Traditional chinese medicine formulation and preparation method therefor

Abstract

The present invention relates to the technical field of medicine, and provides a traditional Chinese medicine formulation and a preparation method therefor. The traditional Chinese medicine formulation is prepared from traditional Chinese medicine spray powder, an excipient, and a sweetener, wherein the addition amount of the excipient accounts for 0-60% of the total weight of the traditional Chinese medicine spray powder and the excipient, and the addition amount of the sweetener accounts for 0.35-0.65% of the total weight of the traditional Chinese medicine spray powder and the excipient. A traditional Chinese medicine solid formulation is prepared by using a dry granulation method.

Description

A Traditional Chinese Medicine Preparation and Its Preparation Method

[0001] This application claims the priority of a Chinese patent application filed with the Chinese Patent Office on October 30, 2024, with the application number 2024115305044 and the invention title "A Traditional Chinese Medicine Preparation and Its Preparation Method", the entire content of which is incorporated herein by reference. Technical Field

[0002] The present invention relates to the technical field of pharmaceuticals, and particularly to a traditional Chinese medicine preparation and its preparation method. Background Art

[0003] As an important part of traditional medicine, the preparation process of traditional Chinese medicine preparations has been continuously optimized and innovated in the process of modernization. Among them, granules, as an important form of traditional Chinese medicine preparations, occupy an important position in the pharmaceutical market due to their advantages such as convenient administration, accurate dosage, and high bioavailability. The preparation processes of granules mainly include wet granulation and dry granulation.

[0004] Wet granulation technology is a method of preparing granules by adding a binder to drug powders and making the powders coalesce together through the bridging or bonding action of the binder. Wet granulation includes various methods such as extrusion granulation, rotational granulation, fluidized granulation, and stirring granulation. The granules prepared by the wet method have advantages such as good granule quality, beautiful appearance, strong abrasion resistance, and good compression molding properties, but there are also problems such as complex processes, long production cycles, and high energy consumption.

[0005] In the process of wet granulation, a series of operations such as mixing, granulation, drying, and screening are required after adding the binder to the materials. Among them, the drying step is a key link in the wet granulation process, which consumes a large amount of energy and time. In addition, the dosage of the binder and the mixing time need to be strictly controlled during the wet granulation process to ensure the quality and stability of the granules.

[0006] Dry granulation technology is a new granulation method that emerged in recent years. Compared with traditional wet granulation, dry granulation avoids adding a large amount of excipients such as sugar and dextrin, and minimizes the dosage of excipients to the greatest extent. At the same time, dry granulation has the advantages of simple production process, high production efficiency, low production cost, and short production cycle, and its application in the preparation of granules is becoming more and more extensive.

[0007] In dry granulation, the drug is usually mixed with a diluent, a disintegrant, or a lubricant, etc., and then processed 1-3 times through a roller press or an open rubber mill to form a thin sheet with the required hardness, and then crushed into granules by a swing granulator. This method does not require the drying step in wet granulation, thus significantly shortening the production cycle and reducing the energy consumption.

[0008] Although dry granulation technology has shown many advantages in the preparation of traditional Chinese medicine granules, existing technologies still have some shortcomings. For example, some dry granulation processes need further optimization in terms of particle uniformity, hardness, and disintegration. At the same time, different drugs have significant differences in adaptability to the dry granulation process, requiring adjustments and optimization of process parameters for specific drugs.

[0009] Furthermore, solid dosage forms of traditional Chinese medicine (TCM), such as granules, tablets, and powders, as an important achievement of the modernization of TCM, meet the modern demand for health care with their convenience and stability. However, due to the complex components and natural properties of TCM, many TCM preparations often have problems with taste, such as bitterness, spiciness, or unpleasant odors. This greatly affects patients' medication experience and compliance, especially for children, where poor taste is often one of the main reasons for medication refusal. Therefore, selecting appropriate flavoring agents or sweeteners is crucial for solid TCM dosage forms. It can not only significantly improve the taste of the medicine and enhance patient compliance, especially for children, but also reduce medication resistance caused by poor taste, ensuring therapeutic efficacy. Through scientific screening and optimization of the use of flavoring agents, interference with the original efficacy of the drug can also be avoided to a certain extent, ensuring the safety and effectiveness of medication. However, the screening of flavoring agents or sweeteners is not a simple task; it requires researchers to have creative thinking and tireless effort to find the optimal combination that can significantly improve the taste of solid TCM dosage forms without affecting the efficacy and safety of the drug.

[0010] In view of the problems existing in the prior art, this invention proposes an optimized dry granulation method. This method aims to further improve the overall performance of the granules while reducing production costs and increasing production efficiency by improving and controlling the types and ratios of excipients and flavoring agents, as well as the step parameters in the dry granulation process. Summary of the Invention

[0011] The purpose of this invention is to provide a traditional Chinese medicine preparation and its preparation method. This invention uses a dry granulation method to prepare solid traditional Chinese medicine preparations.

[0012] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0013] A traditional Chinese medicine preparation comprises traditional Chinese medicine spray powder, excipients, and a sweetener. The amount of excipients added is 0-60% of the total weight of the traditional Chinese medicine spray powder and excipients, and the amount of sweetener added is 0.35%-0.65% of the total weight of the traditional Chinese medicine spray powder and excipients.

[0014] Furthermore, the amount of excipients added is 10-40% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.45%-0.55% of the total weight of the Chinese herbal spray powder and excipients.

[0015] Furthermore, the amount of excipients added is 25-35% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.45%-0.55% of the total weight of the Chinese herbal spray powder and excipients.

[0016] Furthermore, the amount of excipients added is 20% of the total weight of the traditional Chinese medicine spray powder and excipients, and the amount of sweetener added is 0.45% of the total weight of the traditional Chinese medicine spray powder and excipients.

[0017] Furthermore, the amount of excipients added is 40% of the total weight of the traditional Chinese medicine spray powder and excipients, and the amount of sweetener added is 0.55% of the total weight of the traditional Chinese medicine spray powder and excipients.

[0018] Furthermore, the amount of excipients added is 30% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.50% of the total weight of the Chinese herbal spray powder and excipients.

[0019] Furthermore, the herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52-86 parts; Gypsum 194-324 parts; Forsythia 194-324 parts; Scutellaria baicalensis 78-130 parts; Mulberry bark 194-324 parts; Bitter almond 78-130 parts; Peucedanum praeruptorum 78-130 parts; Pinellia ternata 78-130 parts; Tangerine peel 78-130 parts; Fritillaria cirrhosa 78-130 parts; Arctium lappa 78-130 parts; Honeysuckle 78-130 parts; Rheum palmatum 39-65 parts; Platycodon grandiflorus 46-76 parts; Licorice 39-65 parts.

[0020] Furthermore, the herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52 parts; Gypsum 324 parts; Forsythia 194 parts; Scutellaria baicalensis 78 parts; Mulberry bark 194 parts; Bitter almond 130 parts; Peucedanum praeruptorum 78 parts; Pinellia ternata 130 parts; Tangerine peel 78 parts; Fritillaria cirrhosa 78 parts; Arctium lappa 130 parts; Honeysuckle 130 parts; Rheum palmatum 39 parts; Platycodon grandiflorus 76 parts; Licorice 65 parts.

[0021] Furthermore, the herbal spray powder is made from the following raw materials in parts by weight: Ephedra 86 parts; Gypsum 194 parts; Forsythia 324 parts; Scutellaria baicalensis 130 parts; Mulberry bark 324 parts; Bitter almond 78 parts; Peucedanum praeruptorum 130 parts; Pinellia ternata 78 parts; Tangerine peel 130 parts; Fritillaria cirrhosa 130 parts; Arctium lappa 78 parts; Honeysuckle 78 parts; Rheum palmatum 65 parts; Platycodon grandiflorus 46 parts; Licorice 39 parts.

[0022] Furthermore, the herbal spray powder is made from the following raw materials in parts by weight: Ephedra 69 parts; Gypsum 259 parts; Forsythia 259 parts; Scutellaria baicalensis 104 parts; Mulberry bark 259 parts; Bitter almond 104 parts; Peucedanum praeruptorum 104 parts; Pinellia ternata 104 parts; Tangerine peel 104 parts; Fritillaria cirrhosa 104 parts; Arctium lappa 104 parts; Honeysuckle 104 parts; Rheum palmatum 52 parts; Platycodon grandiflorus 61 parts; Licorice 52 parts.

[0023] Furthermore, the herbal spray powder is made from the following raw materials in parts by weight: Ephedra 55 parts; Gypsum 254 parts; Forsythia 318 parts; Scutellaria baicalensis 107 parts; Mulberry bark 203 parts; Bitter almond 107 parts; Peucedanum praeruptorum 82 parts; Pinellia ternata 105 parts; Tangerine peel 84 parts; Fritillaria cirrhosa 125 parts; Arctium lappa 122 parts; Honeysuckle 113 parts; Rheum palmatum 42 parts; Platycodon grandiflorus 60 parts; Licorice 50 parts.

[0024] Furthermore, the bitter almond is stir-fried bitter almond, the fritillaria is Zhejiang fritillaria, the honeysuckle is mountain honeysuckle, and the pinellia is processed pinellia.

[0025] Furthermore, the preparation method of the traditional Chinese medicine spray powder includes the following steps:

[0026] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0027] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 40-70% ethanol and reflux twice, each time for 1-4 hours. Add 8-10 times the amount for the first time and 6-9 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.05-1.20 measured at 60℃, filter, and set aside.

[0028] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, each time for 1-4 hours. Add 9-11 times the amount for the first decoction and 7-9 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10-1.20 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use.

[0029] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0030] Furthermore, in step B, the obtained extract is filtered through a 300-mesh or 200-mesh sieve; in step C, the obtained extract is filtered through a 300-mesh sieve. This effectively removes impurities from the extract, improves the quality and stability of the herbal granules, and ensures that the resulting granules meet the required solubility standards.

[0031] Furthermore, the excipients include at least one of maltodextrin, lactose, or mannitol, preferably maltodextrin.

[0032] Furthermore, the sweetener includes at least one of sucralose, mogroside, or glycyrrhizic acid, preferably sucralose.

[0033] Furthermore, the traditional Chinese medicine preparation is in the form of capsules, tablets, or granules.

[0034] The present invention also provides a method for preparing the above-mentioned granules, comprising the following steps:

[0035] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0036] S2. The obtained mixture is added to the screw feeder, and the mixture is conveyed to the rolling area through the screw feeder to be pressed into sheets;

[0037] S3. The obtained tablets are crushed in the granulation mechanism and then sieved to obtain granules.

[0038] Furthermore, in step S2, the screw feed speed is 25.0±5 rpm; the pressure roller speed is 10.0±4.0 rpm; and the pressure roller oil pressure is 37±5 bar.

[0039] Furthermore, in step S3, granulation is performed using a 12-16 mesh sieve; during the sieving process, the upper layer uses a 12-16 mesh sieve, and the lower layer uses a 40-60 mesh sieve.

[0040] Compared to existing technologies, this invention provides a traditional Chinese medicine preparation, which is prepared into granules using a dry granulation process. In the dry granulation process, this invention significantly improves production efficiency and product quality by optimizing and controlling the types and ratios of excipients and sweeteners, as well as process parameters. Specifically, this invention not only ensures a high yield in the dry granulation process, but also produces granules with high uniformity and consistent color, completely eliminating color difference problems; excellent solubility ensures rapid dissolution and efficient utilization of the product; precise control of moisture content effectively extends the product's shelf life and stability; and uniform particle size distribution meets the precise requirements of different application scenarios. Most importantly, the transfer rate of active ingredients is stabilized, ensuring the consistency of product activity and efficacy, providing consumers with reliable health protection.

[0041] Furthermore, in the dry granulation process, this invention significantly enhances the taste experience of the granules by adding a specific proportion of carefully selected sweeteners. This avoids excessive sweetness that could negatively impact the overall flavor, while effectively masking or balancing any unpleasant tastes in the raw materials, resulting in a pleasantly balanced taste. This improvement not only meets consumers' discerning taste requirements but also broadens the application range of granules, making them more suitable for various consumer groups and market demands. Taste evaluation results show that the optimized granules received high praise in terms of sweetness, flavor harmony, and mouthfeel comfort. This invention, by adding a specific proportion of a particular sweetener, successfully achieved a significant improvement in the taste evaluation results of granules, injecting new vitality into the overall product quality and consumer satisfaction.

[0042] The formulation method provided by this invention not only demonstrates a high degree of technological maturity and stability, but also perfectly meets the needs of industrial production with its excellent adaptability and flexibility. It simplifies the production process, reduces energy consumption and costs, and significantly improves production efficiency and product qualification rate, laying a solid foundation for enterprises to achieve large-scale production and enhance market competitiveness. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0044] Example 1

[0045] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 30% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.5% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0046] The Chinese herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52g; Gypsum 324g; Forsythia 194g; Scutellaria 78g; Mulberry bark 194g; Bitter almond 130g; Peucedanum praeruptorum 78g; Pinellia ternata 130g; Tangerine peel 78g; Fritillaria 78g; Arctium lappa 130g; Honeysuckle 130g; Rhubarb 39g; Platycodon grandiflorus 76g; Licorice 65g.

[0047] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0048] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0049] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 50% ethanol and reflux twice for 3 hours each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.10 measured at 60℃, filter, and set aside.

[0050] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2 hours each time. Add 10 times the amount the first time and 7 times the amount the second time. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use.

[0051] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0052] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0053] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0054] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0055] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0056] Example 2

[0057] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 20% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.45% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0058] The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 86g; Gypsum 194g; Forsythia 324g; Scutellaria baicalensis 130g; Mulberry bark 324g; Bitter almond 78g; Peucedanum praeruptorum 130g; Pinellia ternata 78g; Tangerine peel 130g; Fritillaria cirrhosa 130g; Arctium lappa 78g; Honeysuckle 78g; Rheum palmatum 65g; Platycodon grandiflorus 46g; Licorice 39g.

[0059] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0060] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0061] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 40% ethanol and reflux twice for 4 hours each time. Add 8 times the amount for the first time and 9 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.10 measured at 60℃, filter, and set aside.

[0062] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 4 hours each time. Add 9 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.20 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0063] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0064] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0065] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose in proportion and mix them evenly to obtain the mixture.

[0066] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 20 rpm; the roller speed is 6 rpm; and the roller oil pressure is 32 bar.

[0067] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 12-mesh sieve, and then sieved using an upper 12-mesh sieve and a lower 60-mesh sieve to obtain granules.

[0068] Example 3

[0069] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 40% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.35% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0070] The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 69g; Gypsum 259g; Forsythia 259g; Scutellaria baicalensis 104g; Mulberry bark 259g; Bitter almond 104g; Peucedanum praeruptorum 104g; Pinellia ternata 104g; Tangerine peel 104g; Fritillaria cirrhosa 104g; Arctium lappa 104g; Honeysuckle 104g; Rheum palmatum 52g; Platycodon grandiflorus 61g; Licorice 52g.

[0071] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0072] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0073] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 70% ethanol and reflux twice, one hour each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.20 measured at 60℃, filter, and set aside.

[0074] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, one hour each time. Add 11 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0075] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0076] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0077] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0078] S2. The obtained mixture is added to the screw feed mechanism. The mixture is conveyed to the roller pressing area through the screw feed mechanism and pressed into sheets. The screw feed speed is 30 rpm; the roller speed is 14 rpm; and the roller oil pressure is 42 bar.

[0079] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 16-mesh sieve, and then sieved using an upper 16-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0080] Example 4

[0081] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder and sucralose: the amount of sucralose added is 0.65% of the weight of the traditional Chinese medicine spray powder.

[0082] The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 55g; Gypsum 254g; Forsythia 318g; Scutellaria baicalensis 107g; Mulberry bark 203g; Bitter almond 107g; Peucedanum praeruptorum 82g; Pinellia ternata 105g; Tangerine peel 84g; Fritillaria cirrhosa 125g; Arctium lappa 122g; Honeysuckle 113g; Rheum palmatum 42g; Platycodon grandiflorus 60g; Licorice 50g.

[0083] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0084] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0085] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 60% ethanol and reflux twice, each time for 2 hours. Add 9 times the amount for the first time and 7 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.15 measured at 60℃, filter, and set aside.

[0086] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2.5 hours each time. Add 10 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0087] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0088] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0089] S1. Mix the Chinese herbal spray powder and sucralose evenly to obtain the mixture.

[0090] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0091] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0092] Example 5

[0093] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 29% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.5% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0094] The Chinese herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52g; Gypsum 324g; Forsythia 194g; Scutellaria 78g; Mulberry bark 194g; Bitter almond 130g; Peucedanum praeruptorum 78g; Pinellia ternata 130g; Tangerine peel 78g; Fritillaria 78g; Arctium lappa 130g; Honeysuckle 130g; Rhubarb 39g; Platycodon grandiflorus 76g; Licorice 65g.

[0095] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0096] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0097] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 50% ethanol and reflux twice for 3 hours each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.10 measured at 60℃, filter, and set aside.

[0098] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2 hours each time. Add 10 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.15 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0099] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0100] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0101] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0102] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0103] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0104] Example 6

[0105] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 35% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.5% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0106] The Chinese herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52g; Gypsum 324g; Forsythia 194g; Scutellaria 78g; Mulberry bark 194g; Bitter almond 130g; Peucedanum praeruptorum 78g; Pinellia ternata 130g; Tangerine peel 78g; Fritillaria 78g; Arctium lappa 130g; Honeysuckle 130g; Rhubarb 39g; Platycodon grandiflorus 76g; Licorice 65g.

[0107] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0108] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0109] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 50% ethanol and reflux twice for 3 hours each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.10 measured at 60℃, filter, and set aside.

[0110] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2 hours each time. Add 10 times the amount the first time and 7 times the amount the second time. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use.

[0111] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0112] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0113] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0114] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0115] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0116] Example 7

[0117] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, maltodextrin and sucralose: the amount of maltodextrin added is 34% of the total weight of the traditional Chinese medicine spray powder and maltodextrin, and the amount of sucralose added is 0.5% of the total weight of the traditional Chinese medicine spray powder and maltodextrin.

[0118] The Chinese herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52g; Gypsum 324g; Forsythia 194g; Scutellaria 78g; Mulberry bark 194g; Bitter almond 130g; Peucedanum praeruptorum 78g; Pinellia ternata 130g; Tangerine peel 78g; Fritillaria 78g; Arctium lappa 130g; Honeysuckle 130g; Rhubarb 39g; Platycodon grandiflorus 76g; Licorice 65g.

[0119] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0120] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0121] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 50% ethanol and reflux twice for 3 hours each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.10 measured at 60℃, filter, and set aside.

[0122] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2 hours each time. Add 10 times the amount the first time and 7 times the amount the second time. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use.

[0123] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0124] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0125] S1. Take the Chinese herbal spray powder, maltodextrin and sucralose and mix them evenly to obtain the mixture.

[0126] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0127] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0128] Example 8

[0129] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, lactose, and mogroside: the amount of lactose added is 35% of the total weight of traditional Chinese medicine spray powder and lactose, and the amount of mogroside added is 0.5% of the total weight of traditional Chinese medicine spray powder and lactose.

[0130] The Chinese herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52g; Gypsum 324g; Forsythia 194g; Scutellaria 78g; Mulberry bark 194g; Bitter almond 130g; Peucedanum praeruptorum 78g; Pinellia ternata 130g; Tangerine peel 78g; Fritillaria 78g; Arctium lappa 130g; Honeysuckle 130g; Rhubarb 39g; Platycodon grandiflorus 76g; Licorice 65g.

[0131] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0132] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0133] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 50% ethanol and reflux twice for 3 hours each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.05 measured at 60℃, filter, and set aside.

[0134] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 2 hours each time. Add 10 times the amount the first time and 7 times the amount the second time. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use.

[0135] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0136] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0137] S1. Take the Chinese herbal spray powder, lactose and monk fruit glycosides and mix them evenly to obtain the mixture.

[0138] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 25 rpm; the roller speed is 10 rpm; and the roller oil pressure is 37 bar.

[0139] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 14-mesh sieve, and then sieved using an upper 14-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0140] Example 9

[0141] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, mannitol and glycyrrhizic acid: the amount of mannitol added is 25% of the total weight of traditional Chinese medicine spray powder and mannitol, and the amount of glycyrrhizic acid added is 0.45% of the total weight of traditional Chinese medicine spray powder and mannitol.

[0142] The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 86g; Gypsum 194g; Forsythia 324g; Scutellaria baicalensis 130g; Mulberry bark 324g; Bitter almond 78g; Peucedanum praeruptorum 130g; Pinellia ternata 78g; Tangerine peel 130g; Fritillaria cirrhosa 130g; Arctium lappa 78g; Honeysuckle 78g; Rheum palmatum 65g; Platycodon grandiflorus 46g; Licorice 39g.

[0143] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0144] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0145] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 40% ethanol and reflux twice for 4 hours each time. Add 8 times the amount for the first time and 9 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.05 measured at 60℃, filter, and set aside.

[0146] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, 4 hours each time. Add 9 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.20 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0147] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0148] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0149] S1. Take the Chinese herbal spray powder, mannitol and glycyrrhizic acid in proportion and mix them evenly to obtain the mixture.

[0150] S2. The obtained mixture is added to the screw feeder. The mixture is conveyed to the roller pressing area through the screw feeder and pressed into sheets. The screw feeder speed is 20 rpm; the roller speed is 6 rpm; and the roller oil pressure is 32 bar.

[0151] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 12-mesh sieve, and then sieved using an upper 12-mesh sieve and a lower 60-mesh sieve to obtain granules.

[0152] Example 10

[0153] This embodiment provides a traditional Chinese medicine granule, which is composed of traditional Chinese medicine spray powder, lactose and mogroside: the amount of maltodextrin added is 30% of the total weight of traditional Chinese medicine spray powder and lactose, and the amount of mogroside added is 0.35% of the total weight of traditional Chinese medicine spray powder and lactose.

[0154] The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 69g; Gypsum 259g; Forsythia 259g; Scutellaria baicalensis 104g; Mulberry bark 259g; Bitter almond 104g; Peucedanum praeruptorum 104g; Pinellia ternata 104g; Tangerine peel 104g; Fritillaria cirrhosa 104g; Arctium lappa 104g; Honeysuckle 104g; Rheum palmatum 52g; Platycodon grandiflorus 61g; Licorice 52g.

[0155] The preparation method of the above-mentioned Chinese herbal spray powder is as follows:

[0156] A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside.

[0157] B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 70% ethanol and reflux twice, one hour each time. Add 10 times the amount for the first time and 6 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.20 measured at 60℃, filter, and set aside.

[0158] C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, one hour each time. Add 11 times the amount for the first decoction and 7 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10 measured at 60°C. Filter and combine with the clear extract obtained in step B for later use.

[0159] D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

[0160] The preparation method of this traditional Chinese medicine composition granules is as follows:

[0161] S1. Take the Chinese herbal spray powder, lactose and monk fruit glycosides and mix them evenly to obtain the mixture.

[0162] S2. The obtained mixture is added to the screw feed mechanism. The mixture is conveyed to the roller pressing area through the screw feed mechanism and pressed into sheets. The screw feed speed is 30 rpm; the roller speed is 14 rpm; and the roller oil pressure is 42 bar.

[0163] S3. The obtained tablets are crushed in the granulation mechanism, granulated using a 16-mesh sieve, and then sieved using an upper 16-mesh sieve and a lower 40-mesh sieve to obtain granules.

[0164] Experimental Example 1

[0165] To better verify the characteristics of the traditional Chinese medicine composition formulation of this invention, a comparative study was conducted on different types of excipients. The traditional Chinese medicine spray powder prepared according to Example 1 was mixed with different types of excipients at certain ratios (4:1, 1:1), and then dry-granulated. The effect of different types of excipients on granulation was investigated, and the evaluation indicators were granulation conditions, granule yield, granule solubility, granule size, and moisture content. The results of the excipient type investigation are shown in Table 1 below.

[0166] Table 1 Results of the test on the types of auxiliary materials

[0167] The above experimental results show that maltodextrin was selected as the key excipient for dry granulation in this invention. Compared with dextrin and soluble starch, maltodextrin exhibits significant advantages and unique characteristics in the granulation process, specifically in the following aspects:

[0168] Highly efficient granulation and excellent yield: The test results show that maltodextrin can efficiently form uniform and fine granules, and the granulation yield is significantly higher than that of dextrin and comparable to that of soluble starch. However, it avoids the problem of a small number of black granules and granule color difference that occurs when soluble starch is granulated, ensuring the consistency and aesthetics of the product appearance and improving the overall quality.

[0169] Precise moisture control: Although all tested excipients met the standards for moisture control, the granules refined by maltodextrin had relatively stable moisture content, which reduced the impact of fluctuations in the moisture content of the excipients on the stability of the final product, thus helping to extend the shelf life of the product and improve storage stability.

[0170] Excellent solubility: In the solubility assessment, although the solubility of the granules prepared by the three excipients all met the requirements, maltodextrin showed the best solubility among the three excipients. This characteristic is crucial for improving the bioavailability of drugs or nutritional supplements, ensuring rapid release and efficient absorption of the product during use.

[0171] Experimental Example 2

[0172] A comparative study was conducted on the dosage of the excipient maltodextrin. The traditional Chinese medicine spray powder prepared according to Example 1 was mixed with maltodextrin at different excipient ratios (0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%) and dry-granulated. The effect of excipient dosage on granulation was investigated, and the evaluation indicators were granulation results, granule yield, granule solubility, granule size, and moisture content. The results of the excipient dosage investigation are shown in Table 2 below.

[0173] Table 2 Results of the experiment on maltodextrin dosage

[0174] The above experimental results show that, in terms of dry granulation effect, the dry granulation yield is relatively high when the amount of maltodextrin excipient is 0%, 10%, 20%, 30%, 40%, 50%, and 60%, and the resulting granules are uniform and colorless, with good granulation effect. When the amount of dry granulation is 70% and 80%, the resulting granules are uniform and colorless, but the granule yield is low, and the granulation effect is poor.

[0175] In the process of optimizing the dry granulation process, this invention, through precise control of the amount of maltodextrin excipients within a wide range of 0% to 60%, not only ensures the uniformity and color difference of the granules, but also maintains a high yield, significantly improving the overall granulation effect.

[0176] Of particular note is that when the maltodextrin dosage reached 70% and 80%, although the granules remained uniform and colorless, the significant decrease in yield revealed the negative impact of excessive dosage on granulation efficiency. This invention precisely defines the optimal range for excipient dosage, effectively avoiding resource waste and efficiency loss.

[0177] Furthermore, this invention comprehensively considers key quality indicators such as granule solubility, moisture content, and particle size distribution to ensure that the granules produced within this dosage range fully meet industry standards and product requirements. More flexibly, this invention also allows for flexible adjustment of the maltodextrin addition within a dosage range of 0%-60% based on the specific yield of each batch of traditional Chinese medicine raw materials. This greatly enhances the adaptability and flexibility of the production process, providing a solid guarantee for high-quality production under different production conditions.

[0178] Experimental Example 3

[0179] To better verify the characteristics of the traditional Chinese medicine composition formulation of this invention, a comparative study of sweetener types was conducted. Sixteen clean water cups were taken and numbered sequentially from 1 to 16. Sixteen samples (2g each) were weighed (prepared by mixing 630g of the traditional Chinese medicine spray powder prepared according to Example 1 and 270g of maltodextrin). The corresponding sweeteners were added according to Table 3, poured into the corresponding water cups, and dissolved in approximately 200ml of hot water. The prepared samples were held in the mouth and evenly spread on the tongue for evaluation. Sweetness, bitterness, aroma, and overall taste were used as evaluation indicators. The experimental design for the sweetener type investigation is shown in Table 3.

[0180] Table 3

[0181] The scoring results of the sweetener type investigation test are shown in Table 4.

[0182] Table 4

[0183] The above test results show that No. 1 (without sweetener) scored the lowest in all four categories (sweetness, bitterness, aroma, and overall taste) and the total score. Steviosides (Nos. 5-7) and sucrose (Nos. 14-16) also scored low in these categories, indicating unsatisfactory flavor correction. Sucralose (Nos. 2-4) and acesulfame K (Nos. 11-13) scored higher in all four categories. Compared to acesulfame K, sucralose scored similarly in aroma and overall taste, but scored higher in sweetness and bitterness, demonstrating better flavor correction. This invention uses sucralose as a sweetener, which not only ensures the natural purity of the product's sweetness and effectively reduces the interference of bitterness, but also further optimizes the overall flavor experience.

[0184] Test Example 4

[0185] To further verify the characteristics of the traditional Chinese medicine composition of this invention, a study on the combined use of sweeteners was conducted. Three clean water cups were taken and numbered 1 to 3. Three 2g samples were weighed out (prepared by mixing 630g of the traditional Chinese medicine spray powder prepared according to Example 1 and 270g of maltodextrin). The corresponding excipients were added according to Table 5, and the samples were poured into the corresponding water cups. Approximately 200ml of hot water was added to dissolve the samples. The prepared samples were held in the mouth and evenly spread on the tongue for evaluation. Sweetness, bitterness, aroma, and overall taste were used as evaluation indicators. The experimental design for the combined use of sweeteners is shown in Table 5.

[0186] Table 5

[0187] The scoring results of the combined use of sweeteners are shown in Table 6.

[0188] Table 6

[0189] The above test results show that the flavoring effects of No. 1, No. 2 and No. 3 are not significantly different. The combined use of sweeteners is relatively complicated. This invention uses sucralose as a single sweetener and precisely controls the ratio, which not only achieves a superior taste comparable to the combined compound formula, but also simplifies the production process and greatly reduces the diversity of auxiliary materials used.

[0190] Experimental Example 5

[0191] A comparative study was conducted on the dosage of sweeteners. Six clean water cups were taken and numbered sequentially from 1 to 6. Six samples of 2g each were weighed (prepared by mixing 630g of the herbal spray powder prepared according to Example 1 and 270g of maltodextrin). The corresponding amounts of sucralose were added according to Table 7, poured into the corresponding water cups, and dissolved in approximately 200ml of hot water. The prepared samples were held in the mouth and evenly spread on the tongue for evaluation. Sweetness, bitterness, aroma, and overall taste were used as evaluation indicators. The experimental design for the study on the dosage of sucralose is shown in Table 7.

[0192] Table 7

[0193] The scoring results of the sucralose dosage investigation test are shown in Table 8.

[0194] Table 8

[0195] The above experimental results show that the scores of sweetness, bitterness, odor, overall taste, and total score of sucralose at different dosages (0.25%-2.50%) show a trend of first increasing and then leveling off with increasing dosage. The scores of No. 1 (0.25%), No. 2 (0.50%), and No. 3 (1.00%) increased with increasing dosage, while the scores of No. 3 (1.00%), No. 4 (1.50%), No. 5 (2.00%), and No. 6 (2.50%) were similar. In order to reduce the amount of excipients and ensure the flavoring effect, this invention will continue to investigate the dosage of sucralose below 1%.

[0196] Take six clean water cups and number them 1 to 6. Weigh 2g of each of the six samples (prepared by mixing 630g of the herbal spray powder prepared according to Example 1 and 270g of maltodextrin). Add the corresponding amount of sucralose according to Table 9, pour the mixture into the corresponding water cup, and dissolve it in about 200ml of hot water. Hold the prepared sample in your mouth and spread it evenly on your tongue to taste. Evaluate the taste based on sweetness, bitterness, aroma, and overall mouthfeel. The detailed experimental design for the determination of sucralose dosage is shown in Table 9.

[0197] Table 9

[0198] The scoring results of the sucralose dosage investigation experiment are shown in Table 10.

[0199] Table 10

[0200] The results of the above experiments show that the scores of sweetness, bitterness, odor, overall taste and total score of sucralose at different dosages (0.2%-1%) show an increasing trend with the increase of dosage. Among them, No. 6 (0.2%) scored the lowest, and the subjects generally reported that it was bitter. No. 2 (0.8%) and No. 4 (1%) scored high, but some subjects still reported that it was sweet, which may cause discomfort due to "too much of a good thing". The scores of No. 3 (0.35%), No. 5 (0.5%) and No. 1 (0.65%) were similar.

[0201] This invention limits the addition of sucralose to between 0.35% and 0.65%. Three samples within this range (samples 3, 5, and 1) not only scored similarly but also effectively avoided the bitterness at low concentrations and the excessive sweetness at high concentrations, achieving a harmonious balance of sweetness, bitterness, aroma, and overall taste, providing consumers with a more balanced and pleasant taste experience. This invention's precise limitation of the sucralose addition amount in granules (0.35%-0.65%) not only reflects a meticulous grasp of the taste experience but also highlights its unique and significant creativity in formula innovation.

[0202] This invention's precise control over the amount of sucralose added is not only based on scientific conclusions from extensive experimental data, but also reflects a deep understanding and accurate grasp of consumer needs. It solves the problem in existing technologies where the amount of additives used is difficult to balance sweetness, bitterness, aroma, and overall taste.

[0203] Experimental Example 6

[0204] This invention optimizes the parameters in the dry pelleting process and conducts comparative studies on three dry pelleting process parameters: roller speed, roller hydraulic pressure, and screw feeding speed.

[0205] (1) Investigation of the speed of the dry granulation roller

[0206] Weigh the herbal spray powder and maltodextrin prepared according to Example 1, mix them well, and change the roller speed to investigate the effect of roller speed on dry granulation. The evaluation indicators are granulation condition, granule yield, granule solubility, granule size, and moisture content. The results of the roller speed investigation are shown in Table 11.

[0207] Table 11

[0208] The test results show that when the roller speed is 1.0 rpm and 3.0 rpm, there is a color difference in the granules, which affects the consistency of the product's appearance and market acceptance; when the roller speed is 18.0 rpm and 20.0 rpm, the granule yield is low and the particle size becomes undesirable; when the roller speed is 6.0 rpm, 10.0 rpm and 14.0 rpm, the granulation effect is not significantly different, and the solubility, particle size and moisture content all meet the requirements.

[0209] This invention systematically investigates various performance indicators of granulation at different rotational speeds, revealing the multidimensional impact of rotational speed on granulation quality and precisely identifying the optimal operating range, thereby significantly improving the efficiency and stability of the granulation process. This invention selects 10.0 ± 4.0 rpm as the optimal rotational speed range. This range not only ensures the stability of granulation quality but also provides the production process with a certain degree of flexibility to cope with subtle differences in different production environments and raw material characteristics.

[0210] (2) Hydraulic pressure test of dry granulation roller

[0211] Weigh the herbal spray powder and maltodextrin prepared according to Example 1, mix them well, and change the pressure of the roller oil to investigate the effect of roller oil pressure on dry granulation. The evaluation indicators are granulation condition, granule yield, granule solubility, granule size, and moisture content. The results of the roller oil pressure test are shown in Table 12.

[0212] Table 12

[0213] The test results show that when the pressure roller is pressed at 20 bar and 25 bar, the particle yield is low, which not only affects production efficiency but also increases the cost burden. When the pressure roller is pressed at 45 bar and 50 bar, there is a color difference in the particles, which affects the appearance quality and market acceptance of the product. When the pressure roller is pressed at 32 bar, 37 bar and 42 bar, the granulation effect is not significantly different, and the solubility, particle size and moisture content all meet the requirements.

[0214] This invention precisely defines the optimal operating range of the hydraulic pressure of the pressure roller, namely 37±5 bar, which improves the efficiency and stability of the granulation process. The granulation effect shows good stability and consistency. Whether it is solubility, particle size distribution or moisture content, it perfectly meets the established standards. It not only ensures the controllability and repeatability of the granulation process, but also maximizes the balance between production efficiency and product quality.

[0215] (3) Investigation of spiral feeding speed of dry granulation

[0216] Weigh out the spray-dried powder and maltodextrin, mix them thoroughly, and vary the screw feed speed to investigate its effect on dry granulation. Evaluation indicators included granulation performance, granule yield, granule solubility, granule size, and moisture content. The results of the screw feed speed test are shown in Table 13.

[0217] Table 13

[0218] The above test results show that when the screw feed speed is 10.0 rpm and 15.0 rpm, the particle yield is low; when the screw feed speed is 35.0 rpm and 40.0 rpm, there is a color difference in the particles; when the screw feed speed is 20.0 rpm, 25.0 rpm and 30.0 rpm, the granulation effect is not significantly different, and the solubility, particle size and moisture content all meet the requirements.

[0219] This invention precisely defines the optimal operating range of the screw feed speed, namely 25.0±5 rpm, which improves the fine control capability of the granulation process and the quality stability of the final product.

[0220] Experimental Example 7

[0221] Pilot-scale amplification experiments of the formulation forming process were conducted. Pilot-scale amplification experiments were performed according to Examples 5, 6, and 7 (corresponding batch numbers 220101, 220102, and 220103). Traditional Chinese medicine spray powder, maltodextrin, and sucralose were granulated using the determined dry granulation process. Pilot-scale amplification studies of the formulation forming process were conducted to investigate the stability, feasibility, and adaptability of the established process. The results of the pilot-scale amplification experiments of the formulation forming process are shown in Table 14. The granule yield reached over 96%, and the finished product rate reached over 94%.

[0222] Table 14 Results of Pilot-Scale Experiments on Formulation Process Note: Yield = Actual Output / Theoretical Output = Actual Output / (Total Mixed Quantity × 1000 / Labelled Packing Quantity) × 100%

[0223] In accordance with the relevant provisions of the General Rules for Preparations under Granules in Part IV of the 2020 edition of the Chinese Pharmacopoeia, three batches of pilot-scale finished products were tested, and the test results are shown in Table 15.

[0224] Table 15

[0225] In accordance with the relevant provisions of the General Rules for Preparations under Granules in Part IV of the 2020 edition of the Chinese Pharmacopoeia, three batches of pilot-scale finished products were tested. The results of particle size, moisture content, solubility, fill weight variation, and microbial limit all met the requirements, indicating that the process is stable and feasible and suitable for industrial production.

[0226] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation consists of traditional Chinese medicine spray powder, excipients and sweeteners. The amount of excipients added is 0-60% of the total weight of the traditional Chinese medicine spray powder and excipients, and the amount of sweeteners added is 0.35%-0.65% of the total weight of the traditional Chinese medicine spray powder and excipients.

2. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The amount of excipients added is 10-40% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.45%-0.55% of the total weight of the Chinese herbal spray powder and excipients.

3. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The amount of excipients added is 20% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.45% of the total weight of the Chinese herbal spray powder and excipients.

4. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The amount of excipients added is 40% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.55% of the total weight of the Chinese herbal spray powder and excipients.

5. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The amount of excipients added is 30% of the total weight of the Chinese herbal spray powder and excipients, and the amount of sweetener added is 0.50% of the total weight of the Chinese herbal spray powder and excipients.

6. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52-86 parts; Gypsum 194-324 parts; Forsythia 194-324 parts; Scutellaria baicalensis 78-130 parts; Mulberry bark 194-324 parts; Bitter almond 78-130 parts; Peucedanum praeruptorum 78-130 parts; Pinellia ternata 78-130 parts; Tangerine peel 78-130 parts; Fritillaria cirrhosa 78-130 parts; Arctium lappa 78-130 parts; Honeysuckle 78-130 parts; Rheum palmatum 39-65 parts; Platycodon grandiflorus 46-76 parts; Licorice 39-65 parts.

7. The traditional Chinese medicine preparation as described in claim 6, characterized in that, The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 52 parts; Gypsum 324 parts; Forsythia 194 parts; Scutellaria baicalensis 78 parts; Mulberry bark 194 parts; Bitter almond 130 parts; Peucedanum praeruptorum 78 parts; Pinellia ternata 130 parts; Tangerine peel 78 parts; 78 portions of fritillaria; Burdock seed 130 parts; honeysuckle 130 parts; rhubarb 39 parts; platycodon 76 parts; licorice 65 parts.

8. The traditional Chinese medicine preparation as described in claim 6, characterized in that, The herbal spray powder is made from the following raw materials in parts by weight: Ephedra 86 parts; Gypsum 194 parts; Forsythia 324 parts; Scutellaria baicalensis 130 parts; Mulberry bark 324 parts; Bitter almond 78 parts; Peucedanum praeruptorum 130 parts; Pinellia ternata 78 parts; Tangerine peel 130 parts; Fritillaria cirrhosa 130 parts; Arctium lappa 78 parts; Honeysuckle 78 parts; Rheum palmatum 65 parts; Platycodon grandiflorus 46 parts; Licorice 39 parts.

9. The traditional Chinese medicine preparation as described in claim 6, characterized in that, The bitter almonds mentioned are stir-fried bitter almonds, the fritillaria is Zhejiang fritillaria, the honeysuckle is mountain honeysuckle, and the pinellia is processed pinellia.

10. The traditional Chinese medicine preparation as described in claim 6, characterized in that, The preparation method of the traditional Chinese medicine spray powder includes the following steps: A. Weigh out the following ingredients according to the specified proportions: fritillaria, ephedra; gypsum; forsythia; scutellaria; mulberry bark; bitter almond; angelica; pinellia; tangerine peel; fritillaria; burdock fruit; honeysuckle; rhubarb; platycodon; and licorice. Set aside. B. Take fritillaria, ephedra, forsythia, bitter almond, pinellia, burdock seed, and rhubarb, add 40-70% ethanol and reflux twice, each time for 1-4 hours. Add 8-10 times the amount for the first time and 6-9 times the amount for the second time. Combine the extracts, filter, recover the ethanol from the filtrate under reduced pressure, concentrate to a clear extract with a relative density of 1.05-1.20 measured at 60℃, filter, and set aside. C. Take gypsum, mulberry bark, angelica root, dried tangerine peel, honeysuckle, platycodon root, and licorice root, add water and decoct twice, each time for 1-4 hours. Add 9-11 times the amount for the first decoction and 7-9 times the amount for the second decoction. Combine the decoctions, filter, and concentrate to a clear extract with a relative density of 1.10-1.20 measured at 60℃. Filter and combine with the clear extract obtained in step B for later use. D. Spray dry the combined extract obtained in step C and collect the spray powder for later use.

11. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The excipients include at least one of maltodextrin, lactose, or mannitol.

12. The traditional Chinese medicine preparation as described in claim 1, characterized in that, The sweetener includes at least one of sucralose, mogroside, or glycyrrhizic acid.

13. The traditional Chinese medicine preparation according to any one of claims 1 to 12, characterized in that, The traditional Chinese medicine preparations are capsules, tablets, or granules.

14. The traditional Chinese medicine preparation as described in claim 13, characterized in that, The preparation method of the granules includes the following steps: S1, take traditional Chinese medicine spray powder, maltodextrin and sucralose and mix them evenly to obtain a mixture; S2. The obtained mixture is added to the screw feeder, and the mixture is conveyed to the rolling area through the screw feeder to be pressed into sheets; S3. The obtained tablets are crushed in the granulation mechanism and then sieved to obtain granules.

15. The traditional Chinese medicine preparation as described in claim 14, characterized in that, The screw feed speed is 25.0±5 rpm; the pressure roller speed is 10.0±4.0 rpm; and the pressure roller hydraulic pressure is 37±5 bar.

16. The traditional Chinese medicine preparation as described in claim 14, characterized in that, Granulation is performed using a 12-16 mesh sieve; during the sieving process, the upper layer uses a 12-16 mesh sieve, and the lower layer uses a 40-60 mesh sieve.

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