CN103976962A - Preparation method of traditional Chinese medicine extract tablet - Google Patents
Preparation method of traditional Chinese medicine extract tablet Download PDFInfo
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Abstract
A traditional Chinese medicine extract tablet comprises an extract of traditional Chinese medicine extract and an excipient; wherein the weight ratio of the extract to the excipient is (1.5-4):1, and the excipient is composed of dextrin, starch, and a disintegrating agent. The preparation method of the traditional Chinese medicine extract table comprises the following steps: extracting traditional Chinese herbals, drying the extract to obtain a dried extract, selecting an excipient comprising dextrin, starch, and a disintegrating agent, mixing the extract and the excipient according to a weight ratio of (1.5-4):1, carrying out spray-granulating, and finally pressing the granules into tablets, wherein the water in the extract accounts for 30 to 60% of the total weight of the extract, the material temperature is 60 to 80 DEG C after the extract and excipient mixing process, in the spray-granulating process, the atomizing pressure I is 0.05 to 0.1 MPa, the atomizing pressure II is 0.05 to 1 MPa, and the spraying speed is 10 to 20 r/min. The traditional Chinese medicine extract tablet has the advantages of proper size, uniform appearance, and prominently-reduced disintegration time.
Description
Technical Field
The invention relates to a traditional Chinese medicine extract, in particular to a traditional Chinese medicine extract tablet and a preparation method thereof.
Background
The Chinese medicinal extract tablet is generally a tablet prepared by uniformly mixing and pressing a Chinese medicinal extract or a Chinese medicinal extract with Chinese medicinal fine powder and a proper excipient or preparing the mixture into a tablet by other proper methods, and has the advantages of accurate dose, stable quality, convenient administration, convenient identification, low cost and the like. Because the components in the traditional Chinese medicine extract are complex, components such as protein, polysaccharide, starch, tannin and the like exist, and in addition, a large number of polar groups such as hydroxyl, amino and the like exist in the traditional Chinese medicine extract are easy to combine with polar hydroxyl in water molecules, and generally, the hygroscopicity and the viscosity are high, the problems of splintering, loose pieces, sticking, slow disintegration and the like often occur in the preparation process of the traditional Chinese medicine tablet.
It is common in the art to add large amounts of excipients, such as disintegrants, during the process of making tablets. The prior art discloses that factors influencing slow disintegration of a traditional Chinese medicine tablet comprise main medicine properties and an excipient, and discloses that the disintegration speed of a puerarin tablet can be increased by adding a disintegrant such as 6-8% sodium hydroxymethyl starch, and the moisture in the tablet is controlled to be proper.
The prior art also discloses a tablet composition containing a traditional Chinese medicine extract, which is formed by mixing traditional Chinese medicine extract powder, cellulose glycollic acid and sodium bicarbonate, and the tablet composition has excellent disintegration property and dissolution degree through a process of adding anhydrous silicic acid and water into the traditional Chinese medicine extract powder, stirring and granulating and a process of mixing the cellulose glycollic acid and the sodium bicarbonate into the obtained granules.
The prior art also discloses a tablet composition containing traditional Chinese medicine extract, which has more excellent disintegration and dissolution compared with the prior art, and is prepared by mixing traditional Chinese medicine extract powder, croscarmellose sodium and sodium bicarbonate.
However, although the above prior art partially solves the problem of poor disintegration effect, the addition of excipients also makes the volume of the traditional Chinese medicine tablet larger, and the higher price of excipients such as disintegrant, etc. leads to the increase of production cost.
Disclosure of Invention
The technical problem solved by the invention is that the traditional Chinese medicine extract tablet can not have a good disintegration effect while having a moderate volume.
The technical scheme of the invention is as follows:
a Chinese medicinal extract tablet, comprising: the weight ratio of the extract to the excipient is 1.5-4: 1, and the excipient comprises dextrin, starch and a disintegrating agent.
Further: the ratio of the extract to the excipient is 2-2.5: 1.
Further, the disintegrant comprises: one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone and crosslinked sodium carboxymethyl cellulose.
Further: the weight ratio of the dextrin to the starch to the disintegrant is 2-5: 4-10: 1-3.
Further: the weight ratio of the dextrin to the starch to the disintegrant is 2-3: 4-5: 1-3.
Further: the weight ratio of the extract to the excipient is 2.5:1, and the weight ratio of the dextrin, the starch and the disintegrant is 2.5:5: 1.5; or the weight ratio of the extract to the excipient is 3:2, and the weight ratio of the dextrin, the starch and the disintegrant is 2:10: 1; or the weight ratio of the extract to the excipient is 2:1, and the weight ratio of the dextrin, the starch and the disintegrant is 5:4: 1.5; or the weight ratio of the extract to the excipient is 4:1, and the weight ratio of the dextrin, the starch and the disintegrant is 3:5: 2.
Further: the excipient also comprises a lubricant which accounts for 0.5-3% of the mass of the traditional Chinese medicine extract tablet, and the lubricant is selected from magnesium stearate, aerosil, talcum powder or hydrogenated vegetable oil.
Further: the excipient further comprises: one or more of a diluent, an absorbent, a wetting agent, and a binder.
Further: the diluent is selected from one or more of lactose, powdered sugar, precipitated calcium carbonate, calcium phosphate and kaolin; the absorbent is selected from calcium phosphate, kaolin, sucrose or glucose; the wetting agent is selected from distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose; the adhesive is selected from distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose.
The invention solves another technical problem that the traditional Chinese medicine extract tablet prepared by the existing method cannot have good disintegration effect while the volume is moderate.
The technical scheme of the invention is as follows:
a method for preparing a Chinese medicinal extract tablet comprises: extracting traditional Chinese medicines, drying the extract to obtain an extract, selecting an excipient, mixing the extract with the excipient, performing spray granulation, and pressing to obtain a tablet, wherein the weight ratio of the extract to the excipient is 1.5-4: 1, and the excipient comprises dextrin, starch and a disintegrating agent; the mass percentage content of the water content of the extract is 30-60%; the temperature of the materials after the step of mixing the extract and the excipient is 60-80 ℃; in the step of spray granulation, the atomization pressure I is 0.05-0.1MPa, the atomization pressure II is 0.05-1MPa, and the spray speed is 10-20 r/min.
The technical effects of the invention comprise:
the traditional Chinese medicine extract tablet has the advantages of proper particle size, uniform appearance and obviously shortened disintegration time.
Detailed Description
The present invention will be described in detail with reference to the following preferred embodiments.
The preparation method comprises the following steps: extracting Chinese medicinal materials, drying the extract to obtain extract, selecting excipient, mixing the extract and excipient, spray granulating, and making into tablet. Wherein the temperature of the materials after the step of mixing the extract and the excipient is 60-80 ℃; in the step of spray granulation, the atomization pressure I is 0.05-0.1MPa, the atomization pressure II is 0.05-1MPa, and the spray speed is 10-20 r/min.
The reason for selecting the temperature of the materials is as follows: when the temperature of the material is lower than 60 ℃, the drying of the extract spray and the excipient after forming particles is not enough to cause material adhesion and wall hanging in time, and the atomization pressure and the spray speed can not be greatly adjusted, so that the granulation property of the particles is directly influenced, and the particle size of the obtained particles is smaller. When the material temperature is about 60-80 ℃, the material has better material fluidity, the prepared particles are more uniform, and the particle size is proper.
The reason for selecting the above atomization pressure is: the smaller the atomization pressure I is, the smaller the atomization angle is, and the larger the atomization angle is, so that the spray of the extract is easy to attach to the wall of the tank to cause loss, and tests prove that the atomization pressure I is 0.05-0.1MPa, and the atomization pressure II is more appropriate to be 0.05-1 MPa.
The reason for selecting the above-mentioned spray rate is: when the temperature of the material can be stably maintained at about 60-80 ℃, the spraying speed can be properly adjusted to 10-20 r/min.
Preferably, the temperature of the materials after the step of mixing the extract and the excipient is 65-70 ℃; in the step of spray granulation, the atomization pressure I is 0.1MPa, the atomization pressure II is 0.08MPa, and the spray speed is 10-20 r/min.
The extract can be a traditional Chinese medicine extracting solution product obtained by extracting plant tissues, traditional Chinese medicines and traditional Chinese medicine decoction pieces by using a solvent and concentrating, and can also be a traditional Chinese medicine extracting solution product obtained by extracting all or part of traditional Chinese medicines in the traditional Chinese medicine prescription and concentrating. The solvent is selected from water, organic solvent and organic solvent water solution, and the organic solvent comprises methanol, ethanol, ethyl acetate, petroleum ether, n-hexane, cyclohexane, dichloromethane, chloroform, diethyl ether, acetone, etc. The organic solvent aqueous solution may be an aqueous solution of an organic solvent having a volume concentration of 1 to 99%. The Chinese medicinal prescription can be any Chinese medicinal prescription reported in the prior art, such as XIAOQINGLONG decoction, DACHENQI decoction, XIAOCHAIHU decoction, WULING powder, XIAOYAO powder, XUEFUZHUYU decoction, BUZHONGYIQI decoction, GUIPI decoction, LIUWEIDIHUANG pill, and WENDANTANG decoction.
The extract of the present invention can be extracted with a solvent by methods well known in the art, including maceration, percolation, decoction, reflux, continuous extraction, combinations thereof, and the like.
The dextrin of the present invention is generally a generic term for starch hydrolysis intermediates, and has a chemical formula of (C)6H10O5)n·XH2O, which is about 80% water soluble, dissolves relatively slowly in cold water, relatively easily in hot water, and not in ethanol. Dextrin is used as an excipient of a pharmaceutical tablet, is usually used as a diluent or a filler, has strong caking property, and can cause pocking marks and watermarks on the surface of the tablet or cause disintegration or slow dissolution of the tablet when being improperly used. However, the composition of starch and dextrin with a specific proportion is added into the extract of the traditional Chinese medicine extract, so that the preparation difficulty of the extract of the traditional Chinese medicine extract can be reduced, and the disintegration effect of the tablet containing the disintegrant can be improved.
The disintegrant is a substance which can lead the tablet to be rapidly cracked into fine particles in gastrointestinal fluid, and comprises one or the combination of more than two of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinyl pyrrolidone and cross-linked sodium carboxymethyl cellulose. Preferred disintegrants are sodium carboxymethyl starch and/or low substituted hydroxypropyl cellulose, and more preferred disintegrants are sodium carboxymethyl starch.
The moisture content in the traditional Chinese medicine extract of the invention affects the preparation of tablets. Improper water control can cause the problems of uneven water content of the particles, dull tablet surface, slag falling, moisture absorption of the tablet core, difficulty in polishing the sugar-coated tablet, easiness in fading, mildew and the like of the traditional Chinese medicine tablet. The traditional Chinese medicine extract provided by the invention contains 30-60% of water by mass, preferably 30-50% of water by mass, and more preferably 35-45% of water by mass.
The excipient also comprises a lubricant which accounts for 0.5-3% of the mass of the traditional Chinese medicine extract tablet. The lubricant is selected from magnesium stearate, silica gel, pulvis Talci or hydrogenated vegetable oil.
The excipient of the present invention may further comprise one or more of a diluent, an absorbent, a wetting agent and a binder. The diluent is selected from one or more of lactose, sugar powder, precipitated calcium carbonate, calcium phosphate, and kaolin. The absorbent is selected from calcium phosphate, kaolin, sucrose or glucose. The wetting agent is selected from distilled water, ethanol (preferably ethanol solution with 30-70% of ethanol volume content), starch slurry (preferably starch slurry with 8-15% of starch mass content), sodium carboxymethyl cellulose (preferably sodium carboxymethyl cellulose solution with 1-2% of sodium carboxymethyl cellulose mass content and preferably starch mass content), hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose. The adhesive is selected from distilled water, ethanol (preferably ethanol solution with 30-70% of ethanol volume content), starch slurry (preferably starch slurry with 8-15% of starch mass content), sodium carboxymethyl cellulose (preferably sodium carboxymethyl cellulose solution with 1-2% of sodium carboxymethyl cellulose mass content and preferably starch mass content), hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose. The lubricant is selected from magnesium stearate, silica gel, pulvis Talci or hydrogenated vegetable oil.
Example 1 hedan preparation extract tablet
(1) Extracting the traditional Chinese medicine:
the hedan extract is prepared and extracted according to the method of the hedan tablets recorded in pharmacopoeia. The Chinese medicinal composition is HEDAN tablet, and comprises folium Nelumbinis, fructus crataegi, Saviae Miltiorrhizae radix, folium sennae, and fructus Psoraleae.
(2) Drying the extract to obtain an extract:
concentrating the extract to obtain extract with relative density of 1.22-1.26 (measured at 80 deg.C), and water content of 42.3%.
(3) Selecting an excipient:
taking dextrin, starch and a disintegrating agent to form an excipient according to the mass ratio of 2.5:5:1.5, wherein the disintegrating agent is preferably sodium carboxymethyl starch.
(4) Mixing the extract with an excipient:
and (3) disinfecting the inner wall of the equipment main machine by using ethanol with the volume fraction of 75%, and drying. After the equipment is dried, 0.9kg of excipient is added into the multifunctional granulator, the multifunctional granulator is pushed into a main machine, and 2.25kg of extract is poured into a hopper to be mixed, namely the mass ratio of the extract to the excipient is 2.5: 1.
(5) Spray granulation:
after the mixed materials reach 65-70 ℃, starting a spray button to start spray granulation, wherein the atomization pressure I is 0.1MPa, the atomization pressure II is 0.05MPa, the spray flow rate is 10-20r/min, closing compressed air after spraying, and continuously drying for about 10 min.
(6) And (3) compressing the tablets:
and (3) after drying, closing the steam valve, discharging when the temperature is reduced to below 55 ℃, and tabletting to obtain tablets with the weight of 1.96kg and the yield of 89.16%.
EXAMPLE 2 preparation of Jiangzhiling tablets
(1) Extracting the traditional Chinese medicine:
2.22kg of polygonum multiflorum, 2.22kg of medlar, 2.96kg of rhizoma polygonati, 1.48kg of hawthorn and 0.44kg of cassia seed are taken, and extracted according to a preparation method of lipid-lowering tablet recorded in 2010 version Chinese pharmacopoeia to obtain an extracting solution.
(2) Drying the extract to obtain an extract:
concentrating the extractive solution to obtain extract with water content of 45%.
(3) Selecting an excipient:
taking dextrin, starch and a disintegrating agent to form an excipient according to the mass ratio of 2:10:1, wherein the disintegrating agent is preferably low-substituted hydroxypropyl cellulose.
(4) Mixing the extract with an excipient:
and (3) disinfecting the inner wall of the equipment main machine by using ethanol with the volume fraction of 75%, and drying. After the equipment is dried, 1.77kg of excipient is added into the multifunctional granulator, the multifunctional granulator is pushed into a main machine, and 2.66kg of extract is poured into a hopper to be mixed.
(5) Spray granulation:
after the mixed materials reach 60-70 ℃, starting a spray button to start spray granulation, wherein the atomization pressure I is 0.1MPa, the atomization pressure II is 0.8MPa, the spray flow rate is 10-15r/min, closing compressed air after spraying, and continuously drying for about 10 min.
(6) And (3) compressing the tablets:
and (3) closing a steam valve after drying is finished, discharging when the temperature is reduced to below 55 ℃, adding 90g of talcum powder serving as a lubricant, pressing the materials into 10000 tablets of 0.3g, wherein the mass percentage of the lubricant in each traditional Chinese medicine extract tablet is 3%, and coating sugar coat/film coat to obtain the traditional Chinese medicine extract tablet. The disintegration time of the tablet of example 2 was significantly reduced compared to the commercially available norlipiodol tablets.
EXAMPLE 3 preparation of Reyanning tablets
(1) Extracting the traditional Chinese medicine:
extracting herba Taraxaci 3.72kg, rhizoma Polygoni Cuspidati 3.72kg, herba Patriniae 3.72kg, and herba Scutellariae Barbatae 1.86kg according to the preparation method of REYANNING tablet recorded in 2010 version Chinese pharmacopoeia to obtain extractive solution
(2) Drying the extract to obtain an extract:
concentrating the extractive solution to obtain extract with water content of 30%.
(3) Selecting an excipient:
taking dextrin, starch and a disintegrating agent to form an excipient according to the mass ratio of 5:4:1.5, wherein the disintegrating agent is preferably croscarmellose sodium.
(4) Mixing the extract with an excipient:
and (3) disinfecting the inner wall of the equipment main machine by using ethanol with the volume fraction of 75%, and drying. After the equipment is dried, 1.13kg of excipient is added into the multifunctional granulator, the multifunctional granulator is pushed into a main machine, and 2.27kg of extract is poured into a hopper to be mixed.
(5) Spray granulation:
after the mixed materials reach 70-80 ℃, starting a spray button to start spray granulation, wherein the atomization pressure I is 0.05MPa, the atomization pressure II is 1MPa, the spray flow rate is 15-20r/min, after the extractum is sprayed, closing compressed air, and continuously drying for about 10 min.
(6) And (3) compressing the tablets:
and (3) closing a steam valve after drying is finished, discharging when the temperature is reduced to below 55 ℃, adding 50g of superfine silica gel powder as a lubricant, pressing the material into 10000 tablets of 0.25g, wherein the mass percentage of the lubricant in each traditional Chinese medicine extract tablet is 2%, and coating sugar coat/film coat to obtain the traditional Chinese medicine extract tablet. The disintegration time of the tablet of example 3 was significantly reduced compared to the commercially available antipyretic tablets.
EXAMPLE 4 preparation of anti-inflammatory and cholagogic tablets
(1) Extracting the traditional Chinese medicine:
extracting 8.68kg of common andrographis herb, 8.68kg of rabdosia lophanthide and 8.68kg of quassia according to a preparation method of the inflammation diminishing and gallbladder benefiting tablet recorded in 2010 version Chinese pharmacopoeia to obtain an extracting solution.
(2) Drying the extract to obtain an extract:
concentrating the extractive solution to obtain extract with water content of 60%.
(3) Selecting an excipient:
mixing dextrin, starch and disintegrant at a mass ratio of 3:5:2 to obtain excipient, wherein the disintegrant is preferably crosslinked polyethylene pyrrolidone
(4) Mixing the extract with an excipient:
and (3) disinfecting the inner wall of the equipment main machine by using ethanol with the volume fraction of 75%, and drying. After the equipment is dried, 1.06kg of excipient is added into the multifunctional granulator, the multifunctional granulator is pushed into a main machine, and 4.25kg of extract is poured into a hopper for mixing.
(5) Spray granulation:
after the mixed materials reach 75-80 ℃, starting a spray button to start spray granulation, wherein the atomization pressure I is 0.08MPa, the atomization pressure II is 0.2MPa, the spray flow rate is 10-20r/min, after the extractum is sprayed, closing compressed air, and continuously drying for about 10 min.
(6) And (3) compressing the tablets:
and (3) closing a steam valve after drying is finished, discharging when the temperature is reduced to below 55 ℃, adding 12.5g of magnesium stearate serving as a lubricating agent, pressing the materials into 10000 tablets of 0.25g, wherein the mass percentage of the lubricating agent in each traditional Chinese medicine extract tablet is 0.5%, and coating sugar coat/film coat to obtain the traditional Chinese medicine extract tablet. The disintegration time of the tablet described in example 4 is significantly reduced compared to the commercially available anti-inflammatory and choleretic tablets.
Example 5
The same technical scheme is adopted in example 5 and example 1, except that the excipient in example 5 further comprises a wetting agent accounting for 0.5% of the mass of the traditional Chinese medicine extract tablet, wherein the wetting agent is preferably magnesium stearate. The tablet weight of the prepared tablet was 0.7 g/tablet, and the disintegration time was 16 minutes.
Comparative example 1
The same technical scheme is adopted in the comparative example 1 and the example 1, and the difference is that the excipient in the comparative example 1 consists of starch and sodium carboxymethyl starch according to the mass ratio of 0.8: 0.1.
Comparative example 2
Comparative example 2 and example 1 use the same technical solution, except that the excipient in comparative example 2 is starch.
Comparative example 3
Comparative example 3 and example 5 use the same technical scheme except that the excipient in comparative example 3 consists of starch and sodium carboxymethyl starch in a mass ratio of 0.8: 0.1.
Comparative example 4
Comparative example 4 and example 5 use the same technical solution, except that the excipient in comparative example 4 is starch.
Comparative example 1, comparative example 1 and comparative example 2 were compared as shown in table 1.
TABLE 1 comparative results of example 1, comparative example 1 and comparative example 2
As can be seen from the above table: after the extract is extracted from the Hedan tablets, the extract is further granulated by using different excipients for 3 minutes, and the finished product rate of the tablets prepared by the excipients containing dextrin, starch and sodium carboxymethyl starch is higher.
The difference in tablet weight and the disintegration time of example 5, comparative example 3 and comparative example 4 were compared to further examine the effect of the disintegrant on the quality of the compressed tablets and the product, as shown in table 2.
TABLE 2 comparison of tabletting test data
| Adding auxiliary materials | Tablet weight | Disintegration time | |
| Example 5 | Magnesium stearate (0.5%) | 0.7 g/tablet | 16 minutes |
| Comparative example 3 | Magnesium stearate (0.5%) | 0.7 g/tablet | 20 minutes |
| Comparative example 4 | Magnesium stearate (05%) | 07 g/tablet | 25 minutes |
As can be seen from the above table, in example 5, comparative example 3 and comparative example 4, the wetting agent accounting for 0.5% of the mass of the tablet of the traditional Chinese medicine extract is added for tabletting, and the tablet prepared by containing dextrin, starch and sodium carboxymethyl starch has high yield, and the disintegration time of the tablet is obviously shortened, which is beneficial to the dissolution of the medicine components.
In comparative examples 1 to 4, the ratio of the total amount of dextrin and starch to the content of the disintegrant was changed as the ratio of the extract content to the excipient content was changed as shown in Table 3.
TABLE 3 variation of the proportions of the contents of the mixture in the excipients
| The ratio of extract to excipient | Ratio of total amount of dextrin and starch to content of disintegrant | |
| Example 1 | 2.5 | 5 |
| Example 2 | 1.5 | 12 |
| Example 3 | 2 | 6 |
| Example 4 | 4 | 4 |
As can be seen from Table 3, the ratio of the total amount of dextrin and starch to the content of the disintegrant decreased as the ratio of the extract to the excipient increased. The traditional Chinese medicine extract tablet prepared according to the change rule has short disintegration time, proper particle size and uniform appearance.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.
Claims (10)
1. A Chinese medicinal extract tablet, comprising: the extract and the excipient of the traditional Chinese medicine extract are characterized in that: the weight ratio of the extract to the excipient is 1.5-4: 1, and the excipient comprises dextrin, starch and a disintegrating agent.
2. The traditional Chinese medicine extract tablet as claimed in claim 1, wherein: the weight ratio of the extract to the excipient is 2-2.5: 1.
3. The traditional Chinese medicine extract tablet as claimed in claim 1 or 2, wherein the disintegrant comprises: one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone and crosslinked sodium carboxymethyl cellulose.
4. The traditional Chinese medicine extract tablet as claimed in claim 3, wherein: the weight ratio of the dextrin to the starch to the disintegrant is 2-5: 4-10: 1-3.
5. The traditional Chinese medicine extract tablet as claimed in claim 4, wherein: the weight ratio of the dextrin to the starch to the disintegrant is 2-3: 4-5: 1-3.
6. The traditional Chinese medicine extract tablet as claimed in claim 4 or 5, wherein:
the weight ratio of the extract to the excipient is 2.5:1, and the weight ratio of the dextrin, the starch and the disintegrant is 2.5:5: 1.5;
or the weight ratio of the extract to the excipient is 3:2, and the weight ratio of the dextrin, the starch and the disintegrant is 2:10: 1; or,
the weight ratio of the extract to the excipient is 2:1, and the weight ratio of the dextrin, the starch and the disintegrant is 5:4: 1.5; or,
the weight ratio of the extract to the excipient is 4:1, and the weight ratio of the dextrin, the starch and the disintegrant is 3:5: 2.
7. The traditional Chinese medicine extract tablet as claimed in claim 4 or 5, wherein: the excipient also comprises a lubricant which accounts for 0.5-3% of the mass of the traditional Chinese medicine extract tablet, and the lubricant is selected from magnesium stearate, aerosil, talcum powder or hydrogenated vegetable oil.
8. The herbal extract tablet of claim 1, 2, 4 or 5, wherein: the excipient further comprises: one or more of a diluent, an absorbent, a wetting agent, and a binder.
9. The traditional Chinese medicine extract tablet as claimed in claim 8, wherein:
the diluent is selected from one or more of lactose, powdered sugar, precipitated calcium carbonate, calcium phosphate and kaolin;
the absorbent is selected from calcium phosphate, kaolin, sucrose or glucose;
the wetting agent is selected from distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose;
the adhesive is selected from distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose or hydroxypropyl methyl cellulose.
10. A method for preparing a Chinese medicinal extract tablet comprises: extracting traditional Chinese medicines, drying the extract to obtain an extract, selecting an excipient, mixing the extract with the excipient, performing spray granulation, and pressing into tablets, and is characterized in that:
the weight ratio of the extract to the excipient is 1.5-4: 1, and the excipient comprises dextrin, starch and a disintegrating agent;
the mass percentage content of the water content of the extract is 30-60%;
the temperature of the materials after the step of mixing the extract and the excipient is 60-80 ℃;
in the step of spray granulation, the atomization pressure I is 0.05-0.1MPa, the atomization pressure II is 0.05-1MPa, and the spray speed is 10-20 r/min.
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| CN110624020A (en) * | 2019-09-09 | 2019-12-31 | 嘉应学院医学院 | Compound calyx seu fructus physalis tablet and preparation method thereof |
| CN112569314A (en) * | 2020-12-29 | 2021-03-30 | 北京悦康科创医药科技股份有限公司 | Menstruation regulating and face nourishing medicinal preparation and preparation method thereof |
| CN113082123A (en) * | 2021-04-14 | 2021-07-09 | 嘉应学院 | Postpartum bathing agent and preparation method thereof |
| CN114727961A (en) * | 2019-06-26 | 2022-07-08 | 绿十字生命健康有限公司 | Pharmaceutical composition with improved stability comprising natural product extract |
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| CN1939355A (en) * | 2005-09-30 | 2007-04-04 | 江西本草天工科技有限责任公司 | Ginkgo dispersing tablets |
| CN1778350A (en) * | 2005-10-18 | 2006-05-31 | 安徽济人药业有限公司 | Chinese medicine tablet for treating pelvic inflammatory disease |
| US20090181112A1 (en) * | 2006-06-29 | 2009-07-16 | Tsumura & Co. | Tablet composition containing kampo extract |
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