuscuta chinensis, roasted peach kernel, Atractylodes lancea, dried tangerine peel, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidin, then add the second part of maltodextrin, and mix well to obtain stilbene. Intermediate components of the Tu Qu Shi Fang formula; (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula to obtain Astragalus and Cuscuta Dehumidifying Granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

[0033] The present invention has at least the following beneficial effects: Compared with existing technologies, the present invention has better technical effects in terms of active substance transfer rate, extract yield, powder properties, and moisture content.

[0034] According to experimental tests, the present invention increases the hesperidin transfer rate from 14.39% in the prior art to over 32.55%.

[0035] According to experimental tests, the present invention increases the astragaloside A transfer rate from 34.94% in the prior art to over 76.79%.

[0036] According to experimental tests, the present invention increases the yield of ointment from 17.54% in the prior art to over 25.97%.

[0037] According to experimental tests, the present invention improves the powder in the preparation process from the agglomerated powder of the prior art to a loose and fine powder.

[0038] According to experimental tests, the present invention reduces the moisture content from 7.3% in the prior art to below 6.5%.

[0039] Furthermore, based on the present invention: Based on the comparison of Example 1 and Comparative Examples 1-3, the present invention achieves new technical effects by employing a combination of specific excipient addition order, specific drying method, and specific extraction process. The combined technical effect is superior to the sum of the effects of each individual technical means. Detailed Implementation

[0040] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0041] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0042] The raw materials used in the preparation process research of Qi Tu Qu Shi Granules were all processed medicinal slices, which all met the testing requirements of each medicinal ingredient and corresponding medicinal slice item in the 2020 edition of the Chinese Pharmacopoeia. The specific raw materials and medicinal parts of the processed medicinal slices are as follows: Astragalus: This product is a processed product of the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, a plant of the Fabaceae family.

[0043] Cuscuta: This product is a processed product of the dried, mature seeds of Cuscuta australis R.Br., a plant of the Convolvulaceae family.

[0044] Peach kernel: This product is a processed product of the dried, mature seeds of Prusua davidiana (Carr.) Franch., a plant of the Rosaceae family.

[0045] Atractylodes: This product is a processed product of the dried rhizome of Atractylodes chinensis (DC.) Koidz., a plant of the Asteraceae family.

[0046] Dried tangerine peel: This product is a processed product made from the dried, mature peel of Citrus reticulata Blanco and its cultivated varieties, belonging to the Rutaceae family.

[0047] Centella asiatica: This product is a processed product of the dried whole herb of Centella asiatica (L.) Urb., a plant of the Apiaceae family.

[0048] Cicada Flower: This product is a processed product of the dried complex of the fungal sporangiophores or stromata and larval corpse of the asexual form of the fungus Cordyceps cicadae Shing (Miq.) Samson, which parasitizes the larvae of the cicada Cicada flanmata Dist.

[0049] Example 1: Preparation method of Astragalus and Cuscuta Dehumidifying Granules Composition Prescription: Astragalus membranaceus 666.7g, Cuscuta chinensis 500g, Prunus persica 333.3g, Atractylodes lancea 333.3g, Citrus reticulata 333.3g, Centella asiatica 500g, Cicadae periostracum 266.7g.

[0050] Preparation method: (1) Add water to extract Astragalus membranaceus, Cuscuta chinensis, Prunus persica, Atractylodes lancea, Citrus reticulata, Centella asiatica and Cicadae periostracum. The amount of water added is 10 times the weight of the medicinal materials. The extraction temperature is 100℃ and the extraction time is 1h. After extraction, filter through 120 mesh. Add water to the residue with 6 times the weight of the medicinal materials. The extraction time is 0.5h. After extraction, filter through 120 mesh to obtain the extract.

[0051] (2) The extract was concentrated at 65°C to a relative gravity of 1.04 and passed through a 200-mesh sieve to obtain a clear extract.

[0052] (3) Take 3% of the prescription drug mass of maltodextrin MD20, add it to the 60℃ clear paste, stir until completely dissolved, mix evenly, filter through a 100-mesh sieve and spray dry, inlet air temperature: 165℃; outlet air temperature: 100℃, to obtain dry powder with moisture <6.0wt%, no burnt debris or soft lumps.

[0053] (4) Add 0.5wt% of magnesium stearate to the dry powder, and then add an appropriate amount of maltodextrin to adjust to the prepared amount (the amount of maltodextrin added is: added to 34.1% of the mass of the prepared Astragalus and Cuscuta Dehumidifying Granules), mix for 5 minutes to obtain the intermediate of Astragalus and Cuscuta Dehumidifying Formula.

[0054] (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula into 14-mesh granules and then into 10 / 60-mesh granules to obtain Astragalus and Cuscuta Dehumidifying Granules. The granules have a uniform color, and the total amount of material that cannot pass through a 10-mesh sieve and that can pass through a 60-mesh sieve is ≤13%.

[0055] Example 2: Preparation method of Astragalus and Cuscuta Dehumidifying Granules Composition Prescription of medicinal materials: Astragalus membranaceus 666.7g, Cuscuta chinensis 500g, Prunus persica 333.3g, Atractylodes lancea 333.3g, Citrus reticulata 333.3g, Centella asiatica 500g, Cicadae periostracum 266.7g.

[0056] (1) Add water to extract Astragalus membranaceus, Cuscuta chinensis, Prunus persica, Atractylodes lancea, Citrus reticulata, Centella asiatica and Cicadae periostracum. The amount of water added is 10 times the weight of the medicinal materials. The extraction time is 1 hour. After extraction, filter through 120 mesh. Add water to the residue with 6 times the weight of the medicinal materials. The extraction time is 0.5 hours. After extraction, filter through 120 mesh to obtain the extract.

[0057] (2) The extract was concentrated at 60°C to a relative gravity of 1.06 and passed through a 200-mesh sieve to obtain a clear extract.

[0058] (3) Take 8% of the medicinal material weight of maltodextrin MD15, add it to the 50℃ clear paste, stir until completely dissolved, mix evenly, filter through a 100-mesh sieve and spray dry, inlet air temperature: 185℃; outlet air temperature: 90℃, to obtain dry powder with moisture <6.0wt%, no burnt debris or soft lumps.

[0059] (4) Add 0.5wt% magnesium stearate to the dry powder and add an appropriate amount of maltodextrin to adjust to the prepared amount (the amount of maltodextrin added is: added to 34.1% of the mass of the prepared Astragalus and Cuscuta Dehumidifying Granules), mix for 10 minutes to obtain the intermediate of Astragalus and Cuscuta Dehumidifying Formula.

[0060] (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula into 14-mesh granules and then into 10 / 60-mesh granules to obtain Astragalus and Cuscuta Dehumidifying Granules. The granules have a uniform color, and the total amount of material that cannot pass through a 10-mesh sieve and that can pass through a 60-mesh sieve is ≤13%.

[0061] Example 3: Preparation method of Astragalus and Cuscuta Dehumidifying Granules Composition Prescription: Astragalus membranaceus 666.7g, Cuscuta chinensis 500g, Prunus persica 333.3g, Atractylodes lancea 333.3g, Citrus reticulata 333.3g, Centella asiatica 500g, Cicadae periostracum 266.7g.

[0062] (1) Add water to extract Astragalus membranaceus, Cuscuta chinensis, Prunus persica, Atractylodes lancea, Citrus reticulata, Centella asiatica and Cicadae periostracum. The amount of water added is 10 times the weight of the medicinal materials. The extraction time is 1 hour. After extraction, filter through 120 mesh. Add water to the residue with 6 times the weight of the medicinal materials. The extraction time is 0.5 hours. After extraction, filter through 120 mesh to obtain the extract.

[0063] (2) The extract was concentrated at 60°C to a relative gravity of 1.04 and passed through a 200-mesh sieve to obtain a clear extract.

[0064] (3) Take 6% of the medicinal material weight of maltodextrin MD15, add it to the 55℃ clear paste, stir until completely dissolved, mix evenly, filter through a 100-mesh sieve and spray dry, inlet air temperature: 175℃; outlet air temperature: 96℃, to obtain dry powder with moisture <6.0wt%, no burnt debris or soft lumps.

[0065] (4) Add 0.5wt% of magnesium stearate to the dry powder, and then add an appropriate amount of maltodextrin to adjust to the prepared amount (the amount of maltodextrin added is: added to 34.1% of the mass of the prepared Astragalus and Cuscuta Dehumidifying Granules), mix for 8 minutes to obtain the intermediate of Astragalus and Cuscuta Dehumidifying Formula.

[0066] (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula into 14-mesh granules and then into 10 / 60-mesh granules to obtain Astragalus and Cuscuta Dehumidifying Granules. The granules have a uniform color, and the total amount of material that cannot pass through a 10-mesh sieve and that can pass through a 60-mesh sieve is ≤13%.

[0067] Comparative Example 1 The only difference from Example 1 is that the extraction method in step (1) is different: the amount of water added is 8 times the amount of medicinal material, the extraction temperature is 100℃, the extraction time is 0.5h, and it is extracted only once.

[0068] Table 1 compares the extraction effects of Comparative Example 1 and Example 1, where the transfer rate (%) = content of substance i in the extract / content of substance i in the medicinal material. 100%, wherein substance i is hesperidin or astragaloside A; yield (%) = total weight of clear extract Solid content of the extract / particle weight 100%.

[0069] Hesperidin content determination: HPLC method, using octadecylsilane-bonded silica gel as the packing material; acetonitrile-0.1% phosphoric acid solution (18:82) as the mobile phase; detection wavelength of 283 nm; theoretical plate number calculated based on hesperidin peak should not be less than 5000.

[0070] Astragaloside A content determination: HPLC method, with octadecylsilane-bonded silica gel as the packing material; acetonitrile-water (32:68) as the mobile phase, flow rate of 0.35 ml per minute; detection by evaporative light scattering detector; the theoretical plate number calculated based on the astragaloside A peak should not be less than 4000.

[0071] Table 1

[0072] As shown in Table 1, the hesperidin transfer rate, astragaloside A transfer rate, and extract yield of Comparative Example 1 were all significantly lower than those of Example 1. This indicates that the number of extractions is a key factor affecting the transfer rate of active ingredients. The preferred extraction process of this invention, involving two extractions, can more fully extract the active ingredients from the medicinal materials, providing a better material basis for subsequent formulations.

[0073] Comparative Example 2 The only difference from Example 1 is that spray drying is replaced by vacuum drying (vacuum degree: -0.095Mpa, temperature: 60-70℃) in step (3).

[0074] After drying in Comparative Example 2, the resulting dry paste was in the form of hard lumps and needed to be pulverized twice by a pulverizer before it could proceed to the next step.

[0075] The subsequent steps were the same as in Example 1, and Astragalus and Cuscuta Dehumidifying Granules were prepared as Comparative Example 2.

[0076] Results: The drying effects of Comparative Example 2 and Example 1 are compared in Table 2.

[0077] Table 2

[0078] As shown in Table 2, vacuum drying has extremely low drying efficiency and requires secondary pulverization after drying, increasing process steps and energy consumption. This invention uses spray drying, which can complete drying within minutes, and the resulting dry powder can be directly used for granulation, significantly simplifying the process and improving production efficiency.

[0079] Comparative Example 3 The difference from Example 1 is that maltodextrin is not added in step (3), but all of the maltodextrin is added in step (4).

[0080] Results: The effects of Comparative Example 3 and Example 1 are compared in Table 3. Powder yield (%) = Dry powder weight / (Amount of excipients added + Solid content of clear paste) (weight of ointment) 100%.

[0081] Table 3

[0082] As shown in Table 3, although Comparative Example 3 had a slightly higher powder recovery rate, the resulting dry powder exhibited caking, and its moisture content was also higher than that of Example 1. The caking phenomenon indicates that without excipients, the powder exhibits poor stability, is prone to absorbing moisture and clumping, which is detrimental to subsequent granulation and long-term storage. In this invention, 3% maltodextrin was added before spray drying. Although the powder recovery rate decreased slightly, the resulting dry powder was free of caking, had low moisture content, and uniform properties, providing a better intermediate quality for subsequent granulation. This demonstrates that the appropriate addition of maltodextrin plays a crucial role in improving the spray drying effect.

[0083] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing a composition of Astragalus and Cuscuta chinensis dehumidifying granules, characterized in that, Includes the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus, Cuscuta chinensis, Prunus persica, Atractylodes lancea, Citrus reticulata, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidant, then add the second part of maltodextrin, and mix evenly to obtain the intermediate of the Astragalus and Cuscuta Dehumidifying Formula; (5) Granulate the intermediate of the Qi Tu Qu Shi Fang (Astragalus and Cuscuta Dehumidifying Formula) into whole granules to obtain Qi Tu Qu Shi granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

2. The preparation method according to claim 1, characterized in that, The extraction in step (1) is carried out at an extraction temperature of 95-100℃ for 0.5-1.5 hours, and 2-3 times.

3. The preparation method according to claim 1, characterized in that, The amount of water added in step (1) is 6-10 times the weight of the medicinal material.

4. The preparation method according to claim 1, characterized in that, The medicinal materials mentioned in step (1) include, by weight, 600-700 parts of Astragalus membranaceus, 450-550 parts of Cuscuta chinensis, 300-400 parts of Prunus persica, 300-400 parts of Atractylodes lancea, 300-400 parts of Citrus reticulata peel, 450-550 parts of Centella asiatica, and 200-300 parts of Cicadae periostracum.

5. The preparation method according to claim 1, characterized in that, The concentration in step (2) is to concentrate the extract to a relative specific gravity of 1.04-1.

06.

6. The preparation method according to claim 1, characterized in that, The drying in step (3) is: spray drying; and / or The moisture content of the dry powder in step (3) is <6.0 wt%.

7. The preparation method according to claim 1, characterized in that, The gliding agent in step (4) is at least one of magnesium stearate and silicon dioxide; the amount of gliding agent added in step (4) is 0.3-0.8% of the mass of Astragalus and Cuscuta Dehumidifying Granules.

8. The Astragalus and Cuscuta Dehumidifying Granules Composition prepared by the preparation method according to any one of claims 1-7.

9. A method for improving the stability of a composition of Astragalus and Cuscuta Dehumidifying Granules, characterized in that, Includes the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus and Cuscuta chinensis. Cuscuta chinensis, roasted peach kernel, Atractylodes lancea, dried tangerine peel, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidin, then add the second part of maltodextrin, and mix well to obtain stilbene. Intermediate components of the Tu Qu Shi Fang formula; (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula to obtain Astragalus and Cuscuta Dehumidifying Granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

10. The application of maltodextrin in improving the stability of the Astragalus and Cuscuta Dehumidifying Granules composition, characterized in that, Includes the following steps: (1) The medicinal materials are extracted with water and filtered to obtain an extract; the medicinal materials include: Astragalus membranaceus and Cuscuta chinensis. Cuscuta chinensis, roasted peach kernel, Atractylodes lancea, dried tangerine peel, Centella asiatica, and Cicadae periostracum; (2) The extract was concentrated and sieved to obtain a clear paste; (3) Mix the first part of maltodextrin and clear extract evenly, and dry to obtain dry powder; (4) Mix the dry powder with the glidin, then add the second part of maltodextrin, and mix well to obtain stilbene. Intermediate components of the Tu Qu Shi Fang formula; (5) Granulate the intermediate of the Astragalus and Cuscuta Dehumidifying Formula to obtain Astragalus and Cuscuta Dehumidifying Granules; The amount of the first part of maltodextrin added is 3-8% of the weight of the medicinal material. The amount of the second part of maltodextrin added is adjusted according to the actual yield of dry powder, so that the first part of maltodextrin and the second part of maltodextrin together account for 30-35% of the weight of Qitu Qushi Granules.

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