CN114288255A - High-efficiency lecithin tablet and preparation method thereof - Google Patents
High-efficiency lecithin tablet and preparation method thereof Download PDFInfo
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- CN114288255A CN114288255A CN202111655845.0A CN202111655845A CN114288255A CN 114288255 A CN114288255 A CN 114288255A CN 202111655845 A CN202111655845 A CN 202111655845A CN 114288255 A CN114288255 A CN 114288255A
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Abstract
The invention discloses a high-efficiency lecithin tablet and a preparation method thereof, wherein the formula comprises the following components: the egg yolk lecithin, the soybean isoflavone, the carotene, the filling agent, the disintegrating agent and the lubricant are respectively prepared from the following components in parts by weight: 230 parts of 100-230 parts of egg yolk lecithin, 150 parts of soybean isoflavone 100-75 parts of carotene, 500 parts of a filling agent 350-200 parts of a disintegrating agent and 20-35 parts of a lubricating agent; the preparation method comprises the steps of firstly, selecting materials and burdening; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing; the invention is safe and reliable, and the use of the egg yolk lecithin is convenient for improving the absorption efficiency of human bodies to the lecithin; the use of the soybean isoflavone is convenient for regulating the carbohydrate metabolism balance in vivo; the carotene is used, so that the essential vitamins of the human body can be provided conveniently; the tablet core of the lecithin tablet is easy to loose and fall powder by matching a high-efficiency wet mixing granulator with a coating process, and the tablet core is convenient to popularize and use.
Description
Technical Field
The invention relates to the technical field of tablets and preparation of the tablets, in particular to a high-efficiency lecithin tablet and a preparation method thereof.
Background
Lecithin has the advantages of nutrition supplement, serum lipid regulation, brain benefiting and heart health and the like, and is widely loved by people, so that certain requirements are met for the use of lecithin tablets and preparation processes in the market; however, most of the existing lecithin tablets in the market are soybean lecithin, the absorption effect by human bodies is poor, most of the lecithin tablets are in a soft capsule form, the cost is high, most of the existing preparation processes of the lecithin tablets are dry granulation tabletting processes, the requirements on equipment are high, and tablet cores of the lecithin tablets prepared by the existing wet granulation tabletting processes are easy to loose and fall off; therefore, the invention provides a high-efficiency lecithin tablet and a preparation method thereof.
Disclosure of Invention
The invention aims to provide a high-efficiency lecithin tablet and a preparation method thereof, and aims to solve the problems in the background technology.
In order to achieve the purpose, the invention provides the following technical scheme: a high-efficiency lecithin tablet comprises the following components in percentage by weight: the egg yolk lecithin, the soybean isoflavone, the carotene, the filling agent, the disintegrating agent and the lubricant are respectively prepared from the following components in parts by weight: 230 portions of 100-230 portions of yolk lecithin, 150 portions of 100-150 portions of soybean isoflavone, 50-75 portions of carotene, 500 portions of 350-200 portions of filling agent, 150-200 portions of disintegrating agent and 20-35 portions of lubricating agent.
A preparation method of a high-efficiency lecithin tablet comprises the steps of firstly, selecting materials and mixing; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing;
wherein in the first step, firstly, all raw materials are respectively sieved, and then 100-230 parts of yellow lecithin, 100-150 parts of soybean isoflavone, 50-75 parts of carotene, 350-500 parts of filling agent, 150-200 parts of disintegrating agent and 20-35 parts of lubricant are respectively weighed;
in the second step, the weighed egg yolk lecithin, soybean isoflavone, carotene and filler are mixed and granulated at high speed, and the water content of the dried granules is 0-2%; adding water into the weighed disintegrant for pulping, then stirring at a high speed for granulation, and drying the granules until the moisture content is 0-2%;
in the third step, the 2 kinds of granules prepared in the second step are mixed with the weighed lubricant, then tabletting is carried out through a tablet machine, and dust is removed through a screening machine to prepare a lecithin tablet core;
and in the fourth step, coating the prepared lecithin tablet core with sugar material in a coating machine on the outer surface of the solid pharmaceutical preparation, and drying to ensure that one or more protective layers are tightly adhered outside the lecithin tablet core to prepare the lecithin tablet.
Preferably, in the first step, the filler is one of compressible starch, corn starch or dextrin; the lubricant is one of magnesium stearate, silicon dioxide or talcum powder.
Preferably, the disintegrant in the second step consists of a disintegrant A and a disintegrant B, wherein the disintegrant A is sodium carboxymethyl starch, and the disintegrant B is one of hydroxypropyl cellulose, microcrystalline cellulose or povidone; the specific using mode of the disintegrating agent is to mix purified water and the disintegrating agent A into slurry and stir the slurry evenly, and then add the disintegrating agent B into the slurry and stir the slurry at a high speed for granulation.
Preferably, in the second step, the mass ratio of the purified water to the disintegrant A is 200-250: 60-75, and the mass ratio of the disintegrant A to the disintegrant B is 60-75: 130-150.
Preferably, in the second step, a high-efficiency wet mixing granulator is used for high-speed stirring granulation.
Preferably, in the third step, the tablet press is one of a single-punch tablet press, a basket tablet press, a rotary tablet press, a sub-high-speed rotary tablet press, a full-automatic high-speed tablet press or a rotary core-spun tablet press.
Compared with the prior art, the invention has the beneficial effects that: the invention is safe and reliable, and the use of the egg yolk lecithin is convenient for improving the absorption efficiency of human bodies to the lecithin; the soybean isoflavone is used, so that the sugar metabolism balance in the body can be conveniently adjusted, and the effect of preventing cardiovascular diseases is achieved; the carotene is used to provide essential vitamins for human body.
The addition of the soybean isoflavone increases the effect of the lecithin tablet for preventing cardiovascular diseases, and the use health care effect of the lecithin tablet is further improved. However, the addition of the soybean isoflavone also causes the loose powder falling of the tablet core, and in order to solve the problem, the carotene is added in a large proportion. The tablet core is not loosened and has moderate hardness and good disintegration, and the requirements of pharmacopoeia on tablets are met.
The method of the invention adopts high-speed stirring granulation, the lipid-like egg yolk lecithin is uniformly dispersed in the filling agent, and then the mixture is mixed with the disintegrant particles with the same particle size and the powdered lubricant for tabletting, thereby avoiding the contact of water and the egg yolk lecithin and realizing the uniform dispersion of various components. The content of the yolk lecithin in each yolk lecithin tablet is stable and uniform, and the use safety is high.
Drawings
FIG. 1 is a flow chart of the method of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the 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 invention.
Referring to fig. 1, a technical solution provided by the present invention:
example 1:
a high-efficiency lecithin tablet comprises the following components in percentage by weight: the egg yolk lecithin, the soybean isoflavone, the carotene, the filling agent, the disintegrating agent and the lubricant are respectively prepared from the following components in parts by weight: 200 parts of egg yolk lecithin, 150 parts of soybean isoflavone, 75 parts of carotene, 500 parts of a filling agent, 200 parts of a disintegrating agent and 35 parts of a lubricating agent.
A preparation method of a high-efficiency lecithin tablet comprises the steps of firstly, selecting materials and mixing; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing;
in the first step, firstly, sieving all raw materials respectively, and then weighing 200 parts of egg yolk lecithin, 150 parts of soybean isoflavone, 75 parts of carotene, 500 parts of filler, 200 parts of disintegrant and 35 parts of lubricant respectively, wherein the filler is one of compressible starch, corn starch or dextrin; the lubricant is one of magnesium stearate, silicon dioxide or talcum powder;
in the second step, the weighed egg yolk lecithin, soybean isoflavone, carotene and filler are mixed and granulated at high speed, and the water content of the dried granules is 0-2%; adding water into the weighed disintegrant for pulping, then stirring at a high speed for granulation, and drying the granules until the moisture content is 0-2%; the disintegrating agent consists of a disintegrating agent A and a disintegrating agent B, wherein the disintegrating agent A is sodium carboxymethyl starch, and the disintegrating agent B is one of hydroxypropyl cellulose, microcrystalline cellulose or polyvidone; the specific using mode of the disintegrating agent is that purified water and the disintegrating agent A are mixed and stirred evenly, and then the disintegrating agent B is added to be stirred and granulated at high speed; the mass ratio of the purified water to the disintegrating agent A is 250: 75, and the mass ratio of the disintegrating agent A to the disintegrating agent B is 75: 150; stirring and granulating at high speed by using a high-efficiency wet mixing granulator;
in the third step, the 2 kinds of granules prepared in the second step are mixed with the weighed lubricant, then tabletting is carried out through a tablet machine, and dust is removed through a screening machine to prepare a lecithin tablet core; the tablet press is one of a single-punch tablet press, a basket tablet press, a rotary tablet press, a sub-high-speed rotary tablet press, a full-automatic high-speed tablet press or a rotary core-spun tablet press;
and in the fourth step, coating the prepared lecithin tablet core with sugar material in a coating machine on the outer surface of the solid pharmaceutical preparation, and drying to ensure that one or more protective layers are tightly adhered outside the lecithin tablet core to prepare the lecithin tablet.
Example 2:
a high-efficiency lecithin tablet comprises the following components in percentage by weight: the egg yolk lecithin, the soybean isoflavone, the carotene, the filling agent, the disintegrating agent and the lubricant are respectively prepared from the following components in parts by weight: 150 parts of egg yolk lecithin, 120 parts of soybean isoflavone, 60 parts of carotene, 400 parts of a filling agent, 180 parts of a disintegrating agent and 25 parts of a lubricating agent.
A preparation method of a high-efficiency lecithin tablet comprises the steps of firstly, selecting materials and mixing; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing;
in the first step, all raw materials are respectively sieved, and then 150 parts of egg yolk lecithin, 120 parts of soybean isoflavone, 60 parts of carotene, 400 parts of filler, 180 parts of disintegrant and 25 parts of lubricant are respectively weighed, wherein the filler is one of compressible starch, corn starch or dextrin; the lubricant is one of magnesium stearate, silicon dioxide or talcum powder;
in the second step, the weighed egg yolk lecithin, soybean isoflavone, carotene and filler are mixed and granulated at high speed, and the water content of the dried granules is 0-2%; adding water into the weighed disintegrant for pulping, then stirring at a high speed for granulation, and drying the granules until the moisture content is 0-2%; the disintegrating agent consists of a disintegrating agent A and a disintegrating agent B, wherein the disintegrating agent A is sodium carboxymethyl starch, and the disintegrating agent B is one of hydroxypropyl cellulose, microcrystalline cellulose or polyvidone; the specific using mode of the disintegrating agent is that purified water and the disintegrating agent A are mixed and stirred evenly, and then the disintegrating agent B is added to be stirred and granulated at high speed; the mass ratio of the purified water to the disintegrating agent A is 230: 65, and the mass ratio of the disintegrating agent A to the disintegrating agent B is 65: 140; stirring and granulating at high speed by using a high-efficiency wet mixing granulator;
in the third step, the 2 kinds of granules prepared in the second step are mixed with the weighed lubricant, then tabletting is carried out through a tablet machine, and dust is removed through a screening machine to prepare a lecithin tablet core; the tablet press is one of a single-punch tablet press, a basket tablet press, a rotary tablet press, a sub-high-speed rotary tablet press, a full-automatic high-speed tablet press or a rotary core-spun tablet press;
and in the fourth step, coating the prepared lecithin tablet core with sugar material in a coating machine on the outer surface of the solid pharmaceutical preparation, and drying to ensure that one or more protective layers are tightly adhered outside the lecithin tablet core to prepare the lecithin tablet.
Example 3:
a high-efficiency lecithin tablet comprises the following components in percentage by weight: the egg yolk lecithin, the soybean isoflavone, the carotene, the filling agent, the disintegrating agent and the lubricant are respectively prepared from the following components in parts by weight: 100 parts of egg yolk lecithin, 100 parts of soybean isoflavone, 50 parts of carotene, 350 parts of a filling agent, 150 parts of a disintegrating agent and 20 parts of a lubricating agent.
A preparation method of a high-efficiency lecithin tablet comprises the steps of firstly, selecting materials and mixing; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing;
in the first step, all raw materials are respectively sieved, and then 100 parts of egg yolk lecithin, 100 parts of soybean isoflavone, 50 parts of carotene, 350 parts of filler, 150 parts of disintegrant and 20 parts of lubricant are respectively weighed, wherein the filler is one of compressible starch, corn starch or dextrin; the lubricant is one of magnesium stearate, silicon dioxide or talcum powder;
in the second step, the weighed egg yolk lecithin, soybean isoflavone, carotene and filler are mixed and granulated at high speed, and the water content of the dried granules is 0-2%; adding water into the weighed disintegrant for pulping, then stirring at a high speed for granulation, and drying the granules until the moisture content is 0-2%; the disintegrating agent consists of a disintegrating agent A and a disintegrating agent B, wherein the disintegrating agent A is sodium carboxymethyl starch, and the disintegrating agent B is one of hydroxypropyl cellulose, microcrystalline cellulose or polyvidone; the specific using mode of the disintegrating agent is that purified water and the disintegrating agent A are mixed and stirred evenly, and then the disintegrating agent B is added to be stirred and granulated at high speed; the mass ratio of the purified water to the disintegrating agent A is 200: 60, and the mass ratio of the disintegrating agent A to the disintegrating agent B is 60: 130; stirring and granulating at high speed by using a high-efficiency wet mixing granulator;
in the third step, the 2 kinds of granules prepared in the second step are mixed with the weighed lubricant, then tabletting is carried out through a tablet machine, and dust is removed through a screening machine to prepare a lecithin tablet core; the tablet press is one of a single-punch tablet press, a basket tablet press, a rotary tablet press, a sub-high-speed rotary tablet press, a full-automatic high-speed tablet press or a rotary core-spun tablet press;
and in the fourth step, coating the prepared lecithin tablet core with sugar material in a coating machine on the outer surface of the solid pharmaceutical preparation, and drying to ensure that one or more protective layers are tightly adhered outside the lecithin tablet core to prepare the lecithin tablet.
The properties of the examples are compared in the following table:
based on the above, compared with the traditional dry mixing granulation process and the traditional wet mixing granulation process, the method adopts the high-efficiency wet mixing granulator and the coating process, and solves the problems that the tablet core of the lecithin tablet is easy to loose and fall off; through the matching use of the egg yolk lecithin, the soybean isoflavone and the carotene, the lecithin tablet has the advantages of improving the absorption efficiency of human bodies to the lecithin, adjusting the glycometabolism balance of the human bodies and providing necessary vitamins for the human bodies.
The lecithin tablets prepared in examples 1 to 3 were tested by a BJ-2 disintegration time tester according to the disintegration time test method of 0921 in the fourth part of pharmacopoeia 2015, the disintegration time of the yolk lecithin tablet in this example was 12 to 25 minutes, and the hardness of the yolk lecithin tablet in this example was 45 as measured by a YPD-200C tablet hardness tester.
The lecithin tablets prepared in examples 1 to 3 were subjected to a high temperature test (temperature 60 ℃), a high humidity test (temperature 25 ℃; humidity 90% + -5%), a high light test (illumination intensity 4500lx + -500 lx), an accelerated test (temperature 40 ℃ + -2 ℃; humidity 75% + -5%), and a long term test (temperature 25 ℃ + -2 ℃; humidity 60% + -10%). The experimental result proves that the yolk lecithin tablet prepared by the method has stable quality under the environment of high temperature, high humidity and illumination; under the acceleration condition, the characters, the contents and the related substances change slightly, the disintegration time is slightly increased, and the test results of 1, 2, 3 and 6 months of acceleration meet the quality standard requirements. The yolk lecithin tablet prepared by the method has stable quality at room temperature, has no obvious change in various indexes in 24 months, and meets the requirements of various investigation indexes in 24 months of room-temperature sealed storage.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Claims (7)
1. A high-efficiency lecithin tablet comprises the following components in percentage by weight: egg yolk lecithin, soybean isoflavone, carotene, a filling agent, a disintegrating agent and a lubricating agent, and is characterized in that: the weight parts of the components are respectively as follows: 230 portions of 100-230 portions of yolk lecithin, 150 portions of 100-150 portions of soybean isoflavone, 50-75 portions of carotene, 500 portions of 350-200 portions of filling agent, 150-200 portions of disintegrating agent and 20-35 portions of lubricating agent.
2. A preparation method of a high-efficiency lecithin tablet comprises the steps of firstly, selecting materials and mixing; step two, mixing and granulating; step three, manufacturing a tablet core; step four, coating processing; the method is characterized in that:
wherein in the first step, firstly, all raw materials are respectively sieved, and then 100-230 parts of yellow lecithin, 100-150 parts of soybean isoflavone, 50-75 parts of carotene, 350-500 parts of filling agent, 150-200 parts of disintegrating agent and 20-35 parts of lubricant are respectively weighed;
in the second step, the weighed egg yolk lecithin, soybean isoflavone, carotene and filler are mixed and granulated at high speed, and the water content of the dried granules is 0-2%; adding water into the weighed disintegrant for pulping, then stirring at a high speed for granulation, and drying the granules until the moisture content is 0-2%;
in the third step, the 2 kinds of granules prepared in the second step are mixed with the weighed lubricant, then tabletting is carried out through a tablet machine, and dust is removed through a screening machine to prepare a lecithin tablet core;
and in the fourth step, coating the prepared lecithin tablet core with sugar material in a coating machine on the outer surface of the solid pharmaceutical preparation, and drying to ensure that one or more protective layers are tightly adhered outside the lecithin tablet core to prepare the lecithin tablet.
3. The method for preparing the high-efficiency lecithin tablet according to claim 2, wherein the method comprises the following steps: in the first step, the filling agent is one of compressible starch, corn starch or dextrin; the lubricant is one of magnesium stearate, silicon dioxide or talcum powder.
4. The method for preparing the high-efficiency lecithin tablet according to claim 2, wherein the method comprises the following steps: the disintegrating agent in the second step consists of a disintegrating agent A and a disintegrating agent B, wherein the disintegrating agent A is sodium carboxymethyl starch, and the disintegrating agent B is one of hydroxypropyl cellulose, microcrystalline cellulose or polyvidone; the specific using mode of the disintegrating agent is to mix purified water and the disintegrating agent A into slurry and stir the slurry evenly, and then add the disintegrating agent B into the slurry and stir the slurry at a high speed for granulation.
5. The method for preparing the high-efficiency lecithin tablet according to claim 2, wherein the method comprises the following steps: in the second step, the mass ratio of the purified water to the disintegrating agent A is 200-250: 60-75, and the mass ratio of the disintegrating agent A to the disintegrating agent B is 60-75: 130-150.
6. The method for preparing the high-efficiency lecithin tablet according to claim 2, wherein the method comprises the following steps: and in the second step, a high-speed stirring granulation is carried out by using a high-efficiency wet mixing granulator.
7. The method for preparing the high-efficiency lecithin tablet according to claim 2, wherein the method comprises the following steps: in the third step, the tablet press is one of a single-punch tablet press, a basket-type tablet press, a rotary tablet press, a sub-high-speed rotary tablet press, a full-automatic high-speed tablet press or a rotary core-spun tablet press.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112674344A (en) * | 2021-01-21 | 2021-04-20 | 江苏曼氏生物科技股份有限公司 | Phospholipid granule and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106974894A (en) * | 2017-04-24 | 2017-07-25 | 哈尔滨瀚钧药业有限公司 | A kind of egg yolk lecithin piece and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106974894A (en) * | 2017-04-24 | 2017-07-25 | 哈尔滨瀚钧药业有限公司 | A kind of egg yolk lecithin piece and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112674344A (en) * | 2021-01-21 | 2021-04-20 | 江苏曼氏生物科技股份有限公司 | Phospholipid granule and preparation method thereof |
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