CN101810605A - Salvianic acid A pharmaceutical composition and preparation method thereof - Google Patents
Salvianic acid A pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN101810605A CN101810605A CN200910072215A CN200910072215A CN101810605A CN 101810605 A CN101810605 A CN 101810605A CN 200910072215 A CN200910072215 A CN 200910072215A CN 200910072215 A CN200910072215 A CN 200910072215A CN 101810605 A CN101810605 A CN 101810605A
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Abstract
The invention relates to a salvianic acid A pharmaceutical composition and a preparation method thereof. Salvianic acid A can be dissolved in water, but the preparation of the salvianic acid A has poor stability, is easy for oxidization, is sensitive to light and heat, and causes content reduction and impurity increase, and the guarantee on the stability is a technical problem. The salvianic acid A pharmaceutical composition comprises the salvianic acid A, a pharmacological allowable pH adjusting substance, a stabilizing agent and an excipient. The salvianic acid A in the salvianic acid A pharmaceutical composition has the concentration of 0.5-2,000mg. The weight part of the pH adjusting substance is the adding dosage when a pH value is adjusted to 2.5-7.5, and the stabilizing agent in the salvianic acid A pharmaceutical composition has the concentration of 1mg-0.5g. The salvianic acid A pharmaceutical composition is used as an injection with the effects of protecting the cardiac muscle, promoting blood circulation, removing blood stasis, resisting bacteria, eliminating inflammation, strengthening body immunity, resisting atherosclerosis, reducing blood fat, resisting platelet aggregation, resisting thrombosis, expanding the coronary artery, treating liver injury, resisting cerebral ischemia injury, resisting tumors, and the like and a therapeutical effect on pulmonary heart disease, psoriasis, altitude disease, and the like.
Description
Technical field:
The present invention relates to a kind of effects such as protection cardiac muscle, blood circulation promoting and blood stasis dispelling, anti-inflammation, enhancing human body immunity power, atherosclerosis and blood fat reducing, anti-platelet aggregation, antithrombotic formation, coronary artery dilator, treatment hepatic injury, anti-cerebral ischemia damnification, antitumor that have; and, be specifically related to danshensu injectable powder and preparation method thereof to all medicative injections such as pulmonary heart disease, psoriasis, altitude sickness.
Background technology:
Radix Salviae Miltiorrhizae is that a kind of applicating history of China is long, the Chinese crude drug that is of wide application, the injection that relates to Radix Salviae Miltiorrhizae at present, market has only compound Chinese medicinal preparation such as Radix Salviae Miltiorrhizae Injection, Radix Salviae Miltiorrhizae for injection, FUFANG DANSHEN ZHUSHEYE, DANHONG ZHUSHEYE, does not still have the injection for activated monomer in the Radix Salviae Miltiorrhizae of clinical use.Danshensu is that the dry root and rhizome of labiate-Radix Salviae Miltiorrhizae extracts a kind of water-soluble substances that gets, and is the main water-soluble active monomer in the Radix Salviae Miltiorrhizae, molecular formula: C
9H
10O
5, molecular weight: 198.17, clear and definite chemical constitution is arranged:
By present domestic extraction process, the purity of danshensu raw material can reach more than 98.0%, makes injection and has purity height, pharmacologically active height, impurity is few, side effect is low characteristics.Danshensu can dissolve in water, but its preparation stability is poor, and is easily oxidized, to light, thermo-responsive, causes content to descend and the impurity increase, and the assurance of its stability is technological difficulties.This preparation method considers to guarantee under the stable p H situation, adds the stabilizing agent of the concentration range safety that pharmacology allows, and guaranteed this stability of formulation and quality, can use safely clinically, but and under rated condition long term store.
Summary of the invention:
Can supply salvianic acid A medical composition of safe handling clinically and steady quality long term store and preparation method thereof but the purpose of this invention is to provide.
Above-mentioned purpose realizes by following technical scheme:
Salvianic acid A medical composition, its composition comprises: purity is the danshensu more than 98%, pH regulator material, the stabilizing agent that pharmacology allows, every is in every 50mg-2500mg dry, and danshensu is 0.5mg-2000mg, the addition of stabilizing agent be 1mg/ prop up～0.5g/ props up;
In the above material, described pH regulator material is the addition that pH value was adjusted to 2.5～7.5 o'clock.
Described salvianic acid A medical composition, described pH regulator material is: hydrochloric acid and/or sodium hydroxide.
Described salvianic acid A medical composition, described stabilizing agent are vitamin C.
The preparation method of described salvianic acid A medical composition is dissolved in stabilizing agent in the 500-5500ml water for injection earlier, is heated to 30-40 ℃, whole danshensus is dissolved in the above-mentioned solution again, and then stirs, reuse pH regulator material is transferred pH to 2.5-7.5, use the 0.01%-0.5% injection active carbon, 50 ℃ were stirred 20 minutes, filtered afterwards, supply water for injection again to 1000-6000ml, and the film of mistake 0.22 μ m, fill, inflated with nitrogen, make 1000, lyophilizing.
Beneficial effect:
1. the preparation of this pharmaceutical composition for can directly using clinically is easy to use.Through the preparation of this prepared, its stability and safety meet the preparation requirement of injection fully, can be for clinical a large amount of uses.
2. salvianic acid A medical composition of the present invention using method clinically is direct intramuscular injection or is mixed with the transfusion vein instillation, convenient and swift, add the stability that pH regulator material and stabilizing agent have guaranteed injection, but long term store, safe handling, quality can be guaranteed.PH regulator material that adds and stabilizing agent are the concentration that intramuscular injection, intravenous drip medicine allow use, and be safe and reliable.
3. this pharmaceutical composition is an injection, and input human body and blood of human body, body fluid etc. ooze when being made into transfusion, can not cause side effect such as haemolysis, and are safe and reliable.
4. the stabilizing agent of this pharmaceutical composition adding is the injection adjuvant that clinical permission is used, and safety has no side effect, and has guaranteed stability of formulation, prevents that the medicine qualitative change from producing toxic and side effects, can be for clinical safer use.
5. charge into nitrogen during this product fill, avoided and the contacting of oxygen, stoped oxidation reaction effectively, also avoided oxidation of drug simultaneously and the toxic and side effects that produces, make its safety obtain guarantee.
6. the injectable powder of making for the danshensu monomer because of this pharmaceutical composition, it is few, stable and controllable for quality to have high-purity, high pharmacologically active, impurity, and the characteristics that side effect is low are more having superiority than corresponding compound Chinese medicinal preparation aspect the clinical use.
7. pharmaceutical composition of the present invention has good stability, and concrete quality stability data see the following form:
Salvianic acid A medical composition quality stability tables of data
| The investigation condition | Indicate percentage composition (%) |
| The name of an article | 0 day | Illumination 10 days (4000Lx) | High temperature 10 days (60 ℃) |
| Salvianic acid A medical composition | ??99.2 | ??98.5 | ??98.4 |
Last table data show that salvianic acid A medical composition stability under high temperature, illumination condition is better, and content does not have significant change.
8. the safety testing of salvianic acid A medical composition of the present invention: the result shows this product nonirritant through Sanguis Leporis seu oryctolagi pipe irritation test; The haemolysis agglutination test shows that this product do not have blood coagulation or hemolytic, and the Cavia porcellus sensitivity test shows: this product does not have anaphylaxis, and above evidence this product is clinical safe and reliable.Through accelerated test 6 months, long term test 12 months was carried out assay with this product, and the result there is no obvious change (seeing Table 1), and this product has good stability under these process conditions.This product through 1,5,24,72 hour and 5～7 days, observes that zest and hemolytic see Table 2, table 3 for animal intramuscular injection 1ml.
Table 1 salvianic acid A medical composition quality stability investigation table
Table 2 this product (1ml) was once a day observed stimulation after 24 hours.
Illustrate: "-": non-stimulated
37 ℃ of table 3 this product hemolytics, 100% hemolysis time comparison sheet
| Antioxidant concentration | ??0.001mg/ml | ??0.5mg/ml | ??50mg/ml | ??100mg/ml |
| Salvianic acid A medical composition | 24 hours no haemolysis | 24 hours no haemolysis | 24 hours no haemolysis | 24 hours no haemolysis |
Conclusion: this product is clinical safe and reliable.
9. can add 50 ℃ of depyrogenations of active carbon among the preparation technology of the present invention.Because of active carbon has adsorption to danshensu, if the temperature height, activated carbon dosage is big, will the content of this product be impacted.We take activated carbon in advance, 20 minutes processing method of 50 ℃ of insulations, compare with active carbon depyrogenation method in the past, temperature reduces, time shortens, and activated carbon dosage reduces, and the content loss of danshensu is controlled in 1.5%, promptly guarantee the apyrogeneity of medicine, guaranteed product quality again.
The specific embodiment:
Just for better explanation the present invention, the present invention is not limited to following examples to following examples
Embodiment 1:
Salvianic acid A medical composition, its preparation technology is: get in the 1000ml water for injection that vitamin C 1g is dissolved in 30 ℃, add danshensu 0.5g, and with sodium hydroxide solution adjusting pH to 7.5, add 0.2% injection active carbon again and stirred 20 minutes for 50 ℃, 0.22 μ m membrane filtration after-teeming is penetrated water to full dose 1500ml, make 1000, fill is in cillin bottle, and inflated with nitrogen is pressed the freeze-dry process lyophilizing and got final product.
Embodiment 2:
Described salvianic acid A medical composition, get in the 1000ml water for injection that vitamin C 10g is dissolved in 30 ℃, add danshensu 3g, stir evenly, and regulate pH to 7.0 with sodium hydroxide solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 1500ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 3:
Described salvianic acid A medical composition, get in the 1200ml water for injection that vitamin C 20g is dissolved in 35 ℃, add danshensu 30g, stir evenly, and regulate pH to 6.5 with sodium hydroxide solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 1600ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 4:
Described salvianic acid A medical composition, get in the 1300ml water for injection that vitamin C 20g is dissolved in 30 ℃, add danshensu 50g, stir evenly, and add an amount of sodium hydroxide solution accent pH 6.0, adding 0.01% injection active carbon again stirred 20 minutes for 50 ℃, filter afterwards, supply water for injection again and make 1000 to the film that 1700ml also crosses 0.22 μ m, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 5:
Described salvianic acid A medical composition, get in the 1500ml water for injection that vitamin C 30g is dissolved in 40 ℃, add danshensu 200g, stir evenly, and add an amount of sodium hydroxide solution accent pH 5.5, and add 0.05% injection active carbon again and stirred 20 minutes for 50 ℃, filter after-teeming and penetrate water to full dose 1800ml, and cross 0.22 μ m film, make 1000.Fill is in cillin bottle, and inflated with nitrogen is pressed the freeze-dry process lyophilizing and got final product.
Embodiment 6:
Described salvianic acid A medical composition, get in the 1800ml water for injection that vitamin C 60g is dissolved in 30 ℃, add danshensu 250g, stir evenly, and regulate pH to 5.0 with hydrochloric acid solution, add 0.2% injection active carbon again and stirred 20 minutes for 50 ℃, filter after-teeming and penetrate water, and cross 0.22 μ m film to 2200ml, make 1000, fill is in cillin bottle, and inflated with nitrogen is pressed the freeze-dry process lyophilizing and got final product.
Embodiment 7:
Described salvianic acid A medical composition, get in the 2200ml water for injection that vitamin C 80g is dissolved in 30 ℃, add danshensu 300g, stir evenly, and regulate pH to 4.5 with hydrochloric acid solution, add 50 ℃ of 0.3% injection active carbons again and stir filtration in 20 minutes, after-teeming is penetrated water to full dose 2500ml, and crosses 0.22 μ m film, make 1000, fill is pressed in cillin bottle, inflated with nitrogen, and the freeze-dry process lyophilizing gets final product.
Embodiment 8:
Described salvianic acid A medical composition is got in the 2000ml water for injection that vitamin C 100g is dissolved in 30 ℃, adds danshensu 350g, stir evenly, and with appropriate hydrochloric acid solution accent pH to 4.0, add 0.4% injection active carbon again and stirred 20 minutes for 50 ℃, filter, after-teeming is penetrated water to full dose 2800ml, and cross 0.22 μ m film, and make 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 9:
Described salvianic acid A medical composition is got in the 2500ml water for injection that vitamin C 120g is dissolved in 30 ℃, adds danshensu 350g, stir evenly, and with appropriate hydrochloric acid solution accent pH to 3.5, add 0.05% injection active carbon again and stirred 20 minutes for 50 ℃, filter, after-teeming is penetrated water to full dose 2800ml, and cross 0.22 μ m film, and make 1000, fill is in cillin bottle, charge into nitrogen, press the freeze-dry process lyophilizing and get final product.
Embodiment 10:
Described salvianic acid A medical composition, get in the 2800ml water for injection that vitamin C 150g is dissolved in 30 ℃, add danshensu 400g, stir evenly, and transfer pH to 3.5 with appropriate hydrochloric acid solution, adding 0.1% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 μ m membrane filtration, after-teeming are penetrated water to full dose 3000ml, make 1000, inflated with nitrogen, fill are pressed the freeze-dry process lyophilizing and are got final product in cillin bottle.
Embodiment 11:
Described salvianic acid A medical composition, get in the 2800ml water for injection that vitamin C 100g is dissolved in 30 ℃, add danshensu 500g, stir evenly, and regulate pH to 3.0 with hydrochloric acid solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 3000ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 12:
Described salvianic acid A medical composition, get in the 3000ml water for injection that vitamin C 200g is dissolved in 30 ℃, add danshensu 500g, stir evenly, regulate pH to 3.0 with hydrochloric acid solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 3500ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 13:
Described salvianic acid A medical composition, get in the 4500ml water for injection that vitamin C 400g is dissolved in 30 ℃, add danshensu 1000g, stir evenly, and regulate pH to 2.5 with hydrochloric acid solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 5000ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Embodiment 14:
Described salvianic acid A medical composition, get in the 5000ml water for injection that vitamin C 500g is dissolved in 30 ℃, add danshensu 500g, stir evenly, and regulate pH to 3.0 with hydrochloric acid solution, add 0.2% injection active carbon again and stirred 20 minutes for 50 ℃, 0.22 μ m membrane filtration after-teeming is penetrated water to full dose 5500ml, makes 1000, inflated with nitrogen, fill is in cillin bottle, and inflated with nitrogen is pressed the freeze-dry process lyophilizing and got final product.
Embodiment 15:
Described salvianic acid A medical composition, get in the 5500ml water for injection that vitamin C 100g is dissolved in 30 ℃, add danshensu 2000g, stir evenly, and regulate pH to 3.0 with hydrochloric acid solution, adding 0.2% injection active carbon again stirred 20 minutes for 50 ℃, 0.22 the after-teeming of μ m membrane filtration is penetrated water to full dose 6000ml, makes 1000, fill is in cillin bottle, inflated with nitrogen is pressed the freeze-dry process lyophilizing and is got final product.
Claims (4)
1. salvianic acid A medical composition, its composition comprises: purity is the danshensu more than 98%, pH regulator material, the stabilizing agent that pharmacology allows, it is characterized in that: every is in every 50mg-2500mg dry, danshensu is 0.5mg-2000mg, the addition of stabilizing agent be 1mg/ prop up～0.5g/ props up;
In the above material, described pH regulator material is the addition that pH value was adjusted to 2.5～7.5 o'clock.
2. salvianic acid A medical composition according to claim 1 is characterized in that: described pH regulator material is: hydrochloric acid and/or sodium hydroxide.
3. salvianic acid A medical composition according to claim 1 is characterized in that: described stabilizing agent is a vitamin C.
4. the preparation method of the described salvianic acid A medical composition of claim 1-3, it is characterized in that: earlier stabilizing agent is dissolved in the 500-5500ml water for injection, be heated to 30-40 ℃, again whole danshensus is dissolved in the above-mentioned solution, and then stir, reuse pH regulator material is transferred pH to 2.5-7.5, use the 0.01%-0.5% injection active carbon, 50 ℃ were stirred 20 minutes, filtered afterwards, supply water for injection again to 1000-6000ml, and the film of mistake 0.22 μ m, fill, inflated with nitrogen, make 1000, lyophilizing.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910072215A CN101810605A (en) | 2009-06-08 | 2009-06-08 | Salvianic acid A pharmaceutical composition and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910072215A CN101810605A (en) | 2009-06-08 | 2009-06-08 | Salvianic acid A pharmaceutical composition and preparation method thereof |
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| CN101810605A true CN101810605A (en) | 2010-08-25 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105561302A (en) * | 2016-03-11 | 2016-05-11 | 浙江艾杰斯生物科技有限公司 | Psoriasis treating medicine containing lysozyme |
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2009
- 2009-06-08 CN CN200910072215A patent/CN101810605A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105561302A (en) * | 2016-03-11 | 2016-05-11 | 浙江艾杰斯生物科技有限公司 | Psoriasis treating medicine containing lysozyme |
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Application publication date: 20100825 |