CN112545982A - Large-capacity injection prepared from dipyridamole and preparation method thereof - Google Patents
Large-capacity injection prepared from dipyridamole and preparation method thereof Download PDFInfo
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- CN112545982A CN112545982A CN202011500001.4A CN202011500001A CN112545982A CN 112545982 A CN112545982 A CN 112545982A CN 202011500001 A CN202011500001 A CN 202011500001A CN 112545982 A CN112545982 A CN 112545982A
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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
- A61K9/08—Solutions
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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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
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- 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
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- 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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Abstract
The invention relates to a large-capacity injection prepared from dipyridamole and a preparation method thereof. Dipyridamole belongs to an anti-platelet aggregation medicine and a coronary artery dilating medicine, is commonly used for treating coronary heart disease, preventing angina and preventing thrombosis after operation, but the existing dipyridamole tablets and small-volume injection have strong limitation on clinical application and can only be used as clinical diagnosis medicines. The invention relates to a large-capacity injection prepared from dipyridamole, which can be directly applied to clinical treatment. The concentration of the dipyridamole in the large-volume dipyridamole injection prepared by the invention is reduced, the oxidation of the dipyridamole is weakened, the stability of the medicine is enhanced, and the accessibility, the safety and the convenience of the dipyridamole in clinical application are effectively ensured.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations and processing, in particular to a high-capacity injection (dipyridamole-containing sodium chloride injection and dipyridamole glucose injection) prepared from dipyridamole and a preparation method thereof.
Background
Dipyridamole (dipyridamole) is an antiplatelet aggregation agent and a coronary artery dilating agent, and is used for preventing and treating chronic coronary insufficiency, myocardial infarction and disseminated intravascular coagulation. At present, the medicine is mainly used as an antiplatelet medicine in clinic.
Dipyridamole is commonly used clinically for treating coronary heart disease, preventing angina pectoris, and preventing postoperative thrombosis. With the intensive development of clinical pharmaceutical research, the application value of dipyridamole is further explored and improved.
The Chinese pharmacopoeia 2015 edition contains dipyridamole as raw material, tablets and small-volume injection thereof. However, dipyridamole tablets and small volume injections have limited clinical use. The oral preparation is not practical in clinical use because the patient who is aimed at by the oral preparation often has mobility inconvenience and even mobility loss after the disease is suffered. The current clinical application of the small-volume injection is diagnosis of myocardial ischemia, and the small-volume injection is not a clinical treatment drug in the true sense; and the small-volume injection has high drug concentration and is easy to oxidize.
Disclosure of Invention
The invention aims to provide a large-volume injection prepared from dipyridamole and a preparation method thereof, and the large-volume injection can be directly used for clinical treatment.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a large-volume injection prepared from dipyridamole comprises the following dipyridamole and auxiliary materials in percentage by weight: dipyridamole 0.005-0.05%, and adjuvant 0.005-0.1%; the loading amount is 50ml-500 ml.
A large volume injection prepared from dipyridamole comprises adjuvants including one or more of phosphoric acid, disodium hydrogen phosphate or potassium, sodium dihydrogen phosphate or potassium, hydrochloric acid, sodium chloride, malic acid, tartaric acid, tryptophan, cysteine hydrochloride, L-cysteine, arginine, sodium hydroxide or potassium, lactic acid, lactose, glucose, mannitol, and sorbitol.
A preparation method of a large-volume injection prepared from dipyridamole specifically comprises the following steps:
the method comprises the following steps: weighing the following raw materials and auxiliary materials in percentage by weight: dipyridamole 0.005-0.05%, and adjuvant 0.005-0.1%; placing the raw materials and the auxiliary materials into a container, adding water or buffer solution for dissolving, and then adding water for fixing the volume to 2000-20000 times of the volume of the solution of dipyridamole; adjusting the pH value of the solution to 2.5-7.0 by using a hydrochloric acid solution or a sodium hydroxide solution, and shaking up;
step two: adding 0.1-5.0% of active carbon for injection or not according to the volume of the solution, heating to 100 ℃ at normal temperature or stirring for 30 minutes, decarburizing and filtering; sterile filtration with a 0.22um filter; filling, plugging and capping; subpackaging with glass bottle, plastic bottle or soft bag, and sterilizing.
In the second step, sterilization is carried out for 30 minutes at 115 ℃; or 121 ℃ for 10 minutes.
Compared with the prior art, the invention has the following advantages and effects:
1) compared with dipyridamole small-volume injection as a diagnostic medicine, the dipyridamole large-volume injection prepared by the invention can be used for treating diseases such as chronic coronary insufficiency, myocardial infarction, disseminated intravascular coagulation and the like;
2) dissolving the dipyridamole small-volume injection into the glucose injection, and finishing instillation within 4 minutes; the dipyridamole high-capacity injection prepared by the invention can be directly and slowly instilled, and is safe in clinical application;
3) the dipyridamole small-volume injection adopts propylene glycol as a solvent, and is not suitable for patients allergic to propylene glycol; sodium metabisulfite is also commonly used as an antioxidant for the small-volume injection, but the dipyridamole large-volume injection prepared by the invention does not contain propylene glycol and sodium metabisulfite, so that the clinical applicability is stronger;
4) compared with the dipyridamole hypovolemic injection, the concentration of the dipyridamole in the dipyridamole hypovolemic injection prepared by the invention is reduced, the oxidation of the dipyridamole is weakened, and the stability is increased.
Detailed Description
The present invention will be described in detail with reference to specific embodiments. These examples are intended to illustrate the invention and are not intended to limit the scope of the invention. The implementation conditions used in the examples can be further adjusted according to the specific experimental environment, and the implementation conditions not mentioned are generally the conditions in routine experiments.
The invention relates to a preparation method of a large-capacity injection prepared from dipyridamole, which is realized by the following steps:
the method comprises the following steps: weighing the following raw materials and auxiliary materials in percentage by weight: dipyridamole 0.005-0.05%, and adjuvant 0.005-0.1%; placing the raw materials and the auxiliary materials into a container, adding water or buffer solution for dissolving, and then adding water for fixing the volume to 2000-20000 times of the volume of the solution of dipyridamole; adjusting the pH value of the solution to 2.5-7.0 by using a hydrochloric acid solution or a sodium hydroxide solution, and shaking up;
step two: adding 0.1-5.0% of active carbon for injection or not according to the volume of the solution, heating to 100 ℃ at normal temperature or stirring for 30 minutes, decarburizing and filtering; sterile filtration with a 0.22um filter; filling, plugging and capping; subpackaging with glass bottle, plastic bottle or soft bag, and sterilizing.
In the second step, sterilization is carried out for 30 minutes at 115 ℃; or 121 ℃ for 10 minutes.
The specifications of the dipyridamole high-capacity injection are divided into the following nine types according to the different content of the dipyridamole in each bottle of injection: 5. 10, 12.5, 15, 20, 25, 30, 40, 50 mg/bottle. The specific embodiment is as follows:
example 1:
this example is a procedure for preparing dipyridamole large volume injection with specification of 10 mg/bottle and loading of 100ml, and 1000 bottles were prepared.
Weighing the raw and auxiliary materials according to the following dosage:
putting the weighed raw and auxiliary materials into a container, adding a proper amount of water for dissolving, adjusting the pH value to 2.5-7.0 by using a hydrochloric acid solution, adding water for injection to 100000ml, and uniformly mixing; adding 3g of activated carbon, stirring for 30 minutes at 100 ℃, decarburizing, filtering, and then sterilizing and filtering by using a 0.22-micron filter membrane; packaging with soft bag, each bag containing 100ml, and sterilizing at 121 deg.C for 10 min.
And (3) inspection results of finished products:
the characteristics are as follows: yellow or greenish-yellow clear liquid
And (4) checking: pH value of 4.0
The content is as follows: 100.0 percent
Other indexes all meet the relevant regulations of quality standards.
Example 2:
this example describes the preparation of a large volume injection of dipyridamole, 20 mg/bottle, 100ml in size, and 1000 bottles in total.
Weighing the raw and auxiliary materials according to the following dosage:
putting the weighed raw and auxiliary materials into a container, adding a proper amount of water for dissolving, adjusting the pH value to 2.5-7.0 by using a sodium hydroxide solution, adding water for injection to 100000ml, and uniformly mixing; adding 3g of activated carbon, stirring for 30 minutes at 100 ℃, decarburizing, filtering, and then sterilizing and filtering by using a 0.22-micron filter membrane; packaging with 100ml plastic bottle, and sterilizing at 121 deg.C for 10 min.
And (3) inspection results of finished products:
the characteristics are as follows: yellow or greenish-yellow clear liquid
And (4) checking: pH value of 4.0
The content is as follows: 100.0 percent
Other indexes all meet the relevant regulations of quality standards.
Example 3:
this example describes the preparation of a large volume injection of dipyridamole 30 mg/vial, 100ml in volume, and 1000 vials are prepared.
Weighing the raw and auxiliary materials according to the following dosage:
putting the weighed raw and auxiliary materials into a container, adding a proper amount of water for dissolving, adjusting the pH value to 2.5-7.0 by using a sodium hydroxide solution, adding water for injection to 100000ml, and uniformly mixing; adding 3g of activated carbon, stirring for 30 minutes at 100 ℃, decarburizing, filtering, and then sterilizing and filtering by using a 0.22-micron filter membrane; packaging with 100ml plastic bottle, and sterilizing at 121 deg.C for 10 min.
And (3) inspection results of finished products:
the characteristics are as follows: yellow or greenish-yellow clear liquid
And (4) checking: pH value of 4.0
The content is as follows: 100.0 percent
Other indexes all meet the relevant regulations of quality standards.
Example 4:
this example describes the preparation of a large volume injection of dipyridamole 30 mg/vial, 100ml in volume, and 1000 vials are prepared.
Weighing the raw and auxiliary materials according to the following dosage:
putting the weighed raw and auxiliary materials into a container, adding a proper amount of water for dissolving, adjusting the pH value to 2.5-7.0 by using a sodium hydroxide solution, adding water for injection to 100000ml, and uniformly mixing; adding 3g of activated carbon, stirring for 30 minutes at 100 ℃, decarburizing, filtering, and then sterilizing and filtering by using a 0.22-micron filter membrane; packaging with 100ml plastic bottle, and sterilizing at 121 deg.C for 10 min.
And (3) inspection results of finished products:
the characteristics are as follows: yellow or greenish-yellow clear liquid
And (4) checking: pH value of 4.0
The content is as follows: 100.0 percent
Other indexes all meet the relevant regulations of quality standards.
Example 5:
this example is a procedure for preparing dipyridamole large volume injection with specification of 10 mg/bottle and loading of 100ml, and 1000 bottles were prepared.
Weighing the raw and auxiliary materials according to the following dosage:
putting the weighed raw and auxiliary materials into a container, adding a proper amount of water for dissolving, adjusting the pH value to 2.5-7.0 by using a sodium hydroxide solution, adding water for injection to 100000ml, and uniformly mixing; adding 3g of activated carbon, stirring for 30 minutes at 100 ℃, decarburizing, filtering, and then sterilizing and filtering by using a 0.22-micron filter membrane; packaging with 100ml plastic bottle, and sterilizing at 121 deg.C for 10 min.
And (3) inspection results of finished products:
the characteristics are as follows: yellow or greenish-yellow clear liquid
And (4) checking: pH value of 4.0
The content is as follows: 100.0 percent
Other indexes all meet the relevant regulations of quality standards.
The above embodiments are merely illustrative of the principles and effects of the present invention, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the inventive concept of the present invention, and the scope of the present invention is defined by the appended claims.
Claims (4)
1. A large volume injection prepared from dipyridamole, which is characterized in that: the dipyridamole and the auxiliary materials comprise the following components in percentage by weight: dipyridamole 0.005-0.05%, and adjuvant 0.005-0.1%; the loading amount is 50ml-500 ml.
2. A large volume injection of dipyridamole, according to claim 1, characterized in that: the auxiliary materials are one or a combination of more of phosphoric acid, disodium hydrogen phosphate or potassium, sodium dihydrogen phosphate or potassium, hydrochloric acid, sodium chloride, malic acid, tartaric acid, tryptophan, cysteine hydrochloride, L-cysteine, arginine, sodium hydroxide or potassium, lactic acid, lactose, glucose, mannitol and sorbitol.
3. A method for preparing a large-volume injection prepared from dipyridamole is characterized in that: the method comprises the following steps:
the method comprises the following steps: weighing the following raw materials and auxiliary materials in percentage by weight: dipyridamole 0.005-0.05%, and adjuvant 0.005-0.1%; placing the raw materials and the auxiliary materials into a container, adding water or buffer solution for dissolving, and then adding water for fixing the volume to 2000-20000 times of the volume of the solution of dipyridamole; adjusting the pH value of the solution to 2.5-7.0 by using a hydrochloric acid solution or a sodium hydroxide solution, and shaking up;
step two: adding 0.1-5.0% of active carbon for injection or not according to the volume of the solution, heating to 100 ℃ at normal temperature or stirring for 30 minutes, decarburizing and filtering; sterile filtration with a 0.22um filter; filling, plugging and capping; subpackaging with glass bottle, plastic bottle or soft bag, and sterilizing.
4. A process for the preparation of a large volume injection of dipyridamole according to claim 3, characterized in that:
in the second step, sterilization is carried out for 30 minutes at 115 ℃; or 121 ℃ for 10 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011500001.4A CN112545982A (en) | 2020-12-18 | 2020-12-18 | Large-capacity injection prepared from dipyridamole and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN202011500001.4A CN112545982A (en) | 2020-12-18 | 2020-12-18 | Large-capacity injection prepared from dipyridamole and preparation method thereof |
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| CN112545982A true CN112545982A (en) | 2021-03-26 |
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| CN202011500001.4A Withdrawn CN112545982A (en) | 2020-12-18 | 2020-12-18 | Large-capacity injection prepared from dipyridamole and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1481798A (en) * | 2003-07-31 | 2004-03-17 | 王景成 | Large capacity gingko damole injection and its preparation method |
| CN1543955A (en) * | 2003-11-17 | 2004-11-10 | 李晓祥 | Freeze-dried dipyrimadole preparation for injection and prepartion thereof |
| CN101612170A (en) * | 2008-06-25 | 2009-12-30 | 上海信谊百路达药业有限公司 | A kind of Folium Ginkgo extract and double density reach compound injection and preparation technology thereof not |
| CN102670671A (en) * | 2012-06-12 | 2012-09-19 | 湖北济生医药有限公司 | Ginkgo-dipyridamole medicine combination and preparation method thereof |
-
2020
- 2020-12-18 CN CN202011500001.4A patent/CN112545982A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1481798A (en) * | 2003-07-31 | 2004-03-17 | 王景成 | Large capacity gingko damole injection and its preparation method |
| CN1543955A (en) * | 2003-11-17 | 2004-11-10 | 李晓祥 | Freeze-dried dipyrimadole preparation for injection and prepartion thereof |
| CN101612170A (en) * | 2008-06-25 | 2009-12-30 | 上海信谊百路达药业有限公司 | A kind of Folium Ginkgo extract and double density reach compound injection and preparation technology thereof not |
| CN102670671A (en) * | 2012-06-12 | 2012-09-19 | 湖北济生医药有限公司 | Ginkgo-dipyridamole medicine combination and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 夏险峰: "双嘧达莫注射液处方及工艺研究", 《健康必读》 * |
| 王世宇主编: "《药用辅料学》", 30 April 2019, 中国中医药出版社 * |
| 王生寿等主编: "《新编临床药理及药物应用》", 31 March 2019, 吉林科学技术出版社 * |
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Application publication date: 20210326 |