CN115944598A - Allisartan isoproxil compound preparation and preparation method thereof - Google Patents

Allisartan isoproxil compound preparation and preparation method thereof Download PDF

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Publication number
CN115944598A
CN115944598A CN202310041083.8A CN202310041083A CN115944598A CN 115944598 A CN115944598 A CN 115944598A CN 202310041083 A CN202310041083 A CN 202310041083A CN 115944598 A CN115944598 A CN 115944598A
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allisartan isoproxil
poloxamer
pvp
compound
percent
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CN202310041083.8A
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Chinese (zh)
Inventor
李凳浪
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Wuhan University of Science and Engineering WUSE
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Wuhan University of Science and Engineering WUSE
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses an allisartan isoproxil compound preparation which is prepared from the following raw materials in parts by weight, including 25-55% of allisartan isoproxil, 0.15-0.5% of glidant, 0.2-13% of stabilizer, 4-35% of protective agent, 0.5-4.8% of adhesive, 5-28% of disintegrant and 0.2-3% of lubricant. Compared with the prior art, the invention has the advantages that: the invention can be used for preventing and/or treating hypertension and complications thereof, is also suitable for treating patients with cardiovascular diseases, and improves the compliance of the patients. The alisartan is an angiotensin II receptor antagonist, is a non-peptide precursor drug, and is completely hydrolyzed into a unique pharmacologically active metabolite EXP3174 by esterase in the process of in vivo gastrointestinal tract absorption; the embodiment of the invention can effectively ensure the disintegration and dissolution of the medicine, has stable dissolution rate level and can maintain stable blood concentration, thereby reducing the administration times, prolonging the administration interval and reducing the treatment cost.

Description

Allisartan isoproxil compound preparation and preparation method thereof
Technical Field
The invention relates to the technical field of medical medicines, in particular to an allisartan isoproxil compound preparation and a preparation method thereof.
Background
Cardiovascular and cerebrovascular diseases are the general names of cardiovascular diseases and cerebrovascular diseases, and generally refer to ischemic or hemorrhagic diseases of heart, brain and systemic tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension and the like. Cardiovascular and cerebrovascular diseases are common diseases seriously threatening the health of human beings, particularly the middle-aged and elderly people over 50 years old, and even if the most advanced and perfect treatment means are applied at present, more than 50 percent of the survivors of cerebrovascular accidents can not take care of the life completely! The number of people dying from cardiovascular and cerebrovascular diseases every year in the world is as high as 1500 thousands of people, and the people live at the first position of various causes of death. Cardiovascular and cerebrovascular diseases become the first killer with the highest cause of death for human beings, and are also the soundless and violent in health of people! The cardiovascular and cerebrovascular diseases have the characteristics of high morbidity, high disability rate, high death rate, high recurrence rate and more complications, namely more than four high and more than one high.
The blood vessel wall of the cerebral artery of a person suffering from hypertension for a long time can be thickened or hardened, and the vessel cavity is thinned. When blood pressure rises suddenly, cerebral vessels are easy to rupture and cerebral hemorrhage occurs; or hardened cerebral arterioles form a chestnut-sized microaneurysm, and the microaneurysm breaks down when blood fluctuates, thereby causing cerebral hemorrhage; or the process of hypertension accelerating arteriosclerosis, arterial endothelial cell fluid is damaged, blood platelets are easy to gather at the injured part, and cerebral thrombus is easy to form, so that cardiovascular and cerebrovascular diseases are caused.
Modern life rhythm is tense, pressure of families and public institutions is higher, excessive drinking, too much food fat intake, lack of necessary exercise, pollution of living environment, rapid reduction of anion content in air, and insufficient anion intake in vivo, which directly result in slow metabolism speed of human body, slow blood flow speed, rapid rise of blood viscosity, and insufficient blood supply of heart and brain, and if the prevention and the regulation are not performed in time, cardiovascular and cerebrovascular diseases such as coronary heart disease, hypertension, cerebral thrombosis, fatty liver and the like can be caused.
Controlling blood pressure within a more ideal range is the key to preventing cardiovascular and cerebrovascular diseases. The data show that the incidence rate of cardiovascular and cerebrovascular diseases of hypertension patients insisting on long-term treatment is only 1/10 of that of patients who do not insist on treatment, namely, the cardiovascular and cerebrovascular diseases can be reduced by 90 percent as long as the blood pressure is insisted on for long term treatment.
Disclosure of Invention
The invention aims to overcome the defects of the technology and provides an allisartan isoproxil compound preparation and a preparation method thereof.
In order to solve the technical problems, the technical scheme provided by the invention is that the compound preparation of the allisartan isoproxil comprises the following components: the feed is prepared from the following raw materials in parts by weight: comprises 25 to 55 percent of allisartan isoproxil, 0.15 to 0.5 percent of glidant, 0.2 to 13 percent of stabilizer, 4 to 35 percent of protective agent, 0.5 to 4.8 percent of adhesive, 5 to 28 percent of disintegrant and 0.2 to 3 percent of lubricant.
As an improvement, the glidant is a mixture obtained by mixing one or more than two of magnesium stearate, fumed silica and talcum powder in any proportion.
As an improvement, the stabilizer is one or a mixture of more than two of hydroxypropyl methylcellulose, povidone, poloxamer, arabic gum, xanthan gum, sodium hyaluronate, sodium alginate, carbomer, polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and the like.
As an improvement, the hydroxypropyl methylcellulose in the stabilizer can be HPMC E3, HPMC E5, HPMC E6, HPMC E15 and HPMC E50, the povidone can be PVP K12, PVP K15, PVP K17, PVP K25, PVP K30, PVP K29/32, PVP K60 and PVP K120, and the poloxamer can be F68, poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338 and poloxamer 407.
The improvement is that the protective agent is one or a mixture of more than two of mannitol, glucose, sucrose, sorbitol, lactose, maltose, trehalose, dextran, dodecyl sulfate, hexadecyl sulfate, octadecyl sulfate and poloxamer
As an improvement, the dodecyl sulfate, hexadecyl sulfate and octadecyl sulfate are preferably sodium salt, potassium salt and magnesium salt.
As an improvement, the adhesive comprises one or a mixture of more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, povidone, starch slurry and gelatin.
As an improvement, the disintegrant comprises one or more of croscarmellose sodium, crospovidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, pregelatinized starch, etc
As an improvement, the lubricant comprises one or a mixture of more than two of silicon dioxide, stearic acid, magnesium stearate, polyethylene glycol and hydrogenated castor oil.
A preparation method of an allisartan isoproxil compound preparation comprises the following steps:
s1, screening the allisartan isoproxil in parts by mass through a 120-mesh sieve, and screening other raw materials through a 100-mesh sieve according to the parts by mass for later use;
s2, dissolving the allisartan isoproxil, the stabilizer, the protective agent and the disintegrant into a proper amount of organic solvent to prepare a medicinal solution;
s3, placing the filler in the fluidized bed in parts by mass, spraying the medicine solution, performing fluidized bed spray granulation and drying, and adding the lubricant for mixing to obtain a mixed material;
s4, placing the mixed materials in a wet granulator, spraying an adhesive to prepare a soft material, and then granulating by using a 14-18-mesh nylon screen swing granulator;
s5, placing the prepared wet granules in a dryer, boiling and drying at the air inlet temperature of 55 ℃ to obtain dry granules;
s6, taking the dried particles, and grading the particles by adopting a 25-mesh steel sieve; after finishing the granules, adding a lubricant and a glidant, and mixing the mixture in a three-dimensional mixer for 25 to 35 minutes; and tabletting by adopting a rotary tablet press after mixing to obtain a finished product.
Compared with the prior art, the invention has the advantages that: 1. the invention can be used for preventing and/or treating hypertension and complications thereof, is also suitable for treating patients with cardiovascular diseases, and improves the compliance of the patients. The alisartan is an angiotensin II receptor antagonist, is a non-peptide precursor drug, and is completely hydrolyzed into a unique pharmacologically active metabolite EXP3174 by esterase in the process of in vivo gastrointestinal tract absorption;
2. the embodiment of the invention can effectively ensure the disintegration and dissolution of the medicine, has stable dissolution rate level and can maintain stable blood concentration, thereby reducing the administration times, prolonging the administration interval and reducing the treatment cost.
Detailed Description
The present invention is further described in detail below with reference to a medicament for treating rhinitis.
Example one
An allisartan isoproxil compound preparation: the composition is prepared from the following raw materials in parts by weight: comprises 25 percent of allisartan isoproxil, 0.15 percent of glidant, 0.2 percent of stabilizer, 4 percent of protective agent, 0.5 percent of adhesive, 5 percent of disintegrant and 0.2 percent of lubricant.
The blending ratio between the components is 1 part by mass of the allisartan isoproxil.
The glidant is a mixture obtained by mixing one or more of magnesium stearate, fumed silica and talcum powder in any proportion.
The stabilizer is one or more of hypromellose, polyvidone, poloxamer, acacia, xanthan gum, sodium hyaluronate, sodium alginate, carbomer, polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, etc.
The hydroxypropyl methylcellulose in the stabilizing agent can be HPMC E3, HPMC E5, HPMC E6, HPMC E15 and HPMC E50, the povidone can be PVP K12, PVP K15, PVP K17, PVP K25, PVP K30, PVP K29/32, PVP K60 and PVP K120, and the poloxamer can be F68, poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338 or poloxamer 407.
The protective agent is one or more of mannitol, glucose, sucrose, sorbitol, lactose, maltose, trehalose, dextran, dodecyl sulfate, hexadecyl sulfate, octadecyl sulfate, and poloxamer
The dodecyl sulfate, hexadecyl sulfate and octadecyl sulfate are preferably sodium salt, potassium salt and magnesium salt.
The adhesive comprises one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, polyvidone, starch slurry and gelatin.
The disintegrant comprises one or more of croscarmellose sodium, crospovidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, pregelatinized starch, etc
The lubricant comprises one or more of silicon dioxide, stearic acid, magnesium stearate, polyethylene glycol and hydrogenated castor oil.
A preparation method of an allisartan isoproxil compound preparation comprises the following steps:
s1, screening the allisartan isoproxil in parts by mass through a 120-mesh sieve, and screening other raw materials through a 100-mesh sieve according to the parts by mass for later use;
s2, dissolving the allisartan isoproxil, the stabilizing agent, the protective agent and the disintegrating agent in a proper amount of organic solvent to prepare a medicinal solution;
s3, placing the filler in the fluidized bed in parts by mass, spraying the medicine solution, performing fluidized bed spray granulation drying, and adding the lubricant for mixing to obtain a mixed material;
s4, placing the mixed materials in a wet granulator, spraying an adhesive to prepare a soft material, and then granulating by using a 14-18-mesh nylon screen swing granulator;
s5, placing the prepared wet particles in a dryer, and boiling and drying at the air inlet temperature of 55 ℃ to obtain dry particles;
s6, taking the dried particles, and finishing the particles by adopting a 25-mesh steel screen; after finishing the granules, adding a lubricant and a glidant, and mixing the mixture in a three-dimensional mixer for 25 to 35 minutes; and tabletting by adopting a rotary tablet press after mixing to obtain a finished product.
Example two
An allisartan isoproxil compound preparation: the feed is prepared from the following raw materials in parts by weight: comprises 40 percent of allisartan isoproxil, 0.3 percent of glidant, 6 percent of stabilizer, 19 percent of protective agent, 2.6 percent of adhesive, 16 percent of disintegrant and 1.6 percent of lubricant.
The blending ratio between the components is 1 part by mass of the allisartan isoproxil.
The glidant is a mixture obtained by mixing one or more than two of magnesium stearate, fumed silica and talcum powder in any proportion.
The stabilizer is one or more of hypromellose, polyvidone, poloxamer, acacia, xanthan gum, sodium hyaluronate, sodium alginate, carbomer, polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, etc.
The hydroxypropyl methylcellulose in the stabilizing agent can be HPMC E3, HPMC E5, HPMC E6, HPMC E15 and HPMC E50, the povidone can be PVP K12, PVP K15, PVP K17, PVP K25, PVP K30, PVP K29/32, PVP K60 and PVP K120, and the poloxamer can be F68, poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338 or poloxamer 407.
The protective agent is one or more of mannitol, glucose, sucrose, sorbitol, lactose, maltose, trehalose, dextran, dodecyl sulfate, hexadecyl sulfate, octadecyl sulfate, and poloxamer
The dodecyl sulfate, hexadecyl sulfate and octadecyl sulfate are preferably sodium salt, potassium salt and magnesium salt.
The adhesive comprises one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, polyvidone, starch slurry and gelatin.
The disintegrant comprises one or more of croscarmellose sodium, crospovidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, pregelatinized starch, etc
The lubricant comprises one or more of silicon dioxide, stearic acid, magnesium stearate, polyethylene glycol and hydrogenated castor oil.
A preparation method of an allisartan isoproxil compound preparation comprises the following steps:
s1, screening the allisartan isoproxil in parts by mass through a 120-mesh sieve, and screening other raw materials through a 100-mesh sieve according to the parts by mass for later use;
s2, dissolving the allisartan isoproxil, the stabilizer, the protective agent and the disintegrant into a proper amount of organic solvent to prepare a medicinal solution;
s3, placing the filler in the fluidized bed in parts by mass, spraying the medicine solution, performing fluidized bed spray granulation drying, and adding the lubricant for mixing to obtain a mixed material;
s4, placing the mixed materials in a wet granulator, spraying an adhesive to prepare a soft material, and then granulating by using a 14-18-mesh nylon screen swing granulator;
s5, placing the prepared wet granules in a dryer, boiling and drying at the air inlet temperature of 55 ℃ to obtain dry granules;
s6, taking the dried particles, and finishing the particles by adopting a 25-mesh steel screen; after finishing the granules, adding a lubricant and a flow aid, and placing the mixture into a three-dimensional mixer for mixing for 25 to 35 minutes; and tabletting by adopting a rotary tablet press after mixing to obtain a finished product.
EXAMPLE III
An allisartan isoproxil compound preparation: the composition is prepared from the following raw materials in parts by weight: comprises 55% of allisartan isoproxil, 0.5% of glidant, 13% of stabilizer, 35% of protective agent, 4.8% of adhesive, 28% of disintegrant and 3% of lubricant.
The blending ratio between the components is 1 part by mass of the allisartan isoproxil.
The glidant is a mixture obtained by mixing one or more than two of magnesium stearate, fumed silica and talcum powder in any proportion.
The stabilizer is one or more of hypromellose, polyvidone, poloxamer, acacia, xanthan gum, sodium hyaluronate, sodium alginate, carbomer, polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, etc.
The hydroxypropyl methylcellulose in the stabilizer can be HPMC E3, HPMC E5, HPMC E6, HPMC E15 and HPMC E50, the povidone can be PVP K12, PVP K15, PVP K17, PVP K25, PVP K30, PVP K29/32, PVP K60 and PVP K120, and the poloxamer can be F68, poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338 and poloxamer 407.
The protective agent is one or more of mannitol, glucose, sucrose, sorbitol, lactose, maltose, trehalose, dextran, dodecyl sulfate, hexadecyl sulfate, octadecyl sulfate, and poloxamer
The dodecyl sulfate, hexadecyl sulfate and octadecyl sulfate are preferably sodium salt, potassium salt and magnesium salt.
The adhesive comprises one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, polyvidone, starch slurry and gelatin.
The disintegrant comprises one or more of croscarmellose sodium, crospovidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, starch, pregelatinized starch, etc
The lubricant comprises one or a mixture of more than two of silicon dioxide, stearic acid, magnesium stearate, polyethylene glycol and hydrogenated castor oil.
A preparation method of an allisartan isoproxil compound preparation comprises the following steps:
s1, screening the allisartan isoproxil in parts by mass through a 120-mesh sieve, and screening other raw materials through a 100-mesh sieve according to the parts by mass for later use;
s2, dissolving the allisartan isoproxil, the stabilizer, the protective agent and the disintegrant into a proper amount of organic solvent to prepare a medicinal solution;
s3, placing the filler in the fluidized bed in parts by mass, spraying the medicine solution, performing fluidized bed spray granulation drying, and adding the lubricant for mixing to obtain a mixed material;
s4, placing the mixed materials in a wet granulator, spraying an adhesive to prepare a soft material, and then granulating by using a 14-18-mesh nylon screen swing granulator;
s5, placing the prepared wet granules in a dryer, boiling and drying at the air inlet temperature of 55 ℃ to obtain dry granules;
s6, taking the dried particles, and finishing the particles by adopting a 25-mesh steel screen; after finishing the granules, adding a lubricant and a glidant, and mixing the mixture in a three-dimensional mixer for 25 to 35 minutes; and tabletting by adopting a rotary tablet press after mixing to obtain a finished product.
The present invention and the embodiments thereof have been described above, but the description is not limited thereto, and the embodiment shown is only one of the embodiments of the present invention, and the actual configuration is not limited thereto. In summary, those skilled in the art should appreciate that they can readily use the disclosed conception and specific embodiments as a basis for designing or modifying other structures for carrying out the same purposes of the present invention without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (10)

1. The compound allisartan isoproxil preparation is characterized by being prepared from the following raw materials in parts by weight: comprises 25 to 55 percent of allisartan isoproxil, 0.15 to 0.5 percent of glidant, 0.2 to 13 percent of stabilizer, 4 to 35 percent of protective agent, 0.5 to 4.8 percent of adhesive, 5 to 28 percent of disintegrant and 0.2 to 3 percent of lubricant.
2. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the glidant is a mixture obtained by mixing one or more of magnesium stearate, fumed silica and talcum powder in any proportion.
3. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the stabilizer is one or more of hypromellose, polyvidone, poloxamer, acacia, xanthan gum, sodium hyaluronate, sodium alginate, carbomer, polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, etc.
4. The compound allisartan isoproxil preparation according to claim 3, which is characterized in that: the hydroxypropyl methylcellulose in the stabilizing agent can be HPMC E3, HPMC E5, HPMC E6, HPMC E15 and HPMC E50, the povidone can be PVP K12, PVP K15, PVP K17, PVP K25, PVP K30, PVP K29/32, PVP K60 and PVP K120, and the poloxamer can be F68, poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338 or poloxamer 407.
5. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the protective agent is one or a mixture of more than two of mannitol, glucose, sucrose, sorbitol, lactose, maltose, trehalose, dextran, dodecyl sulfate, hexadecyl sulfate, octadecyl sulfate and poloxamer.
6. The compound allisartan isoproxil preparation according to claim 5, which is characterized in that: the dodecyl sulfate, hexadecyl sulfate and octadecyl sulfate are preferably sodium salt, potassium salt and magnesium salt.
7. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the adhesive comprises one or more of hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, polyvidone, starch slurry and gelatin.
8. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the disintegrant comprises one or more of croscarmellose sodium, crospovidone, sodium starch glycolate, low-substituted hydroxypropyl cellulose, starch, pregelatinized starch, etc.
9. The compound allisartan isoproxil preparation according to claim 1, which is characterized in that: the lubricant comprises one or more of silicon dioxide, stearic acid, magnesium stearate, polyethylene glycol and hydrogenated castor oil.
10. The preparation method of the compound allisartan isoproxil preparation is characterized by comprising the following steps:
s1, screening the allisartan isoproxil in parts by mass through a 120-mesh sieve, and screening other raw materials through a 100-mesh sieve according to the parts by mass for later use;
s2, dissolving the allisartan isoproxil, the stabilizing agent, the protective agent and the disintegrating agent in a proper amount of organic solvent to prepare a medicinal solution;
s3, placing the filler in the fluidized bed in parts by mass, spraying the medicine solution, performing fluidized bed spray granulation drying, and adding the lubricant for mixing to obtain a mixed material;
s4, placing the mixed materials in a wet granulator, spraying an adhesive to prepare a soft material, and then granulating by using a 14-18-mesh nylon screen swing granulator;
s5, placing the prepared wet granules in a dryer, boiling and drying at the air inlet temperature of 55 ℃ to obtain dry granules;
s6, taking the dried particles, and finishing the particles by adopting a 25-mesh steel screen; after finishing the granules, adding a lubricant and a glidant, and mixing the mixture in a three-dimensional mixer for 25 to 35 minutes; and tabletting by adopting a rotary tablet press after mixing to obtain a finished product.
CN202310041083.8A 2023-01-13 2023-01-13 Allisartan isoproxil compound preparation and preparation method thereof Pending CN115944598A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107441048A (en) * 2016-05-31 2017-12-08 深圳信立泰药业股份有限公司 A kind of A Lishatan esters pharmaceutical composition and the preparation containing the pharmaceutical composition and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107441048A (en) * 2016-05-31 2017-12-08 深圳信立泰药业股份有限公司 A kind of A Lishatan esters pharmaceutical composition and the preparation containing the pharmaceutical composition and preparation method thereof

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