CN1311813C - Freeze-dried powder injection of Tianjihuang and its making method - Google Patents
Freeze-dried powder injection of Tianjihuang and its making method Download PDFInfo
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- CN1311813C CN1311813C CNB2005100381930A CN200510038193A CN1311813C CN 1311813 C CN1311813 C CN 1311813C CN B2005100381930 A CNB2005100381930 A CN B2005100381930A CN 200510038193 A CN200510038193 A CN 200510038193A CN 1311813 C CN1311813 C CN 1311813C
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- herba hyperici
- hyperici japonici
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Abstract
The present invention relates to a lyophiled injectable powder with hypericum japonicum thunb for injection, and a preparation method thereof. The lyophiled injectable powder with hypericum japonicum thunb for injection comprises the following components measured by weight: 5 to 80% of an extractive of hypericum japonicum thunb and 20 to 95% of supplementary materials. The preparation method has the processing steps of the preparation of an extractive of hypericum japonicum thunb. An extractive of hypericum japonicum thunb is added with supplementary materials for injection, and the mixture is stirred and evenly mixed. Water for injection is added to the mixture, and the mixture is stirred to make the extractive of hypericum japonicum thunb and the supplementary materials for injection dissolved. Medicinal alkali is used to trgulate the pH of the liquid medicine to 4.0 to 8.0. a heat source is removed. Water for injection is supplemented until the solution reaches a prescribed volume, and the solution is processed through aseptic filtration, subpackage and lyopilization. The present invention solves the problems that preparation products of hypericum japonicum thunb have poor clarity, is easy to generate precipitation when stored for a long time, is difficult put in large-scale industrial production. The water injection has stable quality, good formability, rapid dissolution, good clarity, easy storage, easy transportation, easy use and low water content of the medicine. More than 95 to 99% of moisture content is removed through lyophilisation, so the medicine can not deteriorate when preserved for a long time. The lyophiled injectable powder has easy transportation and easy use.
Description
Technical field
What the present invention relates to is a kind of freeze-dried powder injection of Tianjihuang and preparation method thereof, belongs to medicine
Technical field.
Background technology
Herba Hyperici Japonici is the dry herb of Guttiferae plant Herba Hyperici Japonici, and nature and flavor hardship, suffering, flat are returned Liver Channel, have clearing away heat-damp and promoting diuresis, and the effect of subduing swelling and detoxicating is used for acute and chronic hepatitis, furuncle carbuncle, diseases such as venom.The preparation of Herba Hyperici Japonici is mainly injection clinically, and this injection just recorded in the Pharmacopoeia of the People's Republic of China in 1977, and the clinical acute viral hepatitis that is widely used in due to the treatment liver and gall excess syndrome is the ideal medicament of tcm emergency.But in process of production, producer reflects that generally this product stability is poor, and long term storage easily produces precipitation, and batch qualification rate is low, is difficult to the large scale investment industrialized great production, for clinical extensive use is made troubles.
Summary of the invention
The object of the present invention is to provide a kind of injection of Tianjihuang injectable powder, this product is the intravenously administrable dosage form, for original injection, and said preparation steady quality, determined curative effect; A kind of preparation method of injection of Tianjihuang injectable powder also is provided simultaneously, and this preparation method technology advanced person can satisfy the needs of industrialized great production.Technical solution of the present invention: freeze-dried powder injection of Tianjihuang comprises following component: Herba Hyperici Japonici extract 5～80%, pin be with adjuvant 20～95%, more than each component by weight.
The preparation method of freeze-dried powder injection of Tianjihuang comprises following processing step:
A) preparation of Herba Hyperici Japonici extract;
B) get Herba Hyperici Japonici extract and add the pin adjuvant, stir mixing;
C) adding injection blunges Herba Hyperici Japonici extract and pin is dissolved with adjuvant;
D) regulate the PH to 4.0-8.0 of medicinal liquid with medicinal basic;
E) depyrogenation;
F) replenish water for injection to prescribed volume, aseptic filtration, packing;
G) lyophilizing.
Processing step is the preparation of Herba Hyperici Japonici extract a): get the Herba Hyperici Japonici raw material through extracting preparation Herba Hyperici Japonici extracting solution; Or its extracting solution is condensed into the extractum shape, vacuum drying, Herba Hyperici Japonici extract.
Processing step b) gets Herba Hyperici Japonici extract and add the pin adjuvant, stir mixing: get above-mentioned Herba Hyperici Japonici extract or Herba Hyperici Japonici extracting solution, place container, add the pin adjuvant, stirring, mixing.Wherein the pin adjuvant is a mannitol, glucose, lactose, inositol, glucosan, the combination of one or more in glycine and the dextran.
Processing step c) adding injection blunges Herba Hyperici Japonici extract and pin are dissolved with adjuvant: it is an amount of to add sterile water for injection in said vesse, fully stirs, and Herba Hyperici Japonici extract and pin are dissolved fully with adjuvant.
Processing step d) regulate the PH to 4.0-8.0 of medicinal liquid with medicinal basic: prepare an amount of medicinal basic solution, the pH value of adjusting medicinal liquid is in 4.0～8.0 scopes.Wherein medicinal basic can adopt sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium hydroxide etc.
Processing step e) depyrogenation: taking liquid, the needle-use activated carbon of adding 0.05～1.0% (w/v) boiled 15 minutes, filtered depyrogenation; Perhaps carry out the membrane filtration depyrogenation with ultrafilter membrane (cutoff value 5000～30000).
Processing step f) replenish water for injection to prescribed volume, aseptic filtration, packing: replenish water for injection to prescribed volume in medicinal liquid, by the aseptic manipulation requirement, cross the microporous filter membrane of 0.22 μ m, Entkeimung is sub-packed in the ampoule bottle or cillin bottle of sterilization; Also can direct packaging in the pallet after sterilization, liquid level is 5～15mm.
Processing step g) lyophilizing: the medicinal liquid after the packing is placed on the dividing plate in the freeze drying box, carry out pre-freeze in-30～-50 ℃, when treating that fluid temperature reaches in-30～-50 ℃ of scopes, kept 2～4 hours; Be warming up in-0～-35 ℃ of scope, carrying out sublimation drying one time, keeping 20～50 hours; Be warmed up to 25～50 ℃ once more, be incubated a few hours, get final product outlet.As carrying out lyophilizing with the cillin bottle packing, can seal, packing, promptly; As directly freezing with pallet, need pallet is taken out, under aseptic condition, be ground into fine powder, the reuse aseptic manipulation is sub-packed in the antibiotic glass bottle, seals, and packing gets product.
Advantage of the present invention: the clarity of formulation products that has effectively solved Herba Hyperici Japonici is poor, long term storage easily produces precipitation, be difficult to problems such as large scale investment commercial production, adopt Freeze Drying Technique, at first prepare Herba Hyperici Japonici extract, add an amount of pin adjuvant with Herba Hyperici Japonici extract again, add the injection water and make its dissolving in right amount, be mixed with aseptic aqueous solution, carry out lyophilization, make freeze-dried powder.This freeze-dried powder is guaranteeing under the former effective in cure prerequisite of aqueous injection, thereby is fundamentally solving aqueous injection quality instability problem.It has good moldability, instant, clear and bright, stable, and accumulating and characteristics such as easy to use have remedied the weak point of aqueous injection.Compare with existing product, this dosage form has the following advantages: the medicine water content is low, and lyophilization can be got rid of the above moisture of 95-99%, makes dry back product energy long preservation and unlikely going bad.Dried medicine becomes loose porous shape structure, adds that dissolving recovers original medicinal liquid character rapidly and fully immediately behind the water.After making lyophilized injectable powder, compare, be convenient to transportation and use more with original injection.
The specific embodiment
Freeze-dried powder injection of Tianjihuang comprises following component: Herba Hyperici Japonici extract 5～80%, pin be with adjuvant 20～95%, more than each component by weight.
Embodiment 1
Herba Hyperici Japonici extract 5g mannitol 95g
Embodiment 2
Herba Hyperici Japonici extract 42.5g mannitol 57.5g
Embodiment 3
Herba Hyperici Japonici extract 80g dextran 20g
The foregoing description 1,2,3, the preparation method processing step:
Processing step is a): Herba Hyperici Japonici water extract-alcohol precipitation clear liquid, be condensed into the extractum shape, and vacuum drying promptly gets Herba Hyperici Japonici extract; Also, be used as the Herba Hyperici Japonici extracting solution with Herba Hyperici Japonici water extract-alcohol precipitation clear liquid.
Processing step b): get above-mentioned Herba Hyperici Japonici extract or Herba Hyperici Japonici extracting solution, place container, add mannitol, mannitol, dextran pin adjuvant respectively, stirring, mixing.
Processing step c): the adding sterile water for injection is an amount of in said vesse, fully stirs, and Herba Hyperici Japonici extract and pin are dissolved fully with adjuvant.
Processing step d): preparation sodium hydroxide (medicinal) solution, the pH value difference 4,5,6 of regulating medicinal liquid.
Processing step e: add the needle-use activated carbon of 0.05%, 1.0%, 0.75% (w/v) respectively, boil after-filtration degerming in 15 fens; Or use cutoff value to be respectively 5000,17500,30000 ultrafilter membrane, carry out the membrane filtration depyrogenation.
Processing step f): replenish water for injection to 2000ml in medicinal liquid, by the aseptic manipulation requirement, cross the microporous filter membrane of 0.22um, Entkeimung is sub-packed in the ampoule bottle or cillin bottle of sterilization; Also can direct packaging in the pallet after sterilization, liquid level for be respectively 5,10,15mm.
Processing step g) lyophilizing: the medicinal liquid after the packing is placed on the dividing plate in the freeze drying box, carry out pre-freeze in-30～-50 ℃, when treating that fluid temperature reaches in-30～-50 ℃ of scopes, kept respectively 2,3,4 hours; In being warming up to 0～-35 ℃ of scope, carry out sublimation drying one time, kept respectively 20,35,50 hours; Be warmed up to 25,35,50 ℃ once more, be incubated 2,3,5 hours, get final product outlet.As carrying out lyophilizing with the cillin bottle packing, can seal, packing, promptly; As directly freezing with pallet, need pallet is taken out, under aseptic condition, be ground into fine powder, being sub-packed in the antibiotic glass bottle, to seal with aseptic manipulation, packing gets product.
The clinical practice situation
Herba Hyperici Japonici is the dry herb of Guttiferae plant Herba Hyperici Japonici (Hypericum japonicum Thunb), has Li Wenre clearly, the effect of dissipating blood stasis for subsidence of swelling.Effective ingredient such as flavonoid, aldehydes matter now from Herba Hyperici Japonici, have been isolated.Have antibacterial, anti-liver injury, the liver protecting improves immunologic function, multiple pharmacology's effect such as anticancer.Hepatitis, traumatic injury, venom, infantile convulsion, diarrhoea, the hernia etc. of being used for the treatment of for oral administration.Clinical acute and chronic hepatitis, infectious hepatitis, the constitutional of being used for the treatment of
Hepatocarcinoma, typhoid fever, paratyphoid fever etc.
Claims (2)
1, freeze-dried powder injection of Tianjihuang, it is characterized in that Herba Hyperici Japonici extract: pin adjuvant=1: 4, used pin is a mannitol with the adjuvant raw material, glucose, lactose, inositol, the combination of one or more in glycine and the dextran, Herba Hyperici Japonici extract wherein extracts by the following method and obtains: behind the Herba Hyperici Japonici water extract-alcohol precipitation, extracting solution is condensed into the extractum shape, vacuum drying makes Herba Hyperici Japonici extract.
2, freeze-dried powder injection of Tianjihuang according to claim 1 is characterized in that the preparation method of said preparation comprising following processing step:
A) get Herba Hyperici Japonici extract and add the pin adjuvant, stir mixing: get above-mentioned Herba Hyperici Japonici extract, place container, add the pin adjuvant, stirring, mixing, wherein the pin adjuvant is a mannitol, glucose, lactose, inositol, the combination of one or more in glycine and the dextran;
B) adding injection blunges Herba Hyperici Japonici extract and pin are dissolved with adjuvant: it is an amount of to add sterile water for injection in said vesse, fully stirs, and Herba Hyperici Japonici extract and pin are dissolved fully with adjuvant;
C) regulate the PH to 4.0-8.0 of medicinal liquid with medicinal basic: prepare an amount of medicinal basic solution, the pH value of adjusting medicinal liquid is in 4.0～8.0 scopes, and wherein medicinal basic can adopt sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium hydroxide etc.;
D) depyrogenation: taking liquid, the needle-use activated carbon of adding 0.05～1.0% (w/v) boiled 15 minutes, filtered depyrogenation; Perhaps, carry out the membrane filtration depyrogenation with the ultrafilter membrane of cutoff value 5000～30000;
E) replenish water for injection to prescribed volume, aseptic filtration, packing: replenish water for injection to prescribed volume in medicinal liquid, by the aseptic manipulation requirement, cross the microporous filter membrane of 0.22 μ m, Entkeimung is sub-packed in the ampoule bottle or cillin bottle of sterilization; Also can direct packaging in the pallet after sterilization, liquid level is 5～15mm;
F) lyophilizing: the medicinal liquid after the packing is placed on the dividing plate in the freeze drying box, carry out pre-freeze in-30～-50 ℃, when treating that fluid temperature reaches in-30～-50 ℃ of scopes, kept 2～4 hours; In being warming up to 0～-35 ℃ of scope, carry out sublimation drying one time, kept 20～50 hours; Be warmed up to 25～50 ℃ once more, be incubated a few hours, get final product outlet,, can seal as carrying out lyophilizing with the cillin bottle packing, packing, promptly; As directly freezing with pallet, need pallet is taken out, under aseptic condition, be ground into fine powder, being sub-packed in the antibiotic glass bottle, to seal with aseptic manipulation, packing gets product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100381930A CN1311813C (en) | 2005-01-21 | 2005-01-21 | Freeze-dried powder injection of Tianjihuang and its making method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100381930A CN1311813C (en) | 2005-01-21 | 2005-01-21 | Freeze-dried powder injection of Tianjihuang and its making method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1679816A CN1679816A (en) | 2005-10-12 |
| CN1311813C true CN1311813C (en) | 2007-04-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2005100381930A Expired - Fee Related CN1311813C (en) | 2005-01-21 | 2005-01-21 | Freeze-dried powder injection of Tianjihuang and its making method |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110314131B (en) * | 2019-08-23 | 2020-09-04 | 广州海梦科化妆品有限公司 | Freeze-dried powder and preparation process thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1044760A (en) * | 1989-11-11 | 1990-08-22 | 黑龙江中医学院 | Preparation of injection of Chinese medicines |
-
2005
- 2005-01-21 CN CNB2005100381930A patent/CN1311813C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1044760A (en) * | 1989-11-11 | 1990-08-22 | 黑龙江中医学院 | Preparation of injection of Chinese medicines |
Non-Patent Citations (4)
| Title |
|---|
| 中药药剂学 张兆旺，284.285，中国中医药出版社 2003 * |
| 国家中成药标准汇编(中成药地方标准上繁荣昌盛国家标准部分)内科肝胆分册 255，国家药品监督管理局 2002 * |
| 国家中成药标准汇编(中成药地方标准上繁荣昌盛国家标准部分)内科肝胆分册 255，国家药品监督管理局 2002;药用辅料大全 罗明生，P350.352 702.703，四川科技出版社 1993;中药药剂学 张兆旺，284.285，中国中医药出版社 2003 * |
| 药用辅料大全 罗明生，P350.352 702.703，四川科技出版社 1993 * |
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| CN1679816A (en) | 2005-10-12 |
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| PB01 | Publication | ||
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| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Jiangsu Kingsley Pharmaceutical Co., Ltd. Assignor: Zou Qiaogen Contract record no.: 2010320001189 Denomination of invention: Freeze-dried powder injection of Tianjihuang and its making method Granted publication date: 20070425 License type: Exclusive License Open date: 20051012 Record date: 20101117 |
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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: 20070425 Termination date: 20130121 |