Voglibose tablet and processing technology thereof

Abstract

The invention discloses a voglibose tablet which comprises voglibose, a disintegrating agent, magnesium stearate and a coating material, the voglibose content is 5-20%, the disintegrating agent accounts for 5-20% of the mass of the voglibose, the magnesium stearate accounts for 1-5% of the mass of the voglibose, and the coating material accounts for 1-5% of the mass of the voglibose. The dosage of the coating material is 5-20% of the mass of the voglibose; the invention relates to a voglibose tablet processing technology. The voglibose tablet processing technology comprises the following steps: 1, preparing voglibose powder; step 2, drying treatment; step 3, preparing a tablet core; step 4, coating; and step 5, quality inspection. The improved preparation process can also increase the stability of the medicine, reduce the influence of external factors on the release rate of the medicine, ensure that the medicine keeps stable medicine effect release within the period of validity, and improve the life quality of a patient.

Description

Technical Field

[0001] The invention relates to the technical field of voglibose tablet applications, in particular to a voglibose tablet and a processing technology thereof. Background Art

[0002] Voglibose is an α-glucosidase inhibitor, which has the function of inhibiting α-glucosidase on the surface of the small intestinal mucosa, thereby slowing down the decomposition of starch, reducing the absorption of glucose, and achieving the effect of lowering blood sugar; however, the existing voglibose tablets have some problems, such as slow disintegration speed and poor stability, which affect their clinical application effect; therefore, a voglibose tablet with excellent pharmaceutical properties and stable production process is invented. Summary of the invention

[0003] The object of the present invention is to provide a voglibose tablet and a processing technology thereof to solve the problems raised in the above background technology.

[0004] To achieve the above-mentioned purpose, the present invention provides the following technical scheme: a voglibose tablet, comprising voglibose, a disintegrant, magnesium stearate and a coating material, wherein the content of voglibose is 5%-20%, the amount of the disintegrant is 5%-20% of the mass of the voglibose, the amount of the magnesium stearate is 1%-5% of the mass of the voglibose, and the amount of the coating material is 5%-20% of the mass of the voglibose.

[0005] A processing technology for voglibose tablets, comprising step 1, preparing voglibose powder; step 2, drying; step 3, preparing tablet cores; step 4, coating; step 5, quality inspection;

[0006] In the above step 1, the voglibose raw material is uniformly mixed with appropriate auxiliary materials to prepare a granular powder.

[0007] In the above step 2, the granular powder obtained in step 1 is dried to obtain dry voglibose granules.

[0008] In the above step 3, the voglibose granules dried in step 2 are tableted to obtain voglibose tablet cores.

[0009] In the above step 4, the tablet cores prepared in step 3 are placed in a coating machine, and an appropriate amount of coating material is added to perform coating treatment.

[0010] In the above step 5, the coated voglibose tablets are subjected to quality inspection and packaged after passing the inspection.

[0011] Preferably, the method for preparing voglibose granular powder in step 1 involves mixing voglibose raw materials with a variety of auxiliary materials in precise proportions, first ensuring the purity and quality of the raw material voglibose, then mixing voglibose with auxiliary materials such as dextrin, mannitol, etc. in a specific proportion, using high-efficiency mixing equipment to ensure uniform distribution of the materials, and then converting the mixture into granules by spray drying technology; in this process, the drying conditions are controlled to ensure that the granules have good fluidity and solubility, and finally the granules are crushed and classified to obtain granular powders suitable for different uses.

[0012] Preferably, in step 2, the granular powder is dried by controlling the drying conditions, such as temperature, humidity and drying time, and the dried granular powder is cooled, granulated, sifted and other steps to obtain dried voglibose granules, which can effectively control the water content of the granules, ensure the stability and solubility of the granules, and thus improve the quality and effect of the product.

[0013] Preferably, the voglibose granules dried in step 3 are tableted to obtain voglibose tablet cores. In this process, the voglibose granules are first ensured to maintain their integrity and stability during the drying process to avoid breakage or degradation. The dried granules are then crushed and sieved to obtain a particle size suitable for tableting. Appropriate adhesives, plasticizers and other auxiliary materials are then used to mix the voglibose granules evenly, and the mixture is tableted to obtain tablet cores, which are then dried and granulated as necessary to ensure the uniformity and consistency of the tablet cores.

[0014] Preferably, in step 4, the tablet core is placed in a coating machine, and an appropriate amount of coating material is added for coating treatment. The coating material includes an adhesive, a plasticizer, a lubricant and other additives, which are mixed evenly in a certain proportion. The coating machine heats and rotates the tablet core so that the coating material is evenly attached to the surface of the tablet core to form a protective layer. The protective layer can protect the tablet core from the influence of the external environment, prolong the drug release rate, and improve the drug stability and bioavailability. The type and proportion of the coating material can be adjusted as needed during the coating process to obtain tablet cores with different characteristics.

[0015] Preferably, the step 5 of conducting quality inspection on the coated voglibose tablets is an important step to ensure the safety and effectiveness of the drug. First, an appearance inspection is performed to confirm that the size, shape, color, etc. of the tablets meet the specified requirements, and then a weight difference inspection is performed to ensure that the weight of each tablet is consistent; then a dissolution test is performed to evaluate whether the drug release rate meets the standard; in addition, a content determination is required to ensure that the drug content is accurate; finally, a microbial limit test is performed to ensure that there is no microbial contamination such as bacteria and molds. Packaging can only be carried out after all test items are qualified. The packaging materials must meet the drug storage requirements, and the packaging process must strictly control the environment to ensure the stability of drug quality.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The present invention adopts suitable disintegrants and coating materials, which can significantly accelerate the disintegration speed of voglibose tablets, thereby effectively improving the bioavailability of the drug and improving the convenience of taking the drug. Voglibose is an alpha-glucosidase inhibitor, which is mainly used to treat type 2 diabetes, especially to improve the symptoms of postprandial hyperglycemia. By selecting a high-efficiency disintegrant, such as cross-linked sodium carboxymethyl cellulose (CCMC), combined with a specific coating material, the tablet can be effectively promoted to disintegrate rapidly in the stomach, release more voglibose, and thus quickly reduce blood sugar. In addition, the improved preparation process can also increase the stability of the drug, reduce the influence of external factors on the drug release rate, ensure that the drug maintains a stable drug release during the effective period, and improve the quality of life of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a flow chart of the present invention; DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", "front end", "rear end", "two ends", "one end", "the other end" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0021] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "provided with", "connected", etc. should be understood in a broad sense. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0022] See also Figure 1 , an embodiment provided by the present invention:

[0023] A voglibose tablet comprises voglibose, a disintegrant, magnesium stearate and a coating material, wherein the content of voglibose is 5%-20%, the dosage of the disintegrant is 5%-20% of the mass of the voglibose, the dosage of the magnesium stearate is 1%-5% of the mass of the voglibose, and the dosage of the coating material is 5%-20% of the mass of the voglibose.

[0024] A processing technology for voglibose tablets, comprising step 1, preparing voglibose powder; step 2, drying; step 3, preparing tablet cores; step 4, coating; step 5, quality inspection;

[0025] In the above step 1, the voglibose raw material is uniformly mixed with appropriate auxiliary materials to prepare a granular powder.

[0026] In the above step 2, the granular powder obtained in step 1 is dried to obtain dry voglibose granules.

[0027] In the above step 3, the voglibose granules dried in step 2 are tableted to obtain voglibose tablet cores.

[0028] In the above step 4, the tablet cores prepared in step 3 are placed in a coating machine, and an appropriate amount of coating material is added to perform coating treatment.

[0029] In the above step 5, the coated voglibose tablets are subjected to quality inspection and packaged after passing the inspection.

[0030] Preferably, the method for preparing voglibose granular powder in step 1 involves mixing voglibose raw materials with a variety of auxiliary materials in precise proportions, first ensuring the purity and quality of the raw material voglibose, then mixing voglibose with auxiliary materials such as dextrin, mannitol, etc. in a specific proportion, using high-efficiency mixing equipment to ensure uniform distribution of the materials, and then converting the mixture into granules by spray drying technology; in this process, the drying conditions are controlled to ensure that the granules have good fluidity and solubility, and finally the granules are crushed and classified to obtain granular powders suitable for different uses.

[0031] Preferably, in step 2, the granular powder is dried by controlling the drying conditions, such as temperature, humidity and drying time, and the dried granular powder is cooled, granulated, sifted and other steps to obtain dried voglibose granules, which can effectively control the water content of the granules, ensure the stability and solubility of the granules, and thus improve the quality and effect of the product.

[0032] Preferably, the voglibose granules dried in step 3 are tableted to obtain voglibose tablet cores. In this process, the voglibose granules are first ensured to maintain their integrity and stability during the drying process to avoid breakage or degradation. The dried granules are then crushed and sieved to obtain a particle size suitable for tableting. Appropriate adhesives, plasticizers and other auxiliary materials are then used to mix the voglibose granules evenly, and the mixture is tableted to obtain tablet cores, which are then dried and granulated as necessary to ensure the uniformity and consistency of the tablet cores.

[0033] Preferably, in step 4, the tablet core is placed in a coating machine, and an appropriate amount of coating material is added for coating treatment. The coating material includes an adhesive, a plasticizer, a lubricant and other additives, which are mixed evenly in a certain proportion. The coating machine heats and rotates the tablet core so that the coating material is evenly attached to the surface of the tablet core to form a protective layer. The protective layer can protect the tablet core from the influence of the external environment, prolong the drug release rate, and improve the drug stability and bioavailability. The type and proportion of the coating material can be adjusted as needed during the coating process to obtain tablet cores with different characteristics.

[0034] Preferably, the step 5 of conducting quality inspection on the coated voglibose tablets is an important step to ensure the safety and effectiveness of the drug. First, an appearance inspection is performed to confirm that the size, shape, color, etc. of the tablets meet the specified requirements, and then a weight difference inspection is performed to ensure that the weight of each tablet is consistent; then a dissolution test is performed to evaluate whether the drug release rate meets the standard; in addition, a content determination is required to ensure that the drug content is accurate; finally, a microbial limit test is performed to ensure that there is no microbial contamination such as bacteria and molds. Packaging can only be carried out after all test items are qualified. The packaging materials must meet the drug storage requirements, and the packaging process must strictly control the environment to ensure the stability of drug quality.

[0035] The matters not described in detail in the present invention are all known technologies to those skilled in the art.

[0036] Finally, it should be noted that the above specific implementation methods are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified and replaced by equivalents without departing from the spirit and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. A voglibose tablet, characterized in that: The invention comprises voglibose, a disintegrant, magnesium stearate and a coating material, wherein the content of voglibose is 5%-20%, the dosage of the disintegrant is 5%-20% of the mass of voglibose, the dosage of magnesium stearate is 1%-5% of the mass of voglibose, and the dosage of the coating material is 5%-20% of the mass of voglibose.

2. A processing technology for voglibose tablets, comprising step 1, preparing voglibose powder; step 2, drying; step 3, preparing tablet cores; step 4, coating; step 5, quality inspection; characterized in that: In the above step 1, the voglibose raw material is uniformly mixed with appropriate auxiliary materials to prepare a granular powder. In the above step 2, the granular powder obtained in step 1 is dried to obtain dry voglibose granules. In the above step 3, the voglibose granules dried in step 2 are tableted to obtain voglibose tablet cores. In the above step 4, the tablet cores prepared in step 3 are placed in a coating machine, and an appropriate amount of coating material is added to perform coating treatment. In the above step 5, the coated voglibose tablets are subjected to quality inspection and packaged after passing the inspection.

3. The processing technology of a voglibose tablet according to claim 2, characterized in that: The method for preparing the voglibose granular powder in step 1 involves mixing the voglibose raw material with a variety of auxiliary materials in precise proportions, first ensuring the purity and quality of the raw material voglibose, then mixing the voglibose with auxiliary materials such as dextrin, mannitol, etc. in a specific proportion, using high-efficiency mixing equipment to ensure uniform distribution of the materials, and then converting the mixture into granules through spray drying technology; in this process, the drying conditions are controlled to ensure that the granules have good fluidity and solubility, and finally the granules are crushed and classified to obtain granular powders suitable for different uses.

4. The processing technology of a voglibose tablet according to claim 2, characterized in that: In the step 2, the granular powder is dried by controlling the drying conditions, such as temperature, humidity and drying time. The dried granular powder is cooled, granulated, sieved and other steps to obtain dried voglibose granules, which can effectively control the water content of the granules, ensure the stability and solubility of the granules, and thus improve the quality and effect of the product.

5. The processing technology of a voglibose tablet according to claim 2, characterized in that: The voglibose granules dried in step 3 are tableted to obtain voglibose tablet cores. In this process, the voglibose granules are first ensured to maintain their integrity and stability during the drying process to avoid breakage or degradation. The dried granules are then crushed and sieved to obtain a particle size suitable for tableting. Appropriate adhesives, plasticizers and other auxiliary materials are then used to mix the voglibose granules evenly, and the mixed material is tableted to obtain tablet cores. The necessary drying and granulation are then performed to ensure the uniformity and consistency of the tablet cores.

6. The processing technology of a voglibose tablet according to claim 2, characterized in that: In the step 4, the tablet core is placed in a coating machine, and an appropriate amount of coating material is added for coating treatment. The coating material includes an adhesive, a plasticizer, a lubricant and other additives, which are mixed evenly in a certain proportion. The coating machine heats and rotates the tablet core so that the coating material is evenly attached to the surface of the tablet core to form a protective layer. The protective layer can protect the tablet core from the influence of the external environment, prolong the drug release rate, and improve the drug stability and bioavailability. During the coating process, the type and proportion of the coating material can be adjusted as needed to obtain tablet cores with different characteristics.

7. The processing technology of a voglibose tablet according to claim 2, characterized in that: The step 5 of quality inspection of the coated voglibose tablets is an important step to ensure the safety and effectiveness of the drug. First, an appearance inspection is performed to confirm that the size, shape, color, etc. of the tablets meet the specified requirements, and then a weight difference inspection is performed to ensure that the weight of each tablet is consistent; then a dissolution test is performed to evaluate whether the drug release rate meets the standard; in addition, a content determination is required to ensure that the drug content is accurate; finally, a microbial limit test is performed to ensure that there is no microbial contamination such as bacteria and mold. Packaging can only be carried out after all test items are qualified. The packaging materials must meet the drug storage requirements, and the packaging process must strictly control the environment to ensure the stability of drug quality.

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