CN104027329A - Isosorbide dinitrate sodium chloride injection - Google Patents
Isosorbide dinitrate sodium chloride injection Download PDFInfo
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- CN104027329A CN104027329A CN201410244295.7A CN201410244295A CN104027329A CN 104027329 A CN104027329 A CN 104027329A CN 201410244295 A CN201410244295 A CN 201410244295A CN 104027329 A CN104027329 A CN 104027329A
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- sodium chloride
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Abstract
The invention relates to an isosorbide dinitrate sodium chloride injection which comprises the following components in effective dose: 1200-1300mg of isosorbide dinitrate, 9000-15000mg of sodium chloride, 650-700mg of a cosolvent and the balance of water for injection, wherein a pH adjustor adjusts the pH to 5.0-5.5, and the water for injection is added until the volume of the injection is 2000ml. The isosorbide dinitrate sodium chloride injection provided by the invention has good water solubility and stability.
Description
Technical field
The present invention relates to a kind of sorbide nitrate sodium chloride injection.
Background technology
Sorbide nitrate is the current wider a kind of vasodilator of application, and when low dosage, it can expansion of veins capacitance vessel, and when larger dose, it can dilating coronary blood vessel and resistance vessel, alleviates preload, the afterload of heart and improves coronary circulation.Therefore often carry out allevating angina pectoris and prevent angina pectoris by oral administration by sublingual administration.In the oral rear body of sorbide nitrate, blood drug level reaches rapidly peak, but because this medicine first pass effect is large, oral artifact availability is very low, only has 3% of intravenous injection bioavailability.Therefore sublingual administration and drug administration by injection are optimal route of administration.But for the patient of the deep treatment of needs, when sublingual administration is impossible, drug administration by injection is the unique dosage regimen that can select.Sorbide nitrate has tremulous pulse and venectasia effect concurrently, and therefore sorbide nitrate has more superiority than nitroglycerin.In treatment, when acute myocardial infarction, the less number of times of quiet needs of sorbide nitrate is adjusted dosage, and the dose ratio nitroglycerin increasing in 24 hours is little, and adopts sorbide nitrate to treat can not to resemble nitroglycerin and cause hypotension.
For drug administration by injection, prior art is as " preparation technology of Isosorbide Dinitrate Injection ": CN200310117201.1: a kind of in hydroxypropylβ-cyclodextrin and PVP K30 or two kinds are placed in to solvent, after stirring and dissolving, add again sorbide nitrate, stir to obtain Isosorbide ester solution, after fine straining, obtain clear and bright solution, after aseptic subpackaged again by gained solution after lyophilization, obtain injection sorbide nitrate, gained injection sorbide nitrate injects water and obtains clear liquid.Make Isosorbide Dinitrate Injection safer, more stable.
And for example " pharmaceutical formulation of injection sorbide nitrate and preparation method thereof ": CN200310104969.5: pharmaceutical formulation of injection sorbide nitrate injectable powder and preparation method thereof.Using sorbide nitrate as principal agent, water for injection, acetone, chloroform, ethanol, at least one solvent in ether dissolves, add cyclodextrin and derivant thereof simultaneously, mannitol, dextran, sodium chloride, lactose, glycine, sorbitol, at least one adjuvant in citric acid, make Isosorbide ester solution, adsorb through medicinal carbon, make sterile solution through 0.22um microporous filter membrane filtration, be dried again, as direct freeze-drying, lyophilization subpackage method or drying under reduced pressure subpackage method, spray drying method dehydration make principal agent with adjuvant by 1: 0-1: the injectable powder that 1000 percentage by weights form.
Applicant Yu Yijiu obtains " sorbide nitrate sodium chloride injection " New Drug Certificate for 9 years and produces official written reply, produce in enormous quantities so far for the first time on November 19th, 1, the problems such as the sorbide nitrate existing for original technology dissolves not exclusively, the related substance of product full crystallization and product in storage process, applicant carries out technological improvement constantly.
Summary of the invention
The invention provides a kind of sorbide nitrate sodium chloride injection, adopt specific injection adjuvant, and control medicinal liquid pH value in optimum, can significantly improve the stability of the product of sorbide nitrate sodium chloride injection, increase the dissolubility of sorbide nitrate in water, reduce crystallization and related substance.
Sorbide nitrate sodium chloride injection of the present invention, is grouped into by the following one-tenth of effective dose:
Sorbide nitrate 1200-1300mg
Sodium chloride 9000-15000mg
PH adjusting agent is adjusted to 5.0～5.5 by pH
Cosolvent 650-700mg
Water for injection adds to 2000ml
Preferably, the pH of described sorbide nitrate sodium chloride injection is adjusted to 5.1～5.3.
Above-mentioned sorbide nitrate sodium chloride injection, described pH adjusting agent is one or more of hydrochloric acid, nitric acid, sorbic acid, ascorbic acid, citric acid, acetic acid or sodium hydroxide; The preferably mixture of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid, the two mol ratio is 7:1.
Cosolvent of the present invention is Cys hydrochlorate.
The preferred technical scheme of the present invention is:
A kind of sorbide nitrate sodium chloride injection, is grouped into by the following one-tenth of effective dose:
Sorbide nitrate 1200-1300mg
Sodium chloride 9000-15000mg
PH is adjusted to 5.1-5.3 (most preferably 5.2) by pH adjusting agent (mixture of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid, the two mol ratio is 7:1)
Cys hydrochlorate 650-700mg
Water for injection adds to 2000ml.
Due to sorbide nitrate poorly water-soluble, the injection stability therefore preparing is bad, is easy to produce the phenomenon of separating out precipitation, producing impurity.Applicant is surprised to find that, the pH value of sorbide nitrate sodium chloride injection is controlled in particular range, (pH is adjusted to 5.1～5.3, preferably pH5.2), can increase the dissolubility of sorbide nitrate, strengthen the stability of sorbide nitrate sodium chloride injection.In addition, in the time selecting pH adjusting agent, the injection stabilizing effect that the mixture of multiple acid prepares is better than and adopts single acid, particularly adopting mol ratio is the 0.1mol/L sorbic acid of 7:1 and the mixture of 0.1mol/L ascorbic acid, compared to the mixture of other single acid or multiple acid, there is better effect.Aspect cosolvent, by measuring multiple cosolvent, such as Polyethylene Glycol, tween 80, propylene glycol, polyvinylpyrrolidone, EDTA etc., applicant finds that Cys hydrochlorate has unforeseeable solubilization-aid effect for sorbide nitrate amazedly, the sorbide nitrate sodium chloride injection good water solubility preparing, stability is high.
Detailed description of the invention
Further illustrate by the following examples the present invention, but these embodiment do not limit the present invention in any way.
Embodiment 1 sorbide nitrate sodium chloride injection
Sorbide nitrate 1250mg
Sodium chloride 12000mg
PH is adjusted to 5.2L-cysteine hydrochloride 680mg by the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid
Water for injection adds to 2000ml.
Preparation technology:
Injection formulation technique comprises dense joining with rare joins two steps, dense join to be mainly reduce to greatest extent the use amount of solvent and dissolve raw material, rare joining for dilution constant volume process.
Dense joining: to add fresh water for injection in joining cylinder appropriate dense, adds sodium chloride, the stirring and dissolving of amount of calculation, adds needle-use activated carbon 2% (W/W) to keep micro-and boil 15 minutes, then filters and remove carbon, stays sodium chloride solution filtrate for subsequent use.
Separately in a rustless steel keg, add appropriate water for injection, be heated to closely boil, add sorbide nitrate and the Cys hydrochlorate of amount of calculation, be stirred to dissolve, insulation is placed.
Rare joining: in dilute preparing tank, add proper amount of fresh water for injection, under agitation first add the sodium chloride solution of de-charcoal, after add the aqueous solution of sorbide nitrate and Cys hydrochlorate, add water to full dose, add 0.005% (W/V) active carbon, return stirring is more than 30 minutes, add pH adjusting agent (mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid) to adjust pH value to 5.2, fill again after 0.22 μ m micropore filter element is filtered to without visible foreign matters.Through 115 DEG C of hot pressing steam sterilizings 30 minutes.
Embodiment 2
Sorbide nitrate 1200mg
Sodium chloride 9000mg
0.1mol/L sorbic acid is adjusted to 5.0 by pH
Cys hydrochlorate 650mg
Water for injection adds to 2000ml.
Preparation technology: with embodiment 1.
Embodiment 3
Sorbide nitrate 1300mg
Sodium chloride 15000mg
PH is adjusted to 5.1L-cysteine hydrochloride 700mg by the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid
Water for injection adds to 2000ml.
Preparation technology: with embodiment 1.
Comparative example 1
Sorbide nitrate 1200mg
Sodium chloride 9000mg
0.1mol/L hydrochloric acid is adjusted to 5.2 by pH
Water for injection adds to 2000ml
Preparation technology: with embodiment 1.
Comparative example 2
Sorbide nitrate 1250mg
Sodium chloride 12000mg
0.1mol/L sorbic acid is adjusted to 5.2 by pH
Cys hydrochlorate 700mg
Water for injection adds to 2000ml
Preparation technology: with embodiment 1.
Comparative example 3
Sorbide nitrate 1200g
Sodium chloride 9000g
PH is adjusted to 5.2 propylene glycol 650mg by the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid
Water for injection adds to 2000ml
Preparation technology: with embodiment 1.
Comparative example 4
Sorbide nitrate 250mg
Sodium chloride 2000mg
PH is adjusted to 5.2L-cysteine hydrochloride 280mg by the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid
Water for injection adds to 2000ml.
Preparation technology: with embodiment 1.
Comparative example 5
Sorbide nitrate 1200mg
Sodium chloride 9000mg
PH is adjusted to 6.5L-cysteine hydrochloride 650mg by the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid
Water for injection adds to 2000ml.
Preparation technology: with embodiment 1.
Embodiment 4: cosolvent screening test
The dissolving of sorbide nitrate needs cosolvent, and we investigate several cosolvents.Respectively get 100mg sorbide nitrate and add respectively in 200ml aqueous solution, adjusting pH value is 5.1～5.3, adds in advance 65mg cosolvent in aqueous solution.Place 10 days at 60 DEG C, investigate the variation of Isosorbide ester content, the results are shown in Table 1:
Table 1 Polyethylene Glycol, tween 80, propylene glycol, polyvinylpyrrolidone, EDTA
Result of the test surface, sorbide nitrate dissolubility in the water that adds Cys hydrochlorate is best, almost entirely molten.Place after 10 days for 60 DEG C, the Isosorbide ester content that various cosolvents dissolve has obvious decline, but making Isosorbide ester content in the sample of cosolvent of Cys hydrochlorate declines obviously less, illustrate that using Cys hydrochlorate to make flux not only can improve the dissolubility of sorbide nitrate in water, and can reduce sorbide nitrate and separate out, improve the stability of solution.
Embodiment 5: stability test
The product that above-mentioned 3 embodiment and 6 comparative examples are made and the sorbide nitrate sodium chloride injection (positive reference substance) of CN 101708157A are positioned in 60 DEG C of climatic chambers, in sampling calibrating in the 5th, 10 days, result and comparison in 0 day:
Related substance, content are by high effective liquid chromatography for measuring (be shown in table 2).
Table 2
Result:
Embodiment 1-3: select Cys hydrochlorate as cosolvent, the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid regulates pH to 5.0-5.2 as pH adjusting agent.
Comparative example 1: do not use cosolvent
Comparative example 2: only use sorbic acid as pH adjusting agent
Comparative example 3: use propylene glycol as cosolvent
Comparative example 4: each amounts of components is different from embodiment 1-3
Comparative example 5:pH is adjusted to 6.5
Embodiment 1-3 and comparative example 1-5, the comparison of positive contrast product, pH, related substance, stable content have obvious advantage, select Cys hydrochlorate as cosolvent, the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid regulates pH to 5.0-5.2 as pH adjusting agent, can significantly increase the dissolubility of sorbide nitrate in water, and significantly improve the stability of sorbide nitrate sodium chloride injection.
Embodiment 5: long-term stable experiment
Sorbide nitrate sodium chloride injection prepared by embodiment of the present invention 1-3 and the sorbide nitrate sodium chloride injection of comparative example 1-5, CN101708157A carry out (25 DEG C ± 2 DEG C of long-time stability investigations, RH60% ± 10%), the results are shown in Table 5:
Table 5
Result:
Embodiment 1-3: select Cys hydrochlorate as cosolvent, the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid regulates pH to 5.0-5.2 as pH adjusting agent.
Comparative example 1: do not use cosolvent
Comparative example 2: only use sorbic acid as pH adjusting agent
Comparative example 3: use propylene glycol as cosolvent
Comparative example 4: each amounts of components is different from embodiment 1-3
Comparative example 5:pH is adjusted to 6.5
Result shows: sorbide nitrate sodium chloride injection (embodiment 1-3) prepared by the present invention is compared with comparative example 1-5, positive contrast product, sorbide nitrate dissolubility is good, injection stability is high, crystallization is less, its related substances is few, and quality stability increases significantly.
By above-mentioned dissolubility and stability contrast test, can find that Cys can significantly increase the dissolubility of sorbide nitrate in water.(corresponding to embodiment 1-3, restriction pH value is 5.0-5 to the technical scheme of the application's claim request protection.2, taking Cys hydrochlorate as cosolvent, select the mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid as pH adjusting agent) there is better dissolubility and stability with respect to comparative example 1-5 and positive reference substance.
Claims (5)
1. a sorbide nitrate sodium chloride injection, is characterized in that being grouped into by the following one-tenth of effective dose:
Sorbide nitrate 1200-1300mg
Sodium chloride 9000-15000mg
PH adjusting agent is adjusted to 5.0～5.5 by pH
Cosolvent 650-700mg
Water for injection adds to 2000ml.
2. sorbide nitrate sodium chloride injection as claimed in claim 1, is characterized in that: described pH adjusting agent is one or more of hydrochloric acid, nitric acid, sorbic acid, ascorbic acid, citric acid, acetic acid or sodium hydroxide; The preferably mixture of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid, the two mol ratio is 7:1.
3. sorbide nitrate sodium chloride injection as claimed in claim 1, is characterized in that: the cosolvent adopting is Cys hydrochlorate.
4. sorbide nitrate sodium chloride injection as claimed in claim 1, is characterized in that being grouped into by the following one-tenth of effective dose:
Sorbide nitrate 1200-1300mg
Sodium chloride 9000-15000mg
The mixture of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid, the two mol ratio is that pH is adjusted to 5.1-5.3 by 7:1
Cys hydrochlorate 650-700mg
Water for injection adds to 2000ml.
5. sorbide nitrate sodium chloride injection as claimed in claim 1, is characterized in that being grouped into by the following one-tenth of effective dose:
Sorbide nitrate 1250mg
Sodium chloride 12000mg
The mixture (the two mol ratio is 7:1) of 0.1mol/L sorbic acid and 0.1mol/L ascorbic acid is adjusted to 5.2 by pH
Cys hydrochlorate 680mg
Water for injection adds to 2000ml.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410244295.7A CN104027329B (en) | 2014-06-04 | 2014-06-04 | Isosorbide dinitrate sodium chloride injection |
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| CN201410244295.7A CN104027329B (en) | 2014-06-04 | 2014-06-04 | Isosorbide dinitrate sodium chloride injection |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105476955A (en) * | 2016-01-06 | 2016-04-13 | 山东新时代药业有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN105832664A (en) * | 2016-06-10 | 2016-08-10 | 山东新时代药业有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN105919930A (en) * | 2016-06-10 | 2016-09-07 | 山东新时代药业有限公司 | Isosorbide mononitrate injecta and preparation method thereof |
| CN108853015A (en) * | 2018-09-17 | 2018-11-23 | 广州市力鑫药业有限公司 | A kind of dezocine injecta composition |
| CN115073486A (en) * | 2022-06-29 | 2022-09-20 | 回音必集团抚州制药有限公司 | Isosorbide dinitrate and preparation method of injection thereof |
| CN116251057A (en) * | 2022-12-29 | 2023-06-13 | 平光制药股份有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN116251057B (en) * | 2022-12-29 | 2024-06-07 | 平光制药股份有限公司 | Isosorbide dinitrate injection and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679537A (en) * | 2004-04-07 | 2005-10-12 | 鲁南制药集团股份有限公司 | Single nitrate isosorbide sodium chloride injection |
-
2014
- 2014-06-04 CN CN201410244295.7A patent/CN104027329B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1679537A (en) * | 2004-04-07 | 2005-10-12 | 鲁南制药集团股份有限公司 | Single nitrate isosorbide sodium chloride injection |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105476955A (en) * | 2016-01-06 | 2016-04-13 | 山东新时代药业有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN105832664A (en) * | 2016-06-10 | 2016-08-10 | 山东新时代药业有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN105919930A (en) * | 2016-06-10 | 2016-09-07 | 山东新时代药业有限公司 | Isosorbide mononitrate injecta and preparation method thereof |
| CN108853015A (en) * | 2018-09-17 | 2018-11-23 | 广州市力鑫药业有限公司 | A kind of dezocine injecta composition |
| CN108853015B (en) * | 2018-09-17 | 2019-04-23 | 广州市力鑫药业有限公司 | A kind of dezocine injecta composition |
| CN115073486A (en) * | 2022-06-29 | 2022-09-20 | 回音必集团抚州制药有限公司 | Isosorbide dinitrate and preparation method of injection thereof |
| CN115073486B (en) * | 2022-06-29 | 2024-02-20 | 江西东抚制药有限公司 | Isosorbide dinitrate and preparation method of injection thereof |
| CN116251057A (en) * | 2022-12-29 | 2023-06-13 | 平光制药股份有限公司 | Isosorbide dinitrate injection and preparation method thereof |
| CN116251057B (en) * | 2022-12-29 | 2024-06-07 | 平光制药股份有限公司 | Isosorbide dinitrate injection and preparation method thereof |
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Denomination of invention: A kind of isosorbide nitrate and sodium chloride injection Effective date of registration: 20220826 Granted publication date: 20150415 Pledgee: Bank of China Limited Dongxiang sub branch Pledgor: HUIYINBI GROUP JIANGXI EAST ASIA PHARMACEUTICAL Co.,Ltd. Registration number: Y2022980013720 |
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Effective date of registration: 20221130 Address after: 344000 Jiangxi province Fuzhou City Jinchao Development Zone Zhong Ling Industrial Park Patentee after: JIANGXI DONGFU PHARMACEUTICAL Co.,Ltd. Address before: 331800 No. 6, Dongshan Industrial Park, Dongxiang Economic Development Zone, Fuzhou, Jiangxi. Patentee before: HUIYINBI GROUP JIANGXI EAST ASIA PHARMACEUTICAL Co.,Ltd. |
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