CN110652513A - Pharmaceutical composition containing rosuvastatin calcium and preparation method and application thereof - Google Patents
Pharmaceutical composition containing rosuvastatin calcium and preparation method and application thereof Download PDFInfo
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- CN110652513A CN110652513A CN201810685754.3A CN201810685754A CN110652513A CN 110652513 A CN110652513 A CN 110652513A CN 201810685754 A CN201810685754 A CN 201810685754A CN 110652513 A CN110652513 A CN 110652513A
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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
- A61K31/495—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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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Abstract
The invention provides a pharmaceutical composition containing rosuvastatin calcium, a preparation method and application thereof, belonging to the field of medicines. The pharmaceutical composition comprises rosuvastatin calcium, lactose, microcrystalline cellulose, tricalcium phosphate, magnesium stearate and crospovidone. The preparation method comprises the following steps: mixing microcrystalline cellulose, lactose, tricalcium phosphate and part of crospovidone according to parts by weight, performing wet granulation, drying, and finishing granules by using a 20-40-mesh sieve to obtain blank granules; and mixing the blank granules with rosuvastatin calcium, the rest of crospovidone and magnesium stearate for preparation. The pharmaceutical composition has a reasonable formula, and the inventor finds that the pharmaceutical composition has good curative effect on the I type allergic diseases, can be used for preparing the medicines for preventing or treating the I type allergic diseases, and has wide application prospect.
Description
Technical Field
The invention relates to the field of medicines, and particularly relates to a pharmaceutical composition containing rosuvastatin calcium, and a preparation method and application thereof.
Background
The type I allergic reaction is also called anaphylactic reaction, is the most common clinical one and is characterized in that: IgE-mediated, effector cells such as mast cells and basophils participate in the reaction in a manner that releases bioactive mediators; the occurrence is fast, and the regression is fast; often presents with physiological dysfunction without severe tissue damage; has obvious individual difference and genetic tendency.
After the allergen enters the body, B cells are induced to produce IgE antibodies. IgE has high affinity with target cells, and is firmly adsorbed on the surfaces of mast cells and basophils. When the same antigen re-enters the sensitized organism and binds with the IgE antibody, a series of biochemical reactions of the cell membrane are initiated, starting two processes that occur in parallel: degranulation and synthesis of new media. Firstly, mast cells and basophils generate degranulation change, and a plurality of active mediators, such as histamine, proteolytic enzyme, heparin, chemotactic factors and the like, are released from granules; ② degrading the cell membrane phospholipid to release arachidonic acid. It is metabolized in two ways to synthesize prostaglandin, thromboxane A2, leukotriene and platelet activating factor. Various mediators are dispersed to the whole body along with blood flow and act on effector organs such as skin, mucosa, respiratory tract and the like to cause small blood vessels and capillary vessel dilatation, increase capillary permeability, smooth muscle contraction, increase gland secretion, increase eosinophilia and infiltration, and can cause skin mucosa anaphylaxis (urticaria, eczema and angioneurotic edema), respiratory tract anaphylaxis (allergic rhinitis, bronchial asthma and laryngeal edema), digestive tract anaphylaxis (food allergic gastroenteritis) and whole body anaphylaxis (anaphylactic shock) to seriously affect the physical and psychological health of a patient.
At present, no product with good curative effect on I-type allergy is available in the market, and the patent is especially provided in view of the above.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition, a preparation method and application thereof, wherein the pharmaceutical composition comprises rosuvastatin calcium and has good curative effect on I-type allergy.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
a pharmaceutical composition containing rosuvastatin calcium comprises rosuvastatin calcium and algal polysaccharides.
A pharmaceutical composition, comprising: rosuvastatin calcium, lactose, microcrystalline cellulose, tricalcium phosphate, magnesium stearate, and crospovidone.
A preparation method of the pharmaceutical composition comprises the following steps:
mixing microcrystalline cellulose, lactose, tricalcium phosphate and part of crospovidone according to parts by weight, performing wet granulation, drying, and finishing granules by using a 20-40-mesh sieve to obtain blank granules; and
and mixing the blank granules with rosuvastatin calcium, the rest crospovidone and magnesium stearate to prepare the preparation.
Compared with the prior art, the invention has the beneficial effects that:
the pharmaceutical composition provided by the application mainly comprises rosuvastatin calcium as an active component, and also comprises some pharmaceutically acceptable auxiliary materials, such as lactose, microcrystalline cellulose, tricalcium phosphate, magnesium stearate and crospovidone. The pharmaceutical composition has a reasonable formula, and the inventor finds that the pharmaceutical composition has good curative effect on the I type allergic diseases, can be used for preparing the medicines for preventing or treating the I type allergic diseases, and has wide application prospect.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The present embodiment provides a pharmaceutical composition (first composition) comprising: rosuvastatin calcium and algal polysaccharides.
Further, the weight parts of rosuvastatin calcium are 10 parts, and the weight parts of algal polysaccharide are 1800-4200 parts; or 2400-3800 parts of algal polysaccharide; or 2800-3400 parts of algal polysaccharide.
Further, the pharmaceutical composition also comprises pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials comprise the following components in parts by weight:
80-100 parts of lactose, 25-30 parts of microcrystalline cellulose, 10-15 parts of tricalcium phosphate, 1.5-3.5 parts of magnesium stearate and 3.0-6.0 parts of crospovidone.
Or, by weight, 85-95 parts of lactose, 26-28 parts of microcrystalline cellulose, 12-14 parts of tricalcium phosphate, 2.0-3.0 parts of magnesium stearate and 3.5-5.5 parts of crospovidone.
The present embodiment also provides a pharmaceutical composition (second composition) comprising: rosuvastatin calcium, lactose, microcrystalline cellulose, tricalcium phosphate, magnesium stearate, and crospovidone.
Further, by weight, 10 parts of rosuvastatin calcium, 80-100 parts of lactose, 25-30 parts of microcrystalline cellulose, 10-15 parts of tricalcium phosphate, 1.5-3.5 parts of magnesium stearate and 3.0-6.0 parts of crospovidone;
or, by weight, 10 parts of rosuvastatin calcium, 85-95 parts of lactose, 26-28 parts of microcrystalline cellulose, 12-14 parts of tricalcium phosphate, 2.0-3.0 parts of magnesium stearate and 3.5-5.5 parts of crospovidone.
Further, the pharmaceutical composition also comprises 1800-4200 parts by weight of algal polysaccharide; or 2400-3800 parts by weight of algal polysaccharide; or 2800 to 3200 parts by weight of algal polysaccharide.
The present embodiment also provides a method for preparing the first composition and the second composition, which includes:
step S1: mixing microcrystalline cellulose, lactose, tricalcium phosphate and part of crospovidone according to parts by weight, performing wet granulation, drying, and finishing granules by using a 20-40-mesh sieve to obtain blank granules;
further, the preparation method comprises the step of uniformly mixing 1800-4200 parts by weight of algal polysaccharide, lactose, microcrystalline cellulose, tricalcium phosphate and part of crospovidone, and performing wet granulation.
Further, the drying temperature after the preparation and granulation is 55-65 ℃.
Step S2: and mixing the blank granules with rosuvastatin calcium, the rest crospovidone and magnesium stearate to prepare the preparation.
Further, raw materials of rosuvastatin calcium are sieved by a 80-mesh sieve; the lactose is sieved by a 200-mesh sieve.
Further, the pharmaceutical composition is made into tablets: tabletting by adopting a tablet machine, and performing 6.0-8.0 mm circular deep concave punching on a die with the hardness of 50-70N.
Further, still include: and (3) putting the core material obtained after preparation into film coating liquid for coating, wherein the weight of the core material after coating is increased by 2-4%.
Preferably, the preparation method of the film coating liquid comprises the following steps: weighing iron oxide red in purified water, shearing uniformly, adding the film coating premix and titanium dioxide, and stirring uniformly to obtain the iron oxide red coating.
The pharmaceutical composition prepared by the preparation method has good curative effect on the I type allergic diseases, can be used for preparing medicines for preventing or treating the I type allergic diseases, and has wide application prospect.
The features and properties of the present invention are further described in detail below with reference to examples:
example 1
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation method of the pharmaceutical composition comprises the following steps:
a. preparing soft materials and granulating: weighing microcrystalline cellulose, lactose (200 meshes), tricalcium phosphate and crospovidone according to the prescription amount, uniformly mixing, adding a proper amount of wetting agent (ethanol-water mixed solution) to prepare a soft material, and granulating by using nylon with a 30-mesh sieve;
b. drying and granulating: boiling and drying at 60 ℃, and finishing granules by a 30-mesh nylon sieve to obtain blank granules;
c. total mixing: adding the bulk drugs and the crospovidone according to the amount of the blank particles, uniformly mixing, adding the magnesium stearate according to the amount of the prescription, and uniformly mixing;
d. tabletting: the total mixed particles are punched into tablets by a tabletting machine with a shallow concave circle with the diameter of 7 mm; hardness: 55-65N.
e. Coating: coating the tablet core in a high-efficiency coating machine, and increasing the weight by 3% to obtain the rosuvastatin calcium film coated tablet.
Example 2
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation method of the pharmaceutical composition comprises the following steps:
a. preparing soft materials and granulating: weighing microcrystalline cellulose, lactose (200 meshes), tricalcium phosphate and crospovidone according to the prescription amount, uniformly mixing, adding a proper amount of wetting agent (ethanol-water mixed solution) to prepare a soft material, and granulating nylon with a 20-mesh sieve;
b. drying and granulating: boiling and drying at 55 ℃, and finishing granules by using a 20-mesh nylon sieve to obtain blank granules;
c. total mixing: adding the bulk drugs and the crospovidone according to the amount of the blank particles, uniformly mixing, adding the magnesium stearate according to the amount of the prescription, and uniformly mixing;
d. tabletting: the total mixed particles are punched into tablets by a tabletting machine with a shallow concave circle with the diameter of 6 mm; hardness: 50-60N.
e. Coating: coating the tablet core in a high-efficiency coating machine, and increasing the weight by 2% to obtain the rosuvastatin calcium film coated tablet.
Example 3
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation method of the pharmaceutical composition comprises the following steps:
a. preparing soft materials and granulating: weighing microcrystalline cellulose, lactose (200 meshes), tricalcium phosphate and crospovidone according to the prescription amount, uniformly mixing, adding a proper amount of wetting agent (ethanol-water mixed solution) to prepare a soft material, and granulating nylon with a 40-mesh sieve;
b. drying and granulating: boiling and drying at 65 ℃, and finishing granules by a 40-mesh nylon sieve to obtain blank granules;
c. total mixing: adding the bulk drugs and the crospovidone according to the amount of the blank particles, uniformly mixing, adding the magnesium stearate according to the amount of the prescription, and uniformly mixing;
d. tabletting: the total mixed particles are punched into pieces by a tabletting machine with the diameter of 8 mm; hardness: 60-70N.
e. Coating: coating the tablet core in a high-efficiency coating machine, and increasing the weight by 4% to obtain the rosuvastatin calcium film coated tablet.
Example 4
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation method of the pharmaceutical composition is substantially the same as that of example 1, except that:
a. preparing soft materials and granulating: weighing the algal polysaccharide, microcrystalline cellulose, lactose (200 meshes), tricalcium phosphate and crospovidone according to the prescription amount, uniformly mixing, adding a proper amount of wetting agent (ethanol-water mixed solution) to prepare a soft material, and granulating through a 30-mesh sieve of nylon.
Example 5
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation of the pharmaceutical composition is in accordance with example 4.
Example 6
This example provides a pharmaceutical composition having the components and amounts shown in the following table:
the preparation of the pharmaceutical composition is in accordance with example 4.
Examples of the experiments
The effect of the pharmaceutical composition provided in the present invention on xylene-induced inflammation in mice will be described below with reference to animal experiments.
Firstly, an experimental process:
18-22 g of ICR male mice 80 were randomly divided into 8 groups according to body weight, namely a model group, a dexamethasone group and examples 1-6 groups. The administration is carried out for 7 days by continuous gavage once a day, and the dexamethasone group is administered with the dose of 5mg/kg body weight. Examples 1-6 groups were dosed at 1.5mg/kg body weight in relation to rosuvastatin calcium. After the last administration for 1h, 30 μ L of xylene was coated on the front and back surfaces of the right ear of each mouse to cause inflammation, the left ear was not coated as a control, the mice were sacrificed after 1h, the left and right ears were cut off, round ear pieces were punched at the same position by a punch with a diameter of 8mm, and the difference between the left and right ears was taken as the degree of swelling.
Second, experimental results
The results are shown in Table 7:
TABLE 7 Effect of the invention on xylene-induced inflammation in mice (x. + -. SD)
| Left ear (mg) | Right ear (mg) | Difference (mg) | Inhibition ratio (%) | |
| Model set | 8.0±1.8 | 17.6±2.3 | 9.6±2.6 | ～ |
| Dexamethasone group | 7.9±1.3 | 12.5±2.8 | 4.6±2.5 | 52.08 |
| EXAMPLE 1 group | 8.2±1.8 | 17.7±2.9 | 9.5±3.0 | 1.04 |
| EXAMPLE 2 group | 8.2±1.5 | 17.5±3.1 | 9.3±2.6 | 3.13 |
| EXAMPLE 3 group | 8.0±1.6 | 17.3±2.9 | 9.3±2.8 | 3.13 |
| EXAMPLE 4 group | 8.1±1.3 | 16.2±2.8 | 8.1±2.5 | 15.62 |
| EXAMPLE 5 group | 7.9±1.7 | 15.0±2.3 | 7.1±2.5 | 26.04 |
| EXAMPLE 6 group | 7.8±1.6 | 13.9±2.9 | 6.1±2.6 | 36.46 |
As can be seen from Table 7, the groups of examples 1 to 6 inhibited the swelling of mouse auricle caused by xylene to a different extent than the model group. Compared with the pharmaceutical compositions provided in the embodiments 1 to 3, the pharmaceutical compositions provided in the embodiments 4 to 6 of the present invention, due to the addition of algal polysaccharides, significantly improve the ability of the pharmaceutical compositions to inhibit mouse auricle swelling caused by xylene. The pharmaceutical composition provided by the invention can prevent the I type allergic diseases and can be used for preparing medicines for preventing or treating the I type allergic diseases.
While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.
Claims (10)
1. A pharmaceutical composition comprising rosuvastatin calcium, wherein the pharmaceutical composition comprises rosuvastatin calcium and algal polysaccharides.
2. The pharmaceutical composition according to claim 1, wherein the rosuvastatin calcium is 10 parts by weight, and the algal polysaccharide is 1800-4200 parts by weight.
3. The pharmaceutical composition of claim 1, further comprising pharmaceutically acceptable excipients, wherein the excipients comprise, in parts by weight:
80-100 parts of lactose, 25-30 parts of microcrystalline cellulose, 10-15 parts of tricalcium phosphate, 1.5-3.5 parts of magnesium stearate and 3.0-6.0 parts of crospovidone.
4. A pharmaceutical composition, comprising: rosuvastatin calcium, lactose, microcrystalline cellulose, tricalcium phosphate, magnesium stearate, and crospovidone.
5. The pharmaceutical composition according to claim 4, wherein the rosuvastatin calcium is 10 parts, the lactose is 80-100 parts, the microcrystalline cellulose is 25-30 parts, the tricalcium phosphate is 10-15 parts, the magnesium stearate is 1.5-3.5 parts, and the crospovidone is 3.0-6.0 parts by weight.
6. The pharmaceutical composition of claim 4, further comprising 1800 to 4200 parts by weight of algal polysaccharides.
7. A process for the preparation of a pharmaceutical composition according to any one of claims 4 to 6, comprising:
mixing the microcrystalline cellulose, the lactose and the tricalcium phosphate with part of the crospovidone according to the parts by weight, carrying out wet granulation, drying, and then grading with a 20-40-mesh sieve to obtain blank granules; and
and mixing the blank granules with the rosuvastatin calcium, the rest crospovidone and the magnesium stearate to prepare the preparation.
8. The preparation method of the pharmaceutical composition according to claim 7, further comprising the step of uniformly mixing 1800-4200 parts by weight of algal polysaccharides with the lactose, the microcrystalline cellulose, the tricalcium phosphate and part of the crospovidone.
9. The method of preparing a pharmaceutical composition according to claim 7, further comprising: and (3) putting the core material obtained after preparation into film coating liquid for coating, wherein the weight of the core material after coating is increased by 2-4%.
10. Use of the pharmaceutical composition according to any one of claims 1 to 6 for the preparation of a medicament for the prevention or treatment of type I allergic diseases.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113398086A (en) * | 2021-05-18 | 2021-09-17 | 海南通用三洋药业有限公司 | Preparation method of rosuvastatin calcium capsule and rosuvastatin calcium capsule |
| CN113476423A (en) * | 2021-07-05 | 2021-10-08 | 海南通用三洋药业有限公司 | Preparation method of rosuvastatin calcium capsule and rosuvastatin calcium capsule |
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| CN113398086A (en) * | 2021-05-18 | 2021-09-17 | 海南通用三洋药业有限公司 | Preparation method of rosuvastatin calcium capsule and rosuvastatin calcium capsule |
| CN113476423A (en) * | 2021-07-05 | 2021-10-08 | 海南通用三洋药业有限公司 | Preparation method of rosuvastatin calcium capsule and rosuvastatin calcium capsule |
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