CN108272762B - Toona sinensis old leaf total flavone dispersible tablet and preparation method thereof - Google Patents
Toona sinensis old leaf total flavone dispersible tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese toon old leaf total flavone dispersible tablet, which comprises the following components in percentage by weight: 30-64% of crude extract of the total flavonoids in the old leaves of the Chinese toon, 25-50% of filling agent, 10-35% of disintegrating agent and 0.5-1.5% of lubricating agent. The invention finds the type of the filling agent suitable for direct tabletting by comparing the powder properties of different filling agents, and solves the problem that the crude extract powder of the total flavonoids of Chinese toon has poor fluidity and can not be directly tabletted and molded. Secondly, the invention adopts the direct tabletting method to mix the medicine and the auxiliary materials and then tabletting, compared with the traditional wet granulation tabletting method, the invention has the advantages of simple process, convenient operation, time saving and high efficiency. Finally, on the basis of screening and optimizing the types and the use amount of the auxiliary materials, the stable toona sinensis old leaf total flavone dispersible tablets are prepared by a simpler direct powder tabletting process, and the production process does not need special equipment and has lower production cost.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a toona sinensis old leaf total flavone dispersible tablet and a preparation method thereof.
Background
The flavone component in the old leaves of Toona sinensis has strong antioxidant activity and multiple pharmacological actions of reducing blood lipid, protecting cardiac muscle, resisting tumor, oxidation and virus, etc.
The dispersible tablet is a new dosage form appearing in 80 years, and is a non-coated tablet which can be rapidly disintegrated to form uniform viscous suspension when meeting water. It has the characteristics of convenient taking, quick absorption, high bioavailability and small adverse reaction, and increasingly attracts people's attention.
In order to well utilize and develop the total flavone extract of the old leaves of the Chinese toon, the research takes the crude extract of the total flavone in the old leaves of the Chinese toon as a raw material, and the crude extract is matched with a filling agent, a disintegrating agent and a lubricating agent to prepare the raw material into tablets. Because the extract of the general flavone of the old leaves of the Chinese toon has higher viscosity, the preparation of the tablet is hindered, the wet granulation is not easy, the direct tabletting method is selected to directly tablet the medicine and the auxiliary materials without granulation, the process is simple, the time and the efficiency are saved, but the powder property of most medicines can not meet the requirement of directly tabletting the powder, and the selection of the proper auxiliary materials is the key of the preparation process. In order to increase the solubility of flavone in the tablets and improve the bioavailability of the medicament, the dispersible tablets are selected and prepared, the disintegrating agent in the dispersible tablets rapidly expands in water, so that the tablets are rapidly dissolved, and the disintegrating properties of different disintegrating agents are different, so that the proper disintegrating agent is very important for preparing the dispersible tablets.
Disclosure of Invention
In view of the above, one of the objectives of the present invention is to provide a dispersible tablet of total flavonoids in old leaves of toona sinensis.
The invention also aims to provide a preparation method of the toona sinensis old leaf total flavone dispersible tablet.
In order to achieve the purpose, the invention provides the following technical scheme:
the Chinese toon old leaf total flavone dispersible tablet comprises the following components in percentage by weight: 30-64% of crude extract of the total flavonoids in the old leaves of the Chinese toon, 25-50% of filling agent, 10-35% of disintegrating agent and 0.5-1.5% of lubricating agent.
Preferably, the prescription comprises the following components in percentage by weight: 40% of crude extract of the total flavonoids in the old leaves of the Chinese toon, 30.6% of filling agent, 28.4% of disintegrating agent and 1.0% of lubricating agent.
The filler is selected from one of lactose, microcrystalline cellulose, mannitol and pregelatinized starch or a mixture of the lactose, the microcrystalline cellulose, the mannitol and the pregelatinized starch. Because the direct compression has higher requirement on the flowing compressibility of the powder, the flowing compressibility of the main drug total flavone crude extract is lower, the direct compression requirement can not be met, and the microcrystalline cellulose: lactose =2:1, the composite filler powder has the smallest angle of repose and compression degree and the best fluidity, so the invention preferably selects the composite filler microcrystalline cellulose: lactose =2: 1.
The disintegrant is selected from one or a mixture of crosslinked polyvinylpyrrolidone (PVPP), low-substituted hydroxypropyl cellulose (L-HPC), sodium carboxymethyl starch (CMS-Na) and crosslinked sodium carboxymethyl cellulose (CCMC-Na). According to the record of appendix I of the second part of Chinese pharmacopoeia 2010 edition, the dispersible tablet is required to be completely disintegrated in water at 15-25 ℃ within 3min and pass through a No. 2 sieve. The selection of proper disintegrating agent is the key for preparing dispersible tablets, and the invention preferably selects crosslinked polyvinylpyrrolidone (PVPP): the compound disintegrant with low-substituted hydroxypropyl cellulose (L-HPC) =1:1 has the best effect, the uniform dispersion time is shortest, and the surface of the pressed tablet is smooth and the hardness is qualified.
The lubricant is selected from one or a mixture of magnesium stearate, talcum powder, PEG-4000 and PEG-6000. The lubricant can improve the powder fluidity in the tablet, ensure that the weight difference of the tablet is qualified, ensure the surface of the tablet to be glossy and beautiful and reduce the phenomenon of sticking and punching. Magnesium stearate (1.0%) is preferably selected as a lubricant, so that the tablet weight difference is qualified, the tablet is easy to form, and the surface of the tablet is smooth and glossy.
A method for preparing a toona sinensis old leaf total flavone dispersible tablet comprises the following steps:
(1) weighing crude extract of total flavonoids of old leaves of Toona sinensis, filler, disintegrant and lubricant according to the prescription of the dispersible tablet of claim 1, respectively, drying, and sieving with 60 mesh sieve;
(2) uniformly mixing the weighed crude extract of the total flavonoids in the old leaves of the Chinese toon, a filling agent and a disintegrating agent, and then adding a lubricating agent for uniform mixing;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
Further, the drying condition is hot air drying for 1h at the temperature of 50 ℃.
Further, the crude extract of the total flavonoids in the old leaves of the Chinese toon is prepared by the following preparation method: taking and crushing old toona sinensis leaves, adding cellulase into an acetic acid-sodium acetate buffer solution with the pH value of 4.6, carrying out enzymolysis for 120min at the temperature of 46 ℃, inactivating the enzyme for 30s by boiling water, adding ethanol with the volume fraction of 60% of ethanol according to the material-liquid ratio of 1:25(g/mL), extracting for 20min at the microwave power of 800W and the microwave temperature of 70 ℃, carrying out suction filtration, continuously extracting for two times, combining filtrates, carrying out rotary evaporation concentration, and carrying out spray drying to obtain the total flavone crude extract of the toona sinensis leaves.
Further, the addition amount of the cellulase is 1.0 percent of the weight of the old toona sinensis leaf powder.
The invention has the beneficial effects that: the invention finds the type of the filling agent suitable for direct tabletting by comparing the powder properties of different filling agents, and solves the problem that the crude extract powder of the total flavonoids of Chinese toon has poor fluidity and can not be directly tabletted and molded. Secondly, the invention adopts the direct tabletting method to mix the medicine and the auxiliary materials and then tabletting, compared with the traditional wet granulation tabletting method, the invention has the advantages of simple process, convenient operation, time saving and high efficiency. Finally, on the basis of screening and optimizing the types and the use amount of the auxiliary materials, the stable toona sinensis old leaf total flavone dispersible tablets are prepared by a simpler direct powder tabletting process, and the production process does not need special equipment and has lower production cost.
Drawings
FIG. 1 is a flow chart of the preparation process of the cedrela sinensis old leaf total flavone dispersible tablet.
Detailed Description
The present invention is further illustrated by the following specific examples so that those skilled in the art can better understand the present invention and can practice it, but the examples are not intended to limit the present invention.
Example 1
This example provides a prescription and a method for preparing 100 dispersible tablets of total flavonoids in old leaves of Toona sinensis (tablet weight 204 + -1 mg/tablet, specification 21.30 mg/tablet).
Prescription composition dosage/g
Crude extract 8.400 of total flavonoids of old leaves of Chinese toon
Microcrystalline cellulose 4.284
Lactose 2.142
PVPP 2.982
L-HPC 2.982
Magnesium stearate 0.210
Made into 100 pieces
The preparation method comprises the following steps: (1) respectively weighing 8.400g of crude extract of total flavonoids of old leaves of Chinese toon, 4.284g of microcrystalline cellulose, 2.142g of lactose, 2.982g of PVPP, 2.982g of L-HPC and 0.210g of magnesium stearate, drying the crude extract for 1h (the water content is less than 2%) by hot air at 50 ℃, and sieving the crude extract with a 60-mesh sieve for later use;
(2) mixing the crude extract of the total flavonoids of the old leaves of the Chinese toon, microcrystalline cellulose, lactose, PVPP and L-HPC uniformly, adding magnesium stearate, and mixing uniformly;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
Example 2
This example provides a prescription and a method for preparing 100 tablets of toona sinensis old leaf total flavone dispersible tablets (tablet weight 204 ± 1 mg/tablet, specification 26.63 mg/tablet).
Prescription composition dosage/g
10.500 of crude extract of total flavonoids in old leaves of Chinese toon
Microcrystalline cellulose 4.053
Lactose 2.037
L-HPC 4.200
Magnesium stearate 0.210
Made into 100 pieces
The preparation method comprises the following steps: (1) weighing 10.500g of crude extract of total flavonoids of old leaves of Chinese toon, 4.053g of microcrystalline cellulose, 2.037g of lactose, 4.200g of L-HPC and 0.210g of magnesium stearate, respectively drying for 1h (the water content is less than 2%) at 50 ℃, and sieving with a 60-mesh sieve for later use;
(2) mixing the crude extract of the total flavonoids of the old leaves of the Chinese toon, microcrystalline cellulose, lactose and L-HPC uniformly, adding magnesium stearate, and mixing uniformly;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
Example 3
This example provides a prescription and a preparation method for 100 tablets of toona sinensis old leaf total flavone dispersible tablets (tablet weight 204 ± 1 mg/tablet, specification 27.69 mg/tablet).
Prescription composition dosage/g
Crude extract 10.920 of total flavonoids of old leaves of Chinese toon
Microcrystalline cellulose 5.250
PVPP 4.725
Talcum powder 0.105
Made into 100 pieces
The preparation method comprises the following steps: (1) respectively weighing 10.920g of crude extract of total flavonoids in old leaves of Chinese toon, 5.250g of microcrystalline cellulose, PVPP4.725g and 0.105g of talcum powder, respectively drying for 1h (the water content is less than 2%) at 50 ℃, and sieving by a 60-mesh sieve for later use;
(2) mixing the crude extract of the general flavone of the old leaves of the Chinese toon, microcrystalline cellulose and PVPP uniformly, adding talcum powder and mixing uniformly;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
Example 4
This example provides a prescription and a method for preparing 100 tablets of toona sinensis old leaf total flavone dispersible tablets (tablet weight 204 ± 1 mg/tablet, specification 25.56 mg/tablet).
Prescription composition dosage/g
Crude extract 10.080 of total flavonoids of old leaves of Chinese toon
Microcrystalline cellulose 4.200
Lactose 2.100
PVPP 4.515
Magnesium stearate 0.105
Made into 100 pieces
The preparation method comprises the following steps: (1) 10.080g of crude extract of total flavonoids in old leaves of Chinese toon, 4.200g of microcrystalline cellulose, 2.100g of lactose, 4.515g of PVPP4 and 0.105g of magnesium stearate are respectively weighed, dried for 1h (the water content is less than 2%) at 50 ℃, and sieved by a 60-mesh sieve for later use;
(2) mixing the crude extract of the total flavonoids of the old leaves of the Chinese toon, microcrystalline cellulose, lactose and PVPP uniformly, adding magnesium stearate and mixing uniformly;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
Example dispersion uniformity and tabletting condition of Toona sinensis leaf total flavone dispersible tablet
In this example, the dispersion uniformity test and the tabletting condition investigation of the toona sinensis leaf total flavone dispersible tablets in examples 1 to 4 are carried out, and the test method and the results are as follows:
1. test for Dispersion uniformity
The test conditions are as follows: according to the record of appendix I of the second part of Chinese pharmacopoeia 2010 edition, the dispersible tablet is required to be completely disintegrated in water at 15-25 ℃ within 3min and pass through a No. 2 sieve. The test results are shown in table 1 below:
TABLE 1 Dispersion homogeneity test results
Examples test results
Example 1 the time for uniform dispersion was 64s, which was satisfactory
Example 2 the time for uniform dispersion was 140s, which was satisfactory
Example 3 the time for uniform dispersion was 125s, which was satisfactory
Example 4 the time for uniform dispersion was 115 seconds, which was satisfactory
2. Condition of tablet compression
The test results are shown in table 2 below:
TABLE 2 tabletting test results
Examples test results
Example 1 easy flaking, acceptable hardness, smooth surface
Example 2 easy flaking, acceptable hardness, smooth surface
Example 3 easy flaking, acceptable hardness, smoother surface
Example 4 easy flaking, acceptable hardness, smoother surface
And (3) quality detection: the tablet of the invention is in a light yellow round shape, has smooth and complete surface, uniform color and luster, qualified hardness, yield of more than 95 percent, 12mm diameter of the tablet, 204 plus or minus 1 mg/tablet weight of the tablet, standard difference of the tablet weight, pharmacopoeia standard of the dispersion uniformity and No. two sieves within 3 min.
The above-mentioned embodiments are merely preferred embodiments for fully illustrating the present invention, and the scope of the present invention is not limited thereto. The equivalent substitution or change made by the technical personnel in the technical field on the basis of the invention is all within the protection scope of the invention. The protection scope of the invention is subject to the claims.
Claims (7)
1. The toona sinensis old leaf total flavone dispersible tablet is characterized in that the prescription comprises the following components in percentage by weight: 30-64% of crude extract of total flavonoids in old leaves of Chinese toon, 25-50% of filler, 10-35% of disintegrating agent and 0.5-1.5% of lubricant; the filler is a composite filler of microcrystalline cellulose and lactose, and the mass ratio of the filler to the composite filler is 2: 1; the disintegrating agent is a composite disintegrating agent of cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose, and the mass ratio of the disintegrating agent to the low-substituted hydroxypropyl cellulose is 1: 1; the lubricant is selected from one or mixture of magnesium stearate, talcum powder, PEG-4000 and PEG-6000.
2. The toona sinensis old leaf total flavone dispersible tablet according to claim 1, wherein the prescription comprises the following components in percentage by weight: 40% of crude extract of the total flavonoids in the old leaves of the Chinese toon, 30.6% of filling agent, 28.4% of disintegrating agent and 1.0% of lubricating agent.
3. The dispersible tablet of total flavonoids of old leaves of toona sinensis as claimed in claim 1 or 2, wherein the lubricant is magnesium stearate.
4. A method for preparing the toona sinensis old leaf total flavone dispersible tablet of claim 1, which is characterized by comprising the following steps:
(1) weighing crude extract of total flavonoids of old leaves of Toona sinensis, filler, disintegrant and lubricant according to the prescription of the dispersible tablet of claim 1, respectively, drying, and sieving with 60 mesh sieve;
(2) uniformly mixing the weighed crude extract of the total flavonoids in the old leaves of the Chinese toon, a filling agent and a disintegrating agent, and then adding a lubricating agent for uniform mixing;
(3) directly tabletting with a tabletting machine, and sterilizing the pressed tablet by irradiating under ultraviolet for 30min to obtain the dispersible tablet.
5. The method for preparing the toona sinensis old leaf total flavone dispersible tablet, according to claim 4, wherein the drying condition is hot air drying for 1h at 50 ℃.
6. The method for preparing the toona sinensis old leaf total flavone dispersible tablet according to claim 4, wherein the crude extract of the toona sinensis old leaf total flavone is prepared by the following preparation method: taking and crushing old toona sinensis leaves, adding cellulase into an acetic acid-sodium acetate buffer solution with the pH value of 4.6, carrying out enzymolysis for 120min at the temperature of 46 ℃, inactivating the enzyme for 30s by boiling water, adding ethanol with the volume fraction of 60% of ethanol according to the material-liquid ratio of 1:25(g/mL), extracting for 20min at the microwave power of 800W and the microwave temperature of 70 ℃, carrying out suction filtration, continuously extracting for two times, combining filtrates, carrying out rotary evaporation concentration, and carrying out spray drying to obtain the total flavone crude extract of the toona sinensis leaves.
7. The method for preparing the toona sinensis old leaf total flavone dispersible tablet according to claim 6, wherein the addition amount of the cellulase is 1.0% of the weight of the toona sinensis old leaf powder.
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