CN1568964A - Tanshinone II A sodium sulfonate powder injection preparation - Google Patents

Tanshinone II A sodium sulfonate powder injection preparation Download PDF

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Publication number
CN1568964A
CN1568964A CN 200410024042 CN200410024042A CN1568964A CN 1568964 A CN1568964 A CN 1568964A CN 200410024042 CN200410024042 CN 200410024042 CN 200410024042 A CN200410024042 A CN 200410024042A CN 1568964 A CN1568964 A CN 1568964A
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CN
China
Prior art keywords
sodium sulfonate
tanshinone
injection
radix salviae
salviae miltiorrhizae
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Pending
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CN 200410024042
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Chinese (zh)
Inventor
肖广常
张颖
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Individual
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Individual
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Publication date
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Priority to CN 200410024042 priority Critical patent/CN1568964A/en
Publication of CN1568964A publication Critical patent/CN1568964A/en
Pending legal-status Critical Current

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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention discloses a Tanshinone II A sodium sulfonate powder injection preparation, wherein the preparation comprises tanshinone II A sodium sulfonate 0.125-100%, excipient 0-99.875%. The medicament can be administered through intramuscular injection or venous instillation.

Description

A kind of Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder
(1) technical field
The present invention relates to a kind of Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder belongs to medical technical field.
(2) background technology
Tanshinone I I ASodium sulfonate is brick-red crystalline powder; Odorless, mildly bitter flavor; Have draw moist; Meet hyperpyrexia, see light, the color gradual change is dark.This product is dissolved in hot water, and is molten at methanol or ethanol part omitted, insoluble in chloroform.(national drug standards (trying) WS-10001-(HD-0923)-2002).These characteristics makes its preparation and application be subjected to certain limitation.The usage and dosage of its injection description has been narrated Tanshinone I I AThe sodium sulfonate injection can be used for intramuscular injection or intravenous drip, and its injection easily causes oxidation Decomposition behind high temperature sterilize, and product quality is descended.
(3) summary of the invention
The present invention has avoided the deficiency of above-mentioned technology, and a kind of Radix Salviae Miltiorrhizae for injection ketone II is provided AThe sodium sulfonate injectable powder.
The present invention is a kind of Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder comprises following component, all is weight percentage: Tanshinone I I ASodium sulfonate 0.125%~100%, excipient are 0~99.875%.
Above-mentioned excipient is selected from one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, hydrolysis gel, cyclodextrin, the cyclodextrin derivative.Molecular weight gets final product by this area normal ranges.
Above-mentioned a kind of Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder can be a kind of in sterilized powder, the aseptic freeze-dried product.
Compared with prior art, excellent results of the present invention is as follows:
1) this product has been selected injectable powder, and whole preparation process all is to carry out under the condition of low temperature or room temperature, mild condition, and no high temperature sterilize has avoided injection to adopt high temperature sterilize easily to cause Tanshinone I I AThe sodium sulfonate oxidation Decomposition has reduced the phenomenon of product quality, makes clinical practice safer.
2) Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder has the quick-dissolving characteristics of the water of chance, for clinical use provides convenience.
The Radix Salviae Miltiorrhizae for injection ketone II that makes by said method AThe sodium sulfonate injectable powder all complies with relevant regulations in the check of items such as content, aseptic, pH, has no side effect.This product can be used for intramuscular injection or intravenous drip, is used for the treatment of coronary heart disease, angina pectoris, uncomfortable in chest.
(4) specific embodiment
Embodiment 1 Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 4.762%
Mannitol 95.238%
Preparation method is as follows:
Get Tanshinone I I ASodium sulfonate raw material 10g adds water for injection 1.5L, and stirring and dissolving with mannitol 200g stirring and dissolving, is added water for injection to 2L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is carried out packing by every 2ml, promptly obtains Tanshinone I I through lyophilization AThe aseptic freeze-dried product of sodium sulfonate.
Embodiment 2 Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 100%
Preparation method is with 1.
Embodiment 3 Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 16.667%
Lactose 83.333%
Preparation method is as follows:
Get Tanshinone I I ASodium sulfonate raw material 40g adds water for injection 3.0L, and stirring and dissolving adds lactose 200g stirring and dissolving, adds water for injection to 4L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is at the spray-dried Tanshinone I I that promptly gets AThe sodium sulfonate sterilized powder.Press every 40mg then (with Tanshinone I I AThe sodium sulfonate meter) carries out aseptic subpackagedly, promptly get Radix Salviae Miltiorrhizae for injection ketone II ASodium sulfonate powder pin.
Embodiment 4 Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 1.961%
Glucose 98.039%
Preparation method is with 3.
Embodiment 5 Radix Salviae Miltiorrhizae for injection ketone IIA sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 44.444%
Sorbitol 55.556%
Preparation method is as follows:
Get Tanshinone I I ASodium sulfonate raw material 80g adds water for injection 1.5L, and stirring and dissolving adds sorbitol 100g stirring and dissolving, adds water for injection to 2L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate promptly gets Tanshinone I I through vacuum drying AThe sodium sulfonate sterilized powder.Press every 80mg then (with Tanshinone I I AThe sodium sulfonate meter) carries out aseptic subpackagedly, promptly get Radix Salviae Miltiorrhizae for injection ketone II ASodium sulfonate powder pin.
Embodiment 6 Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder, component is as follows, all is weight percentage:
Tanshinone I I ASodium sulfonate 0.50%
Glucose 99.50%
Preparation method is with 5.

Claims (3)

1, the present invention is a kind of Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder is characterized in that, comprises following component, all is weight percentage: Tanshinone I I ASodium sulfonate 0.125%~100%, excipient are 0~99.875%.
2, a kind of Radix Salviae Miltiorrhizae for injection ketone II as claimed in claim 1 AThe sodium sulfonate injectable powder is characterized in that, described excipient is one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, hydrolysis gel, cyclodextrin, the cyclodextrin derivative.
3, a kind of Radix Salviae Miltiorrhizae for injection ketone II as claimed in claim 1 AThe sodium sulfonate injectable powder is characterized in that, described Radix Salviae Miltiorrhizae for injection ketone II AThe sodium sulfonate injectable powder can be a kind of in sterilized powder, the aseptic freeze-dried product.
CN 200410024042 2004-04-23 2004-04-23 Tanshinone II A sodium sulfonate powder injection preparation Pending CN1568964A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200410024042 CN1568964A (en) 2004-04-23 2004-04-23 Tanshinone II A sodium sulfonate powder injection preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200410024042 CN1568964A (en) 2004-04-23 2004-04-23 Tanshinone II A sodium sulfonate powder injection preparation

Publications (1)

Publication Number Publication Date
CN1568964A true CN1568964A (en) 2005-01-26

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CN 200410024042 Pending CN1568964A (en) 2004-04-23 2004-04-23 Tanshinone II A sodium sulfonate powder injection preparation

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CN (1) CN1568964A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100446771C (en) * 2005-08-18 2008-12-31 山东轩竹医药科技有限公司 New medicinal composition
CN105496973A (en) * 2015-12-24 2016-04-20 海南华益泰康药业有限公司 Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100446771C (en) * 2005-08-18 2008-12-31 山东轩竹医药科技有限公司 New medicinal composition
CN105496973A (en) * 2015-12-24 2016-04-20 海南华益泰康药业有限公司 Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof
CN105496973B (en) * 2015-12-24 2018-09-21 海南华益泰康药业有限公司 A kind of sodium tanshinon Ⅱa silate freeze-dried powder and preparation method thereof

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