Formula granules of costus root and preparation method thereof

By repeatedly decocting and drying beta-cyclodextrin with costus root slices, combined with spray drying and dry granulation, the problem of low content of costus root lactone and dehydrocostus root lactone in costus root formulation granules was solved, and efficient preparation of costus root formulation granules was achieved.

CN119074791BActive Publication Date: 2025-11-11KANGMEI PHARMA
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Patent Information

Application Number
CN202411226299.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-09-03
Publication Date
2025-11-11
Estimated Expiration
2044-09-03

AI Technical Summary

Technical Problem

The existing costus root formula granules contain low levels of costus root hydrolactone and dehydrocostus root hydrolactone, resulting in substandard products.

Method used

The content of costus lactone and dehydrocostus lactone was increased by decocting beta-cyclodextrin with costus root slices, followed by multiple decoctions and drying processes, combined with spray drying and dry granulation.

Benefits of technology

This effectively increased the content of costus lactone and dehydrocostus lactone in the costus formula granules, meeting quality standards and ensuring the consistency of the product's active ingredients.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention provides a costus root formula granule and its preparation method, relating to the technical field of traditional Chinese medicine formula granules. The preparation method includes the following steps: mixing costus root slices with beta-cyclodextrin and decocting to obtain a costus root extract; drying the costus root extract and then granulating it to obtain costus root formula granules. This invention solves the problem of costus root formula granules produced by existing technologies containing costus root lactone (C... 15 H 20 O2) and dehydroaurolactone (C 15 H 18 The technical problem of low O2 content was solved, and the technical effect of effectively increasing the content of costus lactone and dehydrocostus lactone in costus formula granules was achieved.
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Description

Technical Field

[0001] This invention relates to the technical field of traditional Chinese medicine formula granules, and in particular to a costus root formula granule and its preparation method. Background Technology

[0002] Traditional Chinese medicine (TCM) granules are made from single-herb decoction pieces. Guided by TCM theory and formulated according to clinical prescriptions, they are administered to patients by dissolving in water. The active ingredients in TCM granules should be essentially consistent with those in decoctions made from the same herbs. The extraction process and quality evaluation indicators for TCM granules are "essentially consistent with traditional decoctions," meaning that the yield, content and transfer rate of effective (or indicator) components, and characteristic chromatograms are essentially consistent with traditional decoctions, rather than maximizing the yield, content, and transfer rate of effective (or indicator) components.

[0003] The quality standard for Chinese herbal medicine granules specifies the upper and lower limits of the extraction rate. If the extraction rate is too high during the production process, it will exceed this range, resulting in unqualified products. In addition, Chinese herbal medicine granules are extracted using water as a solvent, which will result in a lower extraction rate of components with low polarity and poor water solubility.

[0004] Currently, the costus root formulation granules produced using existing production processes may contain costus root lactones (C). 15 H 20 O2) and dehydroaurolactone (C 15 H 18 The content of O2 is low.

[0005] In view of this, the present invention is hereby proposed. Summary of the Invention

[0006] One of the objectives of this invention is to provide a method for preparing costus root formulation granules, which can effectively increase the content of costus root lactone and dehydrocostus root lactone in the costus root formulation granules.

[0007] The second objective of this invention is to provide a costus root formulation granule with a high content of costus root lactone and a high content of dehydrocostus root lactone.

[0008] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0009] Firstly, a method for preparing costus root granules includes the following steps:

[0010] Costus root slices were mixed with beta-cyclodextrin and decocted to obtain costus root extract. The costus root extract was then dried and granulated to obtain the costus root formula granules.

[0011] Furthermore, the amount of beta-cyclodextrin added is 5% to 10% of the mass of the costus root slices.

[0012] Furthermore, the solvent used for decocting includes water.

[0013] Furthermore, the decoction is performed at least twice;

[0014] Preferably, in the first decoction, the amount of beta-cyclodextrin added is 10% of the mass of the costus root slices;

[0015] Preferably, in the first decoction, the amount of water added is 8 to 12 times the mass of the costus root slices;

[0016] Preferably, in the second decoction, the amount of beta-cyclodextrin added is 5% of the mass of the costus root slices;

[0017] Preferably, in the second decoction, the amount of water added is 6.4 to 9.6 times the mass of the costus root slices.

[0018] Furthermore, the decocting temperature is 95℃~100℃.

[0019] Furthermore, the costus root extract also includes a step of concentrating the costus root extract before drying;

[0020] Preferably, the concentration process further includes a step of mixing the resulting inositol concentrate with excipients;

[0021] Preferably, the density of the concentrated costus root extract is 1.02 to 1.06;

[0022] Preferably, the excipients include betacyclodextrin.

[0023] Furthermore, the drying method includes spray drying.

[0024] Furthermore, the spray drying process further includes a step of mixing the resulting spray-dried powder with magnesium stearate and maltodextrin.

[0025] Furthermore, the granulation method includes dry granulation.

[0026] Secondly, a type of costus root formulation granules prepared by any of the above-described preparation methods.

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

[0028] The method for preparing costus root granules provided by this invention involves adding beta-cyclodextrin during the decoction of costus root slices. After decoction, the product is dried and then granulated. This method effectively increases the content of costus root lactones and dehydrocostus root lactones in the costus root granules. The principle is that beta-cyclodextrin can effectively encapsulate the active ingredients of the medicinal liquid, preventing ester components from floating on the liquid surface and being re-adsorbed by the residue during the liquid extraction process. Therefore, this method solves the problem of costus root lactones (C...) existing in traditional costus root granule production methods. 15 H 20 O2) and dehydroaurolactone (C 15 H 18 Technical issues related to low O2 content.

[0029] The costus root formula granules provided by this invention have a high content of costus root hydrolactone and a high content of dehydrocostus root hydrolactone. Attached Figure Description

[0030] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0031] Figure 1 A flowchart illustrating the preparation process of costus root formulation granules according to one embodiment of the present invention;

[0032] Figure 2 The image shows the characteristic spectra of costunolide and dehydrocostunolide obtained from the experimental examples of this invention. Detailed Implementation

[0033] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0034] According to a first aspect of the present invention, a method for preparing costus root granules is provided, comprising the following steps:

[0035] Costus root slices were mixed with beta-cyclodextrin and decocted to obtain costus root extract. The costus root extract was then dried and granulated to obtain costus root formula granules.

[0036] The method for preparing costus root granules provided by this invention involves adding beta-cyclodextrin during the decoction of costus root slices, followed by drying and granulation. This method effectively increases the content of costus root lactones and dehydrocostus root lactones in the costus root granules, solving the problem of costus root lactones (C...) existing in traditional costus root granule production methods. 15 H 20 O2) and dehydroaurolactone (C 15 H 18 Technical issues related to low O2 content.

[0037] In a preferred embodiment, the amount of beta-cyclodextrin added can be 5% to 10% of the mass of the costus root slices. Typical but non-limiting addition amounts are, for example, 5%, 6%, 7%, 8%, 9%, and 10%. The appropriate amount of beta-cyclodextrin added is more conducive to fully increasing the content of costus root lactone and dehydrocostus root lactone. If the amount of beta-cyclodextrin added is too low, the inclusion effect on esters will be poor, resulting in a low content of ester components in the final product. If the amount of beta-cyclodextrin added is too high, it will dilute the original component content and reduce the ester content.

[0038] In this invention, the solvent used for decocting includes, but is not limited to, water.

[0039] In a preferred embodiment, the decoction is performed at least twice.

[0040] In a preferred embodiment, during the first decoction, the amount of beta-cyclodextrin added can be 10% of the mass of the costus root slices; during the first decoction, the amount of water added can be 8 to 12 times the mass of the costus root slices, for example, 8, 9, 10, 11, or 12 times, but is not limited thereto.

[0041] In a preferred embodiment, during the second decoction, the amount of beta-cyclodextrin added can be 5% of the mass of the costus root slices; during the second decoction, the amount of water added can be 6.4 to 9.6 times the mass of the costus root slices, for example, 6.4, 6.6, 6.8, 7, 7.2, 7.4, 7.6, 7.8, 8, 8.4, 8.8, 9.2, or 9.6 times, but is not limited thereto.

[0042] The first decoction, the second decoction, and the amounts of beta-cyclodextrin and water selected in this invention, along with the synergistic effect of various parameters, are more conducive to further increasing the content of costus lactone and dehydrocostus lactone in the costus formula granules.

[0043] In this invention, the first decoction time can be 1 hour, but is not limited to this; the second decoction time can be 1 hour, but is not limited to this.

[0044] In a preferred embodiment, the decocting temperature can be 95°C to 100°C, with typical but non-limiting temperatures such as 95°C, 96°C, 97°C, 98°C, 99°C, and 100°C.

[0045] In a preferred embodiment, the costus extract further includes a step of concentrating the costus extract before drying.

[0046] In this invention, the extract of costus root can be concentrated using a double-effect concentrator. The process parameters for concentration are as follows: temperature for the first effect 75℃~85℃, temperature for the second effect 65℃~75℃; vacuum degree for the first effect -0.07MPa~-0.03MPa, vacuum degree for the second effect -0.08MPa~-0.06MPa. The density of the concentrated solution after concentration can be 1.02~1.06.

[0047] In this invention, after the concentration treatment of the costus root extract, the process further includes a step of mixing the obtained costus root concentrate with excipients; wherein, the excipients include, but are not limited to, beta-cyclodextrin, which can improve the powder yield of subsequent drying.

[0048] Based on the volume of concentrate and the measured extract yield, calculate the amount of beta-cyclodextrin required. The amount of beta-cyclodextrin added (kg) = (amount of raw materials × 76.8% - volume of concentrate × solid content) × 90%. Based on the volume of concentrate after adding the excipients, control the temperature of the mixing tank to 75℃~95℃, keep stirring, and slowly add the maltodextrin to the mixing tank by vacuum feeding or manual feeding.

[0049] In a preferred embodiment, the drying method includes, but is not limited to, spray drying.

[0050] In this invention, the process parameters for spray drying are as follows: steam temperature 140℃~170℃, inlet air temperature 155℃~165℃, material conveying temperature 45℃~60℃, blower frequency 35Hz~45Hz, induced draft frequency 40Hz~50Hz, atomization frequency conversion 30Hz~45Hz, and tower temperature 80℃~95℃.

[0051] In a preferred embodiment, the spray drying process further includes a step of mixing the resulting spray-dried powder with magnesium stearate and maltodextrin.

[0052] In this invention, the spray-dried powder obtained after spray drying can be sieved through an 80-mesh sieve. After sieving, 0.15% of magnesium stearate and the corresponding amount of maltodextrin are added and mixed. The amount of maltodextrin added (kg) = total amount of raw materials × 76.9% - amount of spray-dried powder after crushing and sieving - amount of magnesium stearate.

[0053] In a preferred embodiment, the granulation method includes, but is not limited to, dry granulation.

[0054] In this invention, dry granulation can be performed using a dry granulator. A 12-mesh screen is installed on the dry granulator, and the main hydraulic cylinder pressure, roller speed, and feeding screw speed are adjusted for granulation. The hydraulic cylinder pressure can be 5MPa to 20MPa, the feeding speed can be 25rpm to 150rpm, the tableting speed can be 8rpm to 40rpm, and the granulation speed can be 80rpm to 120rpm. The produced granules can be sized using 12-mesh and 30-mesh screens.

[0055] A typical preparation method for costus root granules, the flowchart is shown below. Figure 1 This includes the following steps:

[0056] (a) First decoction: Add 10±2 times the amount of water of the costus root slices, and add 10% of the costus root slices of betacyclodextrin. Boil and decoct for 1 hour, filter, and control the decoction temperature at 95℃~100℃ to obtain the first extract.

[0057] (b) Second decoction: Add 8±1.6 times the amount of water of the costus root slices, and add 5% of the costus root slices of betacyclodextrin. Boil and decoct for 1 hour, filter, and control the decoction temperature at 95℃~100℃ to obtain the second extract.

[0058] (c) The first and second extracts are combined and filtered through a 100-mesh double filter into the extract storage tank to obtain the costus root extract;

[0059] Next, the costus root extract was concentrated.

[0060] (d) The extract of Costus root was concentrated using a double-effect concentrator to obtain a concentrated Costus root extract;

[0061] The process parameters for concentration treatment are as follows: temperature for the first effect 75℃~85℃, temperature for the second effect 65℃~75℃; vacuum degree for the first effect -0.07MPa~-0.03MPa, vacuum degree for the second effect -0.08MPa~-0.06MPa; concentration to a density of 1.02~1.06.

[0062] Next, the concentrated costus root extract is mixed with the excipients;

[0063] (e) Based on the volume of concentrate and the measured paste yield, calculate the amount of betacyclodextrin required. The amount of betacyclodextrin added (kg) = (amount of raw materials × 76.8% - volume of concentrate × solid content) × 90%. Based on the volume of concentrate after adding the excipient, control the temperature of the mixing tank to 75℃~95℃ and keep the stirring constantly running. Slowly add the maltodextrin to the mixing tank by vacuum feeding or manual feeding, and keep stirring for 30 minutes to make the materials evenly mixed.

[0064] Next, the mixture is spray-dried;

[0065] (f) The mixture is spray-dried to obtain spray-dried powder;

[0066] The process parameters for spray drying are as follows: steam temperature 140℃~170℃, air inlet temperature 155℃~165℃, material conveying temperature 45℃~60℃, blower frequency 35Hz~45Hz, induced draft frequency 40Hz~50Hz, atomization frequency conversion 30Hz~45Hz, and tower temperature 80℃~95℃.

[0067] (g) The spray-dried powder is sieved through an 80-mesh sieve. After sieving, 0.15% of magnesium stearate and the corresponding amount of maltodextrin are added and mixed. The amount of maltodextrin added (kg) = total amount of raw materials × 76.9% - amount of spray-dried powder after crushing and sieving - amount of magnesium stearate. The mixing speed is 10 rpm and the mixing time is 30 min to obtain dry paste powder.

[0068] Next, the dry powder is granulated using a dry granulation method.

[0069] (h) The dry extract powder is granulated by dry method to obtain the costus root formula granules;

[0070] Granulation is performed using a dry granulator. A 12-mesh screen is installed on the dry granulator, and the main hydraulic cylinder pressure, roller speed, and feeding screw speed are adjusted for granulation. Specifically, the hydraulic cylinder pressure is 5MPa to 20MPa, the feeding speed is 25rpm to 150rpm, the tableting speed is 8rpm to 40rpm, and the granulation speed is 80rpm to 120rpm.

[0071] The produced granules are granulated through 12-mesh and 30-mesh sieves.

[0072] In summary, the method for preparing the costus root formula granules of the present invention, through the steps of extraction, concentration, solution preparation, spray drying, sieving, mixing, and granulation, and with the synergistic coordination of each step and its process parameters, can effectively increase the costus root formula granules by increasing the costus root lactone (C 15 H 20 O2) and dehydroaurolactone (C 15 H 18 The O2 content overcomes the shortcomings of traditional woody incense formula granule production technology.

[0073] According to a second aspect of the present invention, a wood-scented granule prepared by any of the above-described preparation methods is provided.

[0074] The costus root formula granules provided by this invention have a high content of costus root hydrolactone and a high content of dehydrocostus root hydrolactone.

[0075] The present invention will be further illustrated by the following examples. Unless otherwise specified, the materials in the examples are prepared according to existing methods or purchased directly from the market.

[0076] Example 1

[0077] A typical preparation method for a costus root formulation granule includes the following steps:

[0078] (a) First decoction: Add 10 times the weight of the costus root slices of water and 10% of the weight of the costus root slices of beta-cyclodextrin. Boil and decoct for 1 hour. Filter and control the decoction temperature at 95℃~100℃ to obtain the first extract.

[0079] (b) Second decoction: Add 8 times the weight of the costus root slices of water and 5% of the weight of the costus root slices of betacyclodextrin. Boil and decoct for 1 hour. Filter and control the decoction temperature at 95℃~100℃ to obtain the second extract.

[0080] (c) The first and second extracts are combined and filtered through a 100-mesh double filter into the extract storage tank to obtain the costus root extract;

[0081] Next, the costus root extract was concentrated.

[0082] (d) The extract of Costus root was concentrated using a double-effect concentrator to obtain a concentrated Costus root extract;

[0083] The process parameters for concentration treatment are as follows: temperature for the first effect 75℃~85℃, temperature for the second effect 65℃~75℃; vacuum degree for the first effect -0.07MPa~-0.03MPa, vacuum degree for the second effect -0.08MPa~-0.06MPa; concentration to a density of 1.02~1.06.

[0084] Next, the concentrated costus root extract is mixed with the excipients;

[0085] (e) Based on the volume of concentrate and the measured paste yield, calculate the amount of betacyclodextrin required. The amount of betacyclodextrin added (kg) = (amount of raw materials × 76.8% - volume of concentrate × solid content) × 90%. Based on the volume of concentrate after adding the excipient, control the temperature of the mixing tank to 75℃~95℃ and keep the stirring constantly running. Slowly add the maltodextrin to the mixing tank by vacuum feeding or manual feeding, and keep stirring for 30 minutes to make the materials evenly mixed.

[0086] Next, the mixture is spray-dried;

[0087] (f) The mixture is spray-dried to obtain spray-dried powder;

[0088] The process parameters for spray drying are as follows: steam temperature 140℃~170℃, air inlet temperature 155℃~165℃, material conveying temperature 45℃~60℃, blower frequency 35Hz~45Hz, induced draft frequency 40Hz~50Hz, atomization frequency conversion 30Hz~45Hz, and tower temperature 80℃~95℃.

[0089] (g) The spray-dried powder is sieved through an 80-mesh sieve. After sieving, 0.15% of magnesium stearate and the corresponding amount of maltodextrin are added and mixed. The amount of maltodextrin added (kg) = total amount of raw materials × 76.9% - amount of spray-dried powder after crushing and sieving - amount of magnesium stearate. The mixing speed is 10 rpm and the mixing time is 30 min to obtain dry paste powder.

[0090] Next, the dry powder is granulated using a dry granulation method.

[0091] (h) The dry extract powder is granulated by dry method to obtain the costus root formula granules;

[0092] Granulation is performed using a dry granulator. A 12-mesh screen is installed on the dry granulator, and the main hydraulic cylinder pressure, roller speed, and feeding screw speed are adjusted for granulation. Specifically, the hydraulic cylinder pressure is 5MPa to 20MPa, the feeding speed is 25rpm to 150rpm, the tableting speed is 8rpm to 40rpm, and the granulation speed is 80rpm to 120rpm.

[0093] The produced granules are granulated through 12-mesh and 30-mesh sieves.

[0094] Example 2

[0095] The difference between this embodiment and Embodiment 1 is that 5% beta-cyclodextrin by weight of the costus root slices is added in step (a).

[0096] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0097] Example 3

[0098] The difference between this embodiment and Embodiment 1 is that in step (a), 8% by weight of beta-cyclodextrin of the costus root slices is added.

[0099] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0100] Example 4

[0101] The difference between this embodiment and Embodiment 1 is that in step (a), 12% beta-cyclodextrin by weight of the costus root slices is added;

[0102] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0103] Example 5

[0104] The difference between this embodiment and Embodiment 1 is that in step (b), 8% by weight of beta-cyclodextrin of the costus root slices is added.

[0105] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0106] Example 6

[0107] The difference between this embodiment and Embodiment 1 is that in step (b), 10% of the weight of the costus root slices is added as beta-cyclodextrin.

[0108] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0109] Example 7

[0110] The difference between this embodiment and Embodiment 1 is that the second decoction in step (b) was not performed;

[0111] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0112] Example 8

[0113] The difference between this embodiment and Embodiment 1 is that beta-cyclodextrin was not added in step (e);

[0114] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0115] Example 9

[0116] The difference between this embodiment and Embodiment 1 is that maltodextrin was not added in step (g);

[0117] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0118] Comparative Example 1

[0119] The difference between this comparative example and Example 1 is that in step (a), 8 times the mass of the costus root slices of water were added, and no beta-cyclodextrin was added; in step (b), 6 times the mass of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0120] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0121] Comparative Example 2

[0122] The difference between this comparative example and Example 1 is that in step (a), 8 times the mass of the costus root slices of water were added, and no beta-cyclodextrin was added, and the decoction time was 2 hours; in step (b), 6 times the mass of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0123] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0124] Comparative Example 3

[0125] The difference between this comparative example and Example 1 is that in step (a), 8 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added. The slices of costus root were chopped into thin slices with a diameter of 10 mm and decocted for 2 hours. In step (b), 6 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0126] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0127] Comparative Example 4

[0128] The difference between this comparative example and Example 1 is that in step (a), 8 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added. The slices were cut into thin slices with a diameter of 10 mm, soaked for 1 hour, and then decocted for 2 hours. In step (b), 6 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0129] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0130] Comparative Example 5

[0131] The difference between this comparative example and Example 1 is that in step (a), 8 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added. The slices were cut into thin pieces with a diameter of 10 mm, soaked for 4 hours, and then decocted for 2 hours. In step (b), 6 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0132] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0133] Comparative Example 6

[0134] The difference between this comparative example and Example 1 is that in step (a), 8 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added. The slices were cut into thin slices with a diameter of 10 mm, soaked for 8 hours, and then decocted for 2 hours. In step (b), 6 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0135] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0136] Comparative Example 7

[0137] The difference between this comparative example and Example 1 is that in step (a), 8 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added. The slices were cut into thin slices with a diameter of 10 mm, soaked for 12 hours, and then decocted for 2 hours. In step (b), 6 times the weight of the costus root slices of water were added, and no beta-cyclodextrin was added.

[0138] The remaining steps and process parameters are the same as in Example 1, and the costus root formula granules are obtained.

[0139] Test case

[0140] The test results and transfer rates of the costus root formulation particles obtained in each embodiment and comparative example are shown in Table 1.

[0141] Table 1

[0142]

[0143] Formula for calculating transfer rate:

[0144] As shown in Table 1, the costus root formulation granules prepared by this invention effectively increased the costus root lactone (C 15 H 20 O2) and dehydroaurolactone (C 15 H 18 The total content of O2); Meanwhile, the preparation method of the present invention, while significantly increasing the total content of costus lactone and dehydrocostus lactone, still ensures that key test indicators such as characteristic spectra are qualified, see... Figure 2 .

[0145] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing costus root granules, characterized in that, Includes the following steps: Costus root slices were mixed with beta-cyclodextrin and decocted to obtain Costus root extract. The Costus root extract was dried and then granulated to obtain the Costus root formula granules. The solvent used for decocting is water; The boiling process is performed at least twice; In the first decoction, the amount of water added should be 8 to 12 times the weight of the costus root slices; In the second decoction, the amount of water added is 6.4 to 9.6 times the mass of the costus root slices.

2. The preparation method according to claim 1, characterized in that, The amount of beta-cyclodextrin added is 5% to 10% of the mass of the costus root slices.

3. The preparation method according to claim 2, characterized in that, In the first decoction, the amount of beta-cyclodextrin added was 10% of the mass of the costus root slices.

4. The preparation method according to claim 2, characterized in that, In the second decoction, the amount of beta-cyclodextrin added was 5% of the mass of the costus root slices.

5. The preparation method according to claim 1, characterized in that, The decocting temperature is 95℃~100℃.

6. The preparation method according to claim 1, characterized in that, The costus root extract also includes a concentration process before drying; The concentration process further includes a step of mixing the resulting concentrated costus root extract with excipients. The density of the concentrated costus root extract is 1.02~1.06; The excipients include beta-cyclodextrin.

7. The preparation method according to claim 6, characterized in that, The drying method includes spray drying.

8. The preparation method according to claim 7, characterized in that, The spray drying process further includes a step of mixing the resulting spray-dried powder with magnesium stearate and maltodextrin.

9. The preparation method according to claim 1, characterized in that, The granulation method includes dry granulation.

10. A type of costus root granule prepared by the preparation method according to any one of claims 1-9.

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