CN113197941A - Eplerenone pharmaceutical composition, and preparation method and application thereof - Google Patents
Eplerenone pharmaceutical composition, and preparation method and application thereof Download PDFInfo
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- CN113197941A CN113197941A CN202110412653.0A CN202110412653A CN113197941A CN 113197941 A CN113197941 A CN 113197941A CN 202110412653 A CN202110412653 A CN 202110412653A CN 113197941 A CN113197941 A CN 113197941A
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- eplerenone
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- pharmaceutical composition
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- 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
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Abstract
The invention discloses an eplerenone pharmaceutical composition and application thereof, belonging to the technical field of medicines. The pharmaceutical composition comprises the following raw materials: eplerenone, white peony root and sunflower disc. The preparation method comprises the following steps: s1, crushing the white paeony root and the sunflower disc to obtain fine powder; s2, adding an ethanol water solution into the fine powder obtained in the step S1, extracting in a water bath to obtain an extracting solution, concentrating the extracting solution under reduced pressure, drying, and grinding to obtain a traditional Chinese medicine component; s3, mixing the traditional Chinese medicine components and eplerenone obtained in the step S2 uniformly to obtain the eplerenone pharmaceutical composition. By combining eplerenone, white paeony root and sunflower disc, the activity of eplerenone can be improved, the dosage is reduced, and diseases such as hypertension and hyperlipidemia can be effectively treated.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to an eplerenone pharmaceutical composition, and a preparation method and application thereof.
Background
Hypertension is a group of clinical symptoms of raised systolic pressure or diastolic pressure, has obvious causal relationship with the occurrence of diseases such as heart disease, renal dysfunction, cerebral apoplexy and the like, is a disease which is widely concerned in China and the world, and is one of the fields of higher research and development investment and most intense market competition of various pharmaceutical enterprises. The combined treatment is one direction of treating hypertension, and the compound preparation with fixed proportion can reduce the dosage, improve the curative effect, reduce the side effect and improve the compliance of patients so as to improve the treatment rate of the patients with hypertension. The compound preparation of four hypertension medicines has reasonable formula and meets the requirements, and the formula is as follows: 1. angiotensin converting enzyme inhibitor + diuretic; 2. beta blocker + diuretic; 3. beta receptor blocker + calcium antagonist; 4. angiotensin ii receptor blockers + diuretics. The antihypertensive therapy must be individualized, and the most suitable drug should be selected according to the condition of the patient and the economic condition, so that the research and development of a new safe, effective and economical antihypertensive drug is urgently needed.
Among several broad classes of antihypertensive drugs, the renin-angiotensin-aldosterone system is overactivated and hyperaldosteronemia has a damaging effect on the cardiovascular system, Angiotensin Converting Enzyme (ACE) inhibitors and Angiotensin Receptor Blockers (ARBs) have been shown to be effective in lowering blood pressure and protecting target organs, reducing the incidence and mortality of heart failure, but after long-term treatment with ACE inhibitors or ARBs, the aldosterone concentration returns to baseline levels, the so-called "aldosterone escape", thus reducing the further efficacy of these drugs. In recent years, it is found that aldosterone can not only affect the pathophysiology change of cardiovascular system by the action of sodium retention and low potassium and magnesium in plasma, but also cause fibrosis of heart and blood vessels, endothelial dysfunction, vascular damage, thrombosis, baroreceptor dysfunction, control of norepinephrine uptake by cardiac muscle, ventricular arrhythmia possibly caused by cardiac fibrosis, and the like. Clinically, aldosterone may be involved in the pathophysiological processes of hypertension, myocardial ischemia, heart failure, arrhythmia, atherosclerosis, end stage renal disease, stroke, and the like. It is seen that the aldosterone system is highly valued in the treatment of cardiovascular diseases.
Eplerenone (Eplerenone) with the chemical name of (7 alpha, 11 alpha, 17 alpha) -9, 11-epoxy-17-hydroxy-3-oxo-pregn-4-ene-7, 21-dicarboxylic acid, gamma-lactone and 7-methyl ester has the chemical structural formula shown in the following formula, and is mainly characterized by long half life period, and can effectively control blood pressure within one day after being taken once a day, so the Eplerenone is convenient to take. Eplerenone has good curative effect on mild to moderate hypertension and good tolerance of patients.
Chinese patent application 201010256290.8 discloses an inhalation pharmaceutical composition comprising eplerenone and glucocorticoid as active ingredients, which is composed of eplerenone, glucocorticoid and one or more carriers suitable for inhalation administration. The glucocorticoid is selected from one or more of ciclesonide, budesonide, fluticasone, mometasone furoate, beclomethasone dipropionate, flunisolide, triamcinolone acetonide and pharmaceutically acceptable salts or esters thereof, the inhalation pharmaceutical composition is preferably prepared into a powder spray, and consists of eplerenone, glucocorticoid and micro powder of a carrier, the average particle size of the eplerenone and glucocorticoid micro powder is 0.5-10 mu m, and the average particle size of the carrier micro powder is 20-45 mu m.
In view of the problems of high cost, large dosage and the like of the existing eplerenone combined medicine, the invention uses safe and natural traditional Chinese medicine components as entry points to search for medicine components which can be used for treating hypertension and hyperlipidemia together with eplerenone, so as to reduce the dosage and realize better treatment effect.
Disclosure of Invention
The invention aims to provide an eplerenone pharmaceutical composition, a preparation method and application thereof, wherein eplerenone is combined with other traditional Chinese medicine components, so that the dosage of the eplerenone is reduced, and the better blood pressure and blood fat reducing effect is exerted.
In order to achieve the purpose, the invention adopts the following technical scheme:
an eplerenone pharmaceutical composition comprising the following raw materials: eplerenone, white peony root and sunflower disc.
Preferably, the weight ratio of the eplerenone to the white peony root to the sunflower disc is 30-40:15-25:10-20, and more preferably 38:17: 12.
Preferably, the eplerenone pharmaceutical composition comprises the following raw materials in parts by weight: 15-55 parts of eplerenone, 10-30 parts of white peony root and 5-25 parts of sunflower disc.
Further preferably, the eplerenone pharmaceutical composition comprises the following raw materials in parts by weight: 30-40 parts of eplerenone, 15-25 parts of white peony root and 10-20 parts of sunflower disc.
Most preferably, the eplerenone pharmaceutical composition comprises the following raw materials in parts by weight: 38 parts of eplerenone, 17 parts of white peony root and 12 parts of sunflower disc.
On the other hand, the invention also provides a preparation method of the eplerenone pharmaceutical composition, which comprises the following steps:
s1, crushing the white paeony root and the sunflower disc to obtain fine powder;
s2, adding an ethanol water solution into the fine powder obtained in the step S1, extracting in a water bath to obtain an extracting solution, concentrating the extracting solution under reduced pressure, drying, and grinding to obtain a traditional Chinese medicine component;
s3, mixing the traditional Chinese medicine components and eplerenone obtained in the step S2 uniformly to obtain the eplerenone pharmaceutical composition.
Preferably, the mass ratio of the fine powder to the ethanol aqueous solution in the step S2 is 1: 20-30.
Preferably, the mass percentage of the ethanol aqueous solution in the step S2 is 70-75%.
Preferably, the conditions of the water bath extraction in step S2 are as follows: extracting with water bath at 70-85 deg.C for 2-3 hr.
Preferably, the concentration under reduced pressure in step S2 is 20-30 times concentrated.
On the other hand, the invention also provides the application of the eplerenone pharmaceutical composition in preparing medicines for treating hypertension and hyperlipidemia.
Preferably, the dosage forms of the medicine comprise pills, granules, powder, capsules, oral liquid and tablets.
Finally, the invention also provides a medicine for treating hypertension and hyperlipidemia, which comprises the eplerenone medicine composition.
The invention has the beneficial effects that:
by combining eplerenone, white paeony root and sunflower disc, the activity of eplerenone can be improved, the dosage is reduced, and the diseases such as hypertension and hyperlipidemia can be effectively treated.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Before the present embodiments are further described, it is to be understood that the scope of the invention is not limited to the particular embodiments described below; it is also to be understood that the terminology used in the examples is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.
When numerical ranges are given in the examples, it is understood that both endpoints of each of the numerical ranges and any value therebetween can be selected unless the invention otherwise indicated. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
The sources of the raw materials used in the present invention are not limited, and the raw materials used in the present invention are all those commonly available in the art unless otherwise specified.
Examples 1 to 6
The formulations of examples 1-6 are shown in Table 1.
Table 1.
| Parts by weight | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 | Example 6 |
| Eplerenone | 38 | 38 | 30 | 40 | 15 | 55 |
| White peony root | 17 | 17 | 25 | 15 | 30 | 10 |
| Sunflower disk | 12 | 18 | 10 | 20 | 25 | 5 |
Comparative examples 1 to 4
The formulations of comparative examples 1-4 are shown in table 2.
Table 2.
| Parts by weight | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 |
| Eplerenone | 38 | 38 | 38 | 38 |
| White peony root | 40 | 5 | - | 17 |
| Sunflower disk | 30 | 3 | 12 | - |
Examples 1-6 and comparative examples 1-4 were prepared as follows:
s1, crushing the white paeony root and the sunflower disc to obtain fine powder with the particle size of about 40 mu m;
s2, adding an ethanol water solution into the fine powder obtained in the step S1, and extracting in a water bath to obtain an extracting solution; concentrating 25 times of the extractive solution, drying, and grinding into powder to obtain Chinese medicinal components;
the mass ratio of the fine powder to the ethanol water solution is 1: 25; the mass percent of the ethanol water solution is 72 percent; the conditions of the water bath extraction are as follows: extracting with water bath at 80 deg.C for 2.5 hr;
s3, mixing the traditional Chinese medicine components obtained in the step S2 and eplerenone uniformly to obtain the eplerenone pharmaceutical composition.
Result detection
1. Blood lipid lowering experiment
Experimental animals: adult healthy male SD rats.
Feeding conditions are as follows: the raising temperature is 20-23 ℃, the relative humidity is 50% -60%, the illumination is controlled for 12h bright/12 h dark, and the experimental animals can drink water freely.
High fat model: referring to "health food inspection and evaluation technical specification (2003 edition)", 130 SD rats were adaptively raised for 1 week, 10 rats were randomly selected as blank control groups, half of the animals were given ordinary feeds, the remaining 120 rats were given high-fat feeds (78.8% by weight of basal feed, 1% by weight of cholesterol, 10% by weight of egg yolk powder, 10% by weight of lard, 0.2% by weight of bile salt), were raised on a free diet for 10 days, and orbital venous plexus was bled, centrifuged, serum was separated, and serum total cholesterol TC, triglyceride TG, and high-density lipoprotein cholesterol HDL-C were measured. The TC and TG values of the serum are obviously higher than those of a normal control group, namely the molding is successful. After 10 days of molding, the TC value of the rat in the hyperlipidemic group is 6.076 +/-0.969 mmol/L), which is obviously higher than the TC value of a normal control group by 2.512 +/-0.821 mmol/L (P <0.001) and the normal range of the serum total cholesterol level of the rat, so as to obtain a high-fat model.
Experiment: high-fat model rats were randomly divided into 12 groups of 10 animals each, and males and females were administered with examples 1, 2, 3, 4, 5, 6 groups, comparative examples 1, 2, 3, 4 groups, eplerenone, and physiological saline (high-fat model group), respectively. The administration dosage is 10mg/Kg, the sample is prepared by distilled water, the oral administration is carried out once a day, after continuous gavage for 30 days, various indexes are measured, and the gavage volume is 0.5mL/100g mouse weight. During the gavage period, high-fat feed is continuously fed, free water is fed, the gavage is continuously carried out for 25 days, then the stomach is fasted for 16 hours, and the concentration of TC, TG and HDL-C after the feeding is measured again, and the specific experimental result is shown in Table 3.
Table 3.
Note: p <0.01, p <0.05 compared to the high-fat model group
Compared with the high-fat model group, the medicaments of the examples and the comparative examples have significant difference (P <0.05), can effectively reduce the content of TC and TG and improve the content of HDL-C, and prove that the medicaments have the effect of reducing blood fat. And the data show that the effect is more obvious when the weight ratio of the eplerenone to the white paeony root to the sunflower disc is 30-40:15-25:10-20, particularly the similar combination effect of the eplerenone to the white paeony root to the sunflower disc is optimal in weight ratio of 38:17:12, and the blood fat reducing effect is the best.
2. Blood pressure lowering experiment
Experimental animals: male SHR rats of 40 weeks of age, 250 + -20 grams body weight.
Grouping: the test pieces were randomly divided into 11 groups of 6 negative control groups, 6 male and female halves, and examples 1, 2, 3, 4, 5 and 6 and comparative examples 1, 2, 3 and 4, and the negative control group was administered with 0.5% CMC-Na, and the rest was administered with the drugs of examples and comparative examples by intragastric administration at a dose of 20 mg/kg.
Experiment: the blood pressure of the rats before and after the administration of the gavage is measured by a tail sleeve method (BP2010A noninvasive sphygmomanometer) for 1 hour, the blood pressure is measured for three times respectively, the average value is obtained, and the result is statistically processed. The results are shown in the following table.
Table 4.
Note: p <0.01, p <0.05 compared to negative control group
As can be seen, the drug of the embodiment of the application has obvious effect of reducing blood pressure of SHR rats, and the effect is caused by the combined action of eplerenone, white paeony root and sunflower disc.
The present invention has been further described with reference to specific embodiments, which are only exemplary and do not limit the scope of the present invention. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
Claims (10)
1. An eplerenone pharmaceutical composition, comprising the following raw materials: eplerenone, white peony root and sunflower disc.
2. The eplerenone pharmaceutical composition of claim 1, wherein the weight ratio of eplerenone to white peony root to sunflower disc is 30-40:15-25:10-20, preferably 38:17: 12.
3. The eplerenone pharmaceutical composition of claim 1 comprising the following raw materials in parts by weight: 15-55 parts of eplerenone, 10-30 parts of white peony root and 5-25 parts of sunflower disc.
4. The eplerenone pharmaceutical composition of claim 3 comprising the following raw materials in parts by weight: 30-40 parts of eplerenone, 15-25 parts of white peony root and 10-20 parts of sunflower disc.
5. The eplerenone pharmaceutical composition of claim 4 comprising the following raw materials in parts by weight: 38 parts of eplerenone, 17 parts of white peony root and 12 parts of sunflower disc.
6. A process for preparing a pharmaceutical eplerenone composition of any of claims 1-5 comprising the steps of:
s1, crushing the white paeony root and the sunflower disc to obtain fine powder;
s2, adding an ethanol water solution into the fine powder obtained in the step S1, extracting in a water bath to obtain an extracting solution, concentrating the extracting solution under reduced pressure, drying, and grinding to obtain a traditional Chinese medicine component;
s3, mixing the traditional Chinese medicine components and eplerenone obtained in the step S2 uniformly to obtain the eplerenone pharmaceutical composition.
7. The production method according to claim 6, wherein the mass ratio of the fine powder to the ethanol aqueous solution in step S2 is 1: 20-30.
8. Use of the eplerenone pharmaceutical composition of any of claims 1-5 or of the eplerenone pharmaceutical composition prepared by the process of claim 6 or 7 in the manufacture of a medicament for treating hypertension or hyperlipidemia.
9. The use of claim 8, wherein the medicament is in the form of pills, granules, powders, capsules, oral liquids and tablets.
10. A medicament for treating hypertension and hyperlipidemia comprising a pharmaceutical eplerenone composition of any one of claims 1 to 5 or a pharmaceutical eplerenone composition prepared by the process of claim 6 or 7.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110412653.0A CN113197941A (en) | 2021-04-16 | 2021-04-16 | Eplerenone pharmaceutical composition, and preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110412653.0A CN113197941A (en) | 2021-04-16 | 2021-04-16 | Eplerenone pharmaceutical composition, and preparation method and application thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152187A (en) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | Eplerenone pharmaceutical composition |
| CN105362242A (en) * | 2015-12-10 | 2016-03-02 | 合肥久诺医药科技有限公司 | Eplerenone dispersible tablet |
| CN106267147A (en) * | 2015-06-10 | 2017-01-04 | 上药东英（江苏）药业有限公司 | A kind of compound antihypertensive drug composition |
| CN108653581A (en) * | 2018-07-15 | 2018-10-16 | 杭州丹鹤医药有限公司 | The method for preparing treatment hypertension drug with Radix Paeoniae Alba, dendrobium candidum and Irbesartan |
-
2021
- 2021-04-16 CN CN202110412653.0A patent/CN113197941A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152187A (en) * | 2006-09-29 | 2008-04-02 | 北京德众万全药物技术开发有限公司 | Eplerenone pharmaceutical composition |
| CN106267147A (en) * | 2015-06-10 | 2017-01-04 | 上药东英（江苏）药业有限公司 | A kind of compound antihypertensive drug composition |
| CN105362242A (en) * | 2015-12-10 | 2016-03-02 | 合肥久诺医药科技有限公司 | Eplerenone dispersible tablet |
| CN108653581A (en) * | 2018-07-15 | 2018-10-16 | 杭州丹鹤医药有限公司 | The method for preparing treatment hypertension drug with Radix Paeoniae Alba, dendrobium candidum and Irbesartan |
Non-Patent Citations (1)
| Title |
|---|
| 熊方武等: "《中国临床药物大辞典.化学药卷（下）》", 31 August 2018, 中国医药科技出版社 * |
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