CN1899296A - Breviscapine B injection preparation and its preparing method - Google Patents
Breviscapine B injection preparation and its preparing method Download PDFInfo
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- CN1899296A CN1899296A CN 200610010923 CN200610010923A CN1899296A CN 1899296 A CN1899296 A CN 1899296A CN 200610010923 CN200610010923 CN 200610010923 CN 200610010923 A CN200610010923 A CN 200610010923A CN 1899296 A CN1899296 A CN 1899296A
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Abstract
The present invention relates to pharmacy and pharmaceutics, and is especially one breviscapne B injection preparation comprising breviscapne B, amidate and medicinal basic amino acid and organic acid to form stable water solution system of pH 7-8, or one freeze dried powder for injection of the said components and medicinal excipient. The breviscapne B injection preparation is prepared through compounding water solution of breviscapne B and amidate, compounding stable L-arginine and glacial acetic acid system of pH 7-8, mixing the water solution and the stable L-arginine and glacial acetic acid system while adding water for injection to required concentration, sterilizing, filtering and packing; and the freeze dried powder for injection is prepared through further adding excipient, adding water to required concentration, sterilizing, filtering and packing, and freeze drying.
Description
Technical field
The present invention relates to pharmaceutics and pharmacopedics field.
Background technology
Herba Erigerontis is feverfew Erigeron breviscapus (Vant.) Hand.-Mazz. (Erigeron breviscapus (vant) Hand-Mazz), record in " the southern regions of the Yunnan Province book on Chinese herbal medicine " 1974 annual income Yunnan Province drug standards (Herba Erigerontis (Herba Erigerontis), Yunnan Q/W62-1974) the earliest, included Chinese Pharmacopoeia (an one, 245 pages) in 1977 in.Yunnan Pharmaceutical Institute in 1980 extract the flavonoid composition of treatment apoplexy and sequela thereof from Herba Erigerontis, and are developed into aqueous injection.The flavonoid composition called after breviscapine (breviscapine, Yunnan Q/W696-1984) that Yunnan Province Department of Public Health in 1984 will extract from Herba Erigerontis, and worked out the quality standard (Breviscapini injection, Yunnan Q/WS697-1984) of aqueous injection, the listing of approval aqueous injection.Breviscapine belongs to flavonoid glycoside (glycosides) class, and is water insoluble, but dissolve in dilute alkaline soln (institute of Materia Medica,Chinese Academy of Medical Sciences is compiled, " research of Chinese herbal medicine active ingredient ", People's Health Publisher's version in 1972, P220).Breviscapini injection comes down to the breviscapine sodium salt with breviscapine and organic base reaction back generation, and therefore, Yunnan Pharmaceutical Institute has solved the water-fast problem of breviscapine (Herba Erigerontis flavonoid composition).After 1989, breviscapine be made into iron salt, magnesium salt, calcium salt (the Wang Zhao battle-axe used in ancient China, etc., Chinese herbal medicine, 1989,20 (2): 23～25) and alkaline amino acid salt (CN1049121C) be applied to pharmacological research or clinical.
Breviscapine dissolves in the dilute alkaline soln, when PH can not cause breviscapine chain rupture or oxidation (the preparation PH of the quality standard of Breviscapini injection and injection breviscapine regulation was 6～8 so far from 1980) below 8.Yet, the alkaline solution instability of breviscapine: the one, the flavonoid composition of non-flavonoid glycoside (glycosides) class is gathered into flocculent deposit and separates out along with the prolongation of time, cause the clarity of preparation defective; The 2nd, can separate out precipitation when mixing use with glucose injection acid medicinal liquids such as (PH3.2～5.5).For solving the unstability of breviscapine injection, many patents are disclosed.Summary is got up, and the instable method that these solve the breviscapine injection is to add " stabilizing agent " in the breviscapine injection." a kind of stability-enhanced breviscapine injection and preparation method thereof " described stabilizing agent as CN1555807A is organic base, organic acid, antioxidant.A kind of in citrate in the organic base, meglumine, sodium pantothenate, L-cysteine, benzene methanamine, nicotiamide, thiourea, ethanolamine, the urea or two kinds; A kind of in citric acid in the organic acid, acetic acid, oxalic acid, maleic acid, succinic acid, fumaric acid, malic acid, tartaric acid, the ascorbic acid or two kinds; Antioxidant has one or more in sodium sulfite, sodium sulfite, sodium pyrosulfite, L-cysteine, the ascorbic acid.What also have uses the metal ion intercalating agent as stabilizing agent, " prescription that Breviscapini injection is stable and technical process " as CN1187356A, EDTA-2Na is used as the stabilizing agent of Breviscapini injection, L-cysteine, hexamethylenamine, sodium pyrosulfite, phosphoric acid salt, nicotiamide, ethanolamine, propylene glycol, sodium sulfite, carbonate or bicarbonate, thiourea etc. have also been announced simultaneously.CN1476840A " a kind of preparation method of stable Breviscapini injection " is example with CN1187356A, negated above-mentioned series of stable agent: " Chinese patent CN1187356A disclosed in 1998; disclose the stable prescription of a kind of Breviscapini injection; adopt the series of stable agent; pH value is transferred to 7.0～7.8, in fact still can not solve stability problem ".This patent application has proposed to think and can solve the method for stablizing the breviscapine injection: be Main Ingredients and Appearance with the breviscapine, in preparation process, add arginine, and adjusting pH value to 4.5～6.5, and incite somebody to action " add the L-arginine in the preparation process; adjusting pH value to 4.5～5.6, the arginic amount of L-is 40～80mg/100ml " and included claim in.
The breviscapine injection is except because preparation itself instability, separate out precipitation in the storage easily, cause clarity defective outside, when the Herba Erigerontis injection mixes use with glucose injection (PH3.2～5.5), G/NS injection, if the pH value of these preparations is lower than 4, then in preparation or infusion process, can separate out precipitation, bring safety problem.
Breviscapine), rather than lamp-dish flower acetic (scutellarin) the legal notion of breviscapine is flavonoid composition (the 20 in Ministry of Health of the People's Republic of China's drug standard Chinese traditional patent formulation preparation, the P103: in the Herba Erigerontis.A kind of in the plain just breviscapine of second, however but be main efficacy component.Therefore, all be amount with the quality standard of all preparations of breviscapine using names with efficacy component in the content decision preparation of lamp-dish flower acetic.Because the method for legal detection lamp-dish flower acetic content is the uv-spectrophotometric absorption coefficient method in the quality standard before 2005, this method is all thought every absorption value at the 335nm wavelength by mistake to be the absorption value of lamp-dish flower acetic, to not lamp-dish flower acetic, but also there is the material of absorption all to be used as the plain content that calculates of second at the 335nm wavelength, thereby measurement result is inevitable higher, causes the second cellulose content in the now commercially available Breviscapine (oral agents, tablet, aqueous injection, injectable powder etc.) to detect generally all below 90% with high performance liquid chromatography.That is to say that Shang Shi breviscapine and preparation thereof are not pure lamp-dish flower acetic preparations now, but contain the mixture of 6-11 kind Herba Erigerontis Flavonoid substances.The applicant discloses the preparation method of lamp-dish flower acetic content at the breviscapine B raw material medicine that (detects with high performance liquid chromatography) more than 98% in application in 2004, disclosed " preparation technology of high-purity medicine with lamp-dish flower acetic as raw material " (application number is respectively: CN200410010182.1, CN200410040352.6, CN200410062573.3) in 2005, prepares lamp-dish flower acetic (rather than breviscapine) crude drug first.
That is to say, above the technical scheme of the solution breviscapine injection stability problem reported all be at the breviscapine crude drug, rather than at breviscapine B raw material medicine.
The lamp-dish flower acetic of having purified, because its structure is 4 ', 5 ', 6 '-trihydroxyflavone-7-O-glucuronide, (the metal ion displacement of hydrion COOH) and organic base or inorganic base or basic salt of carboxyl on its glucose, the plain salt of the second that generates and soluble in water than breviscapine (mixture of 4-11 kind flavone), but the injection of scutellarin (aqueous injection, injectable powder) also exists the injection lower with PH (is the glucose injection of 3.2-5.5 as PH) to mix when using sedimentary problem can occur; When the breviscapine B injection liquid of preparation high concentration, be prone to the underproof problem of clarity.That is to say that also there is the above-mentioned same problem of breviscapine injection in lamp-dish flower acetic (purity reaches more than 98%) injection.The instability problem that does not relate to above-mentioned breviscapine B injection agent among the Chinese patent application CN1640409A " a kind of highly purified breviscapine B injection agent ", so the stability problem of breviscapine B injection agent is still unresolved so far.
Summary of the invention
Purpose of the present invention is intended to overcome the deficiencies in the prior art, and providing a kind of is ejection preparation crude drug, stable with the lamp-dish flower acetic.
Another object of the present invention is to provide the preparation method of this ejection preparation.
Breviscapine B injection preparation of the present invention is the aqueous injection that the medicinal basic acidic amino acid of 7-8 and stabilized aqueous solution system that organic acid is formed form by lamp-dish flower acetic-amino acid salts and PH, or adds the lyophilized injectable powder that medicinal vehicle group becomes again.
Described lamp-dish flower acetic-amino acid salts lamp-dish flower acetic amino acid salts that to be purity generate greater than 98% breviscapine B raw material medicine and L-lysine or L-arginine reaction back, its mass ratio is 1: 0.32～0.42; Described stabilized aqueous solution system is the L-arginine: glacial acetic acid or L-lysine: the mass ratio of glacial acetic acid is 1: 0.28～0.33 stabilized aqueous solution system that is formed, wherein the addition of L-arginine or L-lysine and the rapid equivalent of previous step.
Described pharmaceutical excipient is a kind of in mannitol, low molecular dextran, the glycine etc. or 2 kinds.
Breviscapine B injection agent of the present invention (aqueous injection and lyophilized injectable powder) is to be efficacy component with the lamp-dish flower acetic more than 98%, form with the plain amino acid salts of second is dissolved in water, with L-arginine-glacial acetic acid or L-lysine-glacial acetic acid is stabilisation systems, and PH is 7-8.
The preparation method of breviscapine B injection preparation of the present invention is made up of following steps: preparation lamp-dish flower acetic-amino acid salts aqueous solution; Preparation PH is L-arginine-ice vinegar stabilisation systems of 7-8; The two mixing is added water for injection to desired concn, and the aseptic filtration packing is aqueous injection; Or add excipient again, and add water for injection to desired concn, the aseptic filtration packing, lyophilizing is lyophilized injectable powder.
Concrete steps are:
One, preparation lamp-dish flower acetic-amino acid salt solution: take by weighing breviscapine B raw material medicine, add in the injection water, the heating hydrotropy, the L-arginine or the L-lysine that add 0.32～0.42 times of the plain crude drug of above-mentioned second, transfer PH to 7-8, mixing is lamp-dish flower acetic-amino acid salt solution;
Two, preparation stabilisation systems: get L-arginine or L-lysine with above-mentioned equivalent, after adding in the injection water dissolving again, the glacial acetic acid that adds 0.28～0.33 times of described L-arginine or L-lysine, mixing, survey PH is 7-8, is L-arginine-glacial acetic acid or L-lysine-glacial acetic acid stabilisation systems;
Three, step 1, two is mixed, add water for injection to required specification breviscapine B injection liquid concentration, aseptic filtration or autoclaving promptly obtain breviscapine B injection liquid; Or injection added excipient again, and add the lamp-dish flower acetic concentration of water for injection to required specification, aseptic filtration or autoclaving, packing, lyophilization is injection lamp-dish flower acetic lyophilized injectable powder.
Stability test of the present invention:
Detect through HPLC, the plain purity of second reaches more than 98%; Embodiment 1 injection is 3.2 at PH, concentration is in 5% the glucose injection＞solution was limpid in 16 hours, and do not have precipitation and separates out; In PH is 4.2 above-mentioned glucose solution＞and solution was limpid in 96 hours, and do not have precipitation and separates out.The lamp-dish flower acetic sodium-salt parenteral solution that does not add stabilisation systems of the present invention is 2 minutes solution muddinesses in 3.2,5% the glucose injection at PH, and there is the graininess precipitation to separate out, at PH is 6 hours muddinesses in 4.2 5% the glucose injection, and has the graininess precipitation to separate out (seeing Table 1).The injection room temperature leaves standstill and occurred precipitation in 24-32 month as yet, uses with the minimum glucose injection of PH etc., also can not become turbid or precipitate (embodiment 1,2).
Table 1 reaches the stable contrast table of the breviscapine B injection liquid (50mg/ml) more than 98% at 5% glucose injection (250ml) moderate purity of different PH
| Second element-amino acid salts+stabilisation systems injection | Second element-sodium injection (not adding stabilisation systems) | ||
| 5% Glucose Liquid pH value | Particulate matter or muddy zero-time are arranged | 5% Glucose Liquid pH value | Particulate matter or muddy zero-time are arranged |
| 3.2 | ＞16h | 3.2 | 2′ |
| 3.3 | ＞16h | 3.3 | 3′ |
| 3.4 | ＞16h | 3.4 | 4′ |
| 3.5 | ＞16h | 3.5 | 7′ |
| 3.6 | ＞32h | 3.6 | 10′ |
| 3.7 | ＞48h | 3.7 | 14′ |
| 3.8 | ＞48h | 3.8 | 42′ |
| 3.9 | ＞48h | 3.9 | 56′ |
| 4.0 | ＞48h | 4.0 | 2h23′ |
| 4.1 | ＞72h | 4.1 | 4h38′ |
| 4.2 | ＞96h | 4.2 | 6h |
The present invention is that the plain monomer of pure second that reaches more than 98% with purity is a crude drug, add brand-new stabilisation systems and form, thereby breviscapine B injection preparation of the present invention is a kind of brand-new ejection preparation.The invention has the advantages that adopting the lamp-dish flower acetic of extreme high purity is crude drug, it is few to bring impurity into, and it is extremely low that the side effect of ejection preparation is dropped to, and avoids the heating phenomenon of feeling cold that occurs in the clinical use; Owing to added stabilisation systems, can make the ejection preparation long preservation and do not produce precipitation; Ejection preparation can mix use with the lower glucose injection of PH, can not produce precipitation.The pharmaceutic adjuvant that is added in the ejection preparation is less relatively, has both saved pharmaceutic adjuvant, can avoid the side effect that brings because of pharmaceutic adjuvant again.
Be essentially different with CN1476840A: 1. the present invention is the monomer injection, rather than breviscapine (total flavones) injection.2, stabilisation systems is made up of L-arginine or L-lysine and glacial acetic acid.(3) PH of adding stabilisation systems is 7-8, and promptly injection PH is 7-8, rather than PH4.5～6.5.4, the arginic concentration C N1476840A of L-is 40-80mg/100ml, and this patent is tens times of CN1476840A patent consumption.5, CN1476840A breviscapine: arginine=1: 2.5, L-arginine consumption are nearly 2.5 times of efficacy component; Patent lamp-dish flower acetic of the present invention: L-arginine or L-lysine are 1: 0.64～0.84, are 64%～84% of efficacy component.
Not mentioned L-arginine of the difference of the present invention and CN155807A: CN155807A and L-lysine.In hundreds of related technical scheme of patents such as CN155807A, all do not relate to L-arginine-glacial acetic acid of the present invention and L-lysine-glacial acetic acid stabilisation systems.
Therefore, the stabilisation systems of lamp-dish flower acetic aqueous solution of the present invention is brand-new stabilisation systems.
The specific embodiment
Embodiment 1: injection (50mg/ml/ bottle):
(1) preparation of lamp-dish flower acetic-amino acid salts (PH7.5):
Lamp-dish flower acetic (purity is more than 98%) 50g
L-lysine 19g
Injection water adds to 750ml
(2) stabilisation systems preparation (PH7.5):
L-lysine 19g
Glacial acetic acid 5.5ml
Injection water adds to 200ml
(3) injection lamp-dish flower acetic:
Lamp-dish flower acetic-amino acid salts (1) 750ml
Stabilisation systems (2) 200ml
Injection water is added to 1000ml
Aseptic filtration, packing, autoclaving promptly get aqueous injection.
Embodiment 2:(100mg/2ml/ bottle) lyophilized preparation
(1) preparation of lamp-dish flower acetic-amino acid salts (PH7.5)
Lamp-dish flower acetic (purity is more than 98%) 100g
L-arginine 34g
Injection water is added to 1500ml
(2) stabilisation systems preparation (PH7.5)
L-arginine 34g
Glacial acetic acid 10ml
Injection water adds to 400ml
(3) injection lamp-dish flower acetic prescription
Lamp-dish flower acetic-amino acid salts 1500ml
Stabilisation systems 400ml
Mannitol (dry powder) 100g
Injection water adds to 2000ml
Aseptic filtration, packing, lyophilizing promptly get lyophilized injectable powder.
Claims (5)
1, a kind of breviscapine B injection preparation is characterized in that by lamp-dish flower acetic-amino acid salts and PH be the aqueous injection that the medicinal basic acidic amino acid of 7-8 and stabilized aqueous solution system that organic acid is formed form, or adds the lyophilized injectable powder that medicinal vehicle group becomes again.
2, breviscapine B injection preparation as claimed in claim 1, it is characterized in that described lamp-dish flower acetic-amino acid salts lamp-dish flower acetic amino acid salts that to be purity generate greater than 98% breviscapine B raw material medicine and L-lysine or L-arginine reaction back, its mass ratio is 1: 0.32～0.42.
3, breviscapine B injection preparation as claimed in claim 1, it is characterized in that described stabilized aqueous solution system is the L-arginine: glacial acetic acid or L-lysine: the mass ratio of glacial acetic acid is 1: 0.28～0.33 stabilized aqueous solution system that is formed.
4, breviscapine B injection preparation as claimed in claim 1 is characterized in that described pharmaceutical excipient is a kind of in mannitol, low molecular dextran, the glycine etc. or 2 kinds.
5, a kind of preparation method of breviscapine B injection preparation as claimed in claim 1 is characterized in that being made up of following steps:
One, preparation lamp-dish flower acetic-amino acid salt solution: take by weighing breviscapine B raw material medicine, add in the injection water, the heating hydrotropy, the L-arginine or the L-lysine that add 0.32～0.42 times of the plain crude drug of above-mentioned second, transfer PH to 7-8, mixing is lamp-dish flower acetic-amino acid salt solution;
Two, preparation stabilisation systems: get L-arginine or L-lysine with above-mentioned equivalent, after adding in the injection water dissolving again, the glacial acetic acid that adds 0.28～0.33 times of described L-arginine or L-lysine, mixing, survey PH is 7-8, is L-arginine-glacial acetic acid or L-lysine-glacial acetic acid stabilisation systems;
Three, step 1, two is mixed, add water for injection to required specification breviscapine B injection liquid concentration, aseptic filtration or autoclaving promptly obtain breviscapine B injection liquid; Or injection added excipient again, and add the lamp-dish flower acetic concentration of water for injection to required specification, aseptic filtration or autoclaving, packing, lyophilization is injection lamp-dish flower acetic lyophilized injectable powder.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006100109230A CN100406021C (en) | 2006-05-26 | 2006-05-26 | Breviscapine B injection preparation and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006100109230A CN100406021C (en) | 2006-05-26 | 2006-05-26 | Breviscapine B injection preparation and its preparing method |
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| CN1899296A true CN1899296A (en) | 2007-01-24 |
| CN100406021C CN100406021C (en) | 2008-07-30 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101708181B (en) * | 2009-11-09 | 2011-07-27 | 昆明龙津药业股份有限公司 | Scutellarin injection preparation |
| CN106236710A (en) * | 2016-08-29 | 2016-12-21 | 上海颂露医药科技有限公司 | Breviscapini injection and preparation method thereof |
| CN106806348A (en) * | 2015-11-30 | 2017-06-09 | 湖南恒生制药股份有限公司 | The preparation method of Breviscapine |
| CN110478361A (en) * | 2018-05-14 | 2019-11-22 | 昆明龙津药业股份有限公司 | A kind of highly-safe lamp-dish flower acetic pharmaceutical composition and preparation method thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1231223C (en) * | 2002-12-19 | 2005-12-14 | 上海博泰医药科技有限公司 | Breviscapine infusion preparation and its preparing method |
| CN1476840A (en) * | 2003-07-15 | 2004-02-25 | 上海博泰医药科技有限公司 | Preparation method of stable fleabane extract injection |
| CN1245987C (en) * | 2004-01-08 | 2006-03-22 | 中国药科大学 | Stability enhanced erigeron breviscapus injection and its preparation method |
-
2006
- 2006-05-26 CN CNB2006100109230A patent/CN100406021C/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101708181B (en) * | 2009-11-09 | 2011-07-27 | 昆明龙津药业股份有限公司 | Scutellarin injection preparation |
| CN106806348A (en) * | 2015-11-30 | 2017-06-09 | 湖南恒生制药股份有限公司 | The preparation method of Breviscapine |
| CN106236710A (en) * | 2016-08-29 | 2016-12-21 | 上海颂露医药科技有限公司 | Breviscapini injection and preparation method thereof |
| CN110478361A (en) * | 2018-05-14 | 2019-11-22 | 昆明龙津药业股份有限公司 | A kind of highly-safe lamp-dish flower acetic pharmaceutical composition and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100406021C (en) | 2008-07-30 |
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