Cassia twig granular preparation as well as preparation method and product thereof

Abstract

The invention belongs to the technical field of medicines, and provides a cassia twig granular preparation as well as a preparation method and a product thereof. The cassia twig granule preparation is prepared from the following components in parts by weight: 35 to 50 parts of cassia twig granule extract dry paste and 50 to 105 parts of auxiliary materials, the auxiliary materials comprise lactose, beta-cyclodextrin and derivatives thereof, and citric acid. According to the invention, beta-cyclodextrin and derivatives thereof are used for replacing dextrin as an auxiliary material in the cassia twig granules, so that the interference problem of dextrin in drug detection is avoided, the formability, solubility and hygroscopicity of the cassia twig granule preparation are ensured, the stability of the preparation is improved, and the comprehensive performance is excellent.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines and provides a cinnamon twig granule preparation and a preparation method and product thereof. Background Art

[0002] Guizhi Decoction is the best among all prescriptions and the basis of many prescriptions for improving immunity. In Treatise on Febrile Diseases, it is described that "when the sun is hit by a wind, the yang is floating and the yin is weak. The yang is floating, and the heat is spontaneous. The yin is weak, and the sweat comes out spontaneously. The person is afraid of cold, afraid of wind, has fever, nasal congestion and dry retching. Guizhi Decoction is the main treatment." It means: afraid of cold, afraid of wind, occasional sweating and fever, runny nose, accompanied by dry retching. Guizhi Decoction is the main treatment. It can achieve the purpose of preventing exogenous evil and maintaining physical health by harmonizing the balance of yin and yang in the human body. It is still used clinically today because of its rigorous compatibility, wide indications and remarkable efficacy. The Chinese patent medicine corresponding to Guizhi Decoction is Guizhi Granule, the main ingredients of which are cinnamon twig, white peony root, licorice, ginger and jujube; the auxiliary materials are dextrin and lactose. It is mainly used to relieve muscles and release exterior, harmonize Ying and Wei, and is used for exogenous wind evil, headache and fever, nasal congestion and dry retching, sweating and aversion to wind. However, long-term use of Guizhi Granule will produce drug resistance, and may also cause adverse reactions such as palpitations and insomnia.

[0003] In order to improve the bioavailability of cinnamon twig preparations and achieve the therapeutic effect of reducing dosage and increasing efficiency, Chinese invention patent application CN1365727A discloses a nano cinnamon twig preparation drug and a preparation method thereof. The new drug preparation is prepared with nano cinnamon twig, nano white peony root, nano ginger, nano licorice and nano jujube as raw materials in proportion. The particle fineness reaches 1200-1500 mesh and the particle size is 0.1-200nm, most of which are less than 100nm in size, thereby improving the bioavailability of the drug and achieving significant therapeutic effects.

[0004] However, Guizhi Granule is a pure Chinese medicine preparation. The dry paste of Guizhi Granule extract has strong hygroscopicity, which makes it difficult to granulate directly. As the particle size of the preparation powder decreases, the specific surface area increases, and the crystal defects and amorphous formation on the powder surface further increase its hygroscopicity. The hygroscopicity of the preparation can affect the external and internal quality of the preparation, such as molding, appearance, stability, effectiveness, and safety.

[0005] On the one hand, dry powder has high fluidity, and the surface tension decreases after moisture absorption. At the same time, due to the action of capillary force, the attraction between particles increases and the fluidity decreases. If the moisture absorption continues to increase, the fluidity will increase and the bonding force will decrease. However, when tableting, it is easy to form a connecting bridge between powders, which is easy to stick. On the other hand, after the drug absorbs moisture, a liquid film is formed on the surface, dissolving air, increasing the probability of the drug contacting oxygen, and water can also directly participate in the oxidation reaction. Therefore, moisture absorption can usually catalyze oxidation reactions (such as ferrous sulfate crystals are more susceptible to oxidation in humid air), and hydrolysis is easy to occur after moisture absorption (such as aspirin). Oxidation and hydrolysis reduce the drug content and even produce toxic substances. On the other hand, drugs can promote microbial growth after moisture absorption. For example, many Chinese medicinal materials and Chinese medicine preparations, starch and yeast with high sugar content, protein drugs, etc., can breed bacteria and molds due to moisture absorption, resulting in a decrease in content and deterioration of quality. Therefore, the hygroscopicity of preparations has important research significance.

[0006] In addition to the drugs that may be hygroscopic, excipients (including disintegrants, diluents, lubricants and binders, etc.) in the preparations may also be hygroscopic to varying degrees. Moisture absorption can cause the preparations to agglomerate, reduce fluidity, deliquescence, change in crystal form, etc., which in turn can cause color changes, reduced content or changes in compatibility between components. After moisture absorption, the preparations are more susceptible to oxidation, hydrolysis, and mildew, which reduces the physical, chemical and biological stability of the preparations.

[0007] "Optimal Selection of Auxiliary Materials for Forming Guizhi Granules" and "Analysis of Optimal Selection of Auxiliary Materials for Forming Guizhi Granules" both investigated the effects of different types and proportions of excipients on the formability, solubility and hygroscopicity of Guizhi Granules. Ultimately, it was determined that the optimal excipients were dextrin and lactose, with a ratio of 1:1. Guizhi granules made with these excipients have good formability and solubility, are not easy to absorb moisture, and have ideal effects.

[0008] However, dextrin affects drug extraction and even interferes with its content determination in drug testing. Therefore, a suitable excipient is found to replace dextrin, which can also improve the formability, solubility and non-hygroscopicity of Guizhi Granules. In addition, cinnamaldehyde, the active ingredient in Guizhi, is poorly soluble in water and easily oxidized when exposed to air. At present, the research on how to improve the formability, solubility and hygroscopicity of Guizhi Granules and improve the stability of the active ingredients of the drug is still in a blank stage. Based on this, it is necessary to conduct in-depth research on its excipients, improve the preparation performance and improve the stability of the preparation, so as to achieve the improvement of the comprehensive performance of Guizhi Granules preparation, so that it can give full play to its therapeutic effect on exogenous wind evil, headache and fever. Summary of the invention

[0009] The present invention aims at the problems existing in the prior art and provides a cinnamon twig granule preparation and a preparation method and product thereof. The cinnamon twig granule preparation of the present invention uses beta-cyclodextrin and its derivatives instead of dextrin on the basis of traditional prescription auxiliary materials, and is used in combination with citric acid, thereby overcoming the interference problem of dextrin in the drug detection process, and at the same time has good formability, solubility and low hygroscopicity, and improves the stability of the preparation, providing a prerequisite for achieving the reduction of the preparation and increasing its efficiency.

[0010] The technical solution of the present invention is as follows:

[0011] The invention provides a cinnamon twig granule preparation, which comprises, by weight, 35-50 parts of a cinnamon twig granule extract dry paste and 50-105 parts of auxiliary materials; the auxiliary materials include lactose, beta-cyclodextrin and its derivatives and citric acid.

[0012] In the technical scheme of the present invention, the β-cyclodextrin and its derivatives have a good inclusion effect. After the dry paste of Guizhi Granule Extract is included by it, it can effectively avoid its contact with moisture in the air during the preparation process, improve the molding properties of the drug, and cooperate with citric acid with antioxidant effect to inhibit the oxidation of active ingredients in the drug; in addition, citric acid, as a pH regulator, can effectively control the pH of the solution within a certain dosage range and improve the solubility of the active ingredients; the auxiliary materials work together to achieve the improvement of the comprehensive effects of molding performance in the preparation process and stability of the preparation.

[0013] In addition, since cyclodextrin is unstable to acid, although citric acid can improve the stability of the active ingredients in the dry paste of Guizhi Granule Extract, it may in turn affect the inclusion effect of cyclodextrin on the drug. The present invention improves this problem to a certain extent through the selection of acid and the regulation of the dosage of drug, β-cyclodextrin and citric acid.

[0014] Furthermore, in parts by weight, it includes: 35-50 parts of dried paste of Guizhi granule extract, 35-50 parts of lactose, 20-50 parts of β-cyclodextrin and its derivatives, and 0.5-5 parts of citric acid.

[0015] Furthermore, in terms of weight, it includes: 50 parts of dried Guizhi granule extract, 50 parts of lactose, 50 parts of β-cyclodextrin and its derivatives, and 5 parts of citric acid.

[0016] Preferably, the mass ratio of the cyclodextrin and its derivatives to citric acid is 1:0.05-0.5; preferably 1:0.1-0.375; further preferably 1:0.1-0.25; further preferably 1:0.1-0.125.

[0017] Furthermore, the β-cyclodextrin and its derivatives are selected from one or more of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, methyl-β-cyclodextrin and sulfobutyl-β-cyclodextrin sodium.

[0018] The present invention also provides a method for preparing the above-mentioned Guizhi granule preparation, comprising the following steps:

[0019] (1) dissolving β-cyclodextrin and its derivatives in water to obtain a saturated aqueous solution of β-cyclodextrin and its derivatives; dissolving citric acid in water to obtain a citric acid aqueous solution;

[0020] (2) using a saturated aqueous solution of β-cyclodextrin and its derivatives to encapsulate the dried extract of Guizhi granules;

[0021] (3) mixing the inclusion dried extract of Guizhi granules with lactose and adding citric acid solution to obtain a mixed solution;

[0022] (4) spray drying the mixed solution to obtain the product.

[0023] Furthermore, the concentration of the citric acid aqueous solution is 15-30wt%.

[0024] Furthermore, in step (4), the inlet air temperature of the spray drying is 120-180° C., the atomization pressure is 0.5-1.0 MPa, and the feed rate is 800-1000 mL / h.

[0025] The present invention also provides a product containing the above-mentioned cinnamon twig granule preparation or the cinnamon twig granule preparation prepared by the above-mentioned preparation method, and the product also includes a pharmaceutically acceptable carrier or excipient.

[0026] Furthermore, the product is a medicine, and the dosage form includes but is not limited to any one of ordinary tablets, coated tablets, capsules, pills and ointments.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] (1) The present invention develops a new auxiliary material system for Guizhi Granules, that is, β-cyclodextrin and its derivatives are used to replace the auxiliary material dextrin in Guizhi Granules, thereby avoiding the interference problem of dextrin in drug detection, and effectively improving the formability, solubility and hygroscopicity of Guizhi Granules during preparation, laying a foundation for the quality uniformity and stability of the preparation; at the same time, the improvement of the solubility of the main active ingredient also provides a prerequisite for reducing the amount of the preparation and increasing its efficacy;

[0029] (2) The present invention improves the hygroscopicity and stability of the preparation through the inclusion effect of β-cyclodextrin and its derivatives and the coordination of a specific antioxidant acid - citric acid; in addition, by optimizing the ratio of the two excipients, it is ensured that β-cyclodextrin can exert the best inclusion effect on the main drug without being damaged by antioxidant acids, thereby achieving an improvement in the comprehensive performance of the preparation;

[0030] (3) The preparation method of the Guizhi granule preparation of the present invention is simple, the main drug can be included by various means, and further granulated by spray drying, the particle size and content of the particles are uniform, and the batch-to-batch difference is small;

[0031] (4) The cinnamon twig granule preparation of the present invention can also be prepared into various dosage forms of medicines with pharmaceutically acceptable carriers or excipients, and has a wide range of uses. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention. It is worth noting that the raw materials used in the present invention are all common commercial products, and their sources are not specifically limited.

[0033] Prepare the dry paste of Guizhi granule extract as follows:

[0034] (1) According to the formula of Guizhi Decoction, weigh 3 parts by weight of cinnamon twig, 3 parts by weight of ginger, 3 parts by weight of white peony root, 2 parts by weight of liquorice and 1 part by weight of jujube;

[0035] (2) adding cinnamon twig and ginger to distilled water in an amount 10 times the total mass, heating and boiling, collecting the distillate through a volatile oil collection device, and stopping the extraction when the distillate becomes colorless and transparent, filtering the distillate to obtain a decoction A, and placing it in a sealed container and freezing it for storage;

[0036] (3) adding white peony root, liquorice and jujube to the residue remaining after decoction and distillation in step (2), adding distilled water 10 times the total weight of the medicinal materials, heating and decocting for 1 hour, filtering to obtain filtrate A for use, adding 10 times the amount of distilled water to the residue, heating and decocting again for 1 hour, filtering to obtain filtrate B, and combining filtrate A and filtrate B to obtain water decoction B;

[0037] (4) combining decoction A and decoction B, centrifuging for 30 min, filtering the supernatant, and ultrafiltrating the filtrate to obtain an ultrafiltrate;

[0038] (5) The ultrafiltrate is concentrated under reduced pressure at 65° C. until the water content is ≤5%, thereby obtaining a dry paste of Guizhi granule extract.

[0039] Example 1: Screening of excipients

[0040] The Guizhi granules preparation was prepared according to the prescription in Table 1.

[0041] Table 1 Example 1 Guizhi Granule Preparation Prescription (Unit: Weight Part)

[0042] Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Prescription 6 Guizhi Granule Extract Dry Paste 50 50 50 50 50 50 lactose 50 50 50 50 50 50 dextrin 50 / / / / / starch / 50 / / / / β-Cyclodextrin / / 50 50 / / Hydroxypropyl-β-cyclodextrin / / / / 50 / Sodium sulfobutyl-β-cyclodextrin / / / / / 50 Citric acid / / / 5 5 5

[0043] Note: “ / ” means not added.

[0044] The preparation methods of Prescription 1 to Prescription 3 are as follows:

[0045] (1) Dissolving dextrin (prescription 1), starch (prescription 2), and β-cyclodextrin (prescription 3) in water respectively, and heating to dissolve to prepare corresponding saturated aqueous solutions;

[0046] (2) adding the dried extract of Guizhi granule extract to the corresponding saturated aqueous solution of the inclusion compound, stirring at 60° C. for 1 h to complete the inclusion compound, and obtaining a Guizhi granule extract inclusion compound solution;

[0047] (3) uniformly mixing the inclusion compound solution of the Guizhi granule extract and lactose to obtain a mixed solution;

[0048] (4) The mixed solution was added to a spray device, and the inlet air temperature was set to 150° C., the atomization pressure was set to 0.8 MPa, and the feed rate was set to 800 mL / h. After spray drying, the Guizhi granule preparation was obtained.

[0049] The preparation methods of Prescription 4 to Prescription 6 are as follows:

[0050] (1) dissolving β-cyclodextrin or its derivatives (prescription 3 is β-cyclodextrin, prescription 4 is hydroxypropyl-β-cyclodextrin, and prescription 5 is sulfobutyl-β-cyclodextrin) in water respectively, and heating to dissolve to obtain the corresponding saturated aqueous solution;

[0051] (2) dissolving citric acid in water to prepare a 20 wt % citric acid aqueous solution;

[0052] (3) adding the dried extract of Guizhi granule extract to the corresponding saturated aqueous solution, stirring at 60° C. for 1 h to complete the inclusion complex, and obtaining the Guizhi granule extract inclusion complex solution;

[0053] (4) mixing the inclusion compound solution of the Guizhi granule extract and lactose uniformly, and then adding citric acid aqueous solution to obtain a mixed solution;

[0054] (5) The mixed solution was added to the spray device, and the inlet air temperature was set to 150° C., the atomization pressure was set to 0.8 MPa, and the feed rate was set to 800 mL / h. After spray drying, the Guizhi granule preparation was obtained.

[0055] Test Example 1:

[0056] (I) Examination of formability

[0057] Weigh the prepared Guizhi Granules, first pass through a No. 1 sieve, then through a No. 4 sieve, collect the particles that can pass through the No. 1 sieve but not through the No. 4 sieve, weigh them, and calculate according to the following formula:

[0058] Forming rate = particle mass after sieving / particle mass before sieving × 100%.

[0059] (II) Investigation of solubility

[0060] Add 1.5 g of Guizhi Granule Preparation accurately weighed to a 10 mL centrifuge tube dried to constant weight, add 10 mL of 80°C hot water, stir and shake for 2 min, centrifuge at 3000 r / min for 15 min, discard the supernatant, dry the residue at 80°C to constant weight, accurately weigh, and calculate according to the following formula:

[0061] Dissolution rate = (mass of particles - mass of dried residue) / mass of particles × 100%.

[0062] (III) Investigation of hygroscopicity

[0063] Place a saturated sodium chloride (NaCl) solution at the bottom of a glass desiccator, and then add NaCl until a supersaturated NaCl solution is formed. The relative humidity in the desiccator is measured to be 75%. Place a 2mm thick Guizhi granule preparation at the bottom of a weighing bottle that has been weighed to a constant weight, weigh it accurately, and place it in the above desiccator (with the weighing bottle open). Weigh it after 48 hours and calculate it according to the following formula:

[0064] Moisture absorption rate = (mass after moisture absorption - mass before moisture absorption) / mass before moisture absorption × 100%.

[0065] The molding rate, solubility and dilution rate of the Guizhi Granule Preparations (Formulation 1-Formulation 4) prepared in Example 1 were tested and evaluated according to the above method. The results are shown in Table 2.

[0066] Table 2 Formability, solubility and hygroscopicity test results of each formulation in Example 1

[0067] Forming rate (%) Solubility (%) Moisture absorption rate (%) Prescription 1 99.01 84.32 9.96 Prescription 2 85.24 67.42 19.42 Prescription 3 99.28 88.36 10.11 Prescription 4 98.95 88.94 9.52 Prescription 5 98.79 92.14 8.37 Prescription 6 99.05 90.25 8.94

[0068] Test Example 2: Stability Examination

[0069] After the Guizhi granules (prescriptions 1 to 4) prepared in Example 1 were placed under accelerated conditions (temperature 40±2°C, humidity 75±5%) for 3 months, HPLC was used to determine the changes in the contents of cinnamaldehyde and cinnamic acid in the Guizhi granules before and after the accelerated test. The specific test conditions were: chromatographic column: Agilent ZORBAXSB-phenyl (4.6mm×250mm, 5μm), mobile phase: acetonitrile-1.0% acetic acid aqueous solution (30:70), detection wavelength 290nm, flow rate 1.0mL / min, injection volume 10μL, column temperature: 35°C. The results are shown in Table 3.

[0070] Table 3 Results of cinnamic acid and cinnamaldehyde contents in each prescription in Example 1

[0071]

[0072]

[0073] It can be seen from Table 2 and Table 3 that compared with prescriptions 1 to 6, prescriptions 3 to 6 use β-cyclodextrin or its auxiliary material to encapsulate the dry powder of Guizhi granules, and their molding rate and moisture absorption rate are comparable to those of prescription 1, and the solubility is further improved. Correspondingly, the initial content of cinnamic acid and cinnamaldehyde in the Guizhi granules preparation is also at a high level; while starch is used as an auxiliary material in prescription 2, and the effects in all aspects are poor. In addition, after citric acid is added to prescription 3, the loss of cinnamic acid and cinnamaldehyde in the preparation after acceleration is further reduced, indicating that the presence of citric acid, combined with the inclusion of β-cyclodextrin and its derivatives, improves the molding property, solubility, and reduces hygroscopicity, while also significantly improving the stability of the preparation.

[0074] Example 2: Screening of antioxidants

[0075] The Guizhi granules preparation was prepared according to the prescription in Table 4.

[0076] Table 4 Example 2 Guizhi Granule Preparation Prescription (Unit: Weight Part)

[0077] Prescription 5 Prescription 7 Prescription 8 Guizhi Granule Extract Dry Paste 50 50 50 lactose 50 50 50 Hydroxypropyl-β-cyclodextrin 50 50 50 Citric acid 5 / / tartaric acid / 5 / L-Ascorbic Acid / / 5

[0078] Note: “ / ” means not added.

[0079] Preparation method: Prepare Guizhi granules preparation according to the preparation method of Prescription 4-Prescription 6.

[0080] The formability, solubility, hygroscopicity and stability of the Guizhi Granule preparations of Prescriptions 7 and 8 were tested according to the methods of Test Examples 1 and 2, and compared with Prescription 5. The results are shown in Tables 5 and 6.

[0081] Table 5 Formability, solubility and hygroscopicity test results of each formulation in Example 2

[0082] Forming rate (%) Solubility (%) Moisture absorption rate (%) Prescription 5 98.79 92.14 8.37 Prescription 7 97.85 90.22 14.42 Prescription 8 96.61 85.37 10.25

[0083] Table 6 Results of cinnamic acid and cinnamaldehyde contents in each prescription in Example 2

[0084]

[0085] It can be seen from Table 5 and Table 6 that: compared with Prescription 5, Prescriptions 7 and 8 use tartaric acid and L-ascorbic acid instead of citric acid, and their forming rate and solubility are slightly worse, but they also achieve the effect of Prescription 1, but the moisture absorption rate is greatly increased, and the hygroscopicity is poor; in addition, the stability of the Guizhi Granule preparations prepared by Prescriptions 7 and 8 is significantly obvious, which shows that the present invention significantly improves the stability of the Guizhi Granule preparations by combining specific antioxidant acids with inclusion compound excipients.

[0086] Example 3: Screening of dosage (ratio) of main drug and auxiliary materials

[0087] The Guizhi granules preparation was prepared according to the prescription in Table 7.

[0088] Table 7 Example 3 Guizhi Granule Preparation Prescription (Unit: Weight Part)

[0089] Prescription 5 Prescription 9 Prescription 10 Prescription 11 Prescription 12 Prescription 13 Prescription 14 Guizhi Granule Extract Dry Paste 50 50 50 40 50 50 50 lactose 50 20 75 50 35 50 50 Sodium sulfobutyl-β-cyclodextrin 50 20 75 20 40 40 52 Citric acid 5 2 7.5 5 0.5 15 3

[0090] Note: “ / ” means not added.

[0091] Preparation method: Prepare Guizhi granules preparation according to the preparation method of Prescription 4-Prescription 6.

[0092] The formability, solubility, hygroscopicity and stability of the Guizhi Granule preparations of Prescriptions 9 to 14 were tested according to the methods of Test Example 1 and Test Example 2, and compared with Prescription 5. The results are shown in Tables 8 and 9.

[0093] Table 8 Formability, solubility and hygroscopicity test results of each formulation in Example 3

[0094]

[0095]

[0096] Table 9 Results of cinnamic acid and cinnamaldehyde contents in each prescription in Example 3

[0097]

[0098] It can be seen from Tables 8 and 9 that compared with Prescription 5, the dosage of excipients in Prescription 9 is too low, and the excipients cannot form a good inclusion effect on the Guizhi Granule Dry Paste. The molding rate and dissolution rate are significantly reduced, the moisture absorption rate is significantly increased, and the stability is poor. The dosage of excipients in Prescription 10 is too high. Although the moisture absorption rate is significantly improved, the molding, solubility and stability are poor. This may be caused by excessive excipients leading to uneven inclusion of the main drug. The formability, solubility, hygroscopicity and stability of Prescriptions 11 to 14 are comparable to those of Prescription 5. Prescriptions 13 and 14 adjust the ratio of sodium sulfobutyl-β-cyclodextrin and citric acid from 1:0.1 to 1:0.375 and 1:0.058, respectively, based on Prescription 5. The performance of each aspect also decreases to varying degrees. This may be due to the fact that β-cyclodextrin and its derivatives are sensitive to acid to a certain extent. While the addition of antioxidant acids improves the stability of the active ingredient of the main drug, it also has a certain destructive effect on the inclusion complex β-cyclodextrin. In order to achieve a good balance between improving stability and maintaining the optimal inclusion effect of β-cyclodextrin, it is necessary to reasonably regulate the amount of antioxidant acid-citric acid. Based on this, the ratio of the inclusion complex to the antioxidant in the present invention is preferably 1:0.05-1.0.375, and more preferably 1:0.1.

[0099] 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 cinnamon twig granule preparation, characterized in that: Calculated by weight, the invention comprises: 35-50 parts of dried paste of cinnamon twig granule extract and 50-105 parts of auxiliary materials; the auxiliary materials include lactose, β-cyclodextrin and its derivatives and citric acid.

2. The cinnamon twig granule preparation according to claim 1, characterized in that Calculated by weight, the invention comprises: 35-50 parts of dried paste of cinnamon twig granule extract, 35-50 parts of lactose, 20-50 parts of beta-cyclodextrin and its derivatives, and 0.5-5 parts of citric acid.

3. The cinnamon twig granule preparation according to claim 2, characterized in that Calculated by weight, it includes: 50 parts of dried paste of Guizhi granule extract, 50 parts of lactose, 50 parts of beta-cyclodextrin and its derivatives, and 5 parts of citric acid.

4. The cinnamon twig granule preparation according to claim 1, characterized in that The mass ratio of the cyclodextrin and its derivatives to citric acid is 1:0.05-0.

5.

5. The cinnamon twig granule preparation according to any one of claims 1 to 4, characterized in that: The β-cyclodextrin and its derivatives are selected from one or more of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, methyl-β-cyclodextrin and sulfobutyl-β-cyclodextrin sodium.

6. The method for preparing the Guizhi granule preparation according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) dissolving β-cyclodextrin and its derivatives in water to obtain a saturated aqueous solution of β-cyclodextrin and its derivatives; dissolving citric acid in water to obtain a citric acid aqueous solution; (2) using a saturated aqueous solution of β-cyclodextrin and its derivatives to encapsulate the dried extract of Guizhi granules; (3) mixing the inclusion dried extract of Guizhi granules with lactose and adding citric acid solution to obtain a mixed solution; (4) spray drying the mixed solution to obtain the product.

7. The preparation method according to claim 6, characterized in that: The concentration of the citric acid aqueous solution is 15-30 wt %.

8. The preparation method according to claim 6, characterized in that: In step (4), the inlet air temperature of the spray drying is 120-180° C., the atomization pressure is 0.5-1.0 MPa, and the feed rate is 800-1000 mL / h.

9. A product containing the cinnamon twig granule preparation according to any one of claims 1 to 5 or the cinnamon twig granule preparation prepared by the preparation method according to any one of claims 6 to 8, characterized in that: The product also includes a pharmaceutically acceptable carrier or excipient.

10. The product according to claim 9, characterized in that The product is a medicine, and the dosage form is any one of ordinary tablets, coated tablets, capsules, pills and ointments.

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