Traditional Chinese medicine directly-taken granules and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to traditional Chinese medicine directly-taken granules and a preparation method thereof.The directly-taken granules comprise traditional Chinese medicine coated pellets and taste-modifying materials, the traditional Chinese medicine coated pellets are formed by wrapping a traditional Chinese medicine dry paste powder mixture through a taste-masking layer, and the traditional Chinese medicine dry paste powder mixture comprises traditional Chinese medicine dry paste powder and an anti-sticking agent; the taste masking layer comprises a coating material. Compared with the prior art, the traditional Chinese medicine granules for direct administration have the advantages that the traditional Chinese medicine granules for direct administration have no bad taste and smell, can be directly swallowed and do not need to be dissolved again before administration, so that the compliance of medication is improved, and particularly the compliance of medication for children is improved; the problems of moisture absorption and moisture absorption of the traditional Chinese medicine are solved, and the problems of particle caking and adhesion are not easy to occur in the storage process.

Description

Technical Field

[0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to a Chinese medicine direct-take granule and a preparation method thereof. Background Art

[0002] At present, the main oral preparations of Chinese medicine include decoctions, pills, pastes, etc. Decoctions take a long time to boil, cannot be stored for a long time and are inconvenient to carry, and have obvious bitterness or odor; pills have large particles, which are not convenient for children to take, and they contain a lot of sugar or honey, which are easy to absorb moisture, and are prone to physical stability problems such as particle agglomeration and adhesion during storage; pastes often have harsh storage conditions and need to be refrigerated to prevent fermentation and deterioration. They are inconvenient to take, and their sticky texture needs to be dissolved in warm water. In addition, the preparation process is complicated, and it takes a long time to concentrate the paste, which is costly.

[0003] Because traditional Chinese medicine has many ingredients, it is difficult to prepare it into a preparation that has no bad taste and odor, is easy to take, and is physically stable. This is a technical problem that needs to be solved in this field. Summary of the Invention

[0004] The present invention aims to provide a traditional Chinese medicine direct-take granule which has no bad taste and odor, can be directly swallowed, and is physically stable.

[0005] On the one hand, the present invention provides a Chinese medicine direct-take granule, which includes Chinese medicine coated micropills and flavor-correcting materials. The Chinese medicine coated micropills are made by coating a mixture of Chinese medicine dry paste powder with a flavor-masking layer, wherein the Chinese medicine dry paste powder mixture includes Chinese medicine dry paste powder and an anti-sticking agent, and the flavor-masking layer includes a coating material.

[0006] In some embodiments, all Chinese medicinal materials that can be effectively extracted with conventional solvents (water, ethanol, etc.) to obtain target components can be prepared into Chinese medicinal dry paste powders, including:

[0007] Tonic: Ginseng, American ginseng, Codonopsis, Astragalus, Chinese yam, Atractylodes, Licorice, Angelica, Rehmannia, White Peony, Polygonum multiflorum, Donkey-hide gelatin (special treatment required), Ophiopogon, Asparagus, Dendrobium, Polygonatum, Lycium barbarum, Ligustrum lucidum, Adenophora, Polygonatum, Epimedium, Morinda officinalis, Cistanche, Eucommia, Cuscuta, Psoralea corylifolia; Heat-clearing: Gypsum, Anemarrhena, Gardenia, Prunella vulgaris, Cassia seed, Scutellaria, Coptis chinensis, Phellodendron, Sophora flavescens, Gentiana scabra, Honeysuckle, Forsythia suspensa, Isatis root, Folium isatidis, Dandelion, Viola yedoensis, Houttuynia cordata, Andrographis paniculata, Chrysanthemum indicum, Sophora flavescens; Rehmannia root, Scrophularia ningpoensis, Paeonia suffruticosa bark, Paeonia lactiflora, Lithospermum officinale, Artemisia annua, Lycium bark, Bupleurum chinense; Blood circulation and stasis-removing herbs: Salvia miltiorrhiza, Chuanxiong, Carthamus tinctorius, Peach kernel, Panax notoginseng, Motherwort, Curcuma zedoaria, Trillium, Achyranthes bidentata, Millettia reticulata, Curcuma aromatica, Turmeric, Corydalis yanhusuo; Qi-regulating herbs: Tangerine peel, Citrus aurantium immaturus, Citrus aurantium fructus, Cyperus rotundus, Aucklandia lappa, Citrus aurantium, Citrus palmatum, Rose; Hemostatic herbs: Bletilla striata, Agrimoniae scabra, Rubia cordifolia, Pollen cattail, Sanguisorba officinalis, Sophora japonica Flowers, Platycladus orientalis leaves, Cirsium japonicum, Cirsium scabra; expectorant, cough-relieving and asthma-relieving: Pinellia ternata (needs to be processed), Arisaema consanguineum (needs to be processed), Fritillaria thunbergii, Fritillaria cirrhosa, Trichosanthes root, Rhizoma Anemarrhenae, Platycodon grandiflorum, Peucedanum chinense, Bitter Apricot kernel, Perilla seed, Morus alba bark, Lepidoptera: Lecithin, Stemona root, Aster tataricus, Coltsfoot flower; rheumatism-relieving: Angelica dahurica, Notopterygium wilfordii, Clematidis root, Gentiana macrophylla, Cynanchum indica, Papaya, Morus alba, Acanthopanax acanthopanax bark; diuretic and dampness-inducing: Poria cocos, Rhizoma Alismatis, Coix seed, Plantago seed, Talcum powder (although it is a mineral, sometimes will be added), Artemisia capillaris, Lysimachia chinensis, Polygonum cuspidatum; sedatives: Ziziphus jujuba seed, Polygala tenuifolia, Platycladus cypress seed, Polygonum multiflorum; astringents: Schisandra chinensis, Cornus officinalis, Rosa laevigata fruit, Rubus idaeus; antipyretics: Ephedra, cinnamon twig, Saposhnikovia divaricata, Schizonepeta tenuifolia, Perilla frutescens leaf, Angelica dahurica, Asarum (pay attention to volatile oils); dispersing wind-heat drugs: peppermint (pay attention to volatile oils), Bupleurum chinense, Pueraria lobata, Cimicifuga heracleifolia, Chrysanthemum flower, Mulberry leaf, Arctium lappa, Vitex rotundifolia; digestive drugs: Hawthorn, malt, Shenqu, Radish seed, Chicken gizzard lining; etc.

[0008] In the present invention, the anti-adhesive agent and coating material are not particularly limited, and commonly used anti-adhesive agents and coating materials can be used. In some embodiments, they include one or more of talc, micropowdered silica, microcrystalline cellulose, mannitol, and pregelatinized starch; the taste-masking layer coating material includes one or more of Eudragit, methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and carboxymethyl cellulose.

[0009] In the present invention, the antistatic agent, plasticizer and / or anti-sticking agent are not particularly limited, and commonly used antistatic agents, plasticizers and / or anti-sticking agents can be used. In some embodiments, the taste-masking layer may further include an antistatic agent, a plasticizer and / or an anti-sticking agent, wherein the antistatic agent includes one or more of talc, titanium dioxide, and silicon dioxide; the plasticizer includes one or more of triethyl citrate, diethyl phthalate, PEG 6000, and monocaprylic glycerol; and the anti-sticking agent includes one or more of talc, micropowdered silica gel, microcrystalline cellulose, mannitol, and pregelatinized starch.

[0010] In some embodiments, the taste-masking layer may further include one or more of a porogen, a surfactant, a flavoring agent, and a lubricant. The porogen, surfactant, flavoring agent, and lubricant are not particularly limited, as long as they can form a stable taste-masking layer.

[0011] The porogen can be selected from hydroxypropyl methylcellulose, polyethylene glycol, polyvinyl pyrrolidone, sucrose, lactose, mannitol, sodium chloride, sodium lauryl sulfate, etc.; the surfactant can be selected from sodium lauryl sulfate, polysorbate 80, poloxamer, sucrose fatty acid ester, etc.; the flavoring agent can be selected from sucralose, aspartame, acesulfame potassium, sucrose, fructose, glycyrrhizin, steviol glycosides, fruit flavor, mint flavor, cream flavor, citric acid, malic acid, etc.; the lubricant can be selected from magnesium stearate, sodium stearyl fumarate, hydrogenated vegetable oil, mono- and diglycerides, colloidal silicon dioxide, etc.

[0012] In some embodiments, the flavoring material includes sweeteners, flavoring agents, and taste modifiers, such as sucralose, aspartame, acesulfame potassium, sucrose, fructose, glycyrrhizin, steviol glycosides, fruit flavors, mint flavors, cream flavors, citric acid, malic acid, xanthan gum, and micro-powdered silica gel; in some embodiments, more specifically, it includes one or more of sorbitol, mannitol, flavors, talc, and arginine.

[0013] The purpose of the flavor correcting material is to further promote the direct-take granules to achieve the taste-masking effect.

[0014] In some embodiments, the Chinese medicine coated micropills are further coated with an isolation layer and / or a smooth layer; the isolation layer includes a coating material, an anti-sticking agent, and an antistatic agent; and the smooth layer includes a gelling agent.

[0015] There is no specific limitation on the coating material, anti-adhesive agent, antistatic agent and gelling agent. The coating material, anti-adhesive agent, antistatic agent and gelling agent commonly used in the art can be used. In some embodiments, the isolation layer coating material includes one or more of Eudragit, methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose and carboxymethyl cellulose; the isolation layer anti-adhesive agent includes one or more of talc, micropowder silica gel, microcrystalline cellulose, mannitol and pregelatinized starch; the isolation layer antistatic agent includes one or more of talc, titanium dioxide and silicon dioxide; the smooth layer gelling agent includes one or more of gelatin, carrageenan, xanthan gum, konjac flour, carbomer and agar.

[0016] In some embodiments, the particle size of the traditional Chinese medicine coated micropellets is less than 400 μm.

[0017] The present invention adopts blank pellet cores with smaller particle sizes to prepare coated micropills, so that the obtained coated micropills have smaller particle sizes, are easier to take, and have less gritty feeling.

[0018] In some embodiments, the Chinese medicine direct-take granules include the following components in parts by weight: the Chinese medicine direct-take granules include the following components in parts by weight: 55-85 parts of Chinese medicine dry paste powder, 0-10 parts of coated micropill anti-sticking agent, 5-25 parts of taste-masking layer coating material, 0.5-3 parts of taste-masking layer antistatic agent, 0-0.5 parts of taste-masking layer plasticizer, 0-0.5 parts of taste-masking layer anti-sticking agent, 0-10 parts of isolation layer coating material, 0-1 part of isolation layer anti-sticking agent, 0-3 parts of isolation layer antistatic agent, 0-10 parts of smoothing layer gel and 1-10 parts of flavor correcting material.

[0019] Another aspect of the present invention provides a method for preparing Chinese medicine direct-dose granules, comprising the following steps:

[0020] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0021] Step 2: mixing the taste masking layer coating material, antistatic agent, optional plasticizer and anti-sticking agent with purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0022] Step 3: Add the mixture obtained in step 1 into a fluidized bed and coat the mixture with the prepared taste-masking coating liquid;

[0023] Step 4: Screen the coated taste-masked pellets using a sieve and collect the pellets to determine which are qualified taste-masked pellets;

[0024] Step 5: Mix the taste-masking micropellets with the flavor-correcting excipients.

[0025] In some embodiments, before the taste masking layer is coated, an isolation layer coating and a smoothing layer coating are further performed, comprising the following steps:

[0026] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0027] Step 2: mixing the isolation layer coating material, anti-sticking agent, antistatic agent and purified water to obtain an isolation layer coating solution;

[0028] Step 3: Add the mixture obtained in step 1 into a fluidized bed and apply the prepared isolation layer coating liquid to the mixture;

[0029] Step 4: mixing the taste masking layer coating material, antistatic agent, optional plasticizer and anti-sticking agent with purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0030] Step 5: Place the isolated pellets in a fluidized bed and coat them with the prepared taste-masking coating solution;

[0031] Step 6: Mix the smooth layer gel with purified water to obtain a smooth layer coating solution;

[0032] Step 7: Place the taste-masked pellets in a fluidized bed and apply a smooth layer coating using the prepared smooth layer coating solution;

[0033] Step 8: Mix the smooth layer pellets with the flavoring excipients.

[0034] The Chinese medicine direct-dose granules of the present invention have the following advantages:

[0035] 1. The Chinese medicine direct-take granules provided by the present invention have no bad taste and odor and can be swallowed directly without the need for re-dissolution before taking, thereby increasing medication compliance, especially increasing medication compliance for children;

[0036] 2. The Chinese medicine direct-take granules provided by the present invention are relatively stable, solving the problem of moisture absorption by Chinese medicine, and the granules are less likely to agglomerate and stick together during storage. DETAILED DESCRIPTION

[0037] The following description sets forth numerous specific details to facilitate a thorough understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific implementations disclosed below.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0039] Example 1-3 investigates the classic Chinese medicine prescriptions named after bitter herbs

[0040] Table 1 Prescription table of Example 1

[0041]

[0042] Table 2 Example 2 Prescription

[0043]

[0044] Table 3 Prescription table of Example 3

[0045]

[0046] Preparation method:

[0047] Step 1: extract the above medicinal materials with water to obtain a Chinese medicine solution, and concentrate it;

[0048] Step 2: Dry the concentrated liquid and grind it into powder to obtain Chinese medicine paste.

[0049] Evaluation method: oral evaluation, hygroscopicity evaluation

[0050] Palate evaluation: Without informing adult volunteers of the product conditions, the taste and palatability of the Chinese medicine dry paste powders prepared in Examples 1-3 were evaluated. The results are as follows:

[0051] Table 4 Oral evaluation of the Chinese medicine dry paste powder prepared in Examples 1-3

[0052]

[0053]

[0054] Hygroscopicity evaluation: The dry Chinese medicine paste powders of Examples 1-3 were placed at room temperature to observe the moisture absorption, adhesion and agglomeration of the materials.

[0055] Table 5: Moisture absorption, adhesion and agglomeration of dry Chinese medicine paste powder prepared in Examples 1-3

[0056]

[0057]

[0058] The oral evaluation of the dry Chinese medicine paste powders obtained in Examples 1-3 showed that the dry Chinese medicine paste powders all had a bitter taste, a pungent odor, and a distinct gritty feel. Furthermore, the dry Chinese medicine paste powders obtained in Examples 1-3 easily absorbed moisture and formed agglomerates, resulting in poor physical stability of the preparations.

[0059] Examples 4-6 were used to investigate the anti-adhesive agent

[0060] The Chinese medicine dry paste powder obtained in Example 2 was used to investigate the anti-adhesive agent.

[0061] Table 6 Prescription table of Examples 4-6

[0062] Prescription composition Example 4 / g Example 5 / g Example 6 / g Example 2 Dry paste powder 20 20 20 Micro-powder silica gel 2 / / Mannitol / 30 10 microcrystalline cellulose / / 20

[0063] Preparation method: Mix the dry paste powder of traditional Chinese medicine and anti-adhesive agent and grind them into powder.

[0064] Evaluation method: Hygroscopicity test

[0065] Hygroscopicity evaluation: The dry Chinese medicine powder of Examples 4-5 was placed at room temperature to observe the moisture absorption, adhesion and agglomeration of the material.

[0066] Table 7: Moisture absorption, adhesion and agglomeration of dry Chinese medicine paste powder prepared in Examples 4-6

[0067]

[0068]

[0069] Through hygroscopicity evaluation, the hygroscopicity of the dry Chinese medicine paste powder prepared in Examples 4-6 was significantly improved.

[0070] Example 7-9 Coating Material Investigation

[0071] The Chinese medicine dry paste powder mixture obtained in Example 4 was used to investigate the coating material.

[0072] Table 8 Prescription table of Examples 7-9

[0073] Prescription composition Example 7 / g Example 8 / g Example 9 / g Example 2 Dry paste powder 20 20 20 Micro-powder silica gel 2 2 2 Eudragit E100 5.7 / / Hydroxypropylcellulose / 5.7 / Hydroxypropyl methylcellulose / / 5.7 talcum powder 0.6 0.6 0.6

[0074] Preparation method:

[0075] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0076] Step 2: mixing the taste masking layer coating material, the antistatic agent, purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0077] Step 3: Add the mixture obtained in step 1 into a fluidized bed and coat the mixture with the prepared taste-masking coating liquid;

[0078] Step 4: Use a sieve to sieve the coated taste-masked micropellets and collect the micropellets, which are qualified taste-masked micropellets.

[0079] Evaluation method: oral evaluation, hygroscopicity evaluation

[0080] Palate evaluation: Without informing adult volunteers of the product conditions, the taste and palatability of the Chinese medicine dry paste powders prepared in Examples 7-9 were evaluated. The results are as follows:

[0081] Table 9 Oral evaluation of Chinese medicine coated pellets prepared in Examples 7-9

[0082]

[0083]

[0084] Hygroscopicity evaluation: The dry Chinese medicine paste powders of Examples 7-9 were placed at room temperature to observe the moisture absorption, adhesion and agglomeration of the materials.

[0085] Table 10: Moisture absorption, adhesion and agglomeration of the Chinese medicine coated micropellets prepared in Examples 7-9

[0086] Duration 0 1min 5min 10min 20min 30min Example 7 Loose material Loose material Loose material Loose material Loose material Loose material Example 8 Loose material Loose material Loose material Loose material Loose material Loose material Example 9 Loose material Loose material Loose material Material adhesion Material agglomeration Material agglomeration

[0087] The Chinese medicine coated pellets prepared in Examples 7-9 have significantly improved taste masking and hygroscopicity.

[0088] The Chinese medicine coated pellets obtained in Example 7 were used to investigate the coating weight gain.

[0089] Table 11 Prescription table of Examples 10-11

[0090] Prescription composition Example 10 / g Example 7 / g Example 11 / g Example 2 Dry paste powder 20 20 20 Micro-powder silica gel 2 2 2 Eudragit E100 5.0 5.7 6.4 talcum powder 0.5 0.6 0.6 Coating weight gain 25％ 28.64％ 32％

[0091] Preparation method:

[0092] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0093] Step 2: mixing the taste masking layer coating material, the antistatic agent, purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0094] Step 3: Add the mixture obtained in step 1 into a fluidized bed and coat the mixture with the prepared taste-masking coating liquid;

[0095] Step 4: Use a sieve to sieve the coated taste-masked micropellets and collect the micropellets, which are qualified taste-masked micropellets.

[0096] Evaluation method: oral evaluation, hygroscopicity evaluation

[0097] Palate evaluation: Without informing adult volunteers of the product conditions, the taste and palatability of the Chinese medicine dry paste powders prepared in Examples 7-9 were evaluated. The results are as follows:

[0098] Table 12 Oral evaluation of Chinese medicine coated pellets prepared in Examples 7, 10, and 11

[0099]

[0100]

[0101] Hygroscopicity evaluation: The Chinese medicine coated micropellets of Examples 7-9 were placed at room temperature to observe the moisture absorption, adhesion and agglomeration of the materials.

[0102] Table 13: Moisture absorption, adhesion and agglomeration of Chinese medicine coated micropellets prepared in Examples 7, 10 and 11

[0103]

[0104] Examples 7, 10, and 11 showed significant improvements in taste masking and hygroscopicity. All volunteers reported that the amount and speed of saliva secretion of the direct-take granules prepared in Examples 7, 10, and 11 after entering the oral cavity met the requirements for drug swallowing, and the granules could be swallowed without water and had no unpleasant odor, and had a good taste.

[0105] Example 12-14: Investigation of flavor correction materials

[0106] The Chinese medicine taste-masking granules obtained in Example 7 were used to investigate the flavor-correcting material.

[0107] Table 14 Prescription table of Examples 12-14

[0108] Prescription composition Example 12 / g Example 13 / g Example 14 / g Example 2 Dry paste powder 20 20 20 Micro-powder silica gel 2 2 2 Eudragit E100 5.7 5.7 5.7 talcum powder 0.6 0.6 0.6 Sucralose 0.15 0.27 0.4 sweet orange flavor 0.15 0.2 0.2 talcum powder 0.2 0.2 0.2

[0109] Preparation method:

[0110] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0111] Step 2: mixing the taste masking layer coating material, the antistatic agent, purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0112] Step 3: Add the mixture obtained in step 1 into a fluidized bed and coat the mixture with the prepared taste-masking coating liquid;

[0113] Step 4: Screen the coated taste-masked pellets using a sieve and collect the pellets to determine which are qualified taste-masked pellets;

[0114] Step 5: Mix the taste-masking micropellets with the flavor-correcting excipients.

[0115] Evaluation method: oral evaluation

[0116] Palate evaluation: Without informing adult volunteers of the product conditions, the taste and palatability of the Chinese medicine dry paste powders prepared in Examples 7-9 were evaluated. The results are as follows:

[0117] Table 15 Oral evaluation of the Chinese medicine direct-dose granules prepared in Examples 12-14

[0118]

[0119]

[0120] All volunteers reported that the amount and speed of saliva secretion after the direct-take granules prepared in Examples 12-14 entered the oral cavity met the requirements for drug swallowing. Example 13 could be smoothly swallowed without water and had no unpleasant odor, a good taste, and no gritty feeling.

[0121] Example 15 Preparation of Direct-Serving Granules

[0122] Table 16 Example 15 Prescription

[0123]

[0124] Preparation method:

[0125] Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them;

[0126] Step 2: mixing the isolation layer coating material, anti-sticking agent, antistatic agent and purified water to obtain an isolation layer coating solution;

[0127] Step 3: Add the mixture obtained in step 1 into a fluidized bed and apply the prepared isolation layer coating liquid to the mixture;

[0128] Step 4: mixing the taste masking layer coating material, antistatic agent, optional plasticizer and anti-sticking agent with purified water and anhydrous ethanol to obtain a taste masking layer coating solution;

[0129] Step 5: Place the isolated pellets in a fluidized bed and coat them with the prepared taste-masking coating solution;

[0130] Step 6: Mix the smooth layer gel with purified water to obtain a smooth layer coating solution;

[0131] Step 7: Place the taste-masked pellets in a fluidized bed and apply a smooth layer coating using the prepared smooth layer coating solution;

[0132] Step 8: Mix the smooth layer pellets with the flavoring excipients.

[0133] Evaluation method: oral evaluation

[0134] Palate evaluation: Without informing adult volunteers of the product's condition, the taste and palatability of the TCM direct-dose granules prepared in Example 15 were evaluated. The results are as follows:

[0135] Table 17 Oral evaluation of the prepared Chinese medicine direct-dose granules in Example 15

[0136]

[0137] All volunteers reported that the amount and speed of saliva secretion of the direct-take granules prepared in Example 15 after entering the oral cavity could meet the requirements for drug swallowing, and the granules could be swallowed smoothly without water and had no unpleasant odor, a good taste, and no gritty feeling.

Claims

1. A Chinese medicine direct-dose granule, characterized in that: The direct-take granules include Chinese medicine coated micro-pellets and flavor-correcting materials. The Chinese medicine coated micro-pellets are made by coating a mixture of Chinese medicine dry paste powder with a flavor-masking layer, wherein the Chinese medicine dry paste powder mixture includes Chinese medicine dry paste powder and an anti-sticking agent, and the flavor-masking layer includes a coating material.

2. The Chinese medicine direct-take granules according to claim 1, characterized in that The anti-sticking agent includes one or more of talc, micropowdered silica gel, microcrystalline cellulose, mannitol, and pregelatinized starch.

3. The Chinese medicine direct-take granules according to claim 1, characterized in that The taste masking layer coating material includes one or more of Eudragit, methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and carboxymethyl cellulose.

4. The Chinese medicine direct-take granules according to claim 1, characterized in that The taste-masking layer may further include an antistatic agent, a plasticizer and / or an anti-sticking agent, wherein the antistatic agent includes one or more of talc, titanium dioxide, and silicon dioxide; the plasticizer includes one or more of triethyl citrate, diethyl phthalate, PEG 6000, and monocaprylic glycerol; and the anti-sticking agent includes one or more of talc, micropowdered silica gel, microcrystalline cellulose, mannitol, and pregelatinized starch.

5. The Chinese medicine direct-take granules according to claim 1, characterized in that The flavoring material includes one or more of sorbitol, mannitol, essence, talc, and arginine.

6. The Chinese medicine direct-take granules according to claim 1, characterized in that The Chinese medicine coated micropills are also coated with an isolation layer and / or a smooth layer; the isolation layer includes a coating material, an anti-adhesive agent, and an antistatic agent; the smooth layer includes a gelling agent; the isolation layer coating material includes one or more of Eudragit, methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, and carboxymethyl cellulose; the isolation layer anti-adhesive agent includes one or more of talc, micropowdered silica gel, microcrystalline cellulose, mannitol, and pregelatinized starch; the isolation layer antistatic agent includes one or more of talc, titanium dioxide, and silicon dioxide; the smooth layer gelling agent includes one or more of gelatin, carrageenan, xanthan gum, konjac flour, carbomer, and agar.

7. The Chinese medicine direct-take granules according to claim 1, characterized in that The particle size of the traditional Chinese medicine coated micropills is less than 400 μm.

8. The Chinese medicine direct-dose granules according to any one of claims 1 to 7, characterized in that: The Chinese medicine direct-take granules include the following components in parts by weight: 55 to 85 parts of Chinese medicine dry paste powder, 0 to 10 parts of anti-sticking agent for coated micropills, 5 to 25 parts of flavor-masking layer coating material, 0.5 to 3 parts of flavor-masking layer antistatic agent, 0 to 0.5 parts of flavor-masking layer plasticizer, 0 to 0.5 parts of flavor-masking layer anti-sticking agent, 0 to 10 parts of isolation layer coating material, 0 to 1 part of isolation layer anti-sticking agent, 0 to 3 parts of isolation layer antistatic agent, 0 to 10 parts of smoothing layer gelling agent and 1 to 10 parts of flavor-correcting material.

9. A method for preparing the Chinese medicine direct-dose granules according to any one of claims 1 to 8, characterized in that: The steps include: Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them; Step 2: mixing the taste masking layer coating material, antistatic agent, optional plasticizer and anti-sticking agent with purified water and anhydrous ethanol to obtain a taste masking layer coating solution; Step 3: Add the mixture obtained in step 1 into a fluidized bed and coat the mixture with the prepared taste-masking coating liquid; Step 4: Screen the coated taste-masked pellets using a sieve and collect the pellets to determine which are qualified taste-masked pellets; Step 5: Mix the taste-masking micropellets with the flavor-correcting excipients.

10. The preparation method according to claim 9, characterized in that Before the taste masking layer is coated, the isolation layer and the smoothing layer are coated, including the following steps: Step 1: Mix the Chinese medicine paste powder and anti-adhesive agent and crush them; Step 2: mixing the isolation layer coating material, anti-sticking agent, antistatic agent and purified water to obtain an isolation layer coating solution; Step 3: Add the mixture obtained in step 1 into a fluidized bed and apply the prepared isolation layer coating liquid to the mixture; Step 4: mixing the taste masking layer coating material, antistatic agent, optional plasticizer and anti-sticking agent with purified water and anhydrous ethanol to obtain a taste masking layer coating solution; Step 5: Place the isolated pellets in a fluidized bed and coat them with the prepared taste-masking coating solution; Step 6: Mix the smooth layer gel with purified water to obtain a smooth layer coating solution; Step 7: Place the taste-masked pellets in a fluidized bed and apply a smooth layer coating using the prepared smooth layer coating solution; Step 8: Mix the smooth layer pellets with the flavoring excipients.

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