Alfacalcidol soft capsule and preparation method thereof

Abstract

The invention discloses an alfacalcidol soft capsule and a preparation method thereof, and belongs to the technical field of skeletal drugs. The content of the alfacalcidol soft capsule comprises alfacalcidol, a rehmannia extract and phospholipid. According to the alfacalcidol soft capsule disclosed by the invention, the rehmannia root extract is particularly added, and the component has a remarkable effect on promoting proliferation of bone cells and enhancing the strength of bones. Active ingredients in the rehmannia extract are combined with alfacalcidol, so that the active effect of the alfacalcidol in the aspect of bone health can be more effectively exerted. The innovative formula design aims to provide a more comprehensive and more effective bone health care product for consumers, is beneficial to improvement and maintenance of bone health, and is particularly suitable for groups needing to strengthen bones.

Description

Technical Field

[0001] The invention belongs to the technical field of bone medicines, and particularly relates to an alfacalcidol soft capsule and a preparation method thereof. Background Art

[0002] Alfacalcidol, chemically known as 1α-hydroxyvitamin D3, is a highly effective vitamin D derivative widely used in clinical treatment. It significantly promotes bone health and mineralization by increasing intestinal absorption of calcium and phosphorus. Alfacalcidol plays an important role in the treatment of osteoporosis, rickets, and mineral metabolism disorders caused by chronic renal failure. Its direct active properties make alfacalcidol a more effective treatment option for patients with liver dysfunction or vitamin D metabolism disorders. In addition, it helps regulate calcium balance in the body and prevent and treat various bone diseases caused by vitamin D deficiency.

[0003] The inventor's prior patent CN104800187A discloses an alfacalcidol soft capsule and its preparation method. The contents of the soft capsule are prepared from the following components by weight: 35-50 parts of alfacalcidol, 15-20 parts of glycerol, 20-40 parts of polyethylene glycol 4000, 10-20 parts of polyethylene glycol 6000, 10-20 parts of accelerator, 45-57 parts of thickener, and 30-60 parts of antioxidant. The present invention increases the content of active ingredients in the preparation and reduces the dosage of the drug; by adding specific ingredients glycerol, polyethylene glycol 4000, and polyethylene glycol 6000, the stability and bioavailability of the soft capsule are effectively improved; the dosage form of the existing alfacalcidol preparation is successfully changed, so that alfacalcidol can be better taken and absorbed by patients. Its 24-month stability is above 90%, and most of them are above 95%. The study found that when the content of alfacalcidol was further increased, the 24-month stability was significantly reduced. Summary of the invention

[0004] In view of the above problems, the present invention provides an alfacalcidol soft capsule, in which the alfacalcidol content is further increased while still having good stability.

[0005] The Chinese herbal medicine Rehmannia root can nourish the liver and kidneys, strengthen the heart and blood, and is a good blood tonic. Modern medicine shows that Rehmannia root can promote the proliferation of bone cells and strengthen bones. When conducting relevant research, the inventor found that adding Rehmannia root extract powder and phospholipids can improve the stability of high-concentration alfacalcidol in soft capsules. This patent is based on this discovery.

[0006] The first aspect of the present invention is to disclose an alfacalcidol soft capsule, the contents of the capsule comprising alfacalcidol, Rehmannia root extract and phospholipids.

[0007] In some embodiments of the present invention, the ratio of the Rehmannia glutinosa extract to phospholipids is (1-3): (1-3), preferably 1: (1-2).

[0008] In some embodiments of the present invention, the weight ratio of alfacalcidol to Rehmannia glutinosa extract and phospholipid is (50-150): (1-10): (5-20).

[0009] In some embodiments of the present invention, the contents of the capsule further include glycerol, polyethylene glycol, a promoter, a thickener and an antioxidant.

[0010] In some embodiments of the present invention, the accelerator is at least one of sodium lauryl sulfate, propylene glycol, sodium lauryl sulfate, castor oil and menthol.

[0011] In some embodiments of the present invention, the thickener is at least one of sodium carboxymethyl cellulose, sodium alginate, xanthan gum, β-cyclodextrin and sodium carboxymethyl starch.

[0012] In some embodiments of the present invention, the antioxidant is one of 2,6-di-tert-butyl-p-cresol, anhydrous sodium sulfite, gallic acid, sodium sorbate and tocopherol.

[0013] In some embodiments of the present invention, the contents of the capsule include the following components in parts by weight: Alfacalcidol 80-150mg Glycerin 20-40mg Macrogol 4000 30-50mg Macrogol 6000 20-30 mg Sodium lauryl sulfate 5-15mg Castor oil 5-15mg β-Cyclodextrin 20.30mg Sodium carboxymethyl starch 40-60mg Anhydrous sodium sulfite 20-40mg Sodium sorbate 20-40mg Rehmannia root extract 1-10mg Phospholipids 5-20mg.

[0014] In some embodiments of the present invention, the Rehmannia glutinosa extract is a water extract powder of Rehmannia glutinosa stems and leaves.

[0015] The second aspect of the present invention is to disclose a method for preparing the alfacalcidol soft capsules described in the first aspect, comprising the following steps: S01, sieving alfacalcidol and polyethylene glycol and mixing; S02, mixing glycerin, a promoter, a thickener, an antioxidant, a Rehmannia root extract, and phospholipids; S03, mixing the powder obtained in S01 with the matrix obtained in S02, and continuously stirring to obtain the contents of the soft capsule; S04, placing the prepared contents in a liquid storage tank, and preparing soft capsules using an automatic rotary capsule rolling machine.

[0016] In some embodiments of the present invention, in S01, the product is sieved through a 80-120 mesh sieve.

[0017] In some embodiments of the present invention, in S02, the mixing is carried out at 70-85° C. and stirring is continued for 0.5-2 hours.

[0018] In some embodiments of the present invention, S03 further includes the steps of shaping in cold air, washing pills and drying.

[0019] In some embodiments of the present invention, S01 further includes an automatic quality control step: S11, using an industrial camera to photograph the powder to be used to obtain a number of pictures to be analyzed, and an enhanced light source can be set if necessary; S12, performing image preprocessing on the image, including color-based image segmentation, mapping the original data of the image with 256 grayscale levels to 1024 grayscale levels to obtain mapped grayscale data; storing the gamma grayscale data of the three color channels of RGB respectively according to a preset three-channel color lookup table, and the three-channel color lookup table is divided into multiple continuous grayscale intervals according to the nodes of the preset multiple grayscale values. The image is divided into multiple regions according to the color difference of the red channel. Then, connected area detection and edge detection are performed to identify the total number of pixels N occupied by each mixed material particle in each image. The pixel particle size d1 of each particle is calculated using formula (1). At the same time, based on the conversion relationship value K1 established between the size of the industrial camera calibration object and the number of pixels occupied by the calibration object in the image (K1 is the ratio of the size of the industrial camera calibration object and the number of pixels occupied by the calibration object in the image, and this proportionality coefficient can be used to convert the pixels in the image into the actual physical size), the equivalent particle size d of each particle is further calculated using formula (2) i .

[0020] , (1); , (2); Among them, S i The area of ​​each pixel in the field of view of the industrial camera.

[0021] Then, according to the preset particle size range, the particles in the image are graded, and the number of particles in each preset particle size range is counted. The sum of the particle area corresponding to each particle size range in each image and the total area of ​​each particle size range are calculated using formula (3).

[0022]

[0023] Among them, S j is the sum of the mixed material particle areas corresponding to the jth preset particle size range in each picture, j is the number of preset intervals in the preset particle size range; C is the number of types of equivalent particle sizes corresponding to the same preset particle size range, and the value range of i is 1 to C; d ji is the i-th equivalent particle size corresponding to the j-th preset particle size range, n ji is the number of mixture particles corresponding to the i-th equivalent particle size in the j-th preset particle size range; Furthermore, the ratio of the particle area of ​​each preset particle size range to the total particle area in each image is calculated using formula (4) to determine the particle size composition of each particle size range.

[0024]

[0025] Among them, A j is the mixture particle size composition corresponding to the jth preset particle size range; is the total area of ​​the mixed material particles corresponding to each preset particle size range in each of the pictures; k is the number of types of the preset particle size range; Finally, the average value of the particle size composition of the same preset particle size range in all images is calculated to determine the particle size composition distribution of the mixture within the preset detection time.

[0026] S13, analyze and judge the color and particle size distribution of the mixed material particles. If the color is unqualified, the raw material will be scrapped or the recycling process will be started; if the particle size distribution is too large, it will be crushed again until it is qualified.

[0027] Beneficial effects: The alfacalcidol soft capsule of the present invention increases the drug content in the soft capsule, adds rehmannia root extract and phospholipids to solve the stability problem of alfacalcidol, and also optimizes the adhesion property.

[0028] The alfacalcidol soft capsule of the present invention is specially added with Rehmannia glutinosa extract, which has a significant effect on promoting the proliferation of bone cells and enhancing the strength of bones. The active ingredients in the Rehmannia glutinosa extract are combined with alfacalcidol to more effectively play its positive role in bone health. This innovative formula design is intended to provide consumers with a more comprehensive and effective bone health product that helps improve and maintain bone health and is particularly suitable for groups that need to strengthen bones. DETAILED DESCRIPTION

[0029] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0030] In the following examples and comparative examples, the Rehmannia glutinosa extract is a water extract powder of Rehmannia glutinosa stems and leaves, and the preparation method is as follows: take fresh Rehmannia glutinosa stems and leaves, add 10 times (v / w) volume of deionized water, boil and extract for 1 hour; add 8 times (v / w) volume of deionized water to the medicinal residue, boil and extract for 1.5 hours; add 8 times (v / w) volume of deionized water to the secondary medicinal residue again, boil and extract for 2 hours; combine the extracts, vacuum concentrate, and freeze-dry.

[0031] Unless otherwise specified, the examples and comparative examples are parallel tests with the same parameters such as components, component contents, preparation steps, preparation parameters, and dimensions.

[0032] Example 1 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 100mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 5mg Phospholipids 10mg.

[0033] The preparation method of the alfacalcidol soft capsules described in this embodiment comprises the following steps: 1) First, alfacalcidol, polyethylene glycol 4000 and polyethylene glycol 6000 are sieved through a 120-mesh sieve to ensure the uniformity of the particles, and then the ingredients are mixed evenly to prepare a powder for use.

[0034] 2) Next, glycerin, accelerators (sodium lauryl sulfate, castor oil), thickeners (β-cyclodextrin, sodium carboxymethyl starch), antioxidants (anhydrous sodium sulfite, sodium sorbate), Rehmannia glutinosa extract, and phospholipids are mixed and stirred at 60°C until they are completely dissolved to form a uniform matrix.

[0035] 3) Thereafter, the powder obtained in step 1 was mixed with the matrix in step 2 at 80°C and stirred continuously for 1 hour to ensure that the mixture was completely dissolved and uniformly mixed to form the contents of the soft capsule.

[0036] 4) The prepared contents are placed in a liquid storage tank and an automatic rotary capsule rolling machine is used to prepare soft capsules. Subsequently, the soft capsules are placed in a cold wind at 18°C ​​and 50% relative humidity to shape them to enhance their structural stability. The shaped soft capsules are washed at 28°C and 50% relative humidity to remove surface impurities. Finally, the soft capsules are dried at 40°C and 50% relative humidity to complete the preparation process and obtain the finished alfacalcidol soft capsules.

[0037] Example 2 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 120mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 8mg Phospholipids 15mg.

[0038] The preparation method of the alfacalcidol soft capsules described in this example is the same as that in Example 1.

[0039] Example 3 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 80mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 8mg Phospholipids 8mg.

[0040] The preparation method of the alfacalcidol soft capsules described in this example is the same as that in Example 1.

[0041] Example 4 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 100mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 5mg Phospholipids 5mg.

[0042] The preparation method of the alfacalcidol soft capsules described in this example is the same as that in Example 1.

[0043] Example 5 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 100mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 2mg Phospholipids 10mg.

[0044] The preparation method of the alfacalcidol soft capsules described in this example is the same as that in Example 1.

[0045] Example 6 A method for preparing alfacalcidol soft capsules, which is different from the embodiment in that step 1) further includes an automatic quality control step: (11) Use an industrial camera to photograph the powder to be used and obtain several pictures to be analyzed. If necessary, an enhanced light source can be set; (12) Perform image preprocessing on the image, including color-based image segmentation to map the original 256-level grayscale data of the image to 1024-level grayscale data to obtain mapped grayscale data; store the gamma grayscale data of the three color channels of RGB respectively according to a preset three-channel color lookup table, and the three-channel color lookup table is divided into multiple continuous grayscale intervals according to the nodes of the preset multiple grayscale values. For example, it is divided into multiple areas according to the color difference of the red channel. This step involves assigning color difference values ​​to each pixel position in the image, where the color difference value of each pixel point is determined based on the degree of difference between its color and that of the adjacent pixel points.

[0046] Then, connected region detection and edge detection are performed to identify the total number of pixels N occupied by each mixed material particle in each image. The pixel size d1 of each particle is calculated using formula (1). At the same time, based on the conversion relationship value K1 established between the size of the industrial camera calibration object and the number of pixels occupied by the calibration object in the image (K1 is the ratio of the size of the industrial camera calibration object and the number of pixels occupied by the calibration object in the image. This proportionality coefficient can be used to convert the pixels in the image into the actual physical size), the equivalent particle size d of each particle is further calculated using formula (2). i .

[0047] , (1); , (2); Among them, S i The area of ​​each pixel in the field of view of the industrial camera.

[0048] Then, according to the preset particle size range, the particles in the image are graded, and the number of particles in each preset particle size range is counted. The sum of the particle area corresponding to each particle size range in each image and the total area of ​​each particle size range are calculated using formula (3).

[0049]

[0050] Among them, S j is the sum of the mixed material particle areas corresponding to the jth preset particle size range in each picture, j is the number of preset intervals in the preset particle size range; C is the number of types of equivalent particle sizes corresponding to the same preset particle size range, and the value range of i is 1 to C; d jiis the i-th equivalent particle size corresponding to the j-th preset particle size range, n ji is the number of mixture particles corresponding to the i-th equivalent particle size in the j-th preset particle size range; Furthermore, the ratio of the particle area of ​​each preset particle size range to the total particle area in each picture is calculated using formula (4) to determine the particle size composition of each particle size range. The particle size composition of each particle size range is comprehensively evaluated to evaluate the particle size composition of the mixed material sample reflected in each picture.

[0051] , (4); Among them, A j is the mixture particle size composition corresponding to the jth preset particle size range; is the total area of ​​the mixed material particles corresponding to each preset particle size range in each of the pictures; k is the number of types of the preset particle size range; Finally, the average value of the particle size composition of the same preset particle size range in all images is calculated to determine the particle size composition distribution of the mixture within the preset detection time.

[0052] (13) Analyze and judge the color and particle size distribution of the mixed material particles. If the color is not up to standard, the raw materials will be scrapped or the recycling process will be initiated; if the particle size distribution is too large, it will be crushed again until it is up to standard.

[0053] In the alfacalcidol soft capsule, alfacalcidol, polyethylene glycol 4000 and polyethylene glycol 6000 are all white particles. If oxidized, color changes will occur, such as yellowing; and if the particles are too large, it will not only affect the mixing effect, but also affect the release of the active substances in the medicine. Selecting the red channel can not only distinguish the colors of the raw materials well, but also facilitate the identification of particles and reduce the amount of data calculation. The optimized preparation method of this embodiment can simultaneously achieve two tests of color quality and particle size distribution quality by taking a photo at one time. In this way, the color and particle size distribution of the mixed material particles can be comprehensively evaluated, providing important data for the quality and performance analysis of the material.

[0054] Comparative Example 1 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 100mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Rehmannia root extract 15mg.

[0055] The preparation method of the alfacalcidol soft capsules described in this example is based on Example 1, except that no phospholipids are added when preparing the matrix in step 2.

[0056] Comparative Example 2 An alfacalcidol soft capsule, the contents of the capsule comprising: Alfacalcidol 100mg Glycerin 30mg Macrogol 4000 40mg Macrogol 6000 20mg Sodium lauryl sulfate 10mg Castor oil 10mg β-Cyclodextrin 27mg Sodium carboxymethyl starch 50mg Anhydrous sodium sulfite 30mg Sodium sorbate 30mg Phospholipids 10mg.

[0057] The preparation method of the alfacalcidol soft capsules described in this example is based on Example 1, except that no Rehmannia root extract is added when preparing the matrix in step 2.

[0058] Comparative Example 3 An alfacalcidol soft capsule is different from Example 1 in that rutin is used instead of Rehmannia root extract in the contents of the capsule.

[0059] The preparation method of the alfacalcidol soft capsules described in this example is based on Example 1, except that rutin is used instead of Rehmannia root extract when preparing the matrix in step 2.

[0060] Comparative Example 4 An alfacalcidol soft capsule is different from Example 1 in that resveratrol is used instead of Rehmannia glutinosa extract in the contents of the capsule.

[0061] The preparation method of the alfacalcidol soft capsules described in this example is based on Example 1, except that resveratrol is used instead of Rehmannia glutinosa extract when preparing the matrix in step 2.

[0062] Comparative Example 5 An alfacalcidol soft capsule, which is different from Example 1 in that the contents of the capsule do not include Rehmannia root extract and phospholipids.

[0063] The preparation method of the alfacalcidol soft capsules described in this example is based on Example 1, except that neither the Rehmannia root extract nor the phospholipids are added when preparing the matrix in step 2.

[0064] Experimental Example 1 Stability Test The alfacalcidol soft capsules of Examples 1-5 and Comparative Examples 1-4 were placed at room temperature and relative humidity of 65% for 24 months, and samples were taken at 0, 4, 8, 12 and 24 months, respectively, and the content was determined by HPLC using the internal standard method (the percentage of the measured amount to the labeled amount). The ultraviolet absorption detector detected a wavelength of 265nm; silica gel was a filler, and the theoretical plate number was not less than 2000 calculated based on the alfacalcidol peak; the mobile phase was ethyl acetate: petroleum ether (60-90°C): chloroform = 42:44:14; column temperature: room temperature. The results are shown in Table 1.

[0065] Table 1 Stability

[0066] The results show that the stability of Examples 1-5 is all above 90%, and Examples 1-3 are all above 95%. In Comparative Example 5, in which no Rehmannia extract and phospholipids are added, the stability is reduced to about 80% because the concentration of alfacalcidol is doubled. Comparative Examples 3 and 4, in which the Rehmannia extract is replaced with rutin, a representative of flavonoids, and a representative of polyphenols, have significantly lower stability than Example 1, indicating that the effect of the Rehmannia extract is not due to the antioxidant properties of plant secondary metabolites. Comparative Examples 1 and 2, which only contain Rehmannia extract and phospholipids, are equivalent to Comparative Example 5, indicating that the Rehmannia extract and phospholipids work synergistically. In Examples 4 and 5, in which the amount and ratio of Rehmannia extract and phospholipids are changed, the stability is also limited to be lower than that of Example 1.

[0067] Experimental Example 2 Adhesion Property Test Take the alfacalcidol soft capsules of Examples 1-5 and Comparative Example 5 and package them according to the prescribed packaging standards (100 grams per bottle, in bottles made of high-density polyethylene HDPE material, which complies with GB4806.7 "National Food Safety Standard Plastic Materials and Products for Food Contact"). After packaging, place the product in a drug stability accelerated test chamber for stability testing (the set conditions are: the temperature is maintained at (37±2)°C, and the relative humidity is controlled at 75%±5%). After the test lasts for 10 days, take out the product, place it at room temperature to restore its temperature to normal, then gently shake and flip the packaging bottle to observe whether adhesion occurs between the soft capsules.

[0068] In the alfacalcidol soft capsules of Examples 1 and 2, no adhesion was found; in Comparative Example 4, a small amount of partial adhesion was found, and the same was true for Examples 3-5, which had no significant difference from Comparative Example 4. This indicates that the Rehmannia glutinosa extract and phospholipids in the embodiments of the present invention also affect the adhesion of the alfacalcidol soft capsules.

[0069] The preferred specific implementation modes and embodiments of the present invention are described in detail above, but the present invention is not limited to the above implementation modes and embodiments, and various changes can be made within the knowledge scope of those skilled in the art without departing from the concept of the present invention.

Claims

1. An alfacalcidol soft capsule, characterized in that: The contents of the capsule include alfacalcidol, Rehmannia root extract and phospholipids.

2. The alfacalcidol soft capsule according to claim 1, characterized in that: The ratio of the Rehmannia root extract to phospholipids is (1-3):(1-3), preferably 1:(1-2).

3. The alfacalcidol soft capsule according to claim 1 or 2, characterized in that: The weight ratio of alfacalcidol, Rehmannia root extract and phospholipid is (50-150): (1-10): (5-20).

4. The alfacalcidol soft capsule according to any one of claims 1 to 3, characterized in that: The contents of the capsule also include glycerin, polyethylene glycol, accelerators, thickeners and antioxidants.

5. The alfacalcidol soft capsule according to any one of claims 1 to 4, characterized in that: The accelerator is at least one of sodium lauryl sulfate, propylene glycol, sodium lauryl sulfate, castor oil and menthol; The thickener is at least one of sodium carboxymethyl cellulose, sodium alginate, xanthan gum, β-cyclodextrin and sodium carboxymethyl starch; The antioxidant is one of 2,6-di-tert-butyl-p-cresol, anhydrous sodium sulfite, gallic acid, sodium sorbate and tocopherol.

6. The alfacalcidol soft capsule according to any one of claims 1 to 5, characterized in that: The contents of the capsule include the following components in parts by weight: Alfacalcidol 80-150mg Glycerin 20-40mg Macrogol 4000 30-50mg Macrogol 6000 20-30 mg Sodium lauryl sulfate 5-15mg Castor oil 5-15mg β-Cyclodextrin 20.30mg Sodium carboxymethyl starch 40-60mg Anhydrous sodium sulfite 20-40mg Sodium sorbate 20-40mg Rehmannia root extract 1-10mg Phospholipids 5-20mg.

7. The alfacalcidol soft capsule according to any one of claims 1 to 6, characterized in that: The Rehmannia root extract is a water extract powder of Rehmannia root stems and leaves.

8. A method for preparing the alfacalcidol soft capsule according to any one of claims 1 to 7, characterized in that: The following steps are involved: S01, sieving alfacalcidol and polyethylene glycol and mixing; S02, mixing glycerin, a promoter, a thickener, an antioxidant, a Rehmannia root extract, and phospholipids; S03, mixing the powder obtained in S01 with the matrix obtained in S02, and continuously stirring to obtain the contents of the soft capsule; S04, placing the prepared contents in a liquid storage tank, and preparing soft capsules using an automatic rotary capsule rolling machine.

9. The method for preparing alfacalcidol soft capsules according to claim 8, characterized in that: S01, passed through 80-120 mesh sieve; In S02, mix at 70-85°C and continue stirring for 0.5-2 hours.

10. The method for preparing alfacalcidol soft capsules according to claim 8, characterized in that: S03 also includes the steps of shaping in cold air, pill washing and drying.

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