CN1559395A - Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method - Google Patents
Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method Download PDFInfo
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- CN1559395A CN1559395A CNA2004100235997A CN200410023599A CN1559395A CN 1559395 A CN1559395 A CN 1559395A CN A2004100235997 A CNA2004100235997 A CN A2004100235997A CN 200410023599 A CN200410023599 A CN 200410023599A CN 1559395 A CN1559395 A CN 1559395A
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- water
- cyclodextrin
- propyl ester
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Abstract
A water-soluble freeze-dried composition of gallopropylate is prepared from gallopropylate, cyclodextrin, and/or cyclodextrin derivative through proportionally mixing them with water, stirring, decoloring by activated carbon, aseptic filter, and freeze drying.
Description
Affiliated technical field
The present invention relates to a kind of under room temperature and cryogenic conditions freezing-drying compound contg. water-soluble gallopropylate and its preparation.
Background technology
The existing Gallate propyl ester freeze-dried powder that is used for the treatment of cardiovascular and cerebrovascular vessel and coronary heart disease (injection promote blood circulation ester, injection Radix Paeoniae Rubra 801, injection propyl gallate, arteries and veins green grass or young crops), special solvent (the being generally the injection propylene glycol) dissolving that need add in use usually with the medicine preparation (or adds normal saline 5ml, the jolting of heating in the water-bath makes dissolving fully) after, add to mixing, slowly intravenous injection in 250～500ml normal saline or 5% glucose injection.The major defect that exists: the one, need special solvent, as propylene glycol, owing to be solvent, very inconvenience in transit; Also because the existence of propylene glycol, bring zest and side effect big (as pain etc.) in the use, and can not join in the lump in the same infusion bottle, use extremely inconvenience with the immiscible medicine of propylene glycol to patient; The 2nd, need heat when adding normal saline, special firing equipment need be equipped with.Therefore, this area is starved of the Gallate propyl ester is formed in the preparation that has good solubility under room temperature and the cryogenic conditions.
Summary of the invention
Purpose of the present invention mainly provides a kind of freezing-drying compound contg. water-soluble gallopropylate and its preparation that has good solubility under room temperature and cryogenic conditions, this freeze-dried composition not only solubility property is good, easy to use, and its manufacturing process is simple, and production cost is low.
The present invention can be water-soluble Gallate propyl ester freeze-dried composition, it is characterized in that: major ingredient is the Gallate propyl ester, adjuvant is the compositions of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof.
The present invention can be water-soluble the preparation technology of Gallate propyl ester freeze-dried composition, it is characterized in that: the compositions of getting Gallate propyl ester and cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof, add water, be stirred to they fully water-soluble after, activated carbon decolorizing carries out aseptic filtration again, then is sub-packed in the container, last lyophilization is sealed.
Than prior art, the present invention can be water-soluble Gallate propyl ester freeze-dried composition since the Gallate propyl ester that shipwreck is molten and the compositions of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof mix, thereby have under room temperature and cryogenic conditions soluble in water and help preparing the remarkable advantage of injection, during use, the present invention can be water-soluble Gallate propyl ester freeze-dried composition in add sodium-chloride water solution or D/W can dissolve fast.
The specific embodiment
Among the embodiment, the weight proportion of the major ingredient Gallate propyl ester of the Gallate propyl ester freeze-dried composition that the present invention can be water-soluble and the compositions of adjuvant cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof is 1: 10～10: 1.
Above-mentioned cyclodextrin and derivant thereof are mainly methylol-beta-schardinger dextrin-, beta-schardinger dextrin-, 2-HP-, 3-HP-, HP-and their compositions.
Also can add an amount of pharmaceutically useful freeze drying excipient in the preparation process of the present invention, described excipient is the mixture of mannitol, sorbitol, sodium chloride, glucose, fructose, sucrose, xylitol, lactose and wherein a kind of excipient and other one or more excipient; The raw material of being made up of aforesaid major ingredient and adjuvant and the weight proportion of excipient are 1: 5～5: 1.
The following is the specific embodiment of Gallate propyl ester freeze-dried composition that preparation the present invention can be water-soluble:
Embodiment one:
Get Gallate propyl ester 60mg, the compositions 6mg of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof adds suitable quantity of water, and the compositions that is stirred to Gallate propyl ester and cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof is dissolved in the water fully; Under stirring condition, also can add or not add an amount of pharmaceutically useful freeze drying excipient such as mannitol; Solution after the stirring and dissolving filters with the sintered filter funnel of crossing through sterilization treatment in advance, and filtrate is sub-packed in the aseptic cillin bottle, puts and carries out lyophilization in the freezer dryer, seals, promptly get can be water-soluble Gallate propyl ester freeze-dried composition.
Embodiment two:
Get Gallate propyl ester 60mg, the compositions 60mg of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof adds suitable quantity of water, and the compositions that is stirred to Gallate propyl ester and cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof is dissolved in the water fully; Under stirring condition, also can add or not add an amount of pharmaceutically useful freeze drying excipient such as mannitol; Solution after the stirring and dissolving filters with the sintered filter funnel of crossing through sterilization treatment in advance, and filtrate is sub-packed in the aseptic cillin bottle, puts and carries out lyophilization in the freezer dryer, seals, promptly get can be water-soluble Gallate propyl ester freeze-dried composition.
Embodiment three:
Get Gallate propyl ester 60mg, the compositions 600mg of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof adds suitable quantity of water, and the compositions that is stirred to Gallate propyl ester and cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof is dissolved in the water fully; Under stirring condition, also can add or not add an amount of pharmaceutically useful freeze drying excipient such as mannitol; Solution after the stirring and dissolving filters with the sintered filter funnel of crossing through sterilization treatment in advance, and filtrate is sub-packed in the aseptic cillin bottle, puts and carries out lyophilization in the freezer dryer, seals, promptly get can be water-soluble Gallate propyl ester freeze-dried composition.
The present invention can be water-soluble Gallate propyl ester freeze-dried composition owing to have fine solubility and stability, not only guaranteed clinical application safety, the also corresponding layoutprocedure of simplifying the medical personnel reduces working strength, has popularizing application prospect preferably.
Claims (5)
- One kind can be water-soluble Gallate propyl ester freeze-dried composition, it is characterized in that: major ingredient is the Gallate propyl ester, adjuvant is the compositions of cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof.
- 2. Gallate propyl ester freeze-dried composition that can be water-soluble according to claim 1, it is characterized in that: described cyclodextrin and derivant thereof are mainly methylol-beta-schardinger dextrin-, beta-schardinger dextrin-, 2-HP-, 3-HP-, HP-and their compositions.
- 3. Gallate propyl ester freeze-dried composition that can be water-soluble according to claim 1 and 2, it is characterized in that: the weight proportion of major ingredient and adjuvant is 1: 10～10: 1.
- 4. the preparation technology of Gallate propyl ester freeze-dried composition that can be water-soluble as claimed in claim 1, it is characterized in that: the compositions of getting Gallate propyl ester and cyclodextrin, cyclodextrin derivative or cyclodextrin and derivant thereof, add water, be stirred to they fully water-soluble after, activated carbon decolorizing carries out aseptic filtration again, then is sub-packed in the container, last lyophilization is sealed.
- 5. Gallate propyl ester freeze-dried composition that can be water-soluble according to claim 3, it is characterized in that: also comprise an amount of pharmaceutically useful freeze drying excipient, described excipient is the mixture of mannitol, sorbitol, sodium chloride, glucose, fructose, sucrose, xylitol, lactose and wherein a kind of excipient and other one or more excipient; The raw material of being made up of aforesaid major ingredient and adjuvant and the weight proportion of excipient are 1: 5～5: 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100235997A CN1559395A (en) | 2004-02-17 | 2004-02-17 | Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100235997A CN1559395A (en) | 2004-02-17 | 2004-02-17 | Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1559395A true CN1559395A (en) | 2005-01-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2004100235997A Pending CN1559395A (en) | 2004-02-17 | 2004-02-17 | Freezing-drying compound contg. water-soluble gallopropylate and its prepn. method |
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| CN (1) | CN1559395A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104510709A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN110680807A (en) * | 2019-08-01 | 2020-01-14 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
-
2004
- 2004-02-17 CN CNA2004100235997A patent/CN1559395A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104510709A (en) * | 2013-09-30 | 2015-04-15 | 瑞阳制药有限公司 | Small-volume propyl gallate freeze-dried powder injection, preparation method and producing apparatus thereof |
| CN110680807A (en) * | 2019-08-01 | 2020-01-14 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
| CN110680807B (en) * | 2019-08-01 | 2021-07-13 | 广东健信制药股份有限公司 | Preparation method of propyl gallate for injection |
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