A granule preparation of cassia twig and a preparation method and product thereof

Abstract

The application belongs to the technical field of medicine, and provides a cassia twig granule preparation, a preparation method thereof and a product.The cassia twig granule preparation is composed of, in terms of weight fractions, 35-50 parts of cassia twig granule extract dry paste and 50-105 parts of auxiliary materials; the auxiliary materials include lactose, β-cyclodextrin and its derivatives, and citric acid.In the application, β-cyclodextrin and its derivatives are used to replace the auxiliary material dextrin in the cassia twig granule, the interference problem of dextrin in drug detection is avoided, the forming property, solubility and hygroscopicity of the cassia twig granule preparation are ensured, and the stability of the preparation is improved, and the comprehensive performance is excellent.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology and provides a cinnamon twig granule preparation, its preparation method, and the product thereof. Background Technology

[0002] Guizhi Tang, considered the pinnacle of traditional Chinese medicine formulas, forms the basis of numerous immune-boosting prescriptions. The *Shanghan Lun* describes it as follows: "In cases of Taiyang wind-stroke, where the Yang is floating and the Yin is weak, the floating Yang causes spontaneous fever, and the weak Yin causes spontaneous sweating, slight aversion to cold, slight aversion to wind, intermittent fever, nasal congestion, and dry retching, Guizhi Tang is the main treatment." This means that symptoms such as aversion to cold and wind, occasional sweating and fever, runny nose, and dry retching are treated with Guizhi Tang. It aims to harmonize the Yin and Yang balance of the body, preventing external pathogens and maintaining health. Due to its precise formulation, wide range of indications, and remarkable efficacy, it remains in clinical practice to this day. The corresponding prepared Chinese medicine is Guizhi Granules, whose main ingredients are cinnamon twig, white peony root, licorice root, ginger, and jujube; excipients are dextrin and lactose. It is used to relieve muscle tension, harmonize the Ying and Wei Qi, and is indicated for external wind-cold syndromes, headache, fever, nasal congestion, dry retching, sweating, and aversion to wind. However, long-term use of Guizhi Granules can lead to drug tolerance and may cause adverse reactions such as palpitations and insomnia.

[0003] To improve the bioavailability of cinnamon twig preparations and achieve therapeutic effects with reduced dosage and increased efficacy, Chinese invention patent application CN1365727A discloses a nano-cinnamon twig preparation and its preparation method. It is made by mixing nano-cinnamon twig, nano-white peony root, nano-ginger, nano-licorice, and nano-jujube as raw materials in a certain proportion to form a new drug preparation. Its particle size reaches 1200-1500 mesh and the particle size is 0.1-200nm, of which most of the particles are less than 100nm, which improves the bioavailability of the drug and has a significant therapeutic effect.

[0004] However, Guizhi granules are a pure traditional Chinese medicine preparation. The dry extract of Guizhi granules has strong hygroscopic properties, making direct granulation difficult. Furthermore, as the particle size of the powder decreases, the specific surface area increases, and the formation of crystal defects and amorphous particles on the powder surface further enhances its hygroscopic capacity. The hygroscopicity of a preparation can affect its external and internal quality, including its molding, appearance, stability, efficacy, and safety.

[0005] On the one hand, dry powders have high fluidity. After absorbing moisture, their surface tension decreases. Simultaneously, due to capillary forces, the attraction between particles increases, further reducing fluidity. Continued moisture absorption increases fluidity and decreases adhesion, but during tableting, powder bridges easily form, leading to sticking and compression. On the other hand, after absorbing moisture, drugs form a liquid film on their surface, dissolving air and increasing the probability of contact between the drug and oxygen. Water can also directly participate in oxidation reactions. Therefore, moisture absorption often catalyzes oxidation reactions (e.g., ferrous sulfate crystals are more easily oxidized in humid air), and hydrolysis easily occurs after moisture absorption (e.g., aspirin). Oxidation and hydrolysis reduce drug content and may even produce toxic substances. Furthermore, drugs that absorb moisture can promote microbial growth. Many traditional Chinese medicinal materials and preparations, starches and yeasts with high sugar content, and protein-based drugs can all grow bacteria and molds due to moisture absorption, leading to decreased content and deterioration in quality. Therefore, the hygroscopicity of pharmaceutical preparations is of significant research importance.

[0006] In addition to the drug itself, excipients (including disintegrants, diluents, lubricants, and binders) in a formulation may also have varying degrees of hygroscopicity. Hygroscopicity can cause the formulation to clump, reduce its fluidity, deliquulate, and change its crystal form, which in turn can lead to color changes, reduced content, or changes in the compatibility between components. After hygroscopicity, the formulation is more prone to oxidation, hydrolysis, and mold growth, which reduces the physical, chemical, and biological stability of the formulation.

[0007] Both "Optimal Selection of Additives for Cinnamon Twig Granule Forming" and "Analysis of Optimal Selection of Additives for Cinnamon Twig Granule Forming" investigated the effects of different types and proportions of additives on the formability, solubility, and hygroscopicity of cinnamon twig granules. Ultimately, the optimal additives were determined to be dextrin and lactose in a 1:1 ratio. Cinnamon twig granules made with these additives exhibited good formability and solubility, were not prone to hygroscopicity, and achieved ideal results.

[0008] However, dextrin affects drug extraction and interferes with content determination in drug testing. Therefore, it is necessary to find a suitable excipient to replace dextrin while improving the formability, solubility, and hygroscopicity of cinnamon twig granules. Furthermore, cinnamaldehyde, the active ingredient in cinnamon twig, is poorly soluble in water and easily oxidized when exposed to air. Currently, research on how to improve the formability, solubility, and hygroscopicity of cinnamon twig granules while simultaneously enhancing the stability of the active ingredient is still lacking. Therefore, it is necessary to conduct in-depth research on excipients to improve preparation performance and formulation stability, thereby enhancing the overall performance of cinnamon twig granule formulations and enabling them to fully exert their therapeutic effects on exogenous wind-cold, headache, and fever. Summary of the Invention

[0009] This invention addresses the problems existing in the prior art by providing a Guizhi granule preparation, its preparation method, and the product. Based on traditional formula excipients, the Guizhi granule preparation of this invention uses β-cyclodextrin and its derivatives to replace dextrin, and simultaneously incorporates citric acid, overcoming the interference problem of dextrin during drug detection. It also exhibits excellent formability, solubility, and low hygroscopicity, and improves the stability of the preparation, thus providing a prerequisite for achieving dosage reduction and increased efficacy.

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

[0011] This invention provides a cinnamon twig granule preparation, comprising, by weight: 35-50 parts of dried cinnamon twig granule extract and 50-105 parts of excipients; the excipients include lactose, β-cyclodextrin and its derivatives and citric acid.

[0012] In the technical solution of this invention, the β-cyclodextrin and its derivatives have excellent inclusion properties. By encapsulating the dry extract of cinnamon twig granules, they can effectively prevent the extract from contacting moisture in the air during preparation, thus improving the formability of the drug. Combined with citric acid, which has antioxidant properties, it can also inhibit the oxidation of the active ingredients in the drug. In addition, citric acid, as a pH adjuster, can effectively control the pH of the solution within a certain dosage range, thus improving the solubility of the active ingredients. The synergistic effect of the various excipients achieves a comprehensive improvement in both the formability and the stability of the formulation during the preparation process.

[0013] Furthermore, since cyclodextrin is unstable in acid, although citric acid can improve the stability of the active ingredients in the dry extract of cinnamon twig granules, it may conversely affect the inclusion effect of cyclodextrin on the drug. This invention improves this problem to some extent by selecting the acid and controlling the dosage of the drug, β-cyclodextrin and citric acid.

[0014] Further, by weight, it includes: 35-50 parts of dried extract of cinnamon twig granules, 35-50 parts of lactose, 20-50 parts of β-cyclodextrin and its derivatives, and 0.5-5 parts of citric acid.

[0015] Furthermore, by weight, it includes: 50 parts of dried extract of cinnamon twig granules, 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; more preferably 1:0.1-0.375; further preferably 1:0.1-0.25; and even more 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 sodium sulfobutyl-β-cyclodextrin.

[0018] This invention also provides a method for preparing the above-mentioned cinnamon twig granule preparation, comprising the following steps:

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

[0020] (2) The dry extract of cinnamon twig granules was encapsulated with a saturated aqueous solution of β-cyclodextrin and its derivatives.

[0021] (3) After mixing the encapsulated cinnamon twig granule extract dry paste with lactose evenly, add citric acid solution to obtain a mixed solution;

[0022] (4) Spray dry the mixed solution to obtain the final product.

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

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

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

[0026] Furthermore, the product is a pharmaceutical product, and its 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) This invention develops a new excipient system for cinnamon twig granules, namely, replacing the excipient dextrin in cinnamon twig granules with β-cyclodextrin and its derivatives, which avoids the interference problem of dextrin in drug detection, and also effectively improves the formability, solubility and hygroscopicity of cinnamon twig granules during preparation, laying the foundation for the quality uniformity and stability of the preparation; at the same time, the improvement of the solubility of the active ingredient of the main drug also provides a premise for reducing the dosage and increasing the efficacy of the preparation.

[0029] (2) This invention improves the hygroscopicity and stability of the formulation through the inclusion effect of β-cyclodextrin and its derivatives and the synergistic effect of the specific antioxidant acid citric acid; in addition, by optimizing the ratio of these two excipients, the best inclusion effect of β-cyclodextrin on the main drug is ensured without being destroyed by the antioxidant acid, thereby improving the overall performance of the formulation.

[0030] (3) The preparation method of the cinnamon twig granule preparation of the present invention is simple. The main drug can be encapsulated by various means. It can be further granulated by spray drying. The particle size and content are uniform and the batch-to-batch difference is small.

[0031] (4) The Guizhi Granules of the present invention can also be formulated into various dosage forms of drugs with pharmaceutically acceptable carriers or excipients, and have a wide range of applications. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort 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 commercially available products, and their sources are not specifically limited.

[0033] Prepare a dry extract of cinnamon twig granules as follows:

[0034] (1) Weigh out 3 parts of cinnamon twig, 3 parts of ginger, 3 parts of white peony root, 2 parts of licorice root and 1 part of jujube according to the formula of Guizhi Tang.

[0035] (2) Add cinnamon twigs and ginger to 10 times the total mass of distilled water, heat and boil, collect the distillate through a volatile oil collection device, stop the extraction when the distillate is colorless and transparent, filter the distillate to obtain water decoction A, and freeze it in a sealed container.

[0036] (3) Add white peony root, licorice root, and jujube to the remaining dregs after decoction and distillation in step (2), add 10 times the total mass of the medicinal materials of distilled water, heat and decoct for 1 hour, filter to obtain filtrate A for later use, add 10 times the amount of distilled water to the dregs, heat and decoct again for 1 hour, filter to obtain filtrate B, combine filtrate A and filtrate B to obtain decoction B.

[0037] (4) Combine decoction A and decoction B, centrifuge for 30 min, take the supernatant and filter, then ultrafilter the filtrate to obtain ultrafiltrate;

[0038] (5) The ultrafiltrate was concentrated under reduced pressure at 65°C until the water content was ≤5% to obtain the dry extract of cinnamon twig granules.

[0039] Example 1: Screening of excipients

[0040] Prepare cinnamon twig granules according to the prescription in Table 1.

[0041] Table 1. Prescription for Guizhi Granules in Example 1 (Unit: Parts by Weight)

[0042] Formulation 1 Formulation 2 Formulation 3 Formulation 4 Formulation 5 Formulation 6 Extracted dry powder of Ramulus Cinnamomi granules 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 / Sulfobutyl-β-cyclodextrin sodium / / / / / 50 Citric acid / / / 5 5 5

[0043] Note: " / " indicates that it was not added.

[0044] The preparation methods for prescriptions 1-3 are as follows:

[0045] (1) Dissolve the dextrin (Formula 1), starch (Formula 2), and β-cyclodextrin (Formula 3) in water respectively, and heat to dissolve to prepare the corresponding saturated aqueous solutions;

[0046] (2) Add the dry extract of cinnamon twig granules to the corresponding saturated aqueous solution of the inclusion complex, stir at 60°C for 1 hour to complete the inclusion complex, and obtain the inclusion complex solution of cinnamon twig granules extract.

[0047] (3) After mixing the cinnamon twig granule extract inclusion complex solution with lactose evenly, a mixed solution is obtained;

[0048] (4) Add the mixed solution to the spray device, set the air inlet temperature to 150℃, the atomization pressure to 0.8Mpa, and the feeding rate to 800mL / h. After spray drying, the Guizhi granule preparation is obtained.

[0049] The preparation methods for prescriptions 4-6 are as follows:

[0050] (1) Dissolve 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 and heat to dissolve to obtain the corresponding saturated aqueous solutions;

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

[0052] (3) Add the dry extract of cinnamon twig granules to the corresponding saturated aqueous solution and stir at 60°C for 1 hour to complete the inclusion and obtain the inclusion solution of cinnamon twig granules extract.

[0053] (4) After mixing the cinnamon twig granule extract inclusion complex solution with lactose evenly, add citric acid aqueous solution to obtain a mixed solution;

[0054] (5) Add the mixed solution to the spray device, set the air inlet temperature to 150℃, the atomization pressure to 0.8Mpa, and the feeding rate to 800mL / h. After spray drying, the Guizhi granules preparation is obtained.

[0055] Test Example 1:

[0056] (I) Examination of Formability

[0057] Weigh the prepared cinnamon twig granules, pass them through a No. 1 sieve, then through a No. 4 sieve, collect the granules that can pass through the No. 1 sieve but not the No. 4 sieve, weigh them, and calculate the weight using the following formula:

[0058] Formation rate = mass of particles after sieving / mass of particles before sieving × 100%.

[0059] (II) Examination of solubility

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

[0061] Dissolution rate = (particle mass - residue dry mass) / particle mass × 100%.

[0062] (III) Examination of hygroscopicity

[0063] A saturated sodium chloride (NaCl) solution was placed at the bottom of a glass desiccator, and more NaCl was added until a supersaturated NaCl solution was formed. The relative humidity inside the desiccator was measured to be 75%. A layer of cinnamon twig granules, approximately 2 mm thick, was placed at the bottom of a pre-weighed weighing bottle. After accurate weighing, the bottle was placed in the desiccator (with the weighing bottle open). After 48 hours, the weight was measured again, and the result was calculated using 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 cinnamon twig granules (Formulas 1-4) prepared in Example 1 were tested and evaluated according to the above method. The results are shown in Table 2.

[0066] Table 2. Results of formability, solubility, and hygroscopicity tests for each formulation in Example 1.

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

[0068] Test Example 2: Stability Assessment

[0069] The cinnamon twig granules prepared in Example 1 (Formulas 1-4) were placed under accelerated conditions (temperature 40±2℃, humidity 75±5%) for 3 months. The changes in cinnamaldehyde and cinnamic acid content in the cinnamon twig granules before and after the accelerated test were determined by HPLC. Specific test conditions were: column: Agilent ZORBAX SB-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℃. The results are shown in Table 3.

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

[0071]

[0072]

[0073] As shown in Tables 2 and 3, compared to Formulas 1-6, Formulas 3-6, using β-cyclodextrin or its derivatives as excipients to encapsulate the dried cinnamon twig granules, achieved comparable molding rate and moisture absorption to Formula 1, with further improved solubility. Correspondingly, the initial contents of cinnamic acid and cinnamaldehyde in the cinnamon twig granule preparation were also at a higher level. In contrast, Formula 2, using starch as an excipient, showed poor results in all aspects. Furthermore, after adding citric acid to Formula 3, Formulas 4-6 further reduced the loss of cinnamic acid and cinnamaldehyde content after accelerated processing, indicating that the presence of citric acid, combined with the encapsulation of β-cyclodextrin and its derivatives, significantly improved the stability of the preparation while enhancing molding properties, solubility, and reducing moisture absorption.

[0074] Example 2: Screening of antioxidants

[0075] Prepare cinnamon twig granules according to the prescription in Table 4.

[0076] Table 4. Prescription for Guizhi Granules in Example 2 (Unit: Parts by Weight)

[0077] Formulation 5 Formulation 7 Formulation 8 Extracted dry powder of Ramulus Cinnamomi granules 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: " / " indicates that it was not added.

[0079] Preparation method: Prepare cinnamon twig granules according to the preparation methods of prescriptions 4-6.

[0080] The formability, solubility, hygroscopicity, and stability of the Guizhi granules in prescriptions 7 and 8 were tested according to the methods of test examples 1 and 2, and compared with those of prescription 5. The results are shown in Tables 5 and 6.

[0081] Table 5. Results of formability, solubility, and hygroscopicity tests for each formulation in Example 2.

[0082] Molding rate (%) Solubility (%) Hygroscopicity (%) Formulation 5 98.79 92.14 8.37 Formulation 7 97.85 90.22 14.42 Formulation 8 96.61 85.37 10.25

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

[0084]

[0085] As can be seen from Tables 5 and 6, compared with Formula 5, Formulas 7 and 8 use tartaric acid and L-ascorbic acid instead of citric acid, resulting in slightly lower molding rate and solubility, but still achieving the effect of Formula 1. However, the hygroscopic rate increases significantly, and the hygroscopicity is poor. In addition, the stability of the Guizhi granule preparations prepared by Formulas 7 and 8 is significantly improved. It can be seen that the present invention significantly improves the stability of Guizhi granule preparations by combining specific antioxidant acids with inclusion complex excipients.

[0086] Example 3: Screening of dosage (ratio) of active pharmaceutical ingredient and excipients

[0087] Prepare cinnamon twig granules according to the prescription in Table 7.

[0088] Table 7. Prescription for Cinnamon Twig Granules in Example 3 (Unit: Parts by Weight)

[0089] Formulation 5 Formulation 9 Formulation 10 Formulation 11 Formulation 12 Formulation 13 Formulation 14 Extracted dry powder of Ramulus Cinnamomi granules 50 50 50 40 50 50 50 Lactose 50 20 75 50 35 50 50 Sulfobutyl-β-cyclodextrin sodium 50 20 75 20 40 40 52 Citric acid 5 2 7.5 5 0.5 15 3

[0090] Note: " / " indicates that it was not added.

[0091] Preparation method: Prepare cinnamon twig granules according to the preparation methods of prescriptions 4-6.

[0092] The formability, solubility, hygroscopicity, and stability of the Guizhi granules in prescriptions 9-14 were tested according to the methods of test examples 1 and 2, and compared with prescription 5. The results are shown in Tables 8 and 9.

[0093] Table 8. Results of formability, solubility, and hygroscopicity tests for each formulation in Example 3.

[0094]

[0095]

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

[0097]

[0098] As can be seen from Tables 8 and 9, compared with prescription 5, prescription 9 has too low an amount of excipients, and the excipients cannot form a good encapsulation effect on the dry extract of Guizhi granules. The forming rate and solubility are significantly reduced, the moisture absorption rate is significantly increased, and the stability is poor. Prescription 10 has too high an amount of excipients. Although the moisture absorption rate is significantly improved, the forming ability, solubility, and stability are poor. This may be due to the uneven encapsulation of the main drug caused by too many excipients. Formulas 11-14 exhibit similar levels of formability, solubility, hygroscopicity, and stability to Formula 5. Formulas 13 and 14, based on Formula 5, adjust the ratio of sodium sulfobutyl-β-cyclodextrin and citric acid from 1:0.1 to 1:0.375 and 1:0.058, respectively, resulting in varying degrees of performance degradation. This may be due to the sensitivity of β-cyclodextrin and its derivatives to acids. While adding antioxidants improves the stability of the active ingredient, it can also damage the inclusion complex β-cyclodextrin. To achieve a good balance between improving stability and maintaining optimal inclusion effect of β-cyclodextrin, the dosage of antioxidant-citric acid needs to be rationally controlled. Therefore, the preferred ratio of inclusion complex to antioxidant in this invention is 1:0.05-1:0.375, 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, 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 cinnamon twig granule preparation, characterized in that, It is made from the following raw materials in parts by weight: 35-50 parts of dried extract of cinnamon twig granules, 35-50 parts of lactose, 20-50 parts of β-cyclodextrin or its derivatives, and 0.5-5 parts of citric acid. The dried extract of cinnamon twig granules is made from the following raw materials in parts by weight: 3 parts cinnamon twig, 3 parts ginger, 3 parts white peony root, 2 parts licorice root, and 1 part jujube.

2. The cinnamon twig granule preparation according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 50 parts dried extract of cinnamon twig granules, 50 parts lactose, 50 parts β-cyclodextrin or a derivative of β-cyclodextrin, and 5 parts citric acid.

3. The cinnamon twig granule preparation according to claim 1, characterized in that, The mass ratio of the cyclodextrin or β-cyclodextrin derivative to citric acid is 1:0.05-0.

5.

4. The cinnamon twig granule preparation according to any one of claims 1-3, characterized in that, The β-cyclodextrin derivative is selected from any one of hydroxypropyl-β-cyclodextrin, methyl-β-cyclodextrin, and sodium sulfobutyl-β-cyclodextrin.

5. The method for preparing the cinnamon twig granule preparation according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Dissolve β-cyclodextrin or its derivatives in water to obtain a saturated aqueous solution of β-cyclodextrin or its derivatives; dissolve citric acid in water to obtain an aqueous solution of citric acid. (2) The dry extract of cinnamon twig granules was encapsulated with a saturated aqueous solution of β-cyclodextrin or a derivative of β-cyclodextrin; (3) After the dry extract of the encapsulated cinnamon twig granules is mixed evenly with lactose, citric acid solution is added to obtain a mixed solution; (4) Spray dry the mixed solution to obtain the final product.

6. The preparation method according to claim 5, characterized in that, The concentration of the citric acid aqueous solution is 15-30 wt%.

7. The preparation method according to claim 5, characterized in that, In step (4), the inlet air temperature for spray drying is 120-180℃, the atomization pressure is 0.5-1.0Mpa, and the feed rate is 800-1000mL / h.

8. A drug comprising the cinnamon twig granule preparation according to any one of claims 1-4 or the cinnamon twig granule preparation prepared by any one of claims 5-7, characterized in that, The drug also includes a pharmaceutically acceptable carrier.

9. The medicament according to claim 8, characterized in that, The dosage form of the drug is any one of granules, tablets, capsules, pills, and ointments.

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