Preparation method of magnesium glycinate enteric sustained-release capsule

Abstract

The invention discloses a preparation method of a magnesium glycinate enteric-coated sustained-release capsule, and relates to the technical field of preparation of enteric-coated sustained-release capsules, and the preparation method is technically characterized by comprising the following steps: preparing a magnesium glycinate pellet: mixing magnesium glycinate with microcrystalline cellulose, starch and cane sugar to form uniform powder, adding the mixed powder into a centrifugal granulating and coating machine, and carrying out granulation and coating to obtain the magnesium glycinate pellet; taking hydroxypropyl methyl cellulose or a methyl cellulose solution as an adhesive, and performing centrifugal granulation at four stages of nucleation, coalescence, lamination and rolling compaction to obtain magnesium glycinate pellets; the nucleation is that the initial particles attract and are connected with one another due to the formation of a three-phase structure in the wetting process of the adhesive; the coalescence is that parent nuclei are combined to form larger particles due to random collision among the large particles; through a synergistic process of four-stage centrifugal granulation, specific-ratio slow-release coating and HPMCP enteric coating, efficient and accurate controlled release of magnesium glycinate is realized, and the problem of too fast release caused by insufficient weight gain of the slow-release coating is effectively avoided.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of enteric-soluble sustained-release capsule preparation, in particular to a preparation method of magnesium glycinate enteric-soluble sustained-release capsules. BACKGROUND

[0002] At present, magnesium glycinate supplements are mostly in the form of ordinary capsules or tablets, which are rapidly released in the stomach after oral administration, are easily affected by gastric acid, have low bioavailability, and cause stomach irritation symptoms in some patients. Although the existing sustained-release preparations can prolong the drug release time, they lack control over the release site and cannot avoid stomach exposure. In addition, the existing enteric-soluble technology mostly relies on pH-sensitive coating materials, and the disintegration speed in the intestinal tract is different, leading to unstable release of magnesium ions and unsatisfactory absorption effect. These limitations restrict the efficient application of magnesium glycinate in the clinic. SUMMARY

[0003] In view of the deficiencies of the prior art, the application provides a preparation method of magnesium glycinate enteric-soluble sustained-release capsules, which can make magnesium glycinate slowly release after entering the intestine and improve the absorption and utilization rate of magnesium glycinate.

[0004] To achieve the above-mentioned purpose, the application provides the following technical scheme: a preparation method of magnesium glycinate enteric-soluble sustained-release capsules, comprising the following steps: Preparation of magnesium glycinate pellets: mixing magnesium glycinate, microcrystalline cellulose, starch and sucrose to form a uniform powder, adding the mixed powder into a centrifugal granulator, using a hydroxypropyl methylcellulose or methylcellulose solution as a binder, and performing four-stage centrifugal granulation of nucleation, coalescence, layering and rolling and compression to obtain magnesium glycinate pellets; The nucleation is the mutual attraction and connection of initial particles due to the formation of a three-phase structure during the wetting process of the binder; the coalescence is the random collision between large particles leading to the merging of parent cores to form larger particles; The layering is the gradual accumulation of powder on the surface of the parent core to promote particle growth, and the rolling and compression is the random transfer of substances from one particle to another to optimize the particle size; Sustained-release coating of the magnesium glycinate pellets: preparing a coating liquid according to the mass fraction, wherein the coating liquid contains 100 parts of cellulose acetate, 8 parts of polyethylene glycol 6000 and 2000 parts of trichloromethane; the obtained magnesium glycinate pellets are added into a bottom-spraying fluidized bed coater, the material temperature is controlled to be 30-40 DEG C, and the coating is performed until the weight gain is 8%-15%, so that magnesium glycinate sustained-release pellets are obtained; Intestinal coating of the glycine magnesium sustained-release pellets: prepare an intestinal coating solution by mass fraction, which comprises 100 parts of hydroxypropyl methylcellulose phthalate (HPMCP), 2000 parts of a mixed solvent of methanol and dichloromethane, the volume ratio of methanol to dichloromethane being 1:1; the obtained glycine magnesium sustained-release pellets are added to the coating equipment, the material temperature is controlled at 28-40℃, and coating is carried out until the weight gain is 15%-30%, to obtain glycine magnesium enteric sustained-release pellets; Capsule filling: the obtained glycine magnesium enteric sustained-release pellets are filled into a capsule shell to obtain glycine magnesium enteric sustained-release capsules.

[0005] Preferably, the mass ratio of the mixture of glycine magnesium, microcrystalline cellulose, starch and sucrose is (5-8):(1-2):(0.5-1):(0.5-1).

[0006] Preferably, the mass concentration of the binder in step 1 is 3%-5%, and the spraying amount of the binder is 15%-20% of the total mass of the mixed powder.

[0007] Preferably, the centrifugal granulation speed is 200-300 r / min, and the granulation time is 30-60 minutes, so as to ensure uniform particle size of the pellets, and the particle size of the glycine magnesium pellets is in the range of 600-1400 μm.

[0008] Preferably, the spraying rate of the bottom-spraying fluidized bed coating machine is 5-10 mL / min, and the air inlet speed is 0.8-1.2 m / s.

[0009] Preferably, during the coating process, sampling and detection are carried out every 15-20 minutes, and the coating is stopped when the weight gain rate reaches 8%-15%.

[0010] Preferably, after the sustained-release coating is completed, the glycine magnesium sustained-release pellets are dried at 40-50℃ for 1-2 hours to remove residual trichloromethane; and after the enteric coating is completed, the glycine magnesium enteric sustained-release pellets are dried at 35-45℃ for 2-3 hours to remove residual methanol and dichloromethane.

[0011] Preferably, the coating equipment is a bottom-spraying fluidized bed coating machine or a high-efficiency coating pot, the spraying pressure of the coating equipment is 0.2-0.4 MPa, and the atomizing air flow is 15-25 m³ / h.

[0012] Preferably, during the coating process, the relative humidity in the coating equipment is controlled at 30%-50% to avoid moisture absorption and caking of the enteric coating layer.

[0013] Preferably, the capsule shell is a gelatin capsule shell or a plant source capsule shell, the size of the capsule shell is No. 0 or No. 1, the filling mass of the magnesium glycinate enteric sustained-release pellets in each capsule is 250-350 mg, and the content of magnesium glycinate in each capsule is 100-150 mg.

[0014] Compared with the prior art, the present application provides a preparation method of a magnesium glycinate enteric sustained-release capsule, which has the following beneficial effects: through the synergistic process of four-stage centrifugal granulation + specific ratio of sustained-release coating + HPMCP enteric coating, the present application realizes efficient and accurate controlled release of magnesium glycinate, effectively avoids the problems of too fast release caused by insufficient weight gain of sustained-release coating and too slow release and insufficient absorption caused by excessive weight gain, and guarantees stable and controllable drug release rate; in terms of targeted release, the risk of gastrointestinal irritation caused by premature release in the stomach is eliminated. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 The dissolution test curve of the sustained-release pellets of Example 3 and Comparative Example 8 of the present application from 0 h to 8 h is shown in the figure. Figure 2 The dissolution test curve of the enteric sustained-release capsule of Example 3 of the present application in artificial gastric juice and artificial intestinal juice is shown in the figure. DETAILED DESCRIPTION

[0016] The technical solutions in the embodiments of the present application will be described below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0017] Nucleation stage: refers to that the initial mixed powder forms small mother nuclei with a diameter of 50-100 pm under the action of solid-liquid-gas interfacial tension through the atomization spraying of the binder; Coalescence stage: the mother nuclei collide and merge with each other under the action of centrifugal force to form secondary particles with a diameter of 100-200 pm; Layering stage: the surface of the particles is gradually accumulated with material through continuous spraying of the binder and the powder, and the diameter is increased to 600-1400 pm; Rolling and compacting stage: the surface material is transferred due to the centrifugal friction between the particles, so that the roundness of the pellets is improved (roundness ≥ 0.85), and the coefficient of variation of particle size distribution is ≤ 15%.

[0018] The above four stages are continuous process, rather than independent step-by-step operation, and those skilled in the art can control the stage conversion through the parameters (rotation speed, liquid spraying amount, time) of the centrifugal granulator.

[0019] The coating weight gain refers to the coating weight gain rate, and the coating weight gain rate = (the mass of the pellets after coating - the mass of the pellets before coating) ÷ the mass of the pellets before coating × 100%. The sustained-release coating weight gain is based on the magnesium glycinate pellets (product of step 1), and the enteric coating weight gain is based on the magnesium glycinate sustained-release pellets (product of step 2), which are both measured by an electronic balance (accuracy 0.1 mg).

[0020] The mixing mass ratio of magnesium glycinate, microcrystalline cellulose, starch, and sucrose is as follows: magnesium glycinate: microcrystalline cellulose: starch: sucrose. For example, when the ratio is 5:1:0.5:0.5, i.e., 5 parts of magnesium glycinate corresponds to 1 part of microcrystalline cellulose, 0.5 parts of starch, and 0.5 parts of sucrose, the ratio is determined based on the synergistic effect of active ingredients and excipients to ensure the pellet formability and drug content uniformity.

[0021] Example 1: Pellet preparation: Mix 50 g of magnesium glycinate, 10 g of microcrystalline cellulose, 5 g of starch, and 5 g of sucrose; the binder is a 3% HPMC solution (spraying liquid amount 15 g); centrifugal granulation speed 200 r / min, time 30 minutes, to obtain pellets with a particle size of 600-900 μm; Sustained-release coating: coating liquid (cellulose acetate 100 g, PEG6000 8 g, chloroform 2000 g); material temperature 30℃, spraying rate 5 mL / min, air inlet wind speed 0.8 m / s; coating weight gain 8%, 40℃ drying for 1 hour; Enteric coating: enteric coating liquid (HPMCP 100 g, methanol / dichloromethane 1:1, total 2000 g); material temperature 28℃, humidity 30%, spraying pressure 0.2 MPa, atomization flow 15 m³ / h; coating weight gain 15%, 35℃ drying for 2 hours; Capsule filling: fill into No. 1 gelatin capsule shell, 250 mg per particle (containing 100 mg of magnesium glycinate).

[0022] Example 2, pellet preparation: Mix 65 g of magnesium glycinate, 15 g of microcrystalline cellulose, 7.5 g of starch, and 7.5 g of sucrose; the binder is a 4% HPMC solution (spraying liquid amount 18 g); centrifugal granulation speed 250 r / min, time 45 minutes, to obtain pellets with a particle size of 900-1200 μm; Sustained-release coating: the coating liquid is the same as in Example 1; material temperature 35℃, spraying rate 7.5 mL / min, air inlet wind speed 1.0 m / s; coating weight gain 11.5%, 45℃ drying for 1.5 hours; Enteric coating: the enteric coating liquid is the same as in Example 1; material temperature 34℃, humidity 40%, spraying pressure 0.3 MPa, atomization flow 20 m³ / h; coating weight gain 22.5%, 40℃ drying for 2.5 hours; Capsule filling: fill into 0 size gelatin capsule shell, 300 mg per capsule (containing 125 mg of magnesium glycinate).

[0023] Example 3, preparation of pellets: mix 80 g of magnesium glycinate, 20 g of microcrystalline cellulose, 10 g of starch and 10 g of sucrose; the binder is 5% HPMC solution (the amount of sprayed liquid is 20 g); the centrifugal granulation speed is 300 r / min, and the time is 60 minutes, to obtain pellets with a particle size of 1200-1400 μm; Sustained-release coating: the coating liquid is the same as in Example 1; the material temperature is 40°C, the spraying rate is 10 mL / min, the air inlet wind speed is 1.2 m / s; the coating weight gain is 15%, and the drying is performed at 50°C for 2 hours; Enteric coating: the enteric coating liquid is the same as in Example 1; the material temperature is 40°C, the humidity is 50%, the spraying pressure is 0.4 MPa, and the atomization flow is 25 m³ / h; the coating weight gain is 30%, and the drying is performed at 45°C for 3 hours; Capsule filling: fill into 0 size plant source capsule shell, 350 mg per capsule (containing 150 mg of magnesium glycinate).

[0024] Example 4, preparation of pellets: the same as in Example 2, but the binder is replaced by 4% methyl cellulose solution (the amount of sprayed liquid is 18 g); Sustained-release coating, enteric coating and capsule filling: the same as in Example 2.

[0025] Comparative Example 1, preparation of pellets, enteric coating and capsule filling: the same as in Example 2; The step of sustained-release coating is omitted, and the magnesium glycinate pellets are directly enteric coated.

[0026] Comparative Example 2, preparation of pellets, enteric coating and capsule filling: the same as in Example 2; The sustained-release coating weight gain is only 5%.

[0027] Comparative Example 3, preparation of pellets, enteric coating and capsule filling: the same as in Example 2; The sustained-release coating weight gain is 20%.

[0028] Comparative Example 4, preparation of pellets, sustained-release coating and capsule filling: the same as in Example 2; The step of enteric coating is omitted, and the magnesium glycinate sustained-release pellets are directly filled into capsules.

[0029] Comparative Example 5, preparation of pellets, sustained-release coating and capsule filling: the same as in Example 2; The enteric coating weight gain is only 10%.

[0030] Comparative Example 6, preparation of pellets, sustained-release coating and capsule filling: the same as in Example 2; The enteric coating material HPMC P is replaced by acrylic resin No. IV.

[0031] Comparative Example 7, sustained-release coating, enteric coating, capsule filling: same as Example 2; The pellet preparation only went through the nucleation-coalescence-roller compaction three stages, and the layering stage was missing.

[0032] Comparative Example 8, directly purchase commercially available ordinary magnesium glycinate capsules (specification: each capsule contains magnesium glycinate 125 mg), no sustained-release, enteric coating.

[0033] All test items in this application are executed in accordance with the Chinese Pharmacopoeia 2020 edition four general rules and relevant preparation specifications, specifically including: dissolution determination: in accordance with general rule 0931 (dissolution and release determination method), pellet particle size determination: in accordance with general rule 0982 (particle size and particle size distribution determination method), capsule filling amount in accordance with general rule 0103 (capsules), gastrointestinal tract stimulation evaluation: in accordance with the Technical Guidelines for Research on Irritability, Allergy and Hemolysis of Chemical Drugs.

[0034] Sustained-release pellet 8-hour dissolution determination: instrument and reagent: intelligent dissolution instrument (in accordance with the requirements of the Pharmacopoeia), 500 mL dissolution cup, 0.45 μm microporous filter membrane, distilled water, magnesium glycinate reference substance; Test steps: Take about 0.5 g of the test product (magnesium glycinate sustained-release pellets) and accurately weigh; Measure 500 mL of distilled water into the dissolution cup and heat to maintain the medium temperature at 37℃±0.5℃; Put the test product into the dissolution cup, immediately start the stirring device, and set the rotation speed to 50 r / min±1 r / min; At the required time points, take 5 mL of sample from each dissolution cup (while supplementing the same temperature and volume of distilled water); Immediately filter the removed sample through a 0.45 μm microporous filter membrane, and take the filtrate as the test product solution; Take another appropriate amount of magnesium glycinate reference substance, accurately weigh, dissolve in distilled water and dilute quantitatively to prepare a solution containing about 0.2 mg per 1 mL as the reference solution; Determine the absorbance of the test product solution and the reference solution by atomic absorption spectrophotometry (detection wavelength 285.2 nm); Calculation method: dissolution (%) = (absorbance of test product solution x weight of reference x dilution multiple) ÷ (absorbance of reference solution x weight of test product x labeled content) x 100%; Take the average of 6 parallel samples as the final result.

[0035] Intestinal capsule artificial gastric juice 2-hour dissolution determination: instrument and reagent: intelligent dissolution instrument, artificial gastric juice (take dilute hydrochloric acid 16.4 mL, add water about 800 mL, and add pepsin 10 g, shake well, then dilute with water to 1000 mL, pH value is 1.2); Test steps: Take 6 test samples (magnesium glycinate enteric sustained-release capsules) and put them into 6 dissolution cups respectively; Measure 500 mL of artificial gastric juice into each dissolution cup and heat to keep the medium temperature at 37℃±0.5℃; Start the stirring device and set the speed to 100 r / min±1 r / min; At 0 hour, 1 hour and 2 hours respectively, take 5 mL samples from each dissolution cup (while supplementing the same temperature and volume of artificial gastric juice); Sample treatment and determination method are the same as the dissolution determination of sustained-release pellets, and the calculation method is the same as the dissolution calculation formula of sustained-release pellets.

[0036] Intestinal capsule artificial intestinal juice 10-hour dissolution determination: instrument and reagent: intelligent dissolution instrument, artificial intestinal juice (take potassium dihydrogen phosphate 6.8 g, add water 500 mL to dissolve, adjust pH value to 6.8 with 0.1 mol / L sodium hydroxide solution, add water to dilute to 1000 mL, add trypsin 10 g and shake well); Test steps: After completing the artificial gastric juice 2-hour dissolution determination, replace the artificial gastric juice in the dissolution cup with 500 mL of artificial intestinal juice; Keep the temperature at 37℃±0.5℃ and the speed at 100 r / min±1 r / min; At the required time point after replacing the medium, take 5 mL samples (while supplementing the same temperature and volume of artificial intestinal juice); Sample treatment and determination method are the same as before, and the calculation method is the same as the dissolution calculation formula of sustained-release pellets.

[0037] Pellet size determination instrument: laser particle size analyzer, microscope; Test steps: Take an appropriate amount of magnesium glycinate pellets and place them on a glass slide, observe and record the appearance under a microscope Take another about 0.1 g of pellets and add an appropriate amount of purified water to make a uniform suspension Inject the suspension into the sample cell of the laser particle size analyzer to determine the particle size distribution Result calculation: record the D50 (median particle size) and particle size range (10%-90% particle size distribution interval) of the pellets.

[0038] Capsule filling amount difference checking instrument: electronic balance (accuracy 0.1 mg); Test steps: Take 20 test samples, and accurately weigh the total weight respectively; Pour out the contents, wipe the shell, and accurately weigh the shell weight respectively; Calculate the loading of each content (total weight-shell weight); The result is judged: compared with the average loading, no more than 2 samples exceed the loading difference limit (±10%), and no sample exceeds the limit by 1 times; The above test steps need to be carried out 3 times in parallel, and the average value is taken as the final result.

[0039] The magnesium glycinate enteric sustained-release capsules obtained from Examples 1, 2, 3, 4 and Comparative Examples 1, 2, 3, 4, 5, 6, 7, 8 are grouped as CRHS-01, CRHS-02, CRHS-03, CRHS-04, CRHS-05, CRHS-06, CRHS-07, CRHS-08, CRHS-09, CRHS-10, CRHS-11, CRHS-12, and the performance of the products of the examples and comparative examples is tested, specifically including the 8h dissolution of the sustained-release pellets, the 2h dissolution in artificial gastric juice and the 10h dissolution in artificial intestinal juice, and the specific test results are shown in Table 1.

[0040] Table 1

[0041] Table 2 is the 0h-8h dissolution test table of the sustained-release pellets of Example 3 and Comparative Example 8

[0042] Table 3 is the dissolution test table of the enteric sustained-release capsules of Example 3 in artificial gastric juice and artificial intestinal juice

[0043] From the dissolution performance and the targeting release effect, the improved process steps of the application realize the precise controlled release of magnesium glycinate through the synergistic effect of four-stage centrifugal granulation, specific ratio of sustained-release coating and HPMCP enteric coating: the 8h dissolution of the sustained-release pellets of the 4 groups of examples is stably at 80.6%-83.6%, which not only avoids the fluctuation of blood drug concentration caused by the too fast release of Comparative Example 2, but also solves the problem of insufficient absorption caused by the too slow release of Comparative Example 3; at the same time, the 2h dissolution of the examples in artificial gastric juice is 0%, which completely avoids the gastrointestinal irritation caused by the gastric release of Comparative Example 4, Comparative Example 5 and Comparative Example 8, and the 10h dissolution in intestinal juice reaches 94.06%-95.89%, which is significantly better than the unstable release of Comparative Example 6 and the uneven dissolution of Comparative Example 7, fully proving that the improved process can guarantee the stable and efficient release of the drug in the intestinal tract.

[0044] The above merely illustrates the specific embodiments of the present application, but the technical features of the present application are not limited thereto. Any simple change, equivalent replacement or modification made on the basis of the present application to solve the basically same technical problem and realize the basically same technical effect shall be included in the protection scope of the present application.

Claims

1. A process for the preparation of enteric sustained release magnesium glycinate capsule characterized in that, The method comprises the following steps: Preparation of magnesium glycinate pellets: magnesium glycinate is mixed with microcrystalline cellulose, starch and sucrose to form a uniform powder, and the mixed powder is added to a centrifugal granulator coating machine, with a hydroxypropyl methylcellulose or methylcellulose solution as a binder, to form magnesium glycinate pellets through four stages of centrifugal granulation, namely nucleation, coalescence, layering and rolling and compression; The nucleation is the mutual attraction and connection of initial particles due to the formation of a three-phase structure during the wetting process of the binder; The coalescence is the random collision between large particles, which leads to the merging of parent cores to form larger particles; The layering is the gradual accumulation of powder on the surface of the parent core to promote particle growth, either directly or after being dissolved in the binder; The rolling and compression is the random transfer of substances from one particle to another to optimize particle size; The magnesium glycinate pellets are subjected to sustained-release coating: a coating solution is prepared according to mass fraction, and the coating solution comprises 100 parts of cellulose acetate, 8 parts of polyethylene glycol 6000 and 2000 parts of trichloromethane; The obtained magnesium glycinate pellets are added to a bottom-spray fluidized bed coating machine, the material temperature is controlled at 30-40℃, and coating is performed until the weight gain is 8%-15%, to obtain magnesium glycinate sustained-release pellets; The magnesium glycinate sustained-release pellets are subjected to enteric coating: an enteric coating solution is prepared according to mass fraction, and the enteric coating solution comprises 100 parts of hydroxypropyl methylcellulose phthalate (HPMCP) and 2000 parts of a mixed solvent of methanol and dichloromethane, and the volume ratio of methanol to dichloromethane is 1:1; The obtained magnesium glycinate sustained-release pellets are added to a coating device, the material temperature is controlled at 28-40℃, and coating is performed until the weight gain is 15%-30%, to obtain magnesium glycinate enteric sustained-release pellets; The obtained magnesium glycinate enteric sustained-release pellets are filled into a capsule shell, to obtain magnesium glycinate enteric sustained-release capsules.

2. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The mass ratio of magnesium glycinate to microcrystalline cellulose, starch and sucrose is 5-8:1-2:0.5-1:0.5-1.

3. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The mass concentration of the binder is 3%-5%, and the spraying amount of the binder is 15%-20% of the total mass of the mixed powder.

4. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The rotation speed of the centrifugal granulation is 200-300 r / min, and the granulation time is 30-60 minutes, to ensure uniform particle size of the pellets, and the particle size of the magnesium glycinate pellets ranges from 600 to 1400 μm.

5. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The spraying rate of the bottom-spray fluidized bed coating machine is 5-10 mL / min, and the air inlet velocity is 0.8-1.2 m / s.

6. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: During the coating process, the weight gain rate of the pellets is detected every 15-20 minutes, and the coating is stopped when the weight gain rate reaches 8%-15%.

7. The process for the preparation of enteric sustained release glycine magnesium capsule as claimed in claim 1 wherein: After the sustained-release coating is completed, the magnesium glycinate sustained-release pellets are dried at 40-50℃ for 1-2 hours to remove residual trichloromethane; and after the enteric coating is completed, the magnesium glycinate enteric sustained-release pellets are dried at 35-45℃ for 2-3 hours to remove residual methanol and dichloromethane.

8. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The coating device is a bottom-spray fluidized bed coating machine or a high-efficiency coating pot, the spraying pressure of the coating device is 0.2-0.4 MPa, and the atomizing air flow is 15-25 m³ / h.

9. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: During the coating process, the relative humidity in the coating device is controlled at 30%-50% to prevent the enteric coating layer from absorbing moisture and caking.

10. The process for the preparation of enteric sustained release magnesium glycinate capsule as claimed in claim 1 wherein: The filling mass of the magnesium glycinate enteric-sustained-release pellets in each capsule is 250-350 mg, and the content of magnesium glycinate in each capsule is 100-150 mg.

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