Preparation and preparation method of soft capsule for improving osteoporosis drug absorption

Abstract

The invention discloses a preparation and preparation method of a soft capsule for improving the absorption of an osteoporosis medicine, and the soft capsule for improving the absorption of the osteoporosis medicine comprises the following main components: a medicine absorption component, a bone health promoting component and a capsule forming component, the drug absorption component is composed of vitamin D3, calcitriol, alfacalcidol, an emulsifier and a stabilizer. The vitamin D3, calcitriol, alfacalcidol, the emulsifying agent and the stabilizing agent are arranged, medicine absorption can be enhanced, it is ensured that internal medicine is fully absorbed, and calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate and milk mineral salt are arranged, so that the content of the calcium molecules, the phosphorus molecules, the collagen, the vitamin D2, the magnesium molecules, the zinc molecules, the vitamin K, the chondroitin sulfate and the milk mineral salt is improved. The bone rehabilitation of a patient can be enhanced again, the rehabilitation rate of the patient is increased, the quality of the capsule can be safer by arranging gelatin, glycerin and water, and the problems that the preparation process is too tedious and the improvement effect of the capsule is insufficient are solved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and specifically to a soft capsule preparation and preparation method for improving the absorption of osteoporosis drugs. Background Art

[0002] According to the patent disclosed on the Chinese Patent Network, the patent name is: Novel eldecalcitol soft capsule and its preparation method, and the patent application number is: 202010609699.7. It includes a soft capsule filling solution and a soft capsule shell. The filling solution is composed of eldecalcitol, refined vegetable oil, antioxidant, buffer, and flavoring agent; the capsule shell is composed of gelatin, thickening agent, flavoring agent, water, and light-shielding agent. The eldecalcitol soft capsule filling solution prepared by the present invention has stable quality, the capsule shell will not absorb water and soften, can be chewed and taken, is used for treating osteoporosis, rickets, etc., has the shortest disintegration time, rapid onset, and high bioavailability, so that the eldecalcitol soft capsule of the present invention is significantly superior to existing products; however, the above-mentioned soft capsule can only wrap the drug and cannot enhance the absorption of osteoporosis drugs, resulting in the failure to guarantee the recovery rate of patients taking the medicine.

[0003] Therefore, it is necessary to design and transform the soft capsule to effectively prevent the phenomenon that it cannot improve the absorbability of osteoporosis drugs. Summary of the Invention

[0004] To solve the problems raised in the above background art, the purpose of the present invention is to provide a soft capsule preparation and preparation method for improving the absorption of osteoporosis drugs, which has the advantage of being able to enhance the absorbability of osteoporosis drugs and solves the problem of inability to improve the absorbability of osteoporosis drugs.

[0005] To achieve the above purpose, the present invention provides the following technical solution: A soft capsule preparation and preparation method for improving the absorption of osteoporosis drugs. The main components of the soft capsule for improving the absorption of osteoporosis drugs are: drug absorption components, bone health promotion components, and capsule forming components.

[0006] Preferably, the drug absorption components are composed of vitamin D3, calcitriol, alfacalcidol, emulsifier, and stabilizer; the bone health promotion components are composed of calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate, and milk mineral salts; the capsule forming components are composed of gelatin, glycerol, and water.

[0007] Preferably in the present invention, the contents of the respective components are 150 micrograms of vitamin D3, 200 g of calcitriol, 150 g of alfacalcidol, 100 g of emulsifier, 305 g of stabilizer, 280 g of calcium molecules, 90 g of phosphorus molecules, 125 g of collagen, 168 micrograms of vitamin D2, 150 g of magnesium molecules, 35 g of zinc molecules, 47 g of vitamin K, 15 g of chondroitin sulfate, 20 g of milk mineral salts, 14 g of gelatin, 50 g of glycerol, and 45 g of water.

[0008] Preferably in the present invention, it includes step a) raw material preparation; step b) equipment preparation; step c) gelatinization treatment; step d) shell making treatment; step e) drug formulation; step f) filling and sealing; step g) shaping and drying; step h) quality inspection; step i) packaging and storage; Step a) Raw material preparation: According to the drug formula, prepare the required main drug and excipients, ensure that all raw materials meet the quality standards, and have been subjected to appropriate inspection and testing; Step b) Equipment preparation: Check and clean the soft capsule production equipment, including gelatinization tanks, pill presses, dryers, etc., ensure that the equipment is in good working condition, and adjust to appropriate process parameters; Step c) Gelatinization treatment: Add gelatin, glycerol, and water to the gelatinization tank in a certain proportion, heat and stir to make the gelatin absorb water and dissolve to form a uniform gelatin solution; Step d) Shell making treatment: Use a soft capsule machine to press the gelatin solution into soft capsule shells. If necessary, pigments or light blockers can be added to the gelatin solution to improve the appearance or stability of the soft capsules; Step e) Drug formulation: Then, according to the formula, dissolve or disperse the main drug and necessary excipients in an appropriate solvent to form a drug solution or suspension, paying attention to controlling the concentration and uniformity of the drug; Step f) Filling and sealing: Inject the drug solution or suspension into the soft capsule shells, and use a pill press to press and seal the two pieces of rubber of the soft capsule shells to form complete soft capsules; Step g) Shaping and drying: Immediately transfer the freshly pressed soft capsules to a drying cage for shaping and drying to reduce the water content to a certain level so that the shape of the soft capsules is basically fixed, and transfer the shaped and dried soft capsules to a tray for continued drying to the target water content; Step h) Quality inspection: Conduct quality inspection on the dried soft capsules, including indicators such as appearance, filling quantity, sewing condition, water content, etc., and reject unqualified products to ensure product quality; Step i) Packaging and storage: Package the qualified soft capsules, including inner packaging and outer packaging, and store the packaged soft capsules in a cool and dry place, avoiding direct sunlight and high temperatures.

[0009] Preferably in the present invention, product information, production date and expiration date need to be marked on the packaging during packaging and storage.

[0010] Preferably in the present invention, for the shaping and drying, the temperature and humidity of the drying environment need to be controlled to avoid deformation or mildew of the soft capsules.

[0011] Preferably in the present invention, during the gelatinization treatment, attention needs to be paid to controlling the gelatinization temperature to avoid a decrease in the quality of gelatin caused by excessive temperature.

[0012] Preferably in the present invention, the drug formulation needs to be operated in a dust-free laboratory to avoid impurities in the air from entering and affecting the drug properties.

[0013] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. Through the setting of vitamin D3, calcitriol, alfacalcidol, emulsifier and stabilizer in the present invention, the absorption of the drug can be enhanced, ensuring that the internal drug is fully absorbed. Through the setting of calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate and milk mineral salts, the bone rehabilitation of patients can be strengthened again, increasing the recovery rate of patients. Through the setting of gelatin, glycerol and water, the quality of the capsules can be made safer, avoiding the phenomenon of deterioration, and solving the problem that the preparation process is too cumbersome and the improvement effect of the agent is not sufficient. Detailed implementation manners

[0014] The technical solutions in the embodiments of the present invention are described clearly and completely. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0015] The present invention provides a soft capsule for improving the absorption of osteoporosis drugs and a preparation method thereof. The main components of the soft capsule for improving the absorption of osteoporosis drugs are: drug absorption components, components for promoting bone health and capsule forming components.

[0016] The present invention is further configured such that the drug absorption components are composed of vitamin D3, calcitriol, alfacalcidol, emulsifier and stabilizer, the components for promoting bone health are composed of calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate and milk mineral salts, and the capsule forming components are composed of gelatin, glycerol and water.

[0017] The present invention is further configured such that the content of each component is 150 micrograms of vitamin D3, 200 g of calcitriol, 150 g of alfacalcidol, 100 g of emulsifier, 305 g of stabilizer, 280 g of calcium molecules, 90 g of phosphorus molecules, 125 g of collagen, 168 micrograms of vitamin D2, 150 g of magnesium molecules, 35 g of zinc molecules, 47 g of vitamin K, 15 g of chondroitin sulfate, 20 g of milk mineral salts, 14 g of gelatin, 50 g of glycerol and 45 g of water.

[0018] The present invention is further configured to include step a) raw material preparation; step b) equipment preparation; step c) gelatinization treatment; step d) shell making treatment; step e) drug formulation; step f) filling and sealing; step g) shaping and drying; step h) quality inspection; step i) packaging and storage; Step a) Raw material preparation: According to the drug formula, prepare the required main drug and excipients, ensure that all raw materials meet the quality standards, and have undergone appropriate inspections and tests; Step b) Equipment preparation: Check and clean the soft capsule production equipment, including gelatinization tanks, pill presses, dryers, etc., ensure that the equipment is in good working condition, and adjust to appropriate process parameters; Step c) Gelatinization treatment: Add gelatin, glycerol and water to the gelatinization tank in a certain proportion, heat and stir to make the gelatin absorb water and dissolve to form a uniform gelatin solution; Step d) Shell making treatment: Use a soft capsule machine to press the gelatin solution into soft capsule shells. If necessary, pigments or light blockers can be added to the gelatin solution to improve the appearance or stability of the soft capsules; Step e) Drug formulation: Then, according to the formula, dissolve or disperse the main drug and necessary excipients in an appropriate solvent to form a drug solution or suspension, and pay attention to controlling the concentration and uniformity of the drug; Step f) Filling and sealing: Inject the drug solution or suspension into the soft capsule shells, and use a pill press to press and seal the two pieces of rubber of the soft capsule shells to form complete soft capsules; Step g) Shaping and drying: Immediately transfer the freshly pressed soft capsules to a drying cage for shaping and drying to reduce the moisture content to a certain level so that the shape of the soft capsules is basically fixed, and transfer the shaped and dried soft capsules to a tray for continued drying to the target moisture content; Step h) Quality inspection: Conduct quality inspection on the dried soft capsules, including indicators such as appearance, filling quantity, stitching condition, moisture content, etc., reject unqualified products, and ensure product quality; Step i) Packaging and storage: Package the qualified soft capsules, including inner packaging and outer packaging, and store the packaged soft capsules in a cool and dry place, avoiding direct sunlight and high temperatures.

[0019] The present invention is further configured such that when packaging and storing, product information, production date, and expiration date need to be marked on the packaging.

[0020] The present invention is further configured such that for shaping and drying, the temperature and humidity of the drying environment need to be controlled to avoid deformation or mildew of the soft capsules.

[0021] The present invention is further configured such that during the gelatinization process, attention needs to be paid to controlling the gelatinization temperature to avoid a decrease in the quality of gelatin caused by excessive temperature.

[0022] The present invention is further configured such that drug formulation needs to be carried out in a dust-free laboratory to avoid impurities in the air from entering and affecting the drug properties.

[0023] The working principle and usage process of the present invention are as follows: First, according to the drug formula, prepare the required main drug and excipients, ensure that all raw materials meet the quality standards, and have undergone appropriate inspections and tests. Check and clean the soft capsule production equipment, including the gelatinization tank, pill press, dryer, etc., ensure that the equipment is in good working condition, and adjust it to appropriate process parameters. Add gelatin, glycerol, and water to the gelatinization tank in a certain proportion, heat and stir to make the gelatin absorb water and dissolve to form a uniform gelatin solution. Use a soft capsule machine to press the gelatin solution into soft capsule shells. If necessary, pigments or light-blocking agents can be added to the gelatin solution to improve the appearance or stability of the soft capsules. Then, according to the formula, dissolve or disperse the main drug and necessary excipients in an appropriate solvent to form a drug solution or suspension, pay attention to controlling the concentration and uniformity of the drug, inject the drug solution or suspension into the soft capsule shells, use a pill press to press and seal the two pieces of rubber of the soft capsule shells to form complete soft capsules. Immediately transfer the freshly pressed soft capsules to a drying cage for shaping and drying to reduce the water content to a certain level so that the shape of the soft capsules is basically fixed. Transfer the shaped and dried soft capsules to a tray and continue drying to the target water content. Conduct quality inspections on the dried soft capsules, including indicators such as appearance, filling quantity, sewing condition, water content, etc., reject unqualified products to ensure product quality. Package the qualified soft capsules, including inner packaging and outer packaging. Store the packaged soft capsules in a cool and dry place, avoiding direct sunlight and high temperature, so as to achieve the effect of enhancing the absorbability of osteoporosis drugs.

[0024] In summary, for the soft capsule preparation and preparation method for enhancing the absorption of osteoporosis drugs, through the setting of vitamin D3, calcitriol, alfacalcidol, emulsifier and stabilizer, the absorption of drugs can be enhanced, ensuring that the internal drugs are fully absorbed. Through the setting of calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate and milk mineral salts, the bone rehabilitation of patients can be further enhanced, increasing the recovery rate of patients. Through the setting of gelatin, glycerol and water, the quality of the capsule can be made safer, avoiding the phenomenon of deterioration, and solving the problem that the preparation process is too cumbersome and the improvement effect of the agent is not sufficient.

[0025] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device.

[0026] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. Preparation of soft capsules for improving the absorption of osteoporosis drugs, characterized in that: The soft capsule for enhancing the absorption of osteoporosis drugs mainly consists of: a drug absorption component, a bone health promotion component, and a capsule forming component.

2. The preparation of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 1, wherein: The drug absorption component consists of vitamin D3, calcitriol, alfacalcidol, an emulsifier, and a stabilizer. The bone health promotion component consists of calcium molecules, phosphorus molecules, collagen, vitamin D2, magnesium molecules, zinc molecules, vitamin K, chondroitin sulfate, and milk mineral salts. The capsule forming component consists of gelatin, glycerol, and water.

3. The preparation of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 2, characterized in that: The content of each component is 150 micrograms of vitamin D3, 200 g of calcitriol, 150 g of alfacalcidol, 100 g of emulsifier, 305 g of stabilizer, 280 g of calcium molecules, 90 g of phosphorus molecules, 125 g of collagen, 168 micrograms of vitamin D2, 150 g of magnesium molecules, 35 g of zinc molecules, 47 g of vitamin K, 15 g of chondroitin sulfate, 20 g of milk mineral salts, 14 g of gelatin, 50 g of glycerol, and 45 g of water.

4. A preparation method for preparing soft capsules for enhancing the absorption of osteoporosis drugs according to any one of the above claims, characterized in that: It includes step a) raw material preparation; step b) equipment preparation; step c) gelatinization treatment; step d) shell making treatment; step e) drug formulation; step f) filling and sealing; step g) shaping and drying; step h) quality inspection; step i) packaging and storage. Step a) Raw material preparation: According to the drug formula, prepare the required main drugs and excipients, ensure that all raw materials meet the quality standards, and have undergone appropriate inspections and tests. Step b) Equipment preparation: Check and clean the soft capsule production equipment, including gelatinization tanks, pill presses, dryers, etc., ensure that the equipment is in good working condition, and adjust to appropriate process parameters. Step c) Gelatinization treatment: Add gelatin, glycerol, and water to the gelatinization tank in a certain proportion, heat and stir to make the gelatin absorb water and dissolve to form a uniform gelatin solution. Step d) Shell making treatment: Use a soft capsule machine to press the gelatin solution into soft capsule shells. If necessary, pigments or light blockers can be added to the gelatin solution to improve the appearance or stability of the soft capsules. Step e) Drug formulation: Then, according to the formula, dissolve or disperse the main drug and necessary excipients in an appropriate solvent to form a drug solution or suspension, paying attention to controlling the drug concentration and uniformity. Step f) Filling and sealing: Inject the drug solution or suspension into the soft capsule shells, and use a pill press to press and seal the two rubber sheets of the soft capsule shells to form complete soft capsules. Step g) Shaping and drying: Immediately transfer the freshly pressed soft capsules to a drying cage for shaping and drying to reduce the water content to a certain level, so that the shape of the soft capsules is basically fixed. Transfer the shaped and dried soft capsules to a tray and continue drying to the target water content. Step h) Quality inspection: Conduct quality inspections on the dried soft capsules, including indicators such as appearance, filling quantity, sewing condition, water content, etc., and reject unqualified products to ensure product quality. Step i) Packaging and storage: Package the qualified soft capsules, including inner packaging and outer packaging, and store the packaged soft capsules in a cool and dry place, avoiding direct sunlight and high temperatures.

5. The preparation method of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 4, characterized in that: When packaging and storing, product information, production date, and expiration date need to be marked on the packaging.

6. The preparation method of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 4, characterized in that: The shaping and drying process requires controlling the temperature and humidity of the drying environment to avoid deformation or mildew of the soft capsules.

7. The preparation method of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 4, characterized in that: During the gelatinization process, attention should be paid to controlling the gelatinization temperature to avoid a decrease in gelatin quality caused by excessive temperature.

8. The preparation method of a soft capsule for enhancing the absorption of osteoporosis drugs according to claim 4, characterized in that: The drug formulation needs to be carried out in a dust-free laboratory to prevent impurities in the air from entering and affecting the drug properties.