Auxiliary material composition, application method thereof and product using auxiliary material composition

Abstract

The invention provides an auxiliary material composition, an application method thereof and a product using the auxiliary material composition, the auxiliary material composition comprises a component A and dextrin, the component A comprises sugar alcohol and / or microcrystalline cellulose, the content of alpha-1, 6-glucosidic bonds of the dextrin is 1-30%, and the mass ratio of the component A to the dextrin is (1-120): 1. The auxiliary material composition can regulate and control the hygroscopicity, cohesion and fluidity of a product using the auxiliary material composition, so that the problems that the product is easy to cake in static storage and is easy to generate secondary segregation in dynamic transportation are solved at the same time.

Description

Technical Field

[0001] This invention relates to the field of excipient technology, specifically to an excipient composition, its application method, and products using the same. Background Technology

[0002] In the production of solid dosage forms (such as powders and tablets) in the food, health product, and pharmaceutical industries, the raw material mixing process often affects the final product form and quality. Sugar alcohols and microcrystalline cellulose can be used as functional excipients in solid dosage forms. Sugar alcohols are often used as fillers and sweeteners to improve taste, while microcrystalline cellulose mainly functions as a shaper, flow aid, and improves compression molding. However, due to the high hygroscopicity of sugar alcohols and / or microcrystalline cellulose, they can exacerbate the adsorption and agglomeration tendency between powders, forming hard lumps that are difficult to disperse. When the formulation contains a large amount of sugar alcohols or microcrystalline cellulose, during the preparation of solid dosage forms, especially during the raw material mixing process, high-intensity stirring can easily lead to local temperature increases in the product, causing the raw materials to soften, increase viscosity, and more easily generate agglomeration and clumping, resulting in a decrease in yield and a significant reduction in production efficiency.

[0003] Although the industry typically uses methods such as controlling mixing speed and temperature, adding anti-caking agents, or optimizing particle morphology to alleviate product clumping problems, existing technologies still lack efficient and universal solutions for hygroscopic agglomeration and heat-sensitive adhesion phenomena directly induced by the content of sugar alcohols and / or microcrystalline cellulose in excipients.

[0004] Therefore, developing a novel composition that can prevent clumping in sugar alcohol and / or microcrystalline cellulose excipient systems has become an urgent need for those skilled in the art. Summary of the Invention

[0005] To address the problems and shortcomings of existing technologies, this invention provides an excipient composition, its application method, and products using the same. This excipient composition can regulate the hygroscopicity, cohesiveness, and flowability of products using it, thereby simultaneously solving the problems of localized overheating and clumping during preparation, clumping during static storage, and secondary segregation during dynamic transportation.

[0006] According to one aspect of the present invention, an excipient composition is provided, comprising component A and dextrin, wherein component A comprises sugar alcohol and / or microcrystalline cellulose, the α-1,6-glycosidic bond content of dextrin is 1-30 wt%, and the mass ratio of component A to dextrin is 1-120:1. For example, the α-1,6-glycosidic bond content of dextrin is 1 wt%, 3 wt%, 5 wt%, 8 wt%, 10 wt%, 11 wt%, 13 wt%, 15 wt%, 18 wt%, 20 wt%, 21 wt%, 23 wt%, 25 wt%, 28 wt%, 30 wt%, etc.; and the mass ratio of component A to dextrin is 1:1, 10:1, 30:1, 50:1, 70:1, 90:1, 100:1, 110:1, 120:1, etc.

[0007] The sugar alcohols and / or microcrystalline cellulose in component A readily absorb moisture. This moisture promotes the dissolution and recrystallization of the crystal surfaces, making it easy for crystal bridges to form at the contact points between components of A. Over time, these crystal bridges combine with each other to gradually form large clumps. On the one hand, if the solid product containing component A forms clumps, secondary segregation and stratification are likely to occur during transportation due to vibration, resulting in uneven distribution of the active ingredients and affecting the quality and efficacy of the product. On the other hand, even if the solid product does not clump, the difference in particle size between the excipient composition and the product's active ingredients can easily lead to uneven distribution during dynamic transportation.

[0008] By selecting dextrin with an α-1,6-glycosidic bond content of 1–30 wt% and simultaneously adjusting the ratio of component A to dextrin, the hygroscopicity, cohesiveness, and flowability of products using this excipient composition can be controlled. This simultaneously addresses the issues of easy clumping during static storage and secondary segregation during dynamic transportation. If the α-1,6-glycosidic bond content of the dextrin is too low, the solid product using this excipient composition is prone to clumping. If the α-1,6-glycosidic bond content of the dextrin is too high, the product particles are difficult to disperse and mix uniformly, easily leading to secondary segregation during dynamic transportation. Specifically, during static storage, component A includes sugar alcohols and / or microcrystalline cellulose, both of which contain a certain number of hydroxyl groups. Dextrin with an α-1,6-glycosidic bond content of 1–30 wt% is combined with hydroxyl-containing component A. This reduces the risk of crystallization after moisture absorption and, based on the steric hindrance effect of the dextrin structure, increases the steric hindrance between powder particles, preventing particle adhesion caused by localized hydration or overheating. During dynamic transport, the branched structure of dextrin, together with the hydroxyl groups provided by component A, enhances the structural stability of the product under dynamic conditions. Utilizing the steric hindrance effect of dextrin with a specific degree of branching and the van der Waals forces of the multiple hydroxyl groups provided by component A, the product's cohesive force is appropriately increased, dispersing the kinetic energy from external vibrations and improving the product's stability during dynamic movement.

[0009] Preferably, the α-1,6-glycosidic bond content of the dextrin is 3 to 12.5 wt%. For example, the α-1,6-glycosidic bond content of the dextrin is 3 wt%, 4 wt%, 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, etc.

[0010] Preferably, the sugar alcohol has a particle size of 20-60 mesh, and / or the microcrystalline cellulose has a particle size of 60-200 mesh. For example, the sugar alcohol has a particle size of 20-30 mesh, 20-40 mesh, 20-50 mesh, 20-60 mesh, 30-40 mesh, 30-50 mesh, 30-60 mesh, 40-50 mesh, 40-60 mesh, 50-60 mesh, etc.; the microcrystalline cellulose has a particle size of 60-80 mesh, 60-100 mesh, 60-120 mesh, 60-150 mesh, 60-180 mesh, 60-200 mesh, 100-120 mesh, 100-150 mesh, 100-180 mesh, 100-200 mesh, etc. By optimizing the particle size range of component A, the contact area between particles is reduced, decreasing the tendency for agglomeration caused by moisture absorption, dissolution, and subsequent recrystallization on the particle surface due to environmental humidity. Simultaneously, the overall uniformity of products using this excipient composition is improved, resulting in particles of different components exhibiting more similar motion characteristics when subjected to vibration, impact, or flow. This weakens the tendency for stratification due to density or particle size differences, effectively suppressing secondary segregation. Specifically, 20 mesh corresponds to 0.850 mm, 60 mesh to 0.42 mm, and 200 mesh to 0.0750 mm.

[0011] Preferably, the particle size of dextrin is 20–60 mesh. For example, the particle size of dextrin can be 20–30 mesh, 20–40 mesh, 20–50 mesh, 20–60 mesh, 30–40 mesh, 30–50 mesh, 30–60 mesh, 40–50 mesh, 40–60 mesh, 50–60 mesh, etc. Specifically, 20 mesh corresponds to 0.850 mm, and 60 mesh corresponds to 0.42 mm.

[0012] Preferably, the dextrin further includes 0.2–0.3 wt% ash. For example, the dextrin may also include 0.2 wt%, 0.25 wt%, or 0.3 wt% ash. By controlling the ash content in the dextrin, the friction between the particles of each component in the excipient composition can be increased, reducing the likelihood of significant stratification in products using this excipient composition during vibration. Specifically, as an inorganic component in dextrin, the ash content can regulate the surface charge state and overall density distribution of dextrin particles. When the ash content is within the aforementioned range, the friction between particles can be increased, causing the movement trajectories of different component particles in the solid product using this excipient composition to tend to be consistent during vibration or transportation, significantly reducing the stratification phenomenon caused by density differences in sedimentation rate.

[0013] Preferably, the dextrin includes at least one of maltodextrin and resistant dextrin.

[0014] Preferably, the dextrin includes maltodextrin with an α-1,6-glycosidic bond content of 3-5 wt% and / or resistant dextrin with an α-1,6-glycosidic bond content of 10-12.5 wt%. For example, the α-1,6-glycosidic bond content of maltodextrin is 3 wt%, 4 wt%, or 5 wt%; the α-1,6-glycosidic bond content of resistant dextrin is 10 wt%, 11 wt%, 12 wt%, or 12.5 wt%, etc.

[0015] Preferably, the dextrin includes maltodextrin and / or resistant dextrin, and the mass ratio of component A to dextrin is 2 to 30:1. For example, the mass ratio of component A to dextrin is 2:1, 5:1, 10:1, 15:1, 20:1, 25:1, 30:1, etc.

[0016] Preferably, the sugar alcohol includes at least one of erythritol, sorbitol, xylitol, and isomaltitol.

[0017] Preferably, component A includes sugar alcohols, including erythritol and / or sorbitol, and the mass ratio of sugar alcohol to dextrin is 2 to 30:1. For example, the mass ratio of sugar alcohol to dextrin is 2:1, 5:1, 10:1, 15:1, 20:1, 25:1, 30:1, etc.

[0018] Preferably, component A includes microcrystalline cellulose, and the mass ratio of microcrystalline cellulose to dextrin is 2 to 30:1. For example, the mass ratio of microcrystalline cellulose to dextrin is 2:1, 5:1, 10:1, 15:1, 20:1, 25:1, 30:1, etc.

[0019] Preferably, using the total mass of component A and dextrin as a benchmark, the mass percentage of component A is not less than 60 wt%. For example, the mass percentage of component A is 60 wt%, 65 wt%, 70 wt%, 75 wt%, 80 wt%, 85 wt%, 90 wt%, 95 wt%, etc. By adjusting the ratio of component A to dextrin, component A occupies a dominant position in the excipient composition system. This not only makes the distribution of water molecule adsorption sites more balanced and significantly reduces the risk of local over-moisture, but also allows the dextrin content that meets the above requirements to exert its spatial barrier effect, precisely controlling the moisture distribution in the gaps between the high proportion of component A, blocking capillary bridging, and avoiding overheating and agglomeration caused by hygroscopic aggregation.

[0020] According to another aspect of the present invention, a method for applying the above-described excipient composition is provided, wherein the excipient composition is applied under conditions of relative humidity of 20% to 65%, and the application includes solid dosage form processing and storage. By optimizing the relative humidity control of the application environment of the excipient composition, the anti-caking properties of the product using the excipient composition can be improved during the preparation and / or storage process. Excessive adsorption of water molecules on the particle surface is inhibited at the source, and capillary bridging caused by hygroscopic dissolution is blocked, thereby avoiding the formation of liquid films between particles and hard agglomeration caused by subsequent recrystallization.

[0021] Preferably, the excipient composition is applied at 18–25°C, and the application includes solid dosage form processing and storage.

[0022] According to another aspect of the present invention, a product is provided comprising the above-described excipient composition.

[0023] Preferably, the product is a solid dosage form.

[0024] Preferably, the product is in the form of powder.

[0025] Preferably, the product also includes food- and / or pharmaceutically acceptable excipients.

[0026] According to another aspect of the present invention, a method for preparing the above-mentioned excipient composition is provided, comprising the following steps: mixing dextrin and component A to obtain the excipient composition. Attached Figure Description

[0027] Figure 1 This is a schematic diagram showing that the excipient composition has not clumped.

[0028] Figure 2 This is a schematic diagram showing the slight clumping of the excipient composition;

[0029] Figure 3 This is a schematic diagram showing the highest degree of agglomeration in the excipient composition. Detailed Implementation

[0030] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of this invention will be clearly and completely described below with reference to the embodiments and accompanying drawings. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this invention.

[0031] Example 1

[0032] 1. Preparation of excipient composition

[0033] The excipient composition includes component A and dextrin, with erythritol as component A in this embodiment. The excipient compositions for each experimental group in this embodiment were prepared according to the material composition provided in Table 1. In this embodiment, the experimental groups are labeled as experimental groups 1A to 7A.

[0034] Table 1. Component composition of the excipient composition in Example 1

[0035]

[0036]

[0037] The maltodextrin has a particle size of 20–60 mesh, and the erythritol has a particle size of 20–60 mesh. The maltodextrin also includes 0.25 ± 0.05 wt% ash.

[0038] The α-1,6-glycosidic bond content of the raw dextrin was tested using the following method:

[0039] 50 mg of dextrin sample was dissolved in 0.55 mL of D2O, and the mixture was freeze-dried twice to ensure sufficient exchange of H atoms with D atoms in the heavy water. The 1H-NMR spectrum was recorded at 25 °C and 400 MHz. According to the Carbohydrate Science Database, the 1H NMR spectrum of dextrin corresponds to an α-1,6 glycosidic bond at δ 4.93.

[0040] The α-1,6-glycosidic bond content of dextrin = peak area at 4.93 / peak area between 4.4 and 5.5 × 100%.

[0041] 2. Test the agglomeration and dispersion of the above composition.

[0042] Test subject: The excipient composition provided in Example 1

[0043] Test method:

[0044] (1) Clumping situation:

[0045] If the degree of agglomeration of the excipient composition is as follows Figure 1 As shown, a value indicating no clumping is recorded as "-"; if the degree of clumping in the excipient composition is as shown... Figure 2 As shown, slight clumping is indicated by a "+" symbol; if the degree of clumping in the excipient composition is as shown... Figure 3 As shown, this indicates a large number of clusters, recorded as "++".

[0046] (2) Dispersion status:

[0047] A trace amount of vitamin C was added to the excipient composition at a dosage of 30 mg vitamin C per 100 g excipient. During the filling process on the production line, powder samples were taken every 2.5 hours for a total of 5 times to test the vitamin C content in the powder and calculate the relative error of vitamin C content in the 5 samples.

[0048] When the relative error is ≤5%, it is recorded as good dispersion and indicated by "-"; when the relative error is 5-10%, it is recorded as passable dispersion and indicated by "+"; when the relative error exceeds 10%, it is recorded as unsatisfactory dispersion and indicated by "++".

[0049] The test results are shown in Table 2.

[0050] Table 2. Performance indicators of the excipient composition in this embodiment.

[0051] Group Caking condition Dispersion condition Experiment group 1A ++ + Experiment group 2A - - Experiment group 3A - - Experiment group 4A - - Experiment group 5A - - Experiment group 6A - - Experiment group 7A + ++

[0052] Results analysis:

[0053] Comparing the test performance of experimental groups 1A to 7A in Table 2, it can be found that the excipient compositions provided in experimental groups 2A to 6A are less prone to clumping and disperse well compared to those provided in experimental groups 1A and 7A. Furthermore, the excipient compositions constitute a large proportion of the powder by mass, and other materials in the powder, such as fragrances, pigments, and active ingredients, are less likely to cause clumping or agglomeration. Therefore, the powder prepared using the above-mentioned excipient compositions is also less prone to clumping and disperses well.

[0054] The effect of dextrin's α-1,6-glycosidic bond content on agglomeration and dispersibility was investigated by controlling the α-1,6-glycosidic bond content. Data showed that in experimental group 1A, the α-1,6-glycosidic bond content of dextrin was only 2.1 wt%, resulting in severe agglomeration of the corresponding excipient composition, although dispersibility met the standard. This indicates that dextrin with low α-1,6-glycosidic bond content is less effective in blocking the formation of crystal bridges after sugar alcohols absorb moisture. In experimental group 7A, the α-1,6-glycosidic bond content of dextrin reached 21.2 wt%, and while the corresponding excipient composition met the agglomeration standard, the dispersion uniformity was slightly poor. This indicates that the steric hindrance between excipient particles is relatively large, making uniform dispersion and mixing difficult, and prone to secondary segregation during dynamic transport.

[0055] Generally, clumping is caused by strong attraction between particles, while secondary segregation can be prevented by increasing the friction between particles, thus preventing the formation of stratification between particles of different sizes under vibration. The excipient compositions provided in experimental groups 2A–6A are less prone to clumping during preparation and storage, exhibiting excellent dispersibility. When dextrin containing 3–12.5 wt% α-1,6-glycosidic bonds is used in combination with component A, the problems of clumping during static storage and secondary segregation during dynamic transportation of powder products can be simultaneously resolved.

[0056] Example 2

[0057] 1. Preparation of excipient composition

[0058] According to the material composition provided in Table 3, the excipient compositions for each experimental group in this embodiment were prepared. In this embodiment, the experimental groups were labeled as experimental group 1B, experimental group 2B, and experimental group 3B, respectively.

[0059] 2. The above excipient composition was tested using the test method for agglomeration and dispersion in Test Example 1. The test results are shown in Table 3.

[0060] Table 3. Component composition and performance indicators of the excipient composition in this embodiment

[0061]

[0062] In this embodiment, the α-1,6-glycosidic bond content of the dextrin used is in the range of 10.3 ± 0.5 wt%.

[0063] Results analysis:

[0064] Comparing the test performance of experimental groups 1B to 3B in Table 3, it can be found that the agglomeration and dispersion of the excipient compositions corresponding to experimental groups 1B to 3B all meet the passing standards. Furthermore, compared to experimental group 3B using white dextrin, the excipient compositions of experimental groups 1B to 2B using maltodextrin or resistant dextrin showed no agglomeration and excellent dispersibility. This indicates that, when the α-1,6-glycosidic bond content of dextrin is similar, the branched structure of maltodextrin and resistant dextrin can better prevent powder agglomeration and improve the dynamic stability of the powder.

[0065] Example 3

[0066] 1. Preparation of excipient composition

[0067] In this embodiment, following the preparation method and raw material composition described in Experimental Group 3A, different excipient compositions were prepared using the type and particle size of component A as variables. The product numbers and the specific details of the corresponding variables are shown in Table 4. Except for the variables shown in Table 4, the other raw material ratios and preparation methods used in the excipient compositions obtained in this experiment were strictly consistent with those in Experimental Group 3A.

[0068] 2. The above excipient composition was tested using the test method for agglomeration and dispersion in Test Example 1. The test results are shown in Table 4. For easy comparison, the relevant data of experimental group 3A are also recorded in Table 4.

[0069] Table 4. Variables and performance indicators among the excipient compositions in this embodiment.

[0070]

[0071]

[0072] Results analysis:

[0073] In this embodiment, the experimental groups are grouped according to the type of variable. Based on this, experimental group 3A and experimental groups 1C to 2C are grouped into the same group for comparison, experimental group 3C and control group 1 are grouped into the same group for comparison, experimental group 3A and experimental groups 4C to 7C are grouped into the same group for comparison, and experimental group 3C and experimental groups 8C to 11C are grouped into the same group for comparison.

[0074] By comparing the groups formed by experimental group 3A and experimental groups 1C-2C with the groups formed by experimental group 3C and control group 1, it can be found that when component A is erythritol, xylitol, sorbitol or microcrystalline cellulose, the agglomeration and dispersion performance of the excipient composition are up to standard. However, due to the chemical structure of hydroxypropyl cellulose, the excipient composition in control group 1 lacks synergistic effect between the hydroxyl groups it provides and the branched structure of dextrin, resulting in agglomeration and secondary segregation.

[0075] In experimental groups 3A and 4C-7C, it was observed that as the mesh size of the sugar alcohol increased, the resulting excipient compositions tended to agglomerate more easily, while the dispersion improved from poor to good and then to slightly poor. In experimental groups 3C and 8C-11C, as the mesh size of the microcrystalline cellulose increased, the resulting excipient compositions showed better anti-agglomeration ability, while the dispersion stability decreased. This is because microcrystalline cellulose has a certain anti-agglomeration effect; if the particle size of the microcrystalline cellulose is smaller, it can better exert its anti-agglomeration effect, but it is not easy to disperse uniformly in the excipient composition. If the particle size of the microcrystalline cellulose is also small, the excipient composition is prone to agglomeration.

[0076] When the particle size of the sugar alcohol is in the range of 20 to 60 mesh, or when the particle size of the microcrystalline cellulose is in the range of 60 to 200 mesh, the overall uniformity of the product using this excipient composition can be improved, effectively suppressing the occurrence of secondary segregation and resulting in better dispersion.

[0077] Example 4

[0078] 1. Preparation of excipient composition

[0079] In this embodiment, following the preparation method and raw material composition described in Experimental Group 3A, different excipient compositions were prepared using the mass ratio of component A to dextrin and the types of dextrin and component A as variables. The product numbers and the specific details of the corresponding variables are shown in Table 5. Except for the variables shown in Table 5, the other raw material ratios and preparation methods used in the excipient compositions obtained in this experiment were strictly consistent with those in Experimental Group 3A.

[0080] 2. The above excipient composition was tested using the test method for agglomeration and dispersion in Test Example 1. The test results are shown in Table 6.

[0081] Table 5. Variables among excipient compositions in this embodiment.

[0082]

[0083]

[0084] Table 6. Performance indicators of the excipient composition in this embodiment.

[0085]

[0086]

[0087] Results analysis:

[0088] Comparing the test performance of experimental groups 1D to 18D in Table 6, it can be found that the agglomeration and dispersion of the excipient compositions corresponding to experimental groups 1D to 18D all meet the passing standards. In other words, when the mass ratio of component A to dextrin is 1–120:1, the hygroscopicity, cohesiveness, and flowability of the excipient composition can be controlled, thereby simultaneously solving the problems of easy agglomeration during static storage and secondary segregation during dynamic transportation.

[0089] In this embodiment, the experimental groups are grouped according to the type of variable. Based on this, experimental groups 1D to 6D are grouped into the same group for comparison, experimental groups 7D to 8D are grouped into the same group for comparison, experimental groups 9D to 10D are grouped into the same group for comparison, experimental groups 11D to 16D are grouped into the same group for comparison, and experimental groups 17D to 18D are grouped into the same group for comparison.

[0090] Based on the data shown in Tables 5 and 6, it can be observed that within the same group, as the mass ratio of component A to dextrin increases, the agglomeration and dispersion of the resulting excipient composition exhibit a trend from poor to good and then back to poor. When component A includes at least one of erythritol, sorbitol, xylitol, isomaltitol, and microcrystalline cellulose, and when the dextrin includes maltodextrin and / or resistant dextrin, the mass ratio of component A to dextrin is 2–30:1. This excipient composition possesses excellent dispersibility and is not prone to agglomeration, and secondary segregation is less likely to occur during dynamic transportation.

[0091] Example 5

[0092] 1. Preparation of excipient composition

[0093] In this embodiment, following the preparation method and raw material composition described in Experimental Group 3A, different excipient compositions were prepared using the type of component A as a variable. The product numbers and corresponding variable details are shown in Table 7. Except for the variables shown in Table 7, the other raw material ratios and preparation methods used in the excipient compositions obtained in this experiment were strictly consistent with those in Experimental Group 3A.

[0094] 2. The above excipient composition was tested using the test method for agglomeration and dispersion in Test Example 1. The test results are shown in Table 7.

[0095] Table 7. Variables among excipient compositions in this embodiment

[0096]

[0097]

[0098] Results analysis:

[0099] Comparing the test performance of experimental groups 3A and 1E in Table 7, it can be found that the excipient composition provided by experimental group 3A is less prone to agglomeration and has better dispersion than that provided by experimental group 1E. In particular, it is less prone to secondary segregation and significant stratification during dynamic transportation. In experimental group 1E, the ash content of dextrin is higher than 0.3 wt%, and the corresponding excipient composition is prone to agglomeration and poor dispersibility, indicating that the friction between powder particles is relatively large, easily leading to uneven dispersion of the powder. When the ash content of dextrin is between 0.2 and 0.3 wt%, the possibility of significant stratification of powder products using this excipient composition during dynamic transportation can be reduced. This is because ash, an inorganic component, is hygroscopic, which can change the surface chemical properties of dextrin particles, increase the internal friction between particles, and affect the flowability of the powder.

[0100] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. An excipient composition, characterized in that, The product comprises component A and dextrin, wherein component A includes sugar alcohol and / or microcrystalline cellulose, the α-1,6-glycosidic bond content of the dextrin is 1-30 wt%, and the mass ratio of component A to the dextrin is 1-120:

1.

2. The excipient composition according to claim 1, characterized in that, The α-1,6-glycosidic bond content of the dextrin is 3 to 12.5 wt%.

3. The excipient composition according to claim 1, characterized in that, The sugar alcohol has a particle size of 20-60 mesh, and / or the microcrystalline cellulose has a particle size of 60-200 mesh.

4. The excipient composition according to claim 1, characterized in that, The dextrin also includes ash in a mass content of 0.2 to 0.3 wt%.

5. The excipient composition according to claim 1, characterized in that, The dextrin includes at least one of maltodextrin and resistant dextrin.

6. The excipient composition according to claim 5, characterized in that, The dextrin includes maltodextrin with an α-1,6-glycosidic bond content of 3-5 wt% and / or resistant dextrin with an α-1,6-glycosidic bond content of 10-12.5 wt%.

7. The excipient composition according to claim 5, characterized in that, The dextrin includes maltodextrin and / or resistant dextrin, and the mass ratio of component A to the dextrin is 2 to 30:

1.

8. The excipient composition according to claim 1, characterized in that, The sugar alcohols include at least one of erythritol, sorbitol, xylitol, and isomaltitol.

9. The excipient composition according to claim 1, characterized in that, Component A includes sugar alcohols, which include erythritol and / or sorbitol, and the mass ratio of the sugar alcohols to the dextrin is 2 to 30:

1. And / or, component A includes microcrystalline cellulose, wherein the mass ratio of microcrystalline cellulose to dextrin is 2 to 30:

1.

10. The excipient composition according to claim 1, characterized in that, Based on the total mass of component A and dextrin, the mass percentage of component A is not less than 60 wt%.

11. The method of using the excipient composition according to any one of claims 1 to 10, characterized in that, The excipient composition is applied under conditions of relative humidity of 20-65%, and the application includes solid dosage form processing and storage.

12. A product characterized in that, Includes the excipient composition as described in any one of claims 1 to 10.

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