CN106983727B - Letrozole tablet and preparation method thereof - Google Patents
Letrozole tablet and preparation method thereof Download PDFInfo
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- CN106983727B CN106983727B CN201710396275.5A CN201710396275A CN106983727B CN 106983727 B CN106983727 B CN 106983727B CN 201710396275 A CN201710396275 A CN 201710396275A CN 106983727 B CN106983727 B CN 106983727B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The invention discloses a letrozole tablet and a preparation method thereof, wherein the letrozole tablet comprises the following raw materials: 30-50 parts of letrozole, 60-80 parts of starch, 45-57 parts of carrageenan, 150 parts of binder, 15-22 parts of disintegrant, 17-32 parts of magnesium stearate, 8-15 parts of talcum powder, 3-9 parts of white oil, 16-27 parts of magnesium hydrogen phosphate and 6-15 parts of glycerol; the preparation method comprises mixing trozole with binder, adding glycerol, evaporating to dryness, sieving, adding starch, carrageenan, disintegrating agent, magnesium stearate, pulvis Talci, magnesium hydrogen phosphate and white oil, mixing, and tabletting. The letrozole tablets have the advantages of good dissolution, strong stability, less impurities after long-time placement, and effective reduction of sticking problem during preparation, so that the letrozole tablets have smooth and flat surfaces and no defects; in addition, the preparation method is simple, strong in operability, safe and environment-friendly.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to letrozole tablets and a preparation method thereof.
Background
Breast cancer is one of the major tumors threatening the health of women, and the incidence rate accounts for about 30% of malignant tumors, and the mortality rate accounts for about 15%. In recent years, the incidence of breast cancer in China is gradually increased, the breast cancer has the development tendency of youth and urban and rural development, and the prevention and treatment work is far and hard. Endocrine therapy, one of the important therapeutic means for breast cancer, undergoes the development processes of adrenal gland resection, ovariectomy, androgen, estrogen, progestin, antiestrogen, aromatase inhibitor treatment and the like. Letrozole is a new generation aromatase inhibitor, is an artificially synthesized benzyl triazole derivative, and can reduce the level of estrogen E2 by inhibiting aromatase, thereby eliminating the stimulation of estrogen on the growth of tumors. However, compared with other aromatase inhibitors and anti-hormonal drugs, letrozole has stronger anti-tumor effect, but has poor water solubility, and is easy to have a sticking phenomenon during preparation.
Disclosure of Invention
The purpose of the invention is as follows: the first purpose of the invention is to provide letrozole tablets which have strong stability and good dissolution rate and can effectively reduce the sticking problem during preparation;
the second purpose of the invention is to provide a preparation method of the letrozole tablet.
The technical scheme is as follows: the letrozole tablets comprise the following raw materials in parts by weight: 30-50 parts of letrozole, 60-80 parts of starch, 45-57 parts of carrageenan, 150-210 parts of binder, 15-22 parts of disintegrant, 17-32 parts of magnesium stearate, 8-15 parts of talcum powder, 3-9 parts of white oil, 16-27 parts of magnesium hydrogen phosphate and 6-15 parts of glycerol.
Firstly, the carrageenan is added into the raw materials and combined with the binder, so that the binding power among particles can be effectively improved, and the sticking is reduced. Preferably, the carrageenan may be 50-54 parts. The binder may comprise starch slurry, ethanol, hydroxypropyl cellulose or hypromellose.
In addition, the white oil is added and combined with the magnesium stearate, so that the lubricating effect of the magnesium stearate is effectively improved, and the magnesium stearate is uniformly distributed, so that the binding force between a punch and a tablet is reduced and the sticking is reduced when the letrozole tablet is prepared. Preferably, the white oil can be 5-8 parts.
In addition, the invention also adds glycerin which can effectively absorb the water in the granules to ensure that the granules are dry and wet uniformly, thereby preventing the tablets from being too soft and reducing the sticking phenomenon when the tablets are made. The stability of the letrozole tablets is effectively improved by adding magnesium hydrogen phosphate. Preferably, the glycerol can be 8-12 parts, and the magnesium hydrogen phosphate can be 20-25 parts.
The invention adopts the mixture of sodium carboxymethyl starch and croscarmellose sodium as the disintegrating agent, and the two agents are combined, so that the disintegrating effect can be fully exerted, and the dissolution performance of the letrozole tablets is improved. Furthermore, the weight portion of the sodium carboxymethyl starch and the cross-linked sodium carboxymethyl cellulose can be 5-16: 1, and preferably 8-12: 1.
The method for preparing the letrozole tablets comprises the following steps: mixing the trozole and the binder according to the weight parts, adding the glycerol, drying by distillation, sieving, adding the starch, the carrageenan, the disintegrant, the magnesium stearate, the talcum powder, the magnesium hydrogen phosphate and the white oil, mixing uniformly, and tabletting.
Furthermore, the sieving of the invention adopts an 80-mesh sieve.
Has the advantages that: compared with the prior art, the invention has the following remarkable advantages: the letrozole tablet has good dissolution rate, strong stability and less impurities after being placed for a long time, and can effectively reduce the sticking problem during preparation, so that the letrozole tablet has a smooth and flat surface without defects; in addition, the preparation method is simple, strong in operability, safe and environment-friendly.
Detailed Description
The technical solution of the present invention will be described in detail with reference to examples.
Example 1
Raw materials: 40 parts of letrozole, 70 parts of starch, 50 parts of carrageenan, 180 parts of starch slurry, 18 parts of disintegrating agent, 25 parts of magnesium stearate, 12 parts of talcum powder, 5 parts of white oil, 20 parts of magnesium hydrogen phosphate and 12 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The preparation method comprises the following steps: mixing trozole and starch slurry, adding glycerol, evaporating to dryness, sieving with 80 mesh sieve, adding starch, carrageenan, disintegrating agent, magnesium stearate, pulvis Talci, magnesium hydrogen phosphate and white oil, mixing, and tabletting.
Example 2
Raw materials: 38 parts of letrozole, 65 parts of starch, 54 parts of carrageenan, 200 parts of ethanol, 20 parts of disintegrating agent, 20 parts of magnesium stearate, 10 parts of talcum powder, 8 parts of white oil, 25 parts of magnesium hydrogen phosphate and 8 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 12: 1.
The preparation method comprises the following steps: mixing trozole and ethanol, adding glycerol, evaporating to dryness, sieving with 80 mesh sieve, adding starch, carrageenan, disintegrating agent, magnesium stearate, pulvis Talci, magnesium hydrogen phosphate and white oil, mixing, and tabletting.
Example 3
Raw materials: 30 parts of letrozole, 80 parts of starch, 45 parts of carrageenan, 210 parts of hydroxypropyl cellulose, 15 parts of disintegrating agent, 32 parts of magnesium stearate, 8 parts of talcum powder, 9 parts of white oil, 16 parts of magnesium hydrogen phosphate and 15 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium in a weight ratio of 5: 1.
The preparation method comprises the following steps: mixing trozole and hydroxypropyl cellulose, adding glycerol, evaporating to dryness, sieving with 80 mesh sieve, adding starch, carrageenan, disintegrating agent, magnesium stearate, pulvis Talci, magnesium hydrogen phosphate and white oil, mixing, and tabletting.
Example 4
Raw materials: 50 parts of letrozole, 60 parts of starch, 57 parts of carrageenan, 150 parts of hydroxypropyl methylcellulose, 22 parts of disintegrating agent, 17 parts of magnesium stearate, 15 parts of talcum powder, 3 parts of white oil, 27 parts of magnesium hydrogen phosphate and 6 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 16: 1.
The preparation method comprises the following steps: mixing trozole and hypromellose, adding glycerol, evaporating to dryness, sieving with 80 mesh sieve, adding starch, carrageenan, disintegrating agent, magnesium stearate, pulvis Talci, magnesium hydrogen phosphate and white oil, mixing, and tabletting.
Performance detection
The content, related substances and dissolution are measured by high performance liquid chromatography according to the appendix of the second part of the Chinese pharmacopoeia, 2010 edition.
The letrozole tablets obtained in examples 1 to 4 were subjected to the performance test, and the results obtained are shown in Table 1.
Table 1:
as can be seen from Table 1, the letrozole tablets prepared by the raw material components and the preparation method of the invention have high dissolution rate, the dissolution rate of 20min can reach 95%, the surface is smooth, flat and free of defects, the sticking problem is obviously reduced, and meanwhile, the letrozole tablets have strong stability, and the content of related substances is not obviously improved after being placed for a long time.
Comparative example 1
The basic steps are basically the same as the embodiment, except that no carrageenan is added into the raw materials, and specifically the method comprises the following steps: raw materials: 40 parts of letrozole, 70 parts of starch, 180 parts of starch slurry, 18 parts of disintegrating agent, 25 parts of magnesium stearate, 12 parts of talcum powder, 5 parts of white oil, 20 parts of magnesium hydrogen phosphate and 12 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The letrozole tablets prepared in comparative example 1 were subjected to the performance test, and the results obtained are shown in table 2.
Table 2:
table 2 shows that carrageenan is not added to the raw materials, which not only reduces the dissolution rate of the letrozole tablet, but also weakens the stability relatively, and during preparation, the carrageenan is bonded, so that the surface of the tablet is not smooth and flat, and the tablet is scratched.
Comparative example 2
The basic steps are basically the same as the examples, except that the raw materials are not added with white oil, and specifically, the method comprises the following steps: raw materials: 40 parts of letrozole, 70 parts of starch, 50 parts of carrageenan, 180 parts of starch slurry, 18 parts of disintegrating agent, 25 parts of magnesium stearate, 12 parts of talcum powder, 20 parts of magnesium hydrogen phosphate and 12 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The letrozole tablets prepared in comparative example 2 were subjected to the performance test, and the results obtained are shown in table 3.
Table 3:
it can be seen from table 3 that, since the white oil is not added to the raw materials, not only is the dissolution rate of the letrozole tablet greatly reduced and the stability is weakened, but also sticking occurs during preparation, so that the surface of the tablet is not smooth and flat and has a defect, because magnesium stearate and talcum powder are respectively used as a lubricant and a glidant, when the magnesium stearate and the talcum powder are used simultaneously, the magnesium stearate does not have a flow aiding effect, the lubricating effect of the talcum powder is poor, the talcum powder interferes with the lubricating effect of the magnesium stearate, so that the lubricating effect of the magnesium stearate is reduced, at the moment, the white oil is added, the lubricating effect of the magnesium stearate can be effectively improved, the distribution is uniform, and meanwhile, the flow aiding effect of the talcum powder is enhanced, and the white oil, the punch and the tablet are cooperated, so that the binding force.
Comparative example 3
The basic steps are basically the same as the examples, except that glycerin is not added into the raw materials, and specifically, the method comprises the following steps: 40 parts of letrozole, 70 parts of starch, 50 parts of carrageenan, 180 parts of starch slurry, 18 parts of disintegrating agent, 25 parts of magnesium stearate, 12 parts of talcum powder, 5 parts of white oil and 20 parts of magnesium hydrogen phosphate. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The letrozole tablets prepared in comparative example 3 were subjected to the performance test, and the results obtained are shown in table 4.
Table 4:
table 4 shows that glycerin is not added to the raw materials, so that not only is the dissolution rate of the letrozole tablet reduced, but also the stability is weakened, and during preparation, sticking occurs, so that the surface of the tablet is not smooth and flat, and a defect occurs, because the moisture content in the granules is high, the sticking of the tablet is caused by the softness of the tablet, and glycerin is added to the raw materials, so that excessive moisture between the granules can be effectively absorbed, the granules are uniform in dryness and wetness, plasticity among the granules can be increased, the elasticity is reduced, the granules are close to each other, sufficient cohesive force is generated, and the occurrence of sticking is reduced.
Comparative example 4
The basic steps are basically the same as the examples, except that magnesium hydrogen phosphate is not added into the raw materials, and specifically the following steps are included: 40 parts of letrozole, 70 parts of starch, 50 parts of carrageenan, 180 parts of starch slurry, 18 parts of disintegrating agent, 25 parts of magnesium stearate, 12 parts of talcum powder, 5 parts of white oil and 12 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The letrozole tablets prepared in comparative example 4 were subjected to the performance test, and the results obtained are shown in table 5.
Table 5:
as can be seen from Table 5, the addition of magnesium hydrogen phosphate to the raw materials not only reduces the dissolution rate of the letrozole tablets and greatly weakens the stability, but also causes the tablets to have rough and uneven surfaces and flaws due to sticking during preparation, and the addition of magnesium hydrogen phosphate can effectively improve the stability of the letrozole tablets.
Example 5
6 sets of parallel tests were designed, the basic procedure was the same as in example 1, except that the ratio of parts by weight of sodium carboxymethyl starch to parts by weight of croscarmellose sodium in the disintegrant, and the separately prepared letrozole tablets were subjected to performance testing, and the results obtained are shown in Table 6.
Table 6:
as can be seen from table 6, when the mixture of sodium carboxymethyl starch and croscarmellose sodium in the weight ratio range of the present invention is used as a disintegrant, the combination of the two agents can fully exert the disintegrating effect, improve the dissolution performance and stability of letrozole tablets, and effectively prevent the occurrence of sticking problem during the preparation process.
Comparative example 5
The basic steps are the same as those of the embodiment 1, except that the weight parts of the raw materials are as follows: 25 parts of letrozole, 85 parts of starch, 40 parts of carrageenan, 220 parts of starch slurry, 10 parts of disintegrating agent, 35 parts of magnesium stearate, 5 parts of talcum powder, 10 parts of white oil, 15 parts of magnesium hydrogen phosphate and 18 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
Comparative example 6
The basic steps are the same as those of the embodiment 1, except that the weight parts of the raw materials are as follows: 52 parts of letrozole, 55 parts of starch, 60 parts of carrageenan, 140 parts of starch slurry, 25 parts of disintegrating agent, 15 parts of magnesium stearate, 20 parts of talcum powder, 2 parts of white oil, 30 parts of magnesium hydrogen phosphate and 5 parts of glycerol. Wherein the disintegrating agent is sodium carboxymethyl starch and croscarmellose sodium with the weight portion ratio of 8: 1.
The letrozole tablets obtained in comparative examples 5 and 6 were subjected to the performance test, and the results obtained are shown in Table 7.
Table 7:
as can be seen from Table 7, the letrozole tablets prepared by adopting the raw materials in the component content range of the invention and the interaction of the raw materials have good dissolution rate, strong stability and less impurities after being placed for a long time, and simultaneously, the problem of sticking can be effectively reduced during preparation, so that the letrozole tablets have smooth, flat and flawless surfaces.
Claims (9)
1. The letrozole tablets are characterized by comprising the following raw materials in parts by weight: 30-50 parts of letrozole, 60-80 parts of starch, 45-57 parts of carrageenan, 150-210 parts of binder, 15-22 parts of disintegrant, 17-32 parts of magnesium stearate, 8-15 parts of talcum powder, 3-9 parts of white oil, 16-27 parts of magnesium hydrogen phosphate and 6-15 parts of glycerol, wherein the binder comprises starch slurry, hydroxypropyl cellulose or hydroxypropyl methylcellulose.
2. Letrozole tablet according to claim 1, wherein: the disintegrating agent is sodium carboxymethyl starch and cross-linked sodium carboxymethyl cellulose with the weight portion ratio of 5-16: 1.
3. Letrozole tablet according to claim 2, wherein: the weight part ratio of the sodium carboxymethyl starch to the croscarmellose sodium is 8-12: 1.
4. Letrozole tablet according to claim 1, wherein: 50-54 parts of carrageenan.
5. Letrozole tablet according to claim 1, wherein: 5-8 parts of white oil.
6. Letrozole tablet according to claim 1, wherein: 20-25 parts of magnesium hydrogen phosphate.
7. Letrozole tablet according to claim 1, wherein: 8-12 parts of glycerol.
8. A process for preparing letrozole tablets according to any of claims 1 to 7, comprising the steps of: mixing the trozole and the binder according to the weight parts, adding the glycerol, drying by distillation, sieving, adding the starch, the carrageenan, the disintegrant, the magnesium stearate, the talcum powder, the magnesium hydrogen phosphate and the white oil, mixing uniformly, and tabletting.
9. The process for preparing letrozole tablets according to claim 8, wherein: the sieving adopts an 80-mesh sieve.
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103356495A (en) * | 2013-05-03 | 2013-10-23 | 海南林恒制药有限公司 | Letrozole tablet and preparation method thereof |
| CN103566368A (en) * | 2012-08-07 | 2014-02-12 | 日东电工株式会社 | Sheet-like preparation containing allergen and manufacturing method thereof |
| CN103860486A (en) * | 2012-12-10 | 2014-06-18 | 天津市汉康医药生物技术有限公司 | Letrozole orally disintegrating tablets and preparation method |
| CN104146974A (en) * | 2014-08-14 | 2014-11-19 | 杭州华东医药集团新药研究院有限公司 | Composition containing letrozole and preparation method thereof |
| CN104586804A (en) * | 2015-02-13 | 2015-05-06 | 孟红琳 | Preparation method for letrozole tablets with good stability |
| CN106580906A (en) * | 2016-12-23 | 2017-04-26 | 江苏苏南药业实业有限公司 | Compound medicine containing letrozole and preparation method of compound medicine |
-
2017
- 2017-05-27 CN CN201710396275.5A patent/CN106983727B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103566368A (en) * | 2012-08-07 | 2014-02-12 | 日东电工株式会社 | Sheet-like preparation containing allergen and manufacturing method thereof |
| CN103860486A (en) * | 2012-12-10 | 2014-06-18 | 天津市汉康医药生物技术有限公司 | Letrozole orally disintegrating tablets and preparation method |
| CN103356495A (en) * | 2013-05-03 | 2013-10-23 | 海南林恒制药有限公司 | Letrozole tablet and preparation method thereof |
| CN104146974A (en) * | 2014-08-14 | 2014-11-19 | 杭州华东医药集团新药研究院有限公司 | Composition containing letrozole and preparation method thereof |
| CN104586804A (en) * | 2015-02-13 | 2015-05-06 | 孟红琳 | Preparation method for letrozole tablets with good stability |
| CN106580906A (en) * | 2016-12-23 | 2017-04-26 | 江苏苏南药业实业有限公司 | Compound medicine containing letrozole and preparation method of compound medicine |
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