CN113116945A - Method for preparing ginkgo leaf dispersible tablets - Google Patents
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Abstract
The application discloses a preparation method of a ginkgo leaf dispersible tablet, which comprises the following steps of preparing raw materials by adjusting the preparation process of a medicament: ginkgo leaf, auxiliary materials: firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% ethanol aqueous solution in the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest of croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing, wherein the mixing time is 15 minutes, and finally tabletting to prepare the ginkgo leaf dispersible tablet.
Description
Technical Field
The application relates to the technical field of ginkgo leaf tablets, in particular to a preparation method of a ginkgo leaf dispersible tablet.
Background
Cerebrovascular diseases are one of the main diseases which are harmful to human health, are common diseases and frequently encountered diseases which are harmful to human life and health, have the characteristics of high morbidity, high disability rate, high death rate and high recurrence rate, are main diseases which are fatal and disabling to middle-aged people, and have continuously increased morbidity due to aging population and improvement of living standard quality. Among cerebrovascular diseases, ischemic vascular diseases are the most common, and cerebral ischemia caused by cerebral thrombosis, cerebral embolism and hemodynamic disorders can be classified according to the causes of cerebral ischemia.
The main active components of folium Ginkgo are flavonol glycoside and terpenoid lactone, and have various pharmacological effects of inhibiting oxygen free radical generation, improving blood rheology, dilating coronary artery, improving blood circulation, and reducing myocardial oxygen consumption. At present, the ginkgo leaf extract preparation is widely applied clinically, but the solubility of active ingredients of the ginkgo leaf extract preparation is low, so that the absorption is influenced, the bioavailability of most common ginkgo leaf extract preparations is low, and therefore, the ginkgo leaf extract preparation is prepared into a dispersible tablet, the bioavailability of the preparation can be improved, and the clinical medication quality is ensured. The ginkgo leaf dispersible tablet is a novel preparation processed by ginkgo leaf extract, has the effects of promoting blood circulation to remove blood stasis and dredging collaterals to relieve pain, is mainly suitable for chest distress, chest pain and hemiplegia caused by blood stasis blocking collaterals, and is mainly applied to patients with coronary heart disease, angina and cerebral infarction. The ginkgo leaf dispersible tablets in the prior art have the problem of low dissolution rate. Therefore, there is a need to develop a ginkgo biloba dispersible tablet to solve the above problems.
Disclosure of Invention
The embodiment of the application provides a preparation method of a ginkgo leaf dispersible tablet, which is used for solving the technical problem of low dissolution rate of the existing ginkgo leaf dispersible tablet.
In view of the above, the present application provides a method for preparing a ginkgo biloba dispersible tablet, which comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 70-80% ethanol water solution by mass ratio in the mixing process, and mixing for 10-20 minutes to prepare a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet particles at the drying temperature of 45-65 ℃ for 30-45 minutes to obtain dried particles;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 10-20 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tabletting machine for tabletting to obtain the ginkgo leaf dispersible tablets.
Optionally, in step S1, the auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide were separately sieved through a 60 mesh sieve.
Optionally, in step S6, the dried pellets have a moisture content of 3.0% to 4.0%.
Optionally, in step S7, the mixing time is 10-15 minutes.
Optionally, in step S8, the weight of the ginkgo biloba dispersible tablet is 0.283g to 0.316 g.
Optionally, in step S2, the ginkgo biloba leaf powder is sieved through a 100 mesh sieve.
Optionally, in step S4, an aqueous solution of ethanol with a mass ratio of 80% is added during the mixing process.
Alternatively, in step S6, the drying temperature is 65 ℃.
Alternatively, in step S6, the drying time is 45 minutes.
According to the technical scheme, the embodiment of the application has the following advantages:
the application provides a preparation method of a ginkgo leaf dispersible tablet, which comprises the following steps: s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide; s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder; s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass; s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 70-80% ethanol water solution by mass ratio in the mixing process, and mixing for 10-20 minutes to prepare a soft material; s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules; s6: drying the wet particles at the drying temperature of 45-65 ℃ for 30-45 minutes to obtain dried particles; s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 10-20 minutes; preparing mixture particles; s8: and putting the mixture granules into a tabletting machine for tabletting to obtain the ginkgo leaf dispersible tablets.
The application provides a preparation method of a ginkgo leaf dispersible tablet, which comprises the following steps of preparing raw materials by adjusting the preparation process of the medicament: ginkgo leaf, auxiliary materials: firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% ethanol aqueous solution in the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest of croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing, wherein the mixing time is 15 minutes, and finally tabletting to prepare the ginkgo leaf dispersible tablet.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art according to the drawings.
Fig. 1 is a schematic flow chart of a method for preparing a ginkgo biloba dispersible tablet provided in the embodiment of the present application.
Detailed Description
In order to make those skilled in the art better understand the technical solutions of the present invention, the following embodiments of the present application are clearly and completely described, and it is obvious that the described embodiments are only a part of the embodiments of the present application, not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application. Unless otherwise specifically stated, various raw materials, reagents, instruments, equipment and the like used in the present application are commercially available or can be prepared by an existing method.
Example 1
For easy understanding, referring to fig. 1, an embodiment of a method for preparing a ginkgo biloba dispersible tablet provided by the present application comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% ethanol water solution by mass in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 15 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tablet machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 2
A method for preparing folium Ginkgo dispersible tablet comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% ethanol water solution by mass in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 20 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tablet machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 3
A method for preparing folium Ginkgo dispersible tablet comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% ethanol water solution by mass in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 10 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tablet machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 4
A method for preparing folium Ginkgo dispersible tablet comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixing machine for mixing, adding 70% ethanol water solution in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 15 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tablet machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 5
A method for preparing folium Ginkgo dispersible tablet comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixing machine for mixing, adding 70% ethanol water solution in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 15 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tablet machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 6
A method for preparing folium Ginkgo dispersible tablet comprises the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide, and mixing the following auxiliary materials: respectively sieving mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide with a 60-mesh sieve;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder, and sieving with 100 mesh sieve;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70-80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide into a mixer for mixing, adding 80% ethanol water solution by mass in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet granules at 65 ℃ for 45 minutes to obtain dried granules, wherein the water content of the dried granules is 3.0-4.0%;
s7: and (3) putting the dry granules into a tabletting machine for tabletting to obtain the ginkgo leaf dispersible tablets, wherein the weight of the ginkgo leaf dispersible tablets is 0.283-0.316 g.
Example 7
Comparative example: according to the preparation method of the ginkgo leaf dispersible tablet in the prior art, ginkgo leaves are taken, crushed, heated and refluxed by diluted ethanol, the extracting solution is combined, the ethanol is recovered and concentrated to a proper amount, the mixture is added on a treated macroporous adsorption resin column, water and ethanol with different concentrations are sequentially used for elution, corresponding eluent is collected, the ethanol is recovered, and spray drying is carried out; or recovering ethanol, concentrating into soft extract, vacuum drying, pulverizing, adding vitamin E starch P and microcrystalline cellulose, and tabletting to obtain folium Ginkgo dispersible tablet.
Dissolution testing
The dissolution rate test method comprises the following steps: taking a ginkgo leaf dispersible tablet sample prepared in example 1-7, according to a dissolution rate determination method (appendix XC first method), using 900mL of water as a solvent, wherein the temperature of the solvent is (37 +/-0.5) DEG C, and the rotating speed is as follows: 100r/min, operating according to the method for 45min, taking a proper amount of solution, filtering through a 0.45-micron filter membrane, precisely taking a proper amount of subsequent filtrate, diluting the filtrate with a solvent to obtain a solution containing about 130 mug of solution in each 1mlL, and measuring the absorbance at the wavelength of 272nm by an ultraviolet-visible spectrophotometry (appendix IV A); taking the contents under the condition of different loading quantities, mixing uniformly, precisely weighing a proper amount (about equal to the average loading quantity), adding a dissolving-out medium according to the marked quantity to dissolve and dilute into a solution containing about 130 mu g of the dissolving-out medium in each 1mL, filtering, taking the subsequent filtrate as a control solution, measuring by the same method, and calculating the dissolving-out quantity of each tablet. The limit is 80%, which should be met.
Comparison group: according to the existing preparation method of the ginkgo leaf dispersible tablet, ginkgo leaf, ethanol, microcrystalline cellulose and vitamin swelling starch P are taken to prepare the ginkgo leaf dispersible tablet as a comparative example, and the result is that: the dissolution rate of the ginkgo leaf dispersible tablets is 93 percent.
A first group: taking ginkgo leaves as raw materials and taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, according to the preparation method of the ginkgo leaf dispersible tablet in the embodiment 1, firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% by mass of ethanol water solution into the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing for 15 minutes, finally tabletting to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, and the dissolution rate of the ginkgo leaf dispersible tablet is higher than the dissolution rate of the ginkgo leaf dispersible tablet in the comparison group.
Second group: taking ginkgo leaves as raw materials and taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, according to the preparation method of the ginkgo leaf dispersible tablet in the embodiment 2, firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% by mass of ethanol water solution into the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing for 20 minutes, finally tabletting to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, and the dissolution rate of the ginkgo leaf dispersible tablet is higher than the dissolution rate of the ginkgo leaf dispersible tablet in the comparison group.
Third group: taking ginkgo leaves as raw materials and taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, according to the preparation method of the ginkgo leaf dispersible tablet in the embodiment 3, firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 80% by mass of ethanol water solution into the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing for 10 minutes, finally tabletting to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, and the dissolution rate of the ginkgo leaf dispersible tablet is higher than the dissolution rate of the ginkgo leaf dispersible tablet in the comparison group.
And a fourth group: taking ginkgo leaves as raw materials and taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, according to the preparation method of the ginkgo leaf dispersible tablet in the embodiment 4, firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 70% by mass of ethanol water solution into the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing for 15 minutes, finally tabletting to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, and the dissolution rate of the ginkgo leaf dispersible tablet is higher than the dissolution rate of the ginkgo leaf dispersible tablet in the comparison group.
And a fifth group: taking ginkgo leaves as raw materials and taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, according to the preparation method of the ginkgo leaf dispersible tablet in the embodiment 5, firstly adding ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 75% by mass of ethanol water solution into the mixing process to prepare a soft material, granulating and drying, then adding dried granules, the rest croscarmellose sodium, magnesium stearate and silicon dioxide into the mixer for mixing for 15 minutes, finally tabletting to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, and the dissolution rate of the ginkgo leaf dispersible tablet is higher than the dissolution rate of the ginkgo leaf dispersible tablet in the comparison group.
A sixth group: taking ginkgo leaves as a raw material, taking mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide as auxiliary materials, adding ginkgo leaf powder, mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide into a mixer for mixing according to the preparation method of the ginkgo leaf dispersible tablet in example 6, adding 80% ethanol aqueous solution in mass ratio during mixing for 10-20 minutes to prepare a soft material, granulating and drying, tabletting dried granules to prepare the ginkgo leaf dispersible tablet, carrying out dissolution rate determination on the ginkgo leaf dispersible tablet, and comparing the determination result with the dissolution rate of the ginkgo leaf dispersible tablet in a comparison group, wherein the dissolution rate of the ginkgo leaf dispersible tablet is higher than that of the ginkgo leaf dispersible tablet in the comparison group.
Table of dissolution test of the product:
| sample (I) | Traits | Dissolution (%) | Appearance of the product |
| Example 1 | Brown tablet | 98.3 | Qualified, smooth and crack-free |
| Example 2 | Brown tablet | 96.1 | Qualified, smooth and crack-free |
| Example 3 | Brown tablet | 95.7 | Qualified, smooth and crack-free |
| Example 4 | Brown tablet | 94.7 | Qualified, smooth and crack-free |
| Example 5 | Brown tablet | 94.8 | Qualified, smooth and crack-free |
| Example 6 | Brown tablet | 93.5 | Qualified, smooth and crack-free |
| Example 7 (comparative example) | Brown tablet | 93.0 | Qualified, smooth and crack-free |
And (4) conclusion: as can be seen from the table, the first, second and third groups showed a higher dissolution rate in comparison with the comparative example, within a certain range of mixing time, 15 minutes.
Compared with the fourth group, the dissolution effect is strongest when 80% ethanol water solution is added in the mixing process.
Compared with the comparison group, the fourth group and the fifth group can improve the dissolution rate of the product by setting the mixing time and adding ethanol water solution with a certain mass ratio.
Compared with the comparison group, the first group and the sixth group have the advantages that after a part of auxiliary materials are mixed, and the dissolution rate of the obtained product is higher than that of the product obtained by mixing all the auxiliary materials.
Therefore, the preparation method of the ginkgo leaf dispersible tablet provided by the application can improve the dissolution rate of the ginkgo leaf dispersible tablet, prepare the ginkgo leaf dispersible tablet with high dissolution rate and solve the technical problem of low dissolution rate of the existing ginkgo leaf dispersible tablet.
The above embodiments are only used for illustrating the technical solutions of the present application, and not for limiting the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.
Claims (9)
1. A preparation method of a ginkgo leaf dispersible tablet is characterized by comprising the following steps:
s1: preparing raw materials: ginkgo leaf, auxiliary materials: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide;
s2: micronizing folium Ginkgo with superfine powder jet mill to obtain folium Ginkgo powder;
s3: adding 95% medicinal ethanol by mass into purified water to prepare 70% -80% ethanol water solution by mass;
s4: adding the ginkgo leaf powder, mannitol, part of croscarmellose sodium and aspartame into a mixer for mixing, adding 70-80% by mass of ethanol water solution in the mixing process, and mixing for 10-20 minutes to obtain a soft material;
s5: sieving the soft material with a 30-mesh sieve, and performing wet granulation to obtain wet granules;
s6: drying the wet particles at the drying temperature of 45-65 ℃ for 30-45 minutes to obtain dried particles;
s7: adding the dried granules, the rest of the croscarmellose sodium, the magnesium stearate and the silicon dioxide into a mixer for mixing for 10-20 minutes; preparing mixture particles;
s8: and putting the mixture granules into a tabletting machine for tabletting to obtain the ginkgo leaf dispersible tablets.
2. The method for preparing the ginkgo biloba dispersible tablet according to claim 1, wherein in step S1, the following excipients: mannitol, croscarmellose sodium, aspartame, magnesium stearate and silicon dioxide were separately sieved through a 60 mesh sieve.
3. The method of claim 1, wherein in step S6, the water content of the dried particles is 3.0-4.0%.
4. The method for preparing the ginkgo biloba leaf dispersible tablet according to claim 1, wherein the mixing time in step S7 is 10-15 minutes.
5. The method of claim 1, wherein in step S8, the weight of the dispersible tablet of ginkgo biloba leaves is 0.283g to 0.316 g.
6. The method of claim 1, wherein in step S2, the ginkgo biloba leaf powder is sieved with 100 mesh sieve.
7. The method of claim 1, wherein in step S4, 80% ethanol water is added during the mixing process.
8. The method for preparing ginkgo biloba dispersible tablet according to claim 1, wherein the drying temperature is 65 ℃ in step S6.
9. The method of claim 1, wherein the drying time in step S6 is 45 minutes.
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