CN1285335C - Pyrithioxine hydrochloride freeze-dried composition and its preparing method - Google Patents
Pyrithioxine hydrochloride freeze-dried composition and its preparing method Download PDFInfo
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- CN1285335C CN1285335C CN 200410017640 CN200410017640A CN1285335C CN 1285335 C CN1285335 C CN 1285335C CN 200410017640 CN200410017640 CN 200410017640 CN 200410017640 A CN200410017640 A CN 200410017640A CN 1285335 C CN1285335 C CN 1285335C
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- Prior art keywords
- divalvon
- pyrithioxin
- freeze
- dihydrochloride
- hours
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- SIXLXDIJGIWWFU-UHFFFAOYSA-N pyritinol Chemical compound OCC1=C(O)C(C)=NC=C1CSSCC1=CN=C(C)C(O)=C1CO SIXLXDIJGIWWFU-UHFFFAOYSA-N 0.000 title claims abstract description 14
- 239000000203 mixture Substances 0.000 title claims abstract description 10
- 229960004986 pyritinol Drugs 0.000 claims abstract description 13
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000000243 solution Substances 0.000 claims abstract description 10
- 239000008215 water for injection Substances 0.000 claims abstract description 9
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 8
- 229910052799 carbon Inorganic materials 0.000 claims abstract description 8
- 238000002360 preparation method Methods 0.000 claims abstract description 8
- 239000000843 powder Substances 0.000 claims description 27
- 238000001035 drying Methods 0.000 claims description 20
- 238000000859 sublimation Methods 0.000 claims description 18
- 230000008022 sublimation Effects 0.000 claims description 18
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 11
- 229930195725 Mannitol Natural products 0.000 claims description 11
- 239000000594 mannitol Substances 0.000 claims description 11
- 235000010355 mannitol Nutrition 0.000 claims description 11
- 238000004108 freeze drying Methods 0.000 claims description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 7
- 239000008101 lactose Substances 0.000 claims description 7
- 238000003756 stirring Methods 0.000 claims description 7
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 5
- 239000000600 sorbitol Substances 0.000 claims description 5
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- 238000002347 injection Methods 0.000 claims description 3
- 239000007924 injection Substances 0.000 claims description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 238000007710 freezing Methods 0.000 claims description 2
- 230000008014 freezing Effects 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 4
- 238000005516 engineering process Methods 0.000 abstract description 3
- HRZWYHGGJOWGRI-UHFFFAOYSA-N Pyrithioxin dihydrochloride Chemical compound Cl.Cl.OCC1=C(O)C(C)=NC=C1CSSCC1=CN=C(C)C(O)=C1CO HRZWYHGGJOWGRI-UHFFFAOYSA-N 0.000 abstract 12
- 239000000463 material Substances 0.000 abstract 8
- 238000013329 compounding Methods 0.000 abstract 1
- 238000005286 illumination Methods 0.000 description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 5
- 239000012456 homogeneous solution Substances 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 210000004556 brain Anatomy 0.000 description 2
- 230000002490 cerebral effect Effects 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 235000021472 generally recognized as safe Nutrition 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 208000024827 Alzheimer disease Diseases 0.000 description 1
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010065559 Cerebral arteriosclerosis Diseases 0.000 description 1
- 206010057315 Daydreaming Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 201000009906 Meningitis Diseases 0.000 description 1
- 206010039966 Senile dementia Diseases 0.000 description 1
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 description 1
- 229930003270 Vitamin B Natural products 0.000 description 1
- 230000037354 amino acid metabolism Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 210000001715 carotid artery Anatomy 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000008451 emotion Effects 0.000 description 1
- 206010014599 encephalitis Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000004153 glucose metabolism Effects 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 206010022437 insomnia Diseases 0.000 description 1
- 201000005851 intracranial arteriosclerosis Diseases 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 210000003715 limbic system Anatomy 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to the technical field of medicine, which particularly relates to a pyrithioxin dihydrochloride freeze-dried composition and a preparation method thereof. The pyrithioxin dihydrochloride freeze-dried composition comprises pyrithioxin dihydrochloride and auxiliary materials, wherein the weight proportion of the pyrithioxin dihydrochloride to the auxiliary materials is 1:0.2 to 2; the auxiliary materials comprise excipient. The preparation method comprises: the pyrithioxin dihydrochloride and the auxiliary materials are put into a material compounding barrel; water for injection is added to the pyrithioxin dihydrochloride and the auxiliary materials; the pyrithioxin dihydrochloride and the auxiliary materials are sufficiently dissolved; active carbon is added to the pyrithioxin dihydrochloride and the auxiliary materials, and is stirred, statically stood and filtered; the filtered solution is then put into a freeze drier to be frozen and dried; after the solution is frozen and dried, the solution is sealed, and the pyrithioxin dihydrochloride freeze-dried composition is obtained. The pyrithioxin dihydrochloride freeze-dried composition of the present invention solves the problem of poor water solubility of pyrithioxin in the prior art, and adopts freeze-dried technology. Moreover, the excipient is added to the pyrithioxin dihydrochloride freeze-dried composition, and the dissolvability of the pyrithioxin is increased. The pyrithioxin dihydrochloride freeze-dried composition solves the problem of poor bioavailability of pyrithioxin.
Description
Technical field
The present invention relates to medical technical field, be specifically related to a kind of divalvon-D lyophilized injectable powder and preparation method thereof.
Background technology
Divalvon-D (molecular formula: C
16H
20N
2O
4S
22HClH
2O) being a kind of metabolic medicine of brain that improves, is vitamin B
6Derivant, can promote glucose and amino acid metabolism in the brain, improve the whole body assimilation, increase the carotid artery flow amount, cerebral function improvement.Limbic system and network structure also there is stimulation.Divalvon-D mainly is applicable to the dizzy distending pain, insomnia, hypomnesis of cerebral trauma sequela, encephalitis and meningitis sequela etc., the improvement of absent minded, emotion changes; Also can be used for cerebral arteriosclerosis, senile dementia mental symptom.
Divalvon-D is used more extensive clinically, and the dosage form of listing is mainly capsule, conventional tablet, Injectable sterile packing powder pin both at home and abroad at present.Its oral formulations exist the problem of bioavailability difference, and its Injectable sterile packing powder pin is also poorly soluble because of it, has been subjected to certain restriction in clinical use because the dissolubility of divalvon-D is relatively poor always, uses very inconvenience.
Summary of the invention
The object of the present invention is to provide the high divalvon-D lyophilized injectable powder of a kind of bioavailability.
Another object of the present invention is to provide a kind of preparation method of divalvon-D lyophilized injectable powder.
A kind of divalvon-D lyophilized injectable powder, form by divalvon-D and excipient, the weight ratio of divalvon-D and excipient is 1: 0.2～2, described excipient is that in mannitol, lactose, sodium chloride, sorbitol, the xylitol one or more mix, wherein the weight ratio of divalvon-D and mannitol be 1: 0.5 except.
The above-mentioned divalvon-D and the weight ratio of excipient are 1: 0.4～1, wherein the weight ratio of divalvon-D and mannitol be 1: 0.5 except.
The specification of described injectable powder is every bottle of hydrochloric pyritinol 100mg, 200mg, 400mg or 600mg.
A kind of preparation method of divalvon-D lyophilized injectable powder, comprise divalvon-D and adjuvant are put into mixer, add water for injection again, fully dissolving, add active carbon and stirring, leave standstill, filter, the solution that will obtain after will filtering is again put into and is carried out lyophilization in the freezer dryer, seal after lyophilizing is finished promptly, it is characterized in that the pre-freeze temperature is-20 ℃～-60 ℃ in the freezing dry process, the pre-freeze time is 2 hours～8 hours, 0 ℃～-40 ℃ of sublimation drying temperature, 15 hours～40 hours sublimation drying time.
Above-mentioned pre-freeze temperature is-30 ℃～-50 ℃, and the pre-freeze time is 4～5 hours; Sublimation drying temperature-10 ℃～-30 ℃, 25 hours～30 hours sublimation drying time.
Divalvon-D lyophilized injectable powder of the present invention, when using clinically, can add an amount of aseptic medicinal aqueous diluent (for example: G/W, normal saline, water for injection and other known aqueous diluent), be diluted to for intravenous drip or intramuscular injection injection.
Divalvon-D lyophilized injectable powder of the present invention, solved the problem of pyritinol poorly water-soluble in the prior art, adopt freeze drying technology, and adding excipient, the dissolubility and the stability of pyritinol have been improved, solve the problem of the bioavailability difference of pyritinol, guaranteed the safety and the convenience of medication.
The specific embodiment
Below by specific embodiment the present invention is further specified.
Embodiment 1: get divalvon-D 400g and mannitol 200g, make 1000 bottles.Divalvon-D and mannitol are added in the mixer, add the water for injection that boils postcooling to 80 ℃, fully dissolving makes it to become homogeneous solution; Add active carbon and stirring, leave standstill, filter, lyophilizing is sealed, and gets white hydrochloride pyritinol lyophilized injectable powder.Parameter control during lyophilization: the pre-freeze temperature is-40 ℃, and the pre-freeze time is 4 hours; Sublimation drying temperature-30 ℃, 30 hours sublimation drying time.
Embodiment 2: get divalvon-D 100g and lactose 200g, make 1000 bottles.Divalvon-D and lactose are added in the mixer, add the water for injection that boils postcooling to 80 ℃, fully dissolving makes it to become homogeneous solution; Add active carbon and stirring, leave standstill, filter, lyophilizing is sealed, and gets white hydrochloride pyritinol lyophilized injectable powder.Parameter control during lyophilization is preferred: the pre-freeze temperature is-30 ℃, and the pre-freeze time is 5 hours; Sublimation drying temperature-10 ℃, 25 hours sublimation drying time.
Embodiment 3: get divalvon-D 200g and mannitol 100g, lactose 100g, make 1000 bottles.Divalvon-D and mannitol, lactose are added in the mixer, add the water for injection that boils postcooling to 80 ℃, fully dissolving makes it to become homogeneous solution; Add active carbon and stirring, leave standstill, filter, lyophilizing is sealed, and gets white hydrochloride pyritinol lyophilized injectable powder.Parameter control during lyophilization is preferred: the pre-freeze temperature is-40 ℃, and the pre-freeze time is 4.5 hours; Sublimation drying temperature-15 ℃, 28 hours sublimation drying time.
Embodiment 4: get divalvon-D 600g and sorbitol 200g, make 1000 bottles.Divalvon-D and sorbitol are added in the mixer, add the water for injection that boils postcooling to 80 ℃, fully dissolving makes it to become homogeneous solution; Add active carbon and stirring, leave standstill, filter, lyophilizing is sealed, and gets white hydrochloride pyritinol lyophilized injectable powder.Parameter control during lyophilization is preferred: the pre-freeze temperature is-35 ℃, and the pre-freeze time is 5 hours; Sublimation drying temperature-20 ℃, 26 hours sublimation drying time.
Embodiment 5: get divalvon-D 400g and sorbitol 100g, mannitol 100g, lactose 100g, add in the mixer, add the water for injection that boils postcooling to 80 ℃, fully dissolving makes it to become homogeneous solution; Add active carbon and stirring, leave standstill, filter, lyophilizing is sealed, and gets white hydrochloride pyritinol lyophilized injectable powder.Parameter control during lyophilization is preferred: the pre-freeze temperature is-45 ℃, and the pre-freeze time is 5 hours; Sublimation drying temperature-30 ℃, 30 hours sublimation drying time.
Experimental example 6: the stability of divalvon-D freeze-dried powder.
The divalvon-D freeze-dried powder that the foregoing description is made carry out the preliminarily stabilised investigation (1. 4500LX illumination place down 10 days, 2. high temperature was placed 10 days down for 60 ℃), in the tenth day sampling and measuring, the result was as table 1-5.
Table 1: embodiment 1 study on the stability result
| Natural law | Character | Content (%) | Related substance (%) | Clarity of solution and color | Clarity |
| 0 | The white block | 99.58 | 0.30 | Up to specification | Up to specification |
| 4500LX illumination in 10 days | The white block | 99.46 | 0.32 | Up to specification | Up to specification |
| High temperature was 60 ℃ in 10 days | The white block | 99.51 | 0.36 | Up to specification | Up to specification |
Table 2: embodiment 2 study on the stability results
| Natural law | Character | Content (%) | Related substance (%) | Clarity of solution and color | Clarity |
| 0 | The white block | 99.64 | 0.38 | Up to specification | Up to specification |
| 4500LX illumination in 10 days | The white block | 99.50 | 0.44 | Up to specification | Up to specification |
| High temperature was 60 ℃ in 10 days | The white block | 99.42 | 0.35 | Up to specification | Up to specification |
Table 3: embodiment 3 study on the stability results
| Natural law | Character | Content (%) | Related substance (%) | Clarity of solution and color | Clarity |
| 0 | The white block | 99.28 | 0.32 | Up to specification | Up to specification |
| 4500LX illumination in 10 days | The white block | 99.35 | 0.34 | Up to specification | Up to specification |
| High temperature was 60 ℃ in 10 days | The white block | 99.24 | 0.35 | Up to specification | Up to specification |
Table 4: embodiment 4 study on the stability results
| Natural law | Character | Content (%) | Related substance (%) | Clarity of solution and color | Clarity |
| 0 | The white block | 99.54 | 0.34 | Up to specification | Up to specification |
| 4500LX illumination in 10 days | The white block | 99.58 | 0.33 | Up to specification | Up to specification |
| High temperature was 60 ℃ in 10 days | The white block | 99.42 | 0.30 | Up to specification | Up to specification |
Table 5: embodiment 5 study on the stability results
| Natural law | Character | Content (%) | Related substance (%) | Clarity of solution and color | Clarity |
| 0 | The white block | 99.15 | 0.30 | Up to specification | Up to specification |
| 4500LX illumination in 10 days | The white block | 99.08 | 0.36 | Up to specification | Up to specification |
| High temperature was 60 ℃ in 10 days | The white block | 99.16 | 0.32 | Up to specification | Up to specification |
Above result shows: divalvon-D freeze-dried powder of the present invention can be rebuild the injection that obtains clear rapidly after adding water, and this fine solubility and stability have guaranteed the safety and the convenience of medication.
Experimental example 7: the Generally Recognized as safe of divalvon-D freeze-dried powder
The divalvon-D freeze-dried powder that the foregoing description 1-5 makes is done the Generally Recognized as safe experiment, and experimental result shows nonirritant, no anaphylactic reaction, does not also have haemolysis.
Claims (5)
1. divalvon-D lyophilized injectable powder, form by divalvon-D and excipient, the weight ratio that it is characterized in that divalvon-D and excipient is 1: 0.2～2, described excipient is that in mannitol, lactose, sodium chloride, sorbitol, the xylitol one or more mix, wherein the weight ratio of divalvon-D and mannitol be 1: 0.5 except.
2. a kind of divalvon-D lyophilized injectable powder as claimed in claim 1, the weight ratio that it is characterized in that divalvon-D and excipient is 1: 0.4～1, wherein the weight ratio of divalvon-D and mannitol be 1: 0.5 except.
3. a kind of divalvon-D lyophilized injectable powder as claimed in claim 1 or 2, the specification that it is characterized in that described injectable powder are every bottle of hydrochloric pyritinol 100mg, 200mg, 400mg or 600mg.
4. the preparation method of a divalvon-D lyophilized injectable powder, comprise divalvon-D and adjuvant are put into mixer, add water for injection again, fully dissolving, add active carbon and stirring, leave standstill, filter, the solution that will obtain after will filtering is again put into and is carried out lyophilization in the freezer dryer, seal after lyophilizing is finished promptly, it is characterized in that the pre-freeze temperature is-20 ℃～-60 ℃ in the freezing dry process, the pre-freeze time is 2 hours～8 hours, 0 ℃～-40 ℃ of sublimation drying temperature, 15 hours～40 hours sublimation drying time.
5. the preparation method of a kind of divalvon-D powder lyophilized injection according to claim 4 is characterized in that the pre-freeze temperature is-30 ℃～-50 ℃, and the pre-freeze time is 4～5 hours; Sublimation drying temperature-10 ℃～-30 ℃, 25 hours～30 hours sublimation drying time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410017640 CN1285335C (en) | 2004-04-13 | 2004-04-13 | Pyrithioxine hydrochloride freeze-dried composition and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410017640 CN1285335C (en) | 2004-04-13 | 2004-04-13 | Pyrithioxine hydrochloride freeze-dried composition and its preparing method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1562007A CN1562007A (en) | 2005-01-12 |
| CN1285335C true CN1285335C (en) | 2006-11-22 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410017640 Expired - Fee Related CN1285335C (en) | 2004-04-13 | 2004-04-13 | Pyrithioxine hydrochloride freeze-dried composition and its preparing method |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101164619B (en) * | 2006-10-20 | 2011-05-18 | 山东轩竹医药科技有限公司 | Pyritinol injection with special purpose solvent |
| CN101810614B (en) * | 2010-04-15 | 2012-06-20 | 杭州康泉德投资管理有限公司 | Stable pyritinol hydrochloride composition for injection and preparation and preparation method thereof |
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2004
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| CN1562007A (en) | 2005-01-12 |
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| C56 | Change in the name or address of the patentee | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 322000 Jinhua Industrial Park, Zhejiang Co-patentee after: Hangzhou Tigermed Pharmaceutical Technology Co., Ltd. Patentee after: Zhejiang Jiafeng Pharmaceutical Co., Ltd. Address before: 322000 Jinhua Industrial Park, Zhejiang Co-patentee before: Hangzhou tiger Pharmaceutical Technology Co., Ltd. Patentee before: Zhejiang Jiafeng Pharmaceutical Co., Ltd. |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20061122 Termination date: 20190413 |