CN116173033B - Piperazine ferulate solid oral preparation and preparation method thereof - Google Patents

Piperazine ferulate solid oral preparation and preparation method thereof Download PDF

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CN116173033B
CN116173033B CN202310302212.4A CN202310302212A CN116173033B CN 116173033 B CN116173033 B CN 116173033B CN 202310302212 A CN202310302212 A CN 202310302212A CN 116173033 B CN116173033 B CN 116173033B
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piperazine ferulate
piperazine
ferulate
solid composition
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CN116173033A (en
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陈湘
林洁希
林尤仁
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Hainan Linheng Pharmaceutical Co ltd
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract

本发明属于固体口服制剂领域，具体涉及阿魏酸哌嗪固体口服制剂及其制备方法。所述的阿魏酸哌嗪固体组合物，包括以下重量份数的组分：阿魏酸哌嗪10‑50份，水溶性螺旋藻多糖10‑20份，壳聚糖5‑15份，微晶纤维素1‑5份，羟丙甲纤维素1‑5份，玉米淀粉10‑50份，预胶化淀粉20‑80份，硬脂酸镁0.5‑3份。本发明所述的阿魏酸哌嗪固体组合物，能够有效提高阿魏酸哌嗪的前期的释放度，并且可以较长时间维持比较平稳的释放，有利于服药后维持平稳的血药浓度，有利于药物的疗效的提升。采用本发明所述的阿魏酸哌嗪固体组合物可用于多种阿魏酸哌嗪固体制剂的制备，其制备方法简单，药物稳定性良好，方便临床使用。The present invention belongs to the field of solid oral preparations, and in particular to piperazine ferulate solid oral preparations and preparation methods thereof. The piperazine ferulate solid composition comprises the following components in parts by weight: 10-50 parts of piperazine ferulate, 10-20 parts of water-soluble spirulina polysaccharides, 5-15 parts of chitosan, 1-5 parts of microcrystalline cellulose, 1-5 parts of hypromellose, 10-50 parts of corn starch, 20-80 parts of pregelatinized starch, and 0.5-3 parts of magnesium stearate. The piperazine ferulate solid composition of the present invention can effectively improve the release degree of piperazine ferulate in the early stage, and can maintain a relatively stable release for a long time, is conducive to maintaining a stable blood drug concentration after taking the medicine, and is conducive to the improvement of the efficacy of the medicine. The piperazine ferulate solid composition of the present invention can be used for the preparation of a variety of piperazine ferulate solid preparations, and its preparation method is simple, and the drug stability is good, which is convenient for clinical use.

Description

Piperazine ferulate solid oral preparation and its preparation method
Technical Field
The invention belongs to the field of solid oral preparations, and in particular relates to a piperazine ferulate solid oral preparation and a preparation method thereof.
Background
Piperazine ferulate is an anticoagulant, and the English name is Piperazine Ferulate. Is often used for clinical adjuvant therapy of nephritis, chronic nephritis, nephrotic syndrome, early uremia, coronary heart disease, cerebral infarction, vasculitis, etc. Because piperazine ferulate is insoluble in water, the piperazine ferulate tablet has long disintegration time, low dissolution rate and low dissolution rate, so the problem that the release of active ingredients is slow in the early stage and the time required for the drug effect to be exerted is long often caused after the medicine is taken. Piperazine ferulate is acidic and is easy to cause gastric diseases, so that it cannot be released too quickly in stomach. Therefore, the release degree of the piperazine ferulate under the gastric acid condition is reasonably controlled, so that the piperazine ferulate can be reasonably released under the gastric acid condition, and the piperazine ferulate has important clinical significance for the exertion of the medicine effect of the piperazine ferulate.
Disclosure of Invention
The invention provides a piperazine ferulate solid oral preparation and a preparation method thereof, which can effectively improve the early-stage release degree of piperazine ferulate under gastric acid condition, can effectively control the reasonable release of piperazine ferulate, and is favorable for keeping the stability and durability of the drug effect after taking the medicine.
The technical scheme of the invention is realized as follows:
The piperazine ferulate solid composition comprises the following components in parts by weight: 10-50 parts of piperazine ferulate, 10-20 parts of water-soluble spirulina polysaccharide, 5-15 parts of chitosan, 1-5 parts of microcrystalline cellulose, 1-5 parts of hydroxypropyl methylcellulose, 10-50 parts of corn starch, 20-80 parts of pregelatinized starch and 0.5-3 parts of magnesium stearate.
Further, the piperazine ferulate solid composition comprises the following components in parts by weight: 50 parts of piperazine ferulate, 15 parts of water-soluble spirulina polysaccharide, 10 parts of chitosan, 3 parts of microcrystalline cellulose, 3 parts of hydroxypropyl methylcellulose, 30 parts of corn starch, 50 parts of pregelatinized starch and 2 parts of magnesium stearate.
Further, the preparation method of the piperazine ferulate solid composition and the water-soluble spirulina polysaccharide comprises the following steps:
Extracting polysaccharide from spirulina dry powder by hot water extraction method after superfine grinding, adding flocculant into the extract, centrifuging to remove protein, concentrating supernatant, adding absolute ethanol, separating to obtain precipitate, and drying to obtain water-soluble spirulina polysaccharide.
The application of the piperazine ferulate solid composition in preparing the piperazine ferulate solid oral preparation.
Furthermore, the piperazine ferulate solid oral preparation is a tablet or a capsule.
Piperazine ferulate tablet comprises the piperazine ferulate solid composition.
A preparation method of piperazine ferulate tablet comprises the following steps:
(1) Superfine pulverizing water-soluble spirulina polysaccharide; piperazine ferulate, chitosan, microcrystalline cellulose, hypromellose, corn starch, pregelatinized starch, and micronizing; mixing with pulverized water-soluble spirulina polysaccharide, adding absolute ethanol, granulating, and drying;
(2) And (3) after finishing the dried granules, adding magnesium stearate, uniformly mixing, and tabletting.
Further, the water-soluble spirulina polysaccharide is superfine crushed to a particle size of 30-50 mu m.
Further, the piperazine ferulate, sodium carboxymethyl cellulose, sodium dodecyl sulfate, polyethylene glycol, citric acid and pregelatinized starch are superfine crushed to a particle size of less than or equal to 50 mu m.
The beneficial effects are that:
The piperazine ferulate solid composition can effectively improve the early-stage release degree of piperazine ferulate by improving the ingredient composition, can maintain stable release for a long time, is favorable for maintaining stable blood concentration after taking medicine, and is favorable for maintaining the stability of curative effect. The piperazine ferulate solid composition can be used for preparing various piperazine ferulate solid preparations, for example, tablets or capsules can be prepared, the preparation method is simple, the medicine stability is good, and the piperazine ferulate solid composition is convenient for clinical use.
Detailed Description
The invention will be further described with reference to specific embodiments to provide a better understanding of the invention.
Example 1
The piperazine ferulate solid composition comprises the following components in parts by weight: piperazine ferulate 10g, water-soluble spirulina polysaccharide 10g, chitosan 5g, microcrystalline cellulose 1g, hypromellose 1g, corn starch 10g, pregelatinized starch 80g, and magnesium stearate 0.5g.
Example 2
The piperazine ferulate solid composition comprises the following components in parts by weight: 50g of piperazine ferulate, 15g of water-soluble spirulina polysaccharide, 10g of chitosan, 3g of microcrystalline cellulose, 3g of hydroxypropyl methylcellulose, 30g of corn starch, 50g of pregelatinized starch and 2g of magnesium stearate.
Example 3
The piperazine ferulate solid composition comprises the following components in parts by weight: piperazine ferulate 30g, water-soluble spirulina polysaccharide 20g, chitosan 15g, microcrystalline cellulose 5g, hypromellose 5g, corn starch 50g, pregelatinized starch 20g, and magnesium stearate 3g.
In the above examples, the preparation method of the water-soluble spirulina polysaccharide used is as follows:
taking spirulina dry powder, superfine grinding, adding water with the mass of 3-5 times of that of spirulina, heating to 80-90 ℃, extracting polysaccharide by adopting a hot water extraction method, adding a flocculating agent (polymeric ferric sulfate) into the extract, standing for 1-2h, centrifuging to remove protein, concentrating supernatant to 10-20% of the original volume, adding absolute ethyl alcohol with the volume of 2 times, standing, centrifuging to obtain precipitate, and drying to obtain the water-soluble spirulina polysaccharide.
The piperazine ferulate composition described in the above embodiments can be used for preparing various piperazine ferulate solid oral preparations, such as tablets or capsules.
Example 4
The piperazine ferulate tablet adopts the piperazine ferulate solid composition in any one of embodiments 1-3 as a raw material, and the preparation method comprises the following steps:
(1) Superfine pulverizing water-soluble spirulina polysaccharide; piperazine ferulate, chitosan, microcrystalline cellulose, hypromellose, corn starch, pregelatinized starch, and micronizing; mixing with pulverized water-soluble spirulina polysaccharide, adding absolute ethanol, granulating, and drying;
(2) And (3) after finishing the dried granules, adding magnesium stearate, uniformly mixing, and pressing into 1000 tablets.
Wherein the water-soluble spirulina polysaccharide is superfine crushed to an average particle size of 30-50 μm; uniformly mixing piperazine ferulate, sodium carboxymethyl cellulose, sodium dodecyl sulfate, polyethylene glycol and pregelatinized starch, and micronizing to average particle diameter less than or equal to 50 μm
The invention relates to detection of the release degree of piperazine ferulate tablet
The piperazine ferulate solid compositions of 3 examples of the present invention were used as raw materials, respectively, piperazine ferulate tablets prepared by the method of example 4 were used as experimental groups, and the water-soluble spirulina polysaccharide was removed from the formulation of example 2 in the control group 1; the chitosan and pregelatinized starch were removed from the formulation of example 2 in control group 2. The control group was prepared as piperazine ferulate tablets according to the method of example 4, and then the release degree was detected. The release degree detection method is carried out by referring to release degree measurement method (rotary basket) of the sustained release preparation in 2020 edition pharmacopoeia, and the samples are respectively measured at 30, 60, 120, 240, 360, 540 and 720 minutes.
Table 1 results of the release test of piperazine ferulate tablets prepared by different methods (%)
30 60 120 240 360 540 720
Example 1 11.2 20.8 28.4 38.9 58.7 81.8 94.3
Example 2 10.6 19.6 27.8 39.5 60.8 83.5 95.0
Example 3 9.7 18.6 29.4 37.6 54.2 79.6 93.1
Control group 1 5.6 13.7 21.9 35.3 69.7 93.5 98.6
Control group 2 3.8 9.7 19.7 45.8 67.5 90.8 97.6
As can be seen from Table 1, the piperazine ferulate tablets prepared by the 3 examples of the invention can reach about 20% in 60 minutes, which is obviously higher than that of 2 control groups. Meanwhile, the 3 embodiment groups can maintain a relatively stable release rate within 12 hours.
The invention relates to detection of the release degree of piperazine ferulate tablet
Piperazine ferulate tablets are prepared according to the method, and are packaged according to the market, and are placed for 6 months under the conditions of 40 ℃ plus or minus 2 ℃ and 75 ℃ plus or minus 5% RH, and are sampled at the end of 0 th, 1 st, 2 nd, 3 rd and 6 th months respectively for content measurement, and the quality changes of the products are compared.
TABLE 2 accelerated stability test piperazine ferulate tablet content variation (%)
As can be seen from table 2, the piperazine ferulate tablet content of the 3 embodiments of the present invention is not significantly changed through the accelerated stability experiment; the content of piperazine ferulate in the 2 control groups is reduced to different degrees along with the progress of experiments, which proves that the stability of the piperazine ferulate tablet disclosed by the invention is obviously higher than that of the 2 control groups.
The above description of the specific embodiments of the present invention has been given by way of example only, and the present invention is not limited to the above described specific embodiments. Any equivalent modifications and substitutions for the present invention will occur to those skilled in the art, and are also within the scope of the present invention. Accordingly, equivalent changes and modifications are intended to be included within the scope of the present invention without departing from the spirit and scope thereof.

Claims (8)

1. The piperazine ferulate solid composition is characterized by comprising the following components in parts by weight: 10-50 parts of piperazine ferulate, 10-20 parts of water-soluble spirulina polysaccharide, 5-15 parts of chitosan, 1-5 parts of microcrystalline cellulose, 1-5 parts of hydroxypropyl methylcellulose, 10-50 parts of corn starch, 20-80 parts of pregelatinized starch and 0.5-3 parts of magnesium stearate.
2. The piperazine ferulate solid composition of claim 1, wherein the piperazine ferulate solid composition comprises the following components in parts by weight: 50 parts of piperazine ferulate, 15 parts of water-soluble spirulina polysaccharide, 10 parts of chitosan, 3 parts of microcrystalline cellulose, 3 parts of hydroxypropyl methylcellulose, 30 parts of corn starch, 50 parts of pregelatinized starch and 2 parts of magnesium stearate.
3. The piperazine ferulate solid composition of claim 1, wherein the preparation method of the piperazine ferulate solid composition comprises the following steps:
Extracting polysaccharide from spirulina dry powder by hot water extraction method after superfine grinding, adding flocculant into the extract, centrifuging to remove protein, concentrating supernatant, adding absolute ethanol, separating to obtain precipitate, and drying to obtain water-soluble spirulina polysaccharide.
4. Use of the piperazine ferulate solid composition of any one of claims 1-3 for the preparation of a piperazine ferulate solid oral preparation.
5. The use according to claim 4, wherein the piperazine ferulate solid oral preparation is a tablet or a capsule.
6. Piperazine ferulate tablet, characterized by comprising the piperazine ferulate solid composition of any one of claims 1-3.
7. The method for preparing piperazine ferulate tablet of claim 6, comprising the steps of:
(1) Superfine pulverizing water-soluble spirulina polysaccharide; piperazine ferulate, chitosan, microcrystalline cellulose, hypromellose, corn starch, pregelatinized starch, and micronizing; mixing with pulverized water-soluble spirulina polysaccharide, adding absolute ethanol, granulating, and drying;
(2) And (3) after finishing the dried granules, adding magnesium stearate, uniformly mixing, and tabletting.
8. The method of manufacturing according to claim 7, wherein: the water-soluble spirulina polysaccharide is superfine crushed to a particle size of 30-50 mu m.
CN202310302212.4A 2023-03-27 2023-03-27 Piperazine ferulate solid oral preparation and preparation method thereof Active CN116173033B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU5750100A (en) * 1999-06-18 2001-01-09 University Of Medicine And Dentistry Of New Jersey Controlled release of therapeutics by in-situ entrapment by matrix cross-linking
CN101491493A (en) * 2008-01-25 2009-07-29 成都摩尔生物医药有限公司 Ferulic acid piperazine slow-release medicine preparation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1433761A (en) * 2003-02-21 2003-08-06 李红洁 Piperazine ferulate slow-released, control-released agent
CN100563637C (en) * 2006-10-13 2009-12-02 北京红林制药有限公司 A kind of medicated core compositions of controlled release drug administration and controlled release preparation and preparation method thereof
CN105707072B (en) * 2014-12-03 2018-08-21 中国科学院大连化学物理研究所 A kind of spirulina polysaccharide and its application
WO2021063366A1 (en) * 2019-09-30 2021-04-08 中国科学院上海药物研究所 Drug for treating artery-related diseases, and use thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU5750100A (en) * 1999-06-18 2001-01-09 University Of Medicine And Dentistry Of New Jersey Controlled release of therapeutics by in-situ entrapment by matrix cross-linking
CN101491493A (en) * 2008-01-25 2009-07-29 成都摩尔生物医药有限公司 Ferulic acid piperazine slow-release medicine preparation

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