Ginkgo dispersible tablet with high dispersion uniformity and processing technology

Abstract

The invention discloses a ginkgo dispersible tablet with high dispersion uniformity and a processing technology. The processing technology comprises the following steps: step 1, taking materials; step 2, pretreatment; step 3, primary mixing; step 4, performing three-dimensional mixing; step five, granulating; step 6, post-processing; step 7, tabletting; step 8, coating; according to the ginkgo dispersible tablet, the high-quality ginkgo leaf extract is selected as the raw material, meanwhile, povidone is added to enhance the strength and stability of the tablet, and the granularity specification is controlled in cooperation with multiple times of sieving, so that the prepared ginkgo dispersible tablet has high dispersion uniformity, and the effectiveness and bioavailability of the medicine are guaranteed; residual particle impurities and moisture are removed through pretreatment, so that the purity of the raw materials is guaranteed, and the processing quality of the ginkgo dispersible tablets is improved; during coating treatment, polyvinyl alcohol is selected as a coating material, polyethylene glycol is added as a plasticizer, and coating is performed twice, so that the surface smoothness is improved, coating cracks are prevented, and the disintegration time limit and the dissolution rate of the dispersible tablet are guaranteed.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical processing, in particular to a ginkgo dispersible tablet with high dispersion uniformity and a processing technology. Background Art

[0002] Ginkgo dispersible tablets (or Ginkgo leaf dispersible tablets) are a kind of Chinese patent medicine, mainly composed of Ginkgo leaf extract. The active ingredients in Ginkgo dispersible tablets can dilate blood vessels, reduce blood viscosity, and thus improve blood circulation; this has a certain regulatory effect on patients with hypertension, hyperlipidemia and other diseases; at the same time, it can also promote blood circulation, prevent thrombosis, and reduce the risk of cardiovascular and cerebrovascular diseases; at the same time, ginkgolides, flavonoids and other ingredients in Ginkgo dispersible tablets have antioxidant and anti-inflammatory effects, which can protect the cardiovascular and cerebrovascular vessels from oxidative stress damage; these ingredients can also lower blood pressure, resist platelet aggregation, and further protect cardiovascular and cerebrovascular health; it is mainly used for symptoms such as chest pain, heart pain, stroke, hemiplegia, tongue stiffness and slurred speech caused by blood stasis and obstruction, as well as stable coronary heart disease Treatment of cardiovascular and cerebrovascular diseases such as angina and cerebral infarction; The existing Ginkgo dispersible tablets and processing technology can basically meet the daily use needs, but there are still certain shortcomings. First, there is a lack of pretreatment process for raw materials in the production process of Ginkgo dispersible tablets, and the residual particulate impurities in the raw materials will be mixed in the tablets, affecting the processing quality of Ginkgo dispersible tablets; second, the limitations of raw materials and process lead to low high dispersion uniformity of tablets, making it difficult to ensure the effectiveness and bioavailability of drugs; third, the coating process of dispersible tablets after tableting is simple, and cracks are easily generated on the surface of tablets after coating, thereby affecting the disintegration time and solubility of dispersible tablets; therefore, it is necessary to design a Ginkgo dispersible tablet and processing technology with high dispersion uniformity. Summary of the invention

[0003] The object of the present invention is to provide a ginkgo dispersible tablet with high dispersion uniformity and a processing technology to solve the problems raised in the above background technology.

[0004] To achieve the above object, the present invention provides the following technical scheme: a ginkgo dispersible tablet with high dispersion uniformity, the formula comprising: ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, polyvinylpyrrolidone, hypromellose, magnesium stearate, talc, steviol glycoside, flavor and vitamin E; the weight proportions of the components are: 180-200 parts of ginkgo leaf extract, 47-53 parts of microcrystalline cellulose, 50-80 parts of lactose, 15-21 parts of cross-linked polyvinylpyrrolidone, 5-20 parts of cross-linked sodium carboxymethyl cellulose, 5-10 parts of polyvinylpyrrolidone, 12-18 parts of hypromellose, 1-5 parts of magnesium stearate, 1-3 parts of talc, 1-3 parts of steviol glycoside, 1-3 parts of flavor and 1-5 parts of vitamin E.

[0005] As a further technical solution of the present invention, the content of flavonoid glycosides in the ginkgo leaf extract is 22% to 25%, and the content of terpene lactones in the ginkgo leaf extract is 5% to 7%.

[0006] A processing technology for a ginkgo dispersible tablet with high dispersion uniformity comprises the following steps: step 1, taking materials; step 2, pretreatment; step 3, primary mixing; step 4, three-dimensional mixing; step 5, granulation; step 6, post-treatment; step 7, tableting; step 8, coating;

[0007] In the above step 1, 180-200 parts of ginkgo leaf extract, 47-53 parts of microcrystalline cellulose, 50-80 parts of lactose, 15-21 parts of cross-linked polyvinylpyrrolidone, 5-20 parts of cross-linked sodium carboxymethyl cellulose, 5-10 parts of polyvinylpyrrolidone, 12-18 parts of hypromellose, 1-5 parts of magnesium stearate, 1-3 parts of talc, 1-3 parts of steviol glycosides, 1-3 parts of flavors and 1-5 parts of vitamin E are weighed according to the mass fraction of each group and set aside;

[0008] In the above step 2, the raw materials prepared in the above step 1 are screened in sequence using a sieve, and after the screening, they are placed in a drying oven for continuous drying, and after continuous drying, they are taken out for use;

[0009] In the above step 3, the dried ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose in the above step 2 are placed in a high shear mixer for primary mixing, and after the primary mixing, the dried polyvinylpyrrolidone and hydroxypropyl methylcellulose are added for fine mixing, and a mixture is obtained after the fine mixing for standby use;

[0010] In the above step 4, the mixture prepared in the above step 3 is placed in a three-dimensional motion mixer, and then the dried stevioside, flavor and vitamin E are added, and three-dimensional mixing is performed in the three-dimensional motion mixer, and the granulation raw material is obtained after three-dimensional mixing for standby use;

[0011] In the above step 5, the granulation raw material prepared in the above step 4 is placed in a granulator for granulation operation, and after the granulation operation, it is dried to obtain a granulated material for standby use;

[0012] In the above step 6, the granular material prepared in the above step 5 is sieved using a vibrating screen, and after sieving, it is put into a mixer, and the dried magnesium stearate and talc are added, and then mixed at a low speed in the mixer, and the tableting material is obtained after low-speed mixing, and is set aside;

[0013] In the above step 7, the tabletting raw material obtained in the above step 6 is placed in a tablet press for tableting, and after the tableting is completed, a tablet is obtained for later use;

[0014] In the above step eight, the tablets prepared in the above step seven are coated, and after the coating, they are dried to obtain the ginkgo dispersible tablets with high dispersion uniformity.

[0015] As a further technical solution of the present invention, in the step 2, the mesh size of the filter used for sequential screening is 40 meshes, the temperature in the drying oven is 52-55°C during continuous drying, and the continuous drying time is 25-30 minutes.

[0016] As a further technical solution of the present invention, in the step three, the rotation speed of the high shear mixer during the initial mixing treatment is 1500-2000 rpm, and the initial mixing treatment time is 5-10 minutes, and the rotation speed of the high shear mixer during the fine mixing treatment is 1600-2200 rpm, and the fine mixing treatment time is 5-10 minutes.

[0017] As a further technical solution of the present invention, in the step 4, when the three-dimensional mixing is performed in the three-dimensional motion mixer, the rotation speed of the three-dimensional motion mixer is 38 to 80 rpm, and the three-dimensional mixing time is 20 to 30 minutes.

[0018] As a further technical solution of the present invention, in the step 5, distilled water is first added for stirring during the granulation operation in the granulator to form a wet soft material, and then the soft material is passed through the screen of the granulator to obtain wet granules to complete the granulation process. The amount of distilled water added during the process is 20% to 30% of the mass fraction of the granulation raw material, the drying temperature is 50 to 60°C, and the moisture content of the granulated material after drying is 0.5% to 3%.

[0019] As a further technical solution of the present invention, in step six, when the granular material is screened, the mesh size of the screen used is 16 meshes, the stirring speed of the mixer during the low-speed mixing process is 65-70 rpm, and the low-speed mixing time is 20-25 minutes.

[0020] As a further technical solution of the present invention, in step eight, the coating treatment is divided into two processes: pre-coating and post-coating. The coating material used in the coating process is polyvinyl alcohol, and polyethylene glycol is selected as a plasticizer, and 2% to 5% of a sunscreen is added as a composite coating material.

[0021] As a further technical solution of the present invention, the coating solution is first filtered using a 0.45 μm filter membrane before coating in the pre-coating process and the post-coating process, while ensuring that the concentration of the coating solution is 10% to 20%, and the process specification during pre-coating is 0.5 to 1.0 mg / cm 2 , and the process specification of the post-coating is 1.0~2.0mg / cm 2After coating, the drying temperature is 40-45°C, and the drying time is 25-30 minutes.

[0022] Compared with the prior art, the invention has the following beneficial effects: the ginkgo dispersible tablet with high dispersion uniformity and the processing technology thereof selects ginkgo leaf extract with a flavonoid glycoside content of 22% to 25% and a terpene lactone content of 5% to 7% as a raw material, and polyvidone is added to help particle formation, thereby enhancing the strength and stability of the tablets; during the preparation process, multiple screenings are successively performed to control the particle size specifications of the raw materials during the mixing process, so that the prepared ginkgo dispersible tablets have high dispersion uniformity, thereby ensuring the effectiveness and bioavailability of the drug; before processing, the raw materials are screened to remove residual granular impurities, and at the same time, the residual moisture is eliminated by drying to ensure the purity of the raw materials and improve the processing quality of the ginkgo dispersible tablets; when coating, polyvinyl alcohol is selected as the coating material, and polyethylene glycol is selected as the plasticizer, and the coating is performed twice, thereby ensuring the surface smoothness of the tablets after coating and preventing the generation of coating cracks, thereby ensuring the disintegration time and dissolution of the dispersible tablets. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a processing flow chart of the present invention. DETAILED DESCRIPTION

[0024] 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.

[0025] See also Figure 1 , the present invention provides a technical solution:

[0026] Embodiment 1:

[0027] A ginkgo dispersible tablet with high dispersion uniformity comprises: ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, povidone, hypromellose, magnesium stearate, talcum powder, stevioside, essence and vitamin E; the weight proportions of the components are: 200 parts of ginkgo leaf extract, 53 parts of microcrystalline cellulose, 80 parts of lactose, 21 parts of cross-linked polyvinylpyrrolidone, 20 parts of cross-linked sodium carboxymethyl cellulose, 10 parts of povidone, 18 parts of hypromellose, 5 parts of magnesium stearate, 3 parts of talcum powder, 3 parts of steviol glycoside, 3 parts of essence and 5 parts of vitamin E; the content of flavonoid glycoside in the ginkgo leaf extract is 22%-25%, and the content of terpene lactone in the ginkgo leaf extract is 5%-7%.

[0028] A processing technology for a ginkgo dispersible tablet with high dispersion uniformity comprises the following steps: step 1, taking materials; step 2, pretreatment; step 3, primary mixing; step 4, three-dimensional mixing; step 5, granulation; step 6, post-treatment; step 7, tableting; step 8, coating;

[0029] In the above step 1, 200 parts of ginkgo leaf extract, 53 parts of microcrystalline cellulose, 80 parts of lactose, 21 parts of cross-linked polyvinylpyrrolidone, 20 parts of cross-linked sodium carboxymethyl cellulose, 10 parts of polyvinylpyrrolidone, 18 parts of hypromellose, 5 parts of magnesium stearate, 3 parts of talc, 3 parts of steviol glycoside, 3 parts of flavor and 5 parts of vitamin E are weighed according to the mass fraction of each group and set aside;

[0030] In the above step 2, the raw materials prepared in the above step 1 are screened in sequence using a sieve, and after the screening is completed, they are placed in a drying oven for continuous drying, and taken out for use after continuous drying; the mesh number of the filter used for the sequential screening is 40 meshes, and the temperature in the drying oven is 52-55° C. during the continuous drying in the drying oven, and the continuous drying time is 25-30 minutes;

[0031] In the above step 3, the dried ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose in the above step 2 are placed in a high shear mixer for primary mixing, and after the primary mixing, the dried polyvinylpyrrolidone and hydroxypropyl methylcellulose are added for fine mixing, and a mixture is obtained after the fine mixing for standby use; during the primary mixing, the rotation speed of the high shear mixer is 2000 rpm, and the time of the primary mixing is 10 minutes, and during the fine mixing, the rotation speed of the high shear mixer is 2200 rpm, and the time of the fine mixing is 10 minutes;

[0032] In the above step 4, the mixture prepared in the above step 3 is placed in a three-dimensional motion mixer, and then the dried stevioside, flavor and vitamin E are added, and three-dimensional mixing is performed in the three-dimensional motion mixer. After three-dimensional mixing, a granulation raw material is obtained for standby use; when the three-dimensional mixing is performed in the three-dimensional motion mixer, the rotation speed of the three-dimensional motion mixer is 80 rpm, and the three-dimensional mixing time is 30 min;

[0033] In the above step 5, the granulation raw material prepared in the above step 4 is put into a granulator for granulation operation, and after the granulation operation, it is dried to obtain a granulated material for standby use; when the granulation operation is performed in the granulator, distilled water is first added for stirring to form a wet soft material, and then the soft material is passed through the screen of the granulator to obtain wet granules to complete the granulation process, the amount of distilled water added during the process is 30% of the mass fraction of the granulation raw material, the drying temperature is 60° C., and the moisture content of the granulated material after drying is 3%;

[0034] In the above step 6, the granular material prepared in the above step 5 is sieved using a vibrating screen, and after sieving, it is put into a mixer, and the dried magnesium stearate and talc are added, and then mixed at a low speed in the mixer, and a tabletting material is obtained after low-speed mixing, which is reserved; when the granular material is sieved, the mesh number of the sieve used is 16 mesh, the stirring speed of the mixer during the low-speed mixing process is 70 rpm, and the low-speed mixing time is 25 min;

[0035] In the above step 7, the tabletting raw material obtained in the above step 6 is placed in a tablet press for tableting, and after the tableting is completed, a tablet is obtained for later use;

[0036] In the above step eight, the tablets prepared in the above step seven are coated. The coating process is divided into two processes: pre-coating and post-coating. The coating material used in the coating process is polyvinyl alcohol, and polyethylene glycol is selected as a plasticizer, and 5% of a sunscreen is added as a composite coating material. In the pre-coating process and the post-coating process, the coating solution is first filtered using a 0.45 μm filter membrane before coating, and the concentration of the coating solution is ensured to be 20%. The process specification during pre-coating is 1.0 mg / cm 2 , and the process specification for post-coating is 2.0mg / cm 2 After coating, the drying temperature is 45°C and the drying time is 30 minutes; after coating, the ginkgo dispersible tablets with high dispersion uniformity are obtained through drying.

[0037] Embodiment 2:

[0038] A ginkgo dispersible tablet with high dispersion uniformity, the formula of which comprises: ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, povidone, hypromellose, magnesium stearate, talcum powder, steviol glycoside, essence and vitamin E; the weight proportions of the components are respectively: 180 parts of ginkgo leaf extract, 47 parts of microcrystalline cellulose, 50 parts of lactose, 15 parts of cross-linked polyvinylpyrrolidone, 5 parts of cross-linked sodium carboxymethyl cellulose, 5 parts of povidone, 12 parts of hypromellose, 1 part of magnesium stearate, 1 part of talcum powder, 1 part of steviol glycoside, 1 part of essence and 1 part of vitamin E; the content of flavonoid glycoside in the ginkgo leaf extract is 22%-25%, and the content of terpene lactone in the ginkgo leaf extract is 5%-7%.

[0039] A processing technology for a ginkgo dispersible tablet with high dispersion uniformity comprises the following steps: step 1, taking materials; step 2, pretreatment; step 3, primary mixing; step 4, three-dimensional mixing; step 5, granulation; step 6, post-treatment; step 7, tableting; step 8, coating;

[0040] In the above step 1, 180 parts of ginkgo leaf extract, 47 parts of microcrystalline cellulose, 50 parts of lactose, 15 parts of cross-linked polyvinylpyrrolidone, 5 parts of cross-linked sodium carboxymethyl cellulose, 5 parts of polyvinylpyrrolidone, 12 parts of hypromellose, 1 part of magnesium stearate, 1 part of talc, 1 part of steviol glycoside, 1 part of flavor and 1 part of vitamin E are weighed according to the mass fraction of each group and set aside;

[0041] In the above step 2, the raw materials prepared in the above step 1 are screened in sequence using a sieve, and after the screening is completed, they are placed in a drying oven for continuous drying, and taken out for use after continuous drying; the mesh number of the filter used for the sequential screening is 40 meshes, and the temperature in the drying oven is 52° C. during the continuous drying in the drying oven, and the continuous drying time is 25 minutes;

[0042] In the above step 3, the dried ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose in the above step 2 are placed in a high shear mixer for primary mixing, and after the primary mixing, the dried polyvinylpyrrolidone and hydroxypropyl methylcellulose are added for fine mixing, and a mixture is obtained after the fine mixing for standby use; during the primary mixing, the rotation speed of the high shear mixer is 1500 rpm, and the time of the primary mixing is 5 minutes, and during the fine mixing, the rotation speed of the high shear mixer is 1600 rpm, and the time of the fine mixing is 5 minutes;

[0043] In the above step 4, the mixture prepared in the above step 3 is placed in a three-dimensional motion mixer, and then the dried stevioside, flavor and vitamin E are added, and three-dimensional mixing is performed in the three-dimensional motion mixer, and a granulation raw material is obtained after three-dimensional mixing, and the granulation raw material is set aside; when the three-dimensional mixing is performed in the three-dimensional motion mixer, the rotation speed of the three-dimensional motion mixer is 38 rpm, and the three-dimensional mixing time is 20 min;

[0044] In the above step 5, the granulation raw material prepared in the above step 4 is placed in a granulator for granulation operation, and after the granulation operation, it is dried to obtain a granulated material for standby use; when the granulation operation is performed in the granulator, distilled water is first added for stirring to form a wet soft material, and then the soft material is passed through the screen of the granulator to obtain wet granules to complete the granulation process, the amount of distilled water added during the process is 20% of the mass fraction of the granulation raw material, the drying temperature is 50° C., and the moisture content of the granulated material after drying is 0.5%;

[0045] In the above step 6, the granular material prepared in the above step 5 is sieved using a vibrating screen, and after sieving, it is put into a mixer, and the dried magnesium stearate and talc are added, and then mixed at a low speed in the mixer, and a tabletting raw material is obtained after low-speed mixing for standby use; when the granular material is sieved, the mesh number of the sieve used is 16 mesh, the stirring speed of the mixer during the low-speed mixing process is 65 rpm, and the low-speed mixing time is 20 min;

[0046] In the above step 7, the tabletting raw material obtained in the above step 6 is placed in a tablet press for tableting, and after the tableting is completed, a tablet is obtained for later use;

[0047] In the above step eight, the tablets prepared in the above step seven are coated. The coating process is divided into two processes: pre-coating and post-coating. The coating material used in the coating process is polyvinyl alcohol, and polyethylene glycol is selected as a plasticizer, and 2% of a sunscreen is added as a composite coating material. In the pre-coating process and the post-coating process, the coating solution is first filtered using a 0.45 μm filter membrane before coating, and the concentration of the coating solution is ensured to be 10%. The process specification during pre-coating is 0.5 mg / cm 2 , and the process specification for post-coating is 1.0mg / cm 2 After coating, the drying temperature is 40°C and the drying time is 25 minutes; after coating, the ginkgo dispersible tablets with high dispersion uniformity are obtained through drying.

[0048] Embodiment 3:

[0049] A ginkgo dispersible tablet with high dispersion uniformity comprises: ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, polyvinylpyrrolidone, hypromellose, magnesium stearate, talcum powder, steviol glycoside, essence and vitamin E; the weight proportions of the components are: 200 parts of ginkgo leaf extract, 47 parts of microcrystalline cellulose, 80 parts of lactose, 15 parts of cross-linked polyvinylpyrrolidone, 20 parts of cross-linked sodium carboxymethyl cellulose, 5 parts of polyvinylpyrrolidone, 18 parts of hypromellose, 1 part of magnesium stearate, 3 parts of talcum powder, 1 part of steviol glycoside, 3 parts of essence and 1 part of vitamin E; the content of flavonoid glycoside in the ginkgo leaf extract is 22%-25%, and the content of terpene lactone in the ginkgo leaf extract is 5%-7%.

[0050] A processing technology for a ginkgo dispersible tablet with high dispersion uniformity comprises the following steps: step 1, taking materials; step 2, pretreatment; step 3, primary mixing; step 4, three-dimensional mixing; step 5, granulation; step 6, post-treatment; step 7, tableting; step 8, coating;

[0051] In the above step 1, 200 parts of ginkgo leaf extract, 47 parts of microcrystalline cellulose, 80 parts of lactose, 15 parts of cross-linked polyvinylpyrrolidone, 20 parts of cross-linked sodium carboxymethyl cellulose, 5 parts of polyvinylpyrrolidone, 18 parts of hypromellose, 1 part of magnesium stearate, 3 parts of talc, 1 part of steviol glycoside, 3 parts of flavor and 1 part of vitamin E are weighed according to the mass fraction of each group and set aside;

[0052] In the above step 2, the raw materials prepared in the above step 1 are screened in sequence using a sieve, and after the screening is completed, they are placed in a drying oven for continuous drying, and taken out for use after continuous drying; the mesh number of the filter used for the sequential screening is 40 meshes, and the temperature in the drying oven is 55° C. during the continuous drying in the drying oven, and the continuous drying time is 25 minutes;

[0053] In the above step 3, the dried ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose in the above step 2 are placed in a high shear mixer for primary mixing, and after the primary mixing, the dried polyvinylpyrrolidone and hydroxypropyl methylcellulose are added for fine mixing, and a mixture is obtained after the fine mixing for standby use; during the primary mixing, the rotation speed of the high shear mixer is 2000 rpm, and the time of the primary mixing is 5 minutes, and during the fine mixing, the rotation speed of the high shear mixer is 2200 rpm, and the time of the fine mixing is 5 minutes;

[0054] In the above step 4, the mixture prepared in the above step 3 is placed in a three-dimensional motion mixer, and then the dried stevioside, flavor and vitamin E are added, and three-dimensional mixing is performed in the three-dimensional motion mixer, and a granulation raw material is obtained after three-dimensional mixing, and the granulation raw material is set aside; when the three-dimensional mixing is performed in the three-dimensional motion mixer, the rotation speed of the three-dimensional motion mixer is 80 rpm, and the three-dimensional mixing time is 20 minutes;

[0055] In the above step 5, the granulation raw material prepared in the above step 4 is placed in a granulator for granulation operation, and after the granulation operation, it is dried to obtain a granulated material for standby use; when the granulation operation is performed in the granulator, distilled water is first added for stirring to form a wet soft material, and then the soft material is passed through the screen of the granulator to obtain wet granules to complete the granulation process, the amount of distilled water added during the process is 30% of the mass fraction of the granulation raw material, the drying temperature is 50° C., and the moisture content of the granulated material after drying is 3%;

[0056] In the above step 6, the granular material prepared in the above step 5 is sieved using a vibrating screen, and after sieving, it is put into a mixer, and the dried magnesium stearate and talc are added, and then mixed at a low speed in the mixer, and a tabletting material is obtained after low-speed mixing, which is reserved; when the granular material is sieved, the mesh number of the sieve used is 16 mesh, the stirring speed of the mixer during the low-speed mixing process is 65 rpm, and the low-speed mixing time is 25 min;

[0057] In the above step 7, the tabletting raw material obtained in the above step 6 is placed in a tablet press for tableting, and after the tableting is completed, a tablet is obtained for later use;

[0058] In the above step eight, the tablets prepared in the above step seven are coated. The coating process is divided into two processes: pre-coating and post-coating. The coating material used in the coating process is polyvinyl alcohol, and polyethylene glycol is selected as a plasticizer, and 5% of a sunscreen is added as a composite coating material. In the pre-coating process and the post-coating process, the coating solution is first filtered using a 0.45 μm filter membrane before coating, and the concentration of the coating solution is ensured to be 10%. The process specification during pre-coating is 1.0 mg / cm 2 , and the process specification for post-coating is 1.0mg / cm 2 After coating, the drying temperature is 45°C and the drying time is 25 minutes; after coating, the ginkgo dispersible tablets with high dispersion uniformity are obtained through drying.

[0059] The performance of the ginkgo dispersible tablets with high uniformity obtained in the above examples was tested respectively, and compared with the common ginkgo dispersible tablets on the market. The results are shown in the following table:

[0060] Moisture content friability Coefficient of variation (CV) calculated by HPLC assay Example 1 1.14％ 0.15％ 2.35％ Example 2 1.18％ 0.21％ 1.98％ Example 3 1.23％ 0.17％ 2.24％ Comparative Example 1.85％ 0.67％ 4.74％

[0061] Based on the above, the advantages of the present invention are that, when used, the present invention uses a ginkgo leaf extract with a flavonoid glycoside content of 22% to 25% and a terpene lactone content of 5% to 7% as a raw material, and polyvidone is added to help particle formation, thereby enhancing the strength and stability of the tablets. During the preparation process, multiple screenings are performed to control the particle size specifications of the raw materials during the mixing process, so that the prepared ginkgo dispersible tablets have high dispersion uniformity, thereby ensuring the effectiveness and bioavailability of the drug; before processing, the raw materials are screened to remove residual particulate impurities, and at the same time, the residual moisture is eliminated by drying to ensure the purity of the raw materials and improve the processing quality of the ginkgo dispersible tablets; when coating, polyvinyl alcohol is selected as the coating material, and polyethylene glycol is selected as the plasticizer, and the coating is performed twice, thereby ensuring the surface smoothness of the tablets after coating while preventing the generation of coating cracks, thereby ensuring the disintegration time and solubility of the dispersible tablets.

[0062] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A ginkgo dispersible tablet with high dispersion uniformity, the formula comprising: Ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, povidone, hypromellose, magnesium stearate, talc, steviol glycoside, flavor and vitamin E; characterized in that the weight proportions of the components are: 180-200 parts of ginkgo leaf extract, 47-53 parts of microcrystalline cellulose, 50-80 parts of lactose, 15-21 parts of cross-linked polyvinylpyrrolidone, 5-20 parts of cross-linked sodium carboxymethyl cellulose, 5-10 parts of povidone, 12-18 parts of hypromellose, 1-5 parts of magnesium stearate, 1-3 parts of talc, 1-3 parts of steviol glycoside, 1-3 parts of flavor and 1-5 parts of vitamin E.

2. The ginkgo dispersible tablet with high dispersion uniformity according to claim 1, characterized in that: The content of flavonoid glycosides in the ginkgo leaf extract is 22% to 25%, and the content of terpene lactones in the ginkgo leaf extract is 5% to 7%.

3. A processing technology for a ginkgo dispersible tablet with high dispersion uniformity, comprising the following steps: Step 1, material collection; Step 2, pretreatment; Step 3, primary mixing; Step 4, three-dimensional mixing; Step 5, granulation; Step 6, post-treatment; Step 7, tableting; Step 8, coating; It is characterized in that: In the above step 1, 180-200 parts of ginkgo leaf extract, 47-53 parts of microcrystalline cellulose, 50-80 parts of lactose, 15-21 parts of cross-linked polyvinylpyrrolidone, 5-20 parts of cross-linked sodium carboxymethyl cellulose, 5-10 parts of polyvinylpyrrolidone, 12-18 parts of hypromellose, 1-5 parts of magnesium stearate, 1-3 parts of talc, 1-3 parts of steviol glycosides, 1-3 parts of flavors and 1-5 parts of vitamin E are weighed according to the mass fraction of each group and set aside; In the above step 2, the raw materials prepared in the above step 1 are screened in sequence using a sieve, and after the screening, they are placed in a drying oven for continuous drying, and after continuous drying, they are taken out for use; In the above step 3, the dried ginkgo leaf extract, microcrystalline cellulose, lactose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose in the above step 2 are placed in a high shear mixer for primary mixing, and after the primary mixing, the dried polyvinylpyrrolidone and hydroxypropyl methylcellulose are added for fine mixing, and a mixture is obtained after the fine mixing for standby use; In the above step 4, the mixture prepared in the above step 3 is placed in a three-dimensional motion mixer, and then the dried stevioside, flavor and vitamin E are added, and three-dimensional mixing is performed in the three-dimensional motion mixer, and the granulation raw material is obtained after three-dimensional mixing for standby use; In the above step 5, the granulation raw material prepared in the above step 4 is placed in a granulator for granulation operation, and after the granulation operation, it is dried to obtain a granulated material for standby use; In the above step 6, the granular material prepared in the above step 5 is sieved using a vibrating screen, and after sieving, it is put into a mixer, and the dried magnesium stearate and talc are added, and then mixed at a low speed in the mixer, and the tableting material is obtained after low-speed mixing, and is set aside; In the above step 7, the tabletting raw material obtained in the above step 6 is placed in a tablet press for tableting, and after the tableting is completed, a tablet is obtained for later use; In the above step eight, the tablets prepared in the above step seven are coated, and after the coating, they are dried to obtain the ginkgo dispersible tablets with high dispersion uniformity.

4. The process for producing a ginkgo dispersible tablet with high dispersion uniformity according to claim 3, characterized in that: In the step 2, the mesh size of the filter used for sequential screening is 40 meshes, the temperature of the drying oven is 52-55° C. during continuous drying, and the continuous drying time is 25-30 minutes.

5. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 3 is characterized in that: In the step 3, the rotation speed of the high shear mixer during the initial mixing process is 1500-2000 rpm, and the initial mixing process time is 5-10 minutes. The rotation speed of the high shear mixer during the fine mixing process is 1600-2200 rpm, and the fine mixing process time is 5-10 minutes.

6. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 3 is characterized by: In the step 4, when the three-dimensional mixing is performed in the three-dimensional motion mixer, the rotation speed of the three-dimensional motion mixer is 38 to 80 rpm, and the three-dimensional mixing time is 20 to 30 minutes.

7. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 3 is characterized by: In the step 5, when the granulation operation is performed in the granulator, distilled water is first added for stirring to form a wet soft material, and then the soft material is passed through the screen of the granulator to obtain wet granules to complete the granulation process. The amount of distilled water added during the process is 20% to 30% of the mass fraction of the granulation raw material, the drying temperature is 50 to 60° C., and the moisture content of the granulated material after drying is 0.5% to 3%.

8. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 3 is characterized by: In the step six, when the granular material is screened, the mesh size of the screen used is 16 meshes, the stirring speed of the mixer during the low-speed mixing process is 65-70 rpm, and the low-speed mixing time is 20-25 minutes.

9. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 3, characterized in that: In the step eight, the coating treatment is divided into two processes: pre-coating and post-coating. The coating material used in the coating process is polyvinyl alcohol, polyethylene glycol is selected as a plasticizer, and 2% to 5% of a sunscreen is added as a composite coating material.

10. The processing technology of the ginkgo dispersible tablets with high dispersion uniformity according to claim 9, characterized in that: In the pre-coating process and the post-coating process, the coating solution is first filtered using a 0.45 μm filter membrane before coating, and the concentration of the coating solution is ensured to be 10% to 20%. The process specification during pre-coating is 0.5 to 1.0 mg / cm 2 , and the process specification of the post-coating is 1.0~2.0mg / cm 2 After coating, the drying temperature is 40-45°C, and the drying time is 25-30 minutes.

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