CN1875925A - Sodium tashinone II A sulfonate injection and preparation method thereof - Google Patents
Sodium tashinone II A sulfonate injection and preparation method thereof Download PDFInfo
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- CN1875925A CN1875925A CN 200610090622 CN200610090622A CN1875925A CN 1875925 A CN1875925 A CN 1875925A CN 200610090622 CN200610090622 CN 200610090622 CN 200610090622 A CN200610090622 A CN 200610090622A CN 1875925 A CN1875925 A CN 1875925A
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Abstract
The invention relates to a sodium tanshinone IIA silate injection and process for preparation, wherein the raw material comprises superfine sodium tanshinone IIA silate and medicinal auxiliary materials for injections. The injection has the advantages of high yield and good stability.
Description
Technical field
The invention belongs to the Chinese medicine field, be specifically related to a kind of sodium tanshinone IIA sulfate injection and preparation method thereof.
Background technology
Superfine grinding is the new technique that development in recent years is got up, present technique adopts the special impact target body Thomson effect in the fluidized bed airflow pulverising mill, can strengthen toughness material superfine grinding effect, and employing BI blade, the super-fine classified system that makes stage turbine adapt to low-gravity Chinese crude drug powder also adopts electrostatic prevention structure and explosion-proof design, and these measures have effectively guaranteed medicine super-refinement effect.The dissolution of solid drugs and preparation add that the micronized degree in the process has substantial connection.The quantitative change of granular size can bring the qualitative change of powder characteristics and then produce many new performances.It is one of important content in the present biopharmacy to improve its dissolution that the principle of powder application body technique and method change the existence of medicine in preparation.
The production of domestic existing sodium tanshinone IIA sulfate injection at present, its national standard announces that standard No. is WS-10001-(HD-1014)-2002, and specification is 2ml:10mg, this product can increase coronary flow, improves the collateral circulation and the local blood supply of ischemic region cardiac muscle.Improve the metabolism disorder of anoxia cardiac muscle, improve myocardial hypoxia tolerance, anticoagulant and antithrombotic form, and dwindle laboratory animal ischemic myocardium infarct size, can strengthen myocardial contraction under doses.Can be used for coronary heart disease, angina pectoris, uncomfortable in chest.The drug standard of sodium tanshinone IIA sulfate injection listing usefulness is the national drug standards that local drug standard rises, though the drug standard integral level has improved.The sodium tanshinone IIA sulfate aqueous stability is poor, and is variable muddy but in the research of the preparation stability of sodium tanshinone IIA sulfate injection not fully not deeply.Because the disease that sodium tanshinone IIA sulfate is treated relates to the cardiovascular and cerebrovascular vessel critical illness, the importance of the stability of its injection is self-evident.
It is more that the patent disclosure of relevant sodium tanshinone IIA sulfate injection gets document, as CN200310111509.5, CN200510064376.X, CN200310125178, CN200410002103.8, CN200310121026.3, CN200510040386.X, CN200510035691.X; Wherein relevant with injection of the present invention have CN200410002103.8, CN200510040386.X and a CN200510035691.X, but it is poor that the technology that adopts these 3 patent documentations still can not effectively solve the sodium tanshinone IIA sulfate aqueous stability, variable muddy problem.
Summary of the invention
The object of the present invention is to provide a kind of sodium tanshinone IIA sulfate injection.
Another object of the present invention is to provide a kind of preparation method of sodium tanshinone IIA sulfate injection.
Particularly, the raw material of sodium tanshinone IIA sulfate injection of the present invention is made up of the sodium tanshinone IIA sulfate and the available pharmaceutic adjuvant of injection of superfine grinding.
The particle diameter of the sodium tanshinone IIA sulfate of described superfine grinding is the 5-50 micron, preferred 5-8 micron.
The available pharmaceutic adjuvant of described injection is selected from sodium sulfite, sodium sulfite, sodium thiosulfate, glycine, alanine, cysteine hydrochloride, tween 20, Tween-40, Tween-60, tween 80, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, xylitol, sorbitol, dextran, glucose, mannitol, the glycerol one or more combination.
Described sodium tanshinone IIA sulfate injection can be made injection or infusion solution.
The preparation method of sodium tanshinone IIA sulfate injection of the present invention is: with sodium tanshinone IIA sulfate superfine grinding particle diameter is to add the available pharmaceutic adjuvant of injection behind the 5-50 micron to be dissolved in water for injection, regulate pH value, add needle-use activated carbon approximately, filtering decarbonization in stirring and adsorbing; Add remaining water for injection after the cooling again to capacity, filter, embedding obtains injection or infusion solution.
The available pharmaceutic adjuvant of the injection described in the preparation method of sodium tanshinone IIA sulfate injection is selected from sodium sulfite, sodium sulfite, sodium thiosulfate, glycine, alanine, cysteine hydrochloride, tween 20, Tween-40, Tween-60, tween 80, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, xylitol, sorbitol, dextran, glucose, mannitol, the glycerol one or more combination among the present invention.
Proof is compared with the product of prior art on quality by the sodium tanshinone IIA sulfate injection of gained of the present invention by experiment, the outstanding advantage stable more, that yield is higher.
The specific embodiment
Further describe the present invention with embodiment below, help understanding, but described embodiment only is used to illustrate the present invention rather than restriction the present invention the present invention and advantage thereof, better effects if.
Embodiment 1
Sodium tanshinone IIA sulfate 100g adopts QWJ air-flow vortex pulverizing mill to pulverize, and gets the sodium tanshinone IIA sulfate of 5-8 micron, makes 10000 of small-volume injections (specification is that 2ml/ props up).
In dense preparing tank, add an amount of water for injection, the superfine grinding particle diameter that adds recipe quantity in dense preparing tank is the sodium tanshinone IIA sulfate 100g of 5-8 micron, fully stir, add active carbon by 0.04% of preparation cumulative volume, be heated to 90 ℃, be incubated 20 minutes, be cooled to 50 ℃, with the medicinal liquid decarbonization filtering to dilute preparing tank, add the 5g alanine in dilute preparing tank, the 0.5g tween 80 fully stirs and makes dissolving fully, add active carbon by 0.02% of preparation cumulative volume, left standstill 20 minutes, and added water for injection to the dosing amount, transferring pH is 4.5 ± 0.2, with the medicinal liquid decarbonization filtering, medicinal liquid is again through end-filtration, and embedding is in the 2ml ampoule, and ampoule fills nitrogen by propping up during embedding, sterilization promptly gets small-volume injection.
Embodiment 2
Sodium tanshinone IIA sulfate 100g adopts QWJ air-flow vortex pulverizing mill to pulverize, and the sodium tanshinone IIA sulfate that gets the 8-50 micron is made 10000 of small-volume injections (specification is that 2ml/ props up).
In dense preparing tank, add an amount of water for injection, the superfine grinding particle diameter that adds recipe quantity in dense preparing tank is the sodium tanshinone IIA sulfate of 5-8 micron, fully stir, add active carbon by 0.04% of preparation cumulative volume, be heated to 90 ℃, be incubated 20 minutes, be cooled to 50 ℃, to dilute preparing tank, adding 5g sodium chloride and 3g sodium sulfite fully stir and make dissolving fully in dilute preparing tank with the medicinal liquid decarbonization filtering, add active carbon by 0.02% of preparation cumulative volume, left standstill 20 minutes, and added water for injection to the dosing amount, transferring pH is 4.5 ± 0.2, with the medicinal liquid decarbonization filtering, medicinal liquid is again through end-filtration, and embedding is in the 2ml ampoule, and ampoule fills nitrogen by propping up during embedding, sterilization promptly gets small-volume injection.
Embodiment 3
Sodium tanshinone IIA sulfate 42g adopts QWJ air-flow vortex pulverizing mill to pulverize, and gets the sodium tanshinone IIA sulfate of 5-8 micron.
Prescription: the sodium tanshinone IIA sulfate 40g of 5-8 micron, sodium chloride 900g, sodium sulfite 100g, 0.1mol/L phosphoric acid solution an amount of (pH=6), water for injection 100000ml.
Preparation method:
(1) standby after infusion bottle, plug, aluminium lid being cleaned respectively, sterilizing; Wherein clear, the sterilization of infusion bottle: infusion bottle cleans with bottle washer earlier, then cleans with deionized water, water for injection, and the reuse clean compressed air dries up, and reaches 350 ℃ ir tunnel baking oven sterilization 5-8 minute at last by temperature, cooling.The wherein cleaning of plug, sterilization: butyl rubber plug is earlier with deionized water prewashing, reuse water for injection fine purifiation, in 125 ℃ of sterilizations 150 minutes.The wherein cleaning of aluminium lid, sterilization: aluminium lid cleaned 15 minutes through abluent earlier, then with water for injection rinsing three times, each 30 minutes, dried through 120 minutes under 120 ℃ of conditions at last.
(2) in 10000 grades of clean areas, get recipe quantity 60% water for injection, add the sodium tanshinone IIA sulfate raw material 40g of 5-8 micron, sodium chloride 900g, sodium sulfite 10g, dissolving.
(3) add 0.2% needle-use activated carbon by amount of liquid, decolouring is 30 minutes under 40 ℃ of conditions, send in 100 grades of clean areas, supply the injection water yield, mixing, regulate pH value to 6 with the 0.1mol/L phosphoric acid solution, behind 0.22-0.45 micron filtering with microporous membrane, packing, fill nitrogen, button plug, Zha Gai, sterilization and leak detection, lamp inspection, be packaged into 1000 bottles.Sterilization is adopted methylene blue solution with 115 ℃ of flowing steam sterilizations 30 minutes, leak detection, and the lattice product label of fitting is after the assay was approved cased after wrapping up in the black paper bag.
Embodiment 4
Sodium tanshinone IIA sulfate 42g adopts QWJ air-flow vortex pulverizing mill to pulverize, and gets the sodium tanshinone IIA sulfate of 8-50 micron.
Take by weighing the sodium tanshinone IIA sulfate 40g of 8-50 micron, the 25g sodium calcium edetate, 500g vitamin C, 12.5kg glucose, add 200 liters of waters for injection, stirring makes dissolving, adds hydrochloric acid and regulates pH to 5.21, measures and adds water for injection to 25 liter behind the content, add 0.05% active carbon, filter, fill is sterilized to the 250ml infusion bottle.Finished product outer housing black plastic bag, sealing is preserved.The whole operation process is to carry out under the lucifuge condition.
Embodiment 5
Sodium tanshinone IIA sulfate 40g adopts QWJ air-flow vortex pulverizing mill to pulverize, and gets the sodium tanshinone IIA sulfate of 8-50 micron.
The sodium tanshinone IIA sulfate 0.4g of 8-50 micron, glucose 250g, antioxidant sodium sulfite 5.0g, cysteine hydrochloride 1.0g, water for injection 5000ml.In the sodium tanshinone IIA sulfate 0.4g of 8-50 micron, add water for injection 4000ml, dissolving; Add glucose, sodium sulfite and cysteine hydrochloride then, regulate pH value to 4.5 with the sodium hydroxide of 0.1mol/L; Needle-use activated carbon insulated and stirred under 80 ℃ of temperature with dose volume 0.1% amount was adsorbed filtering decarbonization about 30 minutes; Add remaining water for injection after the cooling again to capacity, after mensuration content is qualified, with 0.45 micron filtering with microporous membrane; Filtrate is filled in the 500ml infusion bottle, puts mylar, covers plug and gland, and sterilization promptly got final products in 30 minutes under 105 ℃ of flowing steams.Owing to added antioxidant in this product, so that product stability is good, must adds aqueous slkali simultaneously and regulate pH value to 4.5, meet the pH value 3.5-5.5 scope of national drug standards regulation.
Comparative Examples 1
Sodium tanshinone IIA sulfate 100g makes 10000 of small-volume injections (specification is that 2ml/ props up).
In dense preparing tank, add an amount of water for injection, in dense preparing tank, add the sodium tanshinone IIA sulfate of recipe quantity, fully stir, fully stir, add active carbon, be heated to 90 ℃ by 0.04% of preparation cumulative volume, be incubated 20 minutes, be cooled to 50 ℃, the medicinal liquid decarbonization filtering to dilute preparing tank, is added the 5g alanine in dilute preparing tank, 0.5g tween 80, fully stir and make dissolving fully, add active carbon, left standstill 20 minutes by 0.02% of preparation cumulative volume, add water for injection to the dosing amount, transferring pH is 4.5 ± 0.2, and with the medicinal liquid decarbonization filtering, medicinal liquid is again through end-filtration, embedding is in the 2ml ampoule, ampoule fills nitrogen by propping up during embedding, and sterilization promptly gets small-volume injection.
Comparative Examples 2
Sodium tanshinone IIA sulfate 100g makes 10000 of small-volume injections (specification is that 2ml/ props up).
In dense preparing tank, add an amount of water for injection, the sodium tanshinone IIA sulfate that in dense preparing tank, adds recipe quantity, fully stir, add active carbon, be heated to 90 ℃ by 0.04% of preparation cumulative volume, be incubated 20 minutes, be cooled to 50 ℃, to dilute preparing tank, adding 5g sodium chloride and 3g sodium sulfite fully stir and make dissolving fully in dilute preparing tank with the medicinal liquid decarbonization filtering, add active carbon by 0.02% of preparation cumulative volume, left standstill 20 minutes, and added water for injection to the dosing amount, transferring pH is 4.5 ± 0.2, with the medicinal liquid decarbonization filtering, medicinal liquid is again through end-filtration, and embedding is in the 2ml ampoule, and ampoule fills nitrogen by propping up during embedding, sterilization promptly gets small-volume injection.
Comparative Examples 3 (embodiment 1 of CN200510035691.X)
Prescription: sodium tanshinone IIA sulfate (in tanshinone) 40g, sodium chloride 900g, sodium sulfite 100g, 0.1mol/L phosphoric acid solution an amount of (pH=6), water for injection 100000ml.
Preparation method:
(1) standby after infusion bottle, plug, aluminium lid being cleaned respectively, sterilizing; Wherein clear, the sterilization of infusion bottle: infusion bottle cleans with bottle washer earlier, then cleans with deionized water, water for injection, and the reuse clean compressed air dries up, and reaches 350 ℃ ir tunnel baking oven sterilization 5-8 minute at last by temperature, cooling.The wherein cleaning of plug, sterilization: butyl rubber plug is earlier with deionized water prewashing, reuse water for injection fine purifiation, in 125 ℃ of sterilizations 150 minutes.The wherein cleaning of aluminium lid, sterilization: aluminium lid cleaned 15 minutes through abluent earlier, then with water for injection rinsing three times, each 30 minutes, dried through 120 minutes under 120 ℃ of conditions at last.
(2) in 10000 grades of clean areas, get recipe quantity 60% water for injection, add tanshinone 40g, sodium chloride 900g, sodium sulfite 10g, dissolving.
(3) add 0.2% needle-use activated carbon by amount of liquid, decolouring is 30 minutes under 40 ℃ of conditions, send in 100 grades of clean areas, supply the injection water yield, mixing, regulate pH value to 6 with the 0.1mol/L phosphoric acid solution, behind 0.22-0.45 micron filtering with microporous membrane, packing, fill nitrogen, button plug, Zha Gai, sterilization and leak detection, lamp inspection, be packaged into 1000 bottles.Sterilization is adopted methylene blue solution with 115 ℃ of flowing steam sterilizations 30 minutes, leak detection, and the lattice product label of fitting is after the assay was approved cased after wrapping up in the black paper bag.
Comparative Examples 4 (embodiment 1 of CN200510040386.X)
Take by weighing the 40g sodium tanshinone IIA sulfate, the 25g sodium calcium edetate, 500g vitamin C, 12.5kg glucose, add 200 liters of waters for injection, stirring makes dissolving, adds hydrochloric acid and regulates pH to 5.21, measures and adds water for injection to 25 liter behind the content, add 0.05% active carbon, filter, fill is sterilized to the 250ml infusion bottle.Finished product outer housing black plastic bag, sealing is preserved.The whole operation process is to carry out under the lucifuge condition.
Comparative Examples 5 (embodiment 1 of CN200410002103.8)
Sodium tanshinone IIA sulfate 0.4g, glucose 250g, antioxidant sodium sulfite 5.0g, cysteine hydrochloride 1.09, water for injection 5000ml.In sodium tanshinone IIA sulfate 0.4g, add water for injection 4000ml, dissolving; Add glucose, sodium sulfite and cysteine hydrochloride then, regulate pH value to 4.5 with the sodium hydroxide of 0.1mol/L; Needle-use activated carbon insulated and stirred under 80 ℃ of temperature with dose volume 0.1% amount was adsorbed filtering decarbonization about 30 minutes; Add remaining water for injection after the cooling again to capacity, after mensuration content is qualified, with 0.45 micron filtering with microporous membrane; Filtrate is filled in the 500ml infusion bottle, puts mylar, covers plug and gland, and sterilization promptly got final products in 30 minutes under 105 ℃ of flowing steams.Owing to added antioxidant in this product, so that product stability is good, must adds aqueous slkali simultaneously and regulate pH value to 4.5, meet the pH value 3.5-5.5 scope of national drug standards regulation.
Experimental example 1
Embodiment 1-5 and Comparative Examples 1-5 each 400 (bottle) carried out clarity detection, each 200 (bottles) in 0 month for 2 times with dividing March.Clarity detects the regulation inspection according to Ministry of Public Health standard " clarity test detailed rules and regulations and criterion ".Adopt the canopy type device, daylight lamp, it is the device of 1000～2000Lx that the colourless solution injection adopts illumination, and it is the device of 2000～3000Lx that the colored solutions injection adopts illumination, and inspection product to the distance of human eye is 20～25cm.Get inspection product number, clean the ampoule outer wall, concentrate to place umbrella canopy edge, the hand-held ampoule or the cervical region of infusing overturn medicinal liquid gently, look foreign bodies such as having or not macroscopic vitroclastic, white point, fiber in the medicinal liquid with visual inspection.
The clarity of table 1 embodiment 1-5 and Comparative Examples 1-5 relatively
| / | The clarity qualification rate | |
| / | 0 month | March |
| Embodiment 1 | 99％ | 98％ |
| Embodiment 2 | 99.5％ | 98％ |
| Comparative Examples 1 | 95.5％ | 89.0％ |
| Comparative Examples 2 | 93.5％ | 92％ |
| Embodiment 3 | 99.5％ | 98.5％ |
| Embodiment 4 | 99.5％ | 98.5％ |
| Embodiment 5 | 99.8％ | 99.8％ |
| Comparative Examples 3 | 93.5％ | 91.5％ |
| Comparative Examples 4 | 94.0％ | 90.5％ |
| Comparative Examples 5 | 93.5％ | 90.0％ |
As seen the result compares with the sample of Comparative Examples from table 2, and the clarity of sodium tanshinone IIA sulfate injection of the present invention is significantly improved, and this is that prior art can not be instructed.
Experimental example 2
1. test method: the sample of getting each embodiment 1-5 and Comparative Examples 1-5 places the calorstat of 40 ℃ of C to place 6 months, respectively at 0 month, March, contain the content of sodium tanshinone IIA sulfate June in the sampling and measuring sample.
2. working sample is handled: every kind of sample got 10 bottles, add the suitable quantity of water dissolving respectively, and transfer to fully in the measuring bottle of suitable size, thin up is to scale, shake up, make the concentration that contains sodium tanshinone IIA sulfate and be about 0.5-5 μ g/ml, promptly can be used as the need testing solution of measuring sodium tanshinone IIA sulfate.Same method, water is prepared the reference substance solution that the concentration that contains sodium tanshinone IIA sulfate is about 0.5-5 μ g/ml.
3. assay method: each composition in the sample is measured according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005).
4. result processing method: measure the sodium tanshinone IIA sulfate amount in the sample of each embodiment and Comparative Examples in order to last method, calculate every bottle in the average absolute content (milligram/bottle) of each composition.With 0 month absolute content was the relative percentage composition of benchmark 100%, with the absolute content in March or the June absolute content divided by 0 month, was the relative percentage composition (%) in March or June.
5. result of the test: the sample of each embodiment and Comparative Examples places the calorstat of 400C to place 6 months, and the relative percentage composition of sodium tanshinone IIA sulfate when March, June the results are shown in Table 2.
The sample of table 2 embodiment and Comparative Examples is at the relative percentage composition (%) in 40 ℃ of * March, 40 ℃ of * June
| Sample | The sodium tanshinone IIA sulfate changes of contents | |
| The 400C*3 month (%) | The 400C*6 month (%) | |
| Embodiment 1 | 98.6 | 96.9 |
| Embodiment 2 | 98.4 | 96.7 |
| Comparative Examples 1 | 91.1 | 85.1 |
| Comparative Examples 2 | 92.1 | 89.0 |
| Embodiment 3 | 98.0 | 96.8 |
| Embodiment 4 | 97.5 | 96.1 |
| Embodiment 5 | 98.1 | 95.5 |
| Comparative Examples 3 | 88.1 | 80.5 |
| Comparative Examples 4 | 90.7 | 82.3 |
| Comparative Examples 5 | 92.1 | 88.6 |
As seen the result compares with the sample of Comparative Examples from table 2, and the stability of the sodium tanshinone IIA sulfate injection of invention is significantly improved, and this is that prior art can not be instructed.
Claims (5)
1. a sodium tanshinone IIA sulfate injection is characterized in that the raw material of described injection is made up of the sodium tanshinone IIA sulfate and the available pharmaceutic adjuvant of injection of superfine grinding.
2. sodium tanshinone IIA sulfate injection according to claim 1, the particle diameter that it is characterized in that the sodium tanshinone IIA sulfate of described superfine grinding is the 5-50 micron.
3. sodium tanshinone IIA sulfate injection according to claim 2, the particle diameter that it is characterized in that the sodium tanshinone IIA sulfate of described superfine grinding is the 5-8 micron.
4. according to the arbitrary described sodium tanshinone IIA sulfate injection of claim 1-3, it is characterized in that the available pharmaceutic adjuvant of described injection is selected from sodium sulfite, sodium sulfite, sodium thiosulfate, glycine, alanine, cysteine hydrochloride, tween 20, Tween-40, Tween-60, tween 80, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, xylitol, sorbitol, dextran, glucose, mannitol, the glycerol one or more combination.
5. the preparation method of the arbitrary described sodium tanshinone IIA sulfate injection of claim 1-4, it is characterized in that described preparation method is: with sodium tanshinone IIA sulfate superfine grinding particle diameter is to add the available pharmaceutic adjuvant of injection behind the 5-50 micron to be dissolved in water for injection, regulate pH value, add needle-use activated carbon approximately, filtering decarbonization in stirring and adsorbing; Add remaining water for injection after the cooling again to capacity, filter, embedding obtains injection or infusion solution.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103083355A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Compound sodium chloride injection and preparation method thereof |
| CN107703153A (en) * | 2017-08-31 | 2018-02-16 | 芜湖杨燕制药有限公司 | A kind of insect-expelling saligna injection liquid infusion bottle lamp inspection technique |
-
2006
- 2006-06-29 CN CN 200610090622 patent/CN1875925A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103083355A (en) * | 2013-01-18 | 2013-05-08 | 蚌埠丰原涂山制药有限公司 | Compound sodium chloride injection and preparation method thereof |
| CN107703153A (en) * | 2017-08-31 | 2018-02-16 | 芜湖杨燕制药有限公司 | A kind of insect-expelling saligna injection liquid infusion bottle lamp inspection technique |
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