Medicinal auxiliary material compressible dextrin and preparation method thereof

Abstract

The invention provides a medicinal auxiliary material compressible dextrin and a preparation method thereof, and relates to the field of medicinal auxiliary materials, and the preparation method comprises the following steps: S1, acidification hydrolysis: taking starch as a raw material, and adding acid into the starch for acidification hydrolysis; in the process, according to the specific application and viscosity requirements of the target product compressible dextrin, the viscosity of the obtained product can be controlled by controlling the acid adding amount and the hydrolysis temperature and time; s2, sieving to remove impurities; s3, adding water to prepare liquid A; s4, boiling granulation: respectively feeding the dextrin powder obtained in the step S2 and the liquid A obtained in the step S3 into a boiling granulator, and carrying out boiling granulation to obtain compressible dextrin; the compressible dextrin prepared by the preparation method disclosed by the invention is good in compressibility and flowability, and can meet the requirements of a direct compression process, so that the prepared dextrin can be applied to the direct compression process to prepare tablet medicines, and the preparation process flow of the medicines can be greatly shortened and the production efficiency can be improved by combining the direct compression process to prepare the medicine tablets.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical excipients, and in particular to compressible dextrin as a pharmaceutical excipient and a preparation method thereof. Background Art

[0002] Common pharmaceutical dosage forms include injections, tablets, capsules, oral liquid dosage forms, granules, ointments, etc. Among them, the preparation of tablets is the process of mixing the drug with the excipients, filling them into a mold hole of a certain shape, and pressing them into a sheet. According to the granulation method and the material processing method, it can be divided into wet granulation tableting, direct tableting and blank granule tableting. In order to smoothly press out qualified tablets, the raw materials generally need to be pretreated or processed to make them have good fluidity and compressibility.

[0003] The choice of process may be due to the poor fluidity and compressibility of auxiliary materials such as fillers (such as starch, sucrose, dextrin), which makes it difficult to mix the mixed materials evenly, and the poor properties of auxiliary materials make it difficult to meet the process requirements of direct powder compression. Therefore, in the process of solid preparation research and development, most domestic preparation researchers still prefer wet granulation and tableting. For example, the preparation method of amlodipine besylate tablets disclosed in the Chinese invention patent with announcement number CN103356493A adopts wet granulation and tableting, and amlodipine besylate, microcrystalline cellulose, and crospovidone are mixed evenly, and then a soft material is made with 5% starch slurry, sieved and granulated, dried, and then sieved to obtain granules I; starch and dextrin are mixed evenly, and then a soft material is made with 5% starch slurry, sieved and granulated, and dried; then sieved to obtain granules II. Take granules I and granules II, mix them, add magnesium stearate, and mix them evenly; after tableting, a tablet-like medicine is obtained. Another example is the preparation method of dexamethasone acetate oral patch disclosed in the Chinese invention patent with announcement number CN109125281A, which first prepares API into solution, prepares it into stone particles together with dextrin and carbomer, then dries and granulates it to obtain drug-loaded particles, and finally mixes the drug-loaded particles, pre-made carbomer particles and magnesium stearate and compresses them into tablets to obtain drug tablets. However, the process flow of such wet granulation and tableting is relatively complicated, and multiple operations such as mixing raw materials, preparing soft materials, and granulating are required.

[0004] The direct compression process is to directly compress the excipients and active pharmaceutical ingredients (API) into tablets after mixing them. The process is simple, but it has high requirements for the fluidity and compressibility of the excipients. Compared with wet granulation, the direct compression process avoids the contact of API with moisture and heat, and improves the stability of the drug; the direct compression process can improve the disintegration and dissolution of tablets to a certain extent, especially for poorly soluble drugs, which can only play a role if they dissolve quickly and increase the exposure in the body.

[0005] Dextrin is a commonly used pharmaceutical excipient, usually used as a filler, diluent and auxiliary adhesive in prescriptions. The conventional preparation method of dextrin is to add acid to powdered starch to hydrolyze the starch, and then sieve it to obtain the finished dextrin powder. Most of the current medicinal dextrins are powdered dextrins of this type, and powdered dextrins have the characteristics of poor compressibility and molding agent in tablet production. The hardness and brittleness of the tablets cannot meet the quality standard requirements of the direct tableting process, especially the requirements of small-dose tablet preparations. There are certain disadvantages. Therefore, when applied to tablet drugs, the above-mentioned wet granulation tableting process is usually used.

[0006] Based on this, the present application aims to develop a compressible dextrin as a pharmaceutical excipient and a preparation method thereof, so that the compressible dextrin can be directly applied to the direct compression process to prepare tablet drugs. Summary of the invention

[0007] The present invention aims at the above problems existing in the prior art and provides a compressible dextrin as a pharmaceutical excipient and a preparation method thereof.

[0008] The technical solution of the present invention to solve the above technical problems is as follows:

[0009] In one aspect, the present invention provides a method for preparing compressible dextrin as a pharmaceutical excipient, characterized in that the method comprises the following steps:

[0010] S1. Acid hydrolysis: using starch as raw material, adding acid to the starch for acid hydrolysis; in this process, according to the specific application and viscosity requirements of the target product, compressible dextrin, the viscosity of the obtained product can be controlled by controlling the amount of acid added and the hydrolysis temperature and time;

[0011] S2, sieving to remove impurities to obtain dextrin powder;

[0012] S3, taking the dextrin powder obtained in step S2, adding water to prepare liquid A, and keeping it warm for later use;

[0013] S4, boiling granulation: the dextrin powder obtained in step S2 and the liquid A obtained in step S3 are respectively fed into a boiling granulator for boiling granulation to obtain compressible dextrin.

[0014] Furthermore, the starch in step S1 is corn starch, potato starch or tapioca starch. The acid in step S1 is hydrochloric acid or nitric acid, preferably 32% hydrochloric acid or 68% nitric acid.

[0015] Furthermore, in step S3, the mass concentration of liquid A is 15-30%, and the insulation temperature is 60-90°C.

[0016] Furthermore, in the boiling granulation in step S4, the dextrin powder enters the boiling granulator through the feed port at a preset feed speed, and the liquid A enters the boiling granulator and is sprayed out through the spray gun to contact the powdered material to form compressible dextrin particles.

[0017] Furthermore, in step S4, in the boiling granulator, the spray gun pressure is 0.1-0.4MPa, the atomization pressure is 0.08-0.2MPa; the peristaltic pump speed for feeding the dextrin powder is controlled at 80-180rpm. The injection speed of liquid A should be determined according to the actual granulation conditions in the tower to avoid the collapse and agglomeration of the bed caused by too fast injection speed and too low material temperature.

[0018] Furthermore, in step S4, the boiling granulator has an air inlet mechanism located at the bottom and an air exhaust mechanism located at the top, wherein the air inlet temperature is 80-120° C. and the air exhaust frequency is 15-30 Hz.

[0019] On the other hand, the present invention provides a compressible dextrin as a pharmaceutical excipient, characterized in that it is a directly compressible dextrin, which is prepared by the preparation method as described above and has a particle size between 20 and 80 meshes.

[0020] The beneficial effects of the present invention are as follows: the present invention creatively uses boiling granulation equipment to granulate the dextrin powder obtained by acid hydrolysis, and in the boiling granulation process, the aqueous solution made from the dextrin powder and the dextrin powder are used as the raw materials for boiling granulation, and no other additional adhesive is required. The prepared compressible dextrin has good compressibility and fluidity, which can meet the requirements of the direct compression process, and the prepared dextrin can be applied to the direct compression process to prepare tablet drugs. The compressible dextrin prepared by the present invention has direct compressibility as a pharmaceutical excipient, and the preparation of pharmaceutical tablets in combination with the direct compression process can greatly shorten the preparation process of the drug and improve production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a product photo of the compressible corn starch dextrin prepared in Example 1 of the present invention;

[0022] Figure 2 This is a product photo of compressible potato dextrin prepared in Example 2 of the present invention;

[0023] Figure 3 is a microscopic structure diagram of compressible potato dextrin prepared in Example 2 of the present invention;

[0024] Figure 4 This is a product photo of compressible tapioca starch dextrin prepared in Example 3 of the present invention;

[0025] Figure 5 is a microstructure diagram of compressible tapioca starch dextrin prepared in Example 3 of the present invention;

[0026] Figure 6 This is a product photo of the dextrin powder prepared in Comparative Example 1 of the present invention;

[0027] Figure 7 is a particle size analysis diagram of the compressible dextrin prepared in Example 1 of the present invention;

[0028] Figure 8 is a particle size analysis diagram of dextrin prepared in Comparative Example 1 of the present invention; DETAILED DESCRIPTION

[0029] The principles and features of the present invention are described below. The examples given are only used to explain the present invention but not to limit the scope of the present invention.

[0030] The main materials and equipment specifications used in the following examples and comparative examples are as follows:

[0031] Corn starch, food grade, was purchased from Shandong Shouguang Juneng Golden Corn Development Co., Ltd.;

[0032] Potato starch, food grade, purchased from Dingxi Yinjishan Starch Processing Co., Ltd.

[0033] Cassava starch, food grade, was purchased from Guangxi Nanning Jushun Yijiu Trading Co., Ltd.;

[0034] Fluidized bed granulator, FL-300 fluidized bed granulator.

[0035] Example 1

[0036] The preparation of the compressible dextrin in this embodiment is carried out according to the following steps:

[0037] S1. Acid hydrolysis: Set the temperature of the heat transfer oil in the reactor to 100-160°C. When the temperature rises to 100°C, evenly add 500 parts by weight of corn starch into the reactor, start stirring, and then spray 0.3 parts of nitric acid (concentration 68%) into the reactor. After reacting for 1 hour, pass cooling water with a temperature below 20°C into the jacket of the reactor to reduce the temperature inside the reactor to below 40°C. The viscosity of the obtained product is 13.6mpa·s using the No. 1 rotor of a DNJ-6 rotary viscometer.

[0038] S2. Sieving and removing impurities: After the reaction in step S1 is completed and the temperature is lowered, the mixture is sieved through a 40-80 mesh stainless steel sieve to remove impurities such as protein to obtain dextrin powder.

[0039] S3. Slurry preparation: take 75 parts of the dextrin powder after screening in step S2 and put it in a stainless steel tank insulation kettle, add boiling purified water to prepare a 15% concentration solution, stir evenly to form a transparent liquid A, and keep warm at 60-90°C for later use.

[0040] S4, boiling granulation: The equipment used in this step is a boiling granulator (existing technology). The dextrin powder screened in step S2 is conveyed to the boiling granulator through the feed port by a peristaltic pump. The boiling granulator has an air inlet mechanism at the bottom and an exhaust mechanism at the top. Set the inlet air temperature to 90°C, the exhaust frequency to 15Hz (inlet air temperature to 80-120°C, exhaust frequency to 15-30Hz), and the peristaltic pump speed to 100rpm (the peristaltic pump speed for controlling the dextrin powder feeding is set to 80-180rpm); set the spray gun pressure to 0.1MPa, the atomization pressure to 0.1MPa (spray gun pressure to 0.1-0.4MPa, atomization pressure to 0.08-0.2MPa), liquid A enters the boiling granulator and is slowly sprayed into the boiling granulator through the spray gun, the spray contacts the powdered material to form compressible dextrin particles; the spray time is controlled to 1.5-2 hours, and the material temperature is controlled to 43-48°C.

[0041] S5. Cooling: After liquid A is sprayed, when the moisture content of the particles is ≤5.0%, the hot air valve is closed to cool down the material. When the material temperature drops below 40°C, the machine is stopped for discharging.

[0042] S6. Screening: Use 20-mesh and 80-mesh stainless steel screens to screen in the screening machine, and collect particles between 20 and 80 mesh, which are the target compressible dextrin particles (see attached product photos). Figure 1 ).

[0043] Example 2

[0044] S1. Acid hydrolysis: Set the temperature of the heat transfer oil in the reactor to 100-160°C. When the temperature rises to 100°C, evenly add 500 parts by weight of potato starch into the reactor, start stirring, and then spray 0.2 parts of hydrochloric acid (concentration 30%) into the reactor. After reacting for 1.5 hours, pass cooling water with a temperature below 20°C into the jacket of the reactor to reduce the temperature inside the reactor to below 40°C. The viscosity of the obtained product is 7.2mpa·s using the No. 1 rotor of a DNJ-6 rotary viscometer.

[0045] S2. Sieving and removing impurities: After the reaction in step S1 is completed and the temperature is lowered, the mixture is sieved through a 40-80 mesh stainless steel sieve to remove impurities such as protein to obtain dextrin powder.

[0046] S3. Slurry preparation: take 75 parts of the dextrin powder after screening in step S2 and put it in a stainless steel tank insulation kettle, add boiling purified water to prepare a 15% concentration solution, stir evenly to form a transparent liquid A, and keep warm at 60-90°C for later use.

[0047] S4, boiling granulation: The equipment used in this step is a boiling granulator (existing technology). The dextrin powder screened in step S2 is conveyed to the boiling granulator through the feed port by a peristaltic pump. The boiling granulator has an air inlet mechanism at the bottom and an exhaust mechanism at the top. Set the inlet air temperature to 90°C, the exhaust frequency to 15Hz (inlet air temperature to 80-120°C, exhaust frequency to 15-30Hz), and the peristaltic pump speed to 100rpm (the peristaltic pump speed for controlling the dextrin powder feeding is 80-180rpm); set the spray gun pressure to 0.1MPa, the atomization pressure to 0.1MPa (spray gun pressure to 0.1-0.4MPa, atomization pressure to 0.08-0.2MPa), liquid A enters the boiling granulator and is slowly sprayed into the boiling granulator through the spray gun, the spray contacts the powdered material to form compressible dextrin particles; the spray time is controlled to 1-1.5 hours, and the material temperature is controlled to 43-48°C.

[0048] S5. Cooling: After liquid A is sprayed, when the moisture content of the particles is ≤5.0%, the hot air valve is closed to cool down the material. When the material temperature drops below 40°C, the machine is stopped for discharging.

[0049] S6. Screening: Use 20-mesh and 80-mesh stainless steel screens to screen in the screening machine, and collect particles between 20 and 80 mesh, which are the target compressible dextrin particles (see attached product photos). Figure 2 , microscopic picture see Figure 3 ).

[0050] Example 3

[0051] S1. Acid hydrolysis: Set the temperature of the heat transfer oil in the reactor to 100-160°C. When the temperature rises to 100°C, evenly add 500 parts by weight of cassava starch into the reactor, start stirring, and then spray 0.3 parts of nitric acid (concentration 68%) into the reactor. After reacting for 1.5 hours, pass cooling water with a temperature below 20°C into the jacket of the reactor to reduce the temperature inside the reactor to below 40°C. The viscosity of the obtained product is 11.1 mpa·s using the No. 1 rotor of a DNJ-6 rotary viscometer.

[0052] S2. Sieving and removing impurities: After the reaction in step S1 is completed and the temperature is lowered, the mixture is sieved through a 40-80 mesh stainless steel sieve to remove impurities such as protein to obtain dextrin powder.

[0053] S3. Slurry preparation: take 75 parts of the dextrin powder after screening in step S2 and put it in a stainless steel tank insulation kettle, add boiling purified water to prepare a 15% concentration solution, stir evenly to form a transparent liquid A, and keep warm at 60-90°C for later use.

[0054] S4, boiling granulation: The equipment used in this step is a boiling granulator (existing technology). The dextrin powder screened in step S2 is conveyed to the boiling granulator through the feed port by a peristaltic pump. The boiling granulator has an air inlet mechanism at the bottom and an exhaust mechanism at the top. Set the inlet air temperature to 90°C, the exhaust frequency to 15Hz (inlet air temperature to 80-120°C, exhaust frequency to 15-30Hz), and the peristaltic pump speed to 100rpm (the peristaltic pump speed for controlling the dextrin powder feeding is set to 80-180rpm); set the spray gun pressure to 0.1MPa, the atomization pressure to 0.1MPa (spray gun pressure to 0.1-0.4MPa, atomization pressure to 0.08-0.2MPa), liquid A enters the boiling granulator and is slowly sprayed into the boiling granulator through the spray gun, the spray contacts the powdered material to form compressible dextrin particles; the spray time is controlled to 1.5-2 hours, and the material temperature is controlled to 43-48°C.

[0055] S5. Cooling: After liquid A is sprayed, when the moisture content of the particles is ≤5.0%, the hot air valve is closed to cool down the material. When the material temperature drops below 40°C, the machine is stopped for discharging.

[0056] S6. Screening: Use 20-mesh and 80-mesh stainless steel screens to screen in the screening machine, and collect particles between 20 and 80 mesh, which are the target compressible dextrin particles (see attached product photos). Figure 4 , microscopic picture see Figure 5 ).

[0057] Comparative Example 1

[0058] This comparative example adopts the existing process to prepare dextrin, that is, only steps S1 and S2 in Example 1 are adopted, which are as follows:

[0059] S1. Acid hydrolysis: Set the temperature of the heat transfer oil in the reactor to 100-160°C. When the temperature rises to 100°C, evenly add 500 parts by weight of corn starch into the reactor, start stirring, and then spray 0.3 parts of nitric acid (concentration 68%) into the reactor. After reacting for 1 hour, pass cooling water with a temperature below 20°C into the jacket of the reactor to reduce the temperature inside the reactor to below 40°C. The viscosity of the obtained product is 13.6mpa·s using the No. 1 rotor of a DNJ-6 rotary viscometer.

[0060] S2. Sieve to remove impurities: After the reaction in step S1 is completed and the temperature is lowered, pass through a 40-80 mesh stainless steel sieve to remove protein and other impurities to obtain dextrin powder. See the product photo for details. Figure 6 .

[0061] test:

[0062] The particle size distribution of Example 1 and Comparative Example 1 was analyzed by laser particle size analyzer. Figure 7 and Figure 8.

[0063] Depend on Figure 7 and Figure 8 It can be seen that the D50 of the compressible dextrin prepared in Example 1 is 236.6, and the D50 of the dextrin prepared in Comparative Example 1 is 53.06, that is, the particle size of the compressible dextrin in Example 1 is significantly larger than that of the dextrin in Comparative Example 1.

[0064] Compressibility test: The test standard refers to the chapter <0993 Determination of bulk density and tap density> of Part IV of the 2020 edition of the Chinese Pharmacopoeia. The bulk density and tap density of the dextrin samples prepared in the above embodiments and comparative examples were measured respectively. The test results are shown in Tables 1 to 3.

[0065] Table 1 Bulk density and tap density test data

[0066]

[0067] Table 2 Compressibility test data

[0068]

[0069] Table 3 Repose angle test data

[0070] Test items Example 1 Example 2 Example 3 Comparative Example 1 Angle of repose 42.21° 41.63° 41.26° 52.21°

[0071] In the above data, the closer the tap density is to the bulk density, the closer the Hausner ratio is to 1, the better the fluidity, the lower the compressibility index, the better the fluidity, the lower the angle of repose, the better the fluidity, and the better the compressibility of the auxiliary materials.

[0072] It can be seen from the data in Tables 1 to 3 that the ratio of the tap density / bulk density of Example 1, Example 2, and Example 3 is closer to 1 than that of Comparative Example 1, and the Hausner ratio is also closer to 1. The compressibility of Example 1, Example 2, and Example 3 is lower than that of Comparative Example 1, and the repose angle detection data of Example 1, Example 2, and Example 3 are all lower than that of Comparative Example 1. This shows that the fluidity of Example 1, Example 2, and Example 3 is significantly better than that of Comparative Example 1. It can be seen that the compressibility and reasonable fluidity of the compressible dextrin prepared by the present invention are significantly better than the dextrin powder obtained by acidification and hydrolysis in Comparative Example 1.

[0073] Tableting example:

[0074] Example 4

[0075] In this embodiment, the compressible dextrin prepared in Example 1 is used as an auxiliary material, and after being mixed with API dexamethasone acetate and other auxiliary materials, a direct compression process is used to prepare dexamethasone acetate tablets. The specific process steps are as follows:

[0076] Dexamethasone acetate and carbomer were mixed and crushed, passed through a 20-mesh sieve, and then mixed evenly with the compressible dextrin and magnesium stearate prepared in Example 1. The mixture was discharged and pressed into 900,000 small tablets (pressure 5-8 KN), with a tableting rate of 99.2%, each tablet weighing 50 mg, and each tablet containing 0.3 mg of dexamethasone acetate.

[0077] Among them, the raw material dosage ratio is the same as that recorded in paragraph 0105 of the patent document specification with announcement number CN109125281A: 270g of dexamethasone acetate, 33kg of compressible dextrin, 11.31kg of carbomer, and 300g of magnesium stearate.

[0078] Comparative Example 2

[0079] This comparative example is used as a control for Example 4. The dextrin prepared in Comparative Example 1 is used as an auxiliary material. After being mixed with API dexamethasone acetate and other auxiliary materials, a direct compression process is used to prepare dexamethasone acetate tablets. The specific process steps are as follows:

[0080] Dexamethasone acetate and carbomer were mixed and crushed, passed through a 20-mesh sieve, and then mixed evenly with the compressible dextrin and magnesium stearate obtained in Comparative Example 1, and discharged, and pressed into 900,000 small tablets (pressure 5-8KN), with a tableting rate of 50.2%, a tablet weight range of 29.30-62.40 mg (standard 50 mg ± 6%), a hardness range of 5-18 N (standard 20-60 N), a tablet thickness of 0.88-1.18 mm (standard 1.35-1.55 mm), a plain tablet melting time of 46-70 min, a content of 52.00-76.10% (standard 80-120%), and a content uniformity of 15.59-22.30% (standard ≤15.00%). The tablets were severely cracked, too many loose tablets, the tablet weights varied greatly, the hardness did not meet the requirements, the content was too low and uneven, the tablet thickness did not meet the standards, and the plain tablet melting time was short and uneven.

[0081] Among them, the raw material dosage ratio is the same as that recorded in paragraph 0105 of the patent document specification with announcement number CN109125281A: 270g of dexamethasone acetate, 33kg of dextrin, 11.31kg of carbomer, and 300g of magnesium stearate.

[0082] Comparative Example 3

[0083] This comparative example is used as a control for Example 4. The dextrin prepared in Comparative Example 1 is used as an excipient, and the API dexamethasone acetate and other excipients are wet granulated and then tableted to prepare dexamethasone acetate tablets. The specific process steps are cited from the process described in paragraphs 0103 to 0113 of the patent document specification with announcement number CN109125281A, and the dextrin used therein is replaced by the dextrin prepared in Comparative Example 1 of this application. The tableting rate is 99.5%, each tablet weighs 50 mg, and each tablet contains 0.3 mg of dexamethasone acetate.

[0084] The above results show that: the tableting rate of comparative example 2 is extremely low, that is, the dextrin prepared in comparative example 1 cannot be applied to the preparation of pharmaceutical tablets by direct compression process; while both Example 4 and comparative example 3 are successfully tableted, and the indicators of the dexamethasone acetate tablets prepared in Example 4 and comparative example 3 are all within the following ranges: tablet weight range 49.30-51.40 mg (standard 50 mg ± 6%), hardness range 29-36 N (standard 20-60 N), tablet thickness 1.38-1.48 mm (standard 1.35-1.55 mm), plain tablet dissolution time 76-80 min, content 92.00-96.10% (standard 80-120%), content uniformity 5.59-12.30% (standard ≤15.00%). That is, in Example 4, the compressible dextrin prepared in Example 1 of the present invention is used as an auxiliary material to prepare tablets by direct compression. The tableting indicators are equivalent to those of the tablets prepared in Comparative Example 2 by the traditional wet granulation tableting process. That is, the compressible dextrin prepared by the preparation process of the present invention can fully meet the use requirements of the direct compression process. The compressible dextrin prepared by the present invention is used for preparing pharmaceutical tablets by direct compression process, which can greatly improve the production efficiency.

Claims

1. A method for preparing compressible dextrin as a pharmaceutical excipient, characterized in that: The steps include: S1. Acid hydrolysis: using starch as raw material, adding acid to the starch for acid hydrolysis; S2, sieving to remove impurities to obtain dextrin powder; S3, taking the dextrin powder obtained in step S2, adding water to prepare liquid A, and keeping it warm for later use; S4, boiling granulation: the dextrin powder obtained in step S2 and the liquid A obtained in step S3 are respectively fed into a boiling granulator for boiling granulation to obtain compressible dextrin.

2. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 1, characterized in that: The starch in step S1 is corn starch, potato starch or tapioca starch.

3. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 1, characterized in that: The acid in step S1 is hydrochloric acid or nitric acid.

4. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 1, characterized in that: The mass concentration of liquid A in step S3 is 15-30%.

5. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 1, characterized in that: In the boiling granulation in step S4, the dextrin powder enters the boiling granulator through the feed port at a preset feed speed, and the liquid A enters the boiling granulator and is sprayed out through the spray gun to contact the powdered material to form compressible dextrin particles.

6. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 5, characterized in that: In step S4, in the boiling granulator, the spray gun pressure is 0.1-0.4 MPa, and the atomization pressure is 0.08-0.2 MPa.

7. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 5, characterized in that: In step S4, in the boiling granulator, the speed of the peristaltic pump for feeding the dextrin powder is controlled to be 80-180 rpm.

8. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 5, characterized in that: In step S4, the boiling granulator has an air inlet mechanism located at the bottom and an air exhaust mechanism located at the top, wherein the air inlet temperature is 80-120° C. and the air exhaust frequency is 15-30 Hz.

9. The method for preparing compressible dextrin as a pharmaceutical excipient according to claim 1, characterized in that: The insulation temperature of step S3 is 60-90°C.

10. A compressible dextrin as a pharmaceutical excipient, characterized in that: The invention relates to a directly compressible dextrin, which is prepared by the preparation method according to any one of claims 1 to 9.

Images