CN107744505A - A kind of double auxiliary material breviscapine frozen dry powder for injection agent - Google Patents
A kind of double auxiliary material breviscapine frozen dry powder for injection agent Download PDFInfo
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- CN107744505A CN107744505A CN201711079984.7A CN201711079984A CN107744505A CN 107744505 A CN107744505 A CN 107744505A CN 201711079984 A CN201711079984 A CN 201711079984A CN 107744505 A CN107744505 A CN 107744505A
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- auxiliary material
- breviscapine
- dry powder
- injection agent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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Abstract
The present invention provides a kind of double auxiliary material breviscapine frozen dry powder for injection agent, it is related to pharmaceutical preparation and preparation method field, mainly solve freeze-drying time during production present in the auxiliary material of breviscapine frozen dry powder for injection agent factory formula in the prior art to grow, drying temperature is high, energy consumption is big, the shortcomings that finished product clarity and low solution colour qualification rate.The breviscapine frozen dry powder for injection agent includes mannitol and HES 130/0.4 using double auxiliary materials, auxiliary material, and main ingredient is Breviscapinun, and wherein the weight of main ingredient Breviscapinun and auxiliary material ratio is 100:100‑100:120, the weight ratio between mannitol and HES 130/0.4 is 100:70‑100:90.Breviscapine frozen dry powder for injection agent is prepared into above-mentioned main ingredient and auxiliary material.Breviscapine frozen dry powder for injection agent steady quality provided by the invention, safely and effectively, product processes are simple, and freeze-drying time is short, drying temperature is low, energy consumption is low during production, finished product clarity and solution colour qualification rate are high.
Description
Technical field:
The present invention relates to the Breviscapine of pharmaceutical preparation and preparation method field, more particularly to a kind of double auxiliary materials to freeze
Dry powder injection and preparation method thereof.
Background technology:
Breviscapine frozen dry powder for injection agent main ingredient Breviscapinun is the Breviscapinun extracted from Erigeron,
With heart brain blood supplies are improved, increase brain tissue hemoperfusion amount, reduce the effect such as vascular resistence and anti-platelet aggregation.It is clinical
Observation shows this product lasting medicines curative for effect, there is the characteristics of efficient is quick-acting, and preferable effect can be played in first aid rescue
Fruit.It is mainly used in promoting blood circulation and removing blood stasis, removes obstruction in channels to relieve pain, for apoplexy sequelae, coronary heart disease, angina pectoris.Industrial production injection at present
The auxiliary material used during with lyophilized powder injection of breviscapinum is divided into following a few classes:
(1) polyalcohols, such as glycerine, sorbierite, mannitol, inositol, adonite, ethylene glycol, polyethylene glycol;
(2) carbohydrate, such as dextran (glucan), 13 1 cyclodextrin, maltodextrin, trehalose, sucrose, lactose, malt
Sugar, glucose etc.;
(3) amino acids, such as sodium glutamate, proline, lysine and alanine;
(4) inorganic salts, such as phosphate, calcium carbonate, manganese sulfate, sodium acetate;
(5) protein and peptides, such as mucopolysaccharide albumen, casein, bovine serum albumin.
HES 130/0.4 is the semi-synthetic macromolecular compound nontoxic to human body, parmacodynamics-less activity, is being cured
Frequently as blood volume expander, existing more than the 50 years history of its Clinical practice during heavy dose of use in treatment.
Auxiliary material used is single mannitol when commercially available breviscapine frozen dry powder for injection agent is due to production, and it is present
Freeze-drying time is grown during production, and drying temperature is high, and energy consumption is big, the shortcomings that finished product clarity and low solution colour qualification rate.It is to this
Clinic provide it is a kind of safely and effectively, reliable in quality, production when freeze-drying time is short, drying temperature bottom, energy consumption are small, finished product clarity and
Solution colour qualification rate is high, make the auxiliary material of breviscapine frozen dry powder for injection agent and technique it is more scientific method it is necessary,
In consideration of it, propose the present invention.
The content of the invention:
A kind of the defects of technical problems to be solved by the invention are to overcome prior art, there is provided safe and effective, quality
The injection that freeze-drying time is short, drying temperature is low, energy consumption is low, finished product clarity and solution colour qualification rate are high when reliably, producing
Lyophilized powder injection of breviscapinum.
The technical problems to be solved by the invention are realized using following technical scheme.
A kind of breviscapine frozen dry powder for injection agent of double auxiliary materials, it is characterised in that the freeze drying powder injection uses double auxiliary
Material, auxiliary material is mannitol and HES 130/0.4, and main ingredient is Breviscapinun, and wherein the weight ratio of main ingredient auxiliary material is 100:
100-100:120, the weight ratio of mannitol and HES 130/0.4 is 100:70-100:90.With above-mentioned main ingredient and auxiliary material
It is prepared into breviscapine frozen dry powder for injection agent.
The preferred weight ratio of above-mentioned main ingredient and auxiliary material is 100:110, mannitol is preferred heavy with HES 130/0.4
Amount is than being 100:80.
It is a further object to provide be prepared into a kind of breviscapine frozen dry powder for injection agent of double auxiliary materials
Method, it is characterised in that this method concretely comprises the following steps:
(1) Breviscapinun, mannitol and the solution of HES 130/0.4 are prepared
Preparing Breviscapinun, mannitol and the solution component of HES 130/0.4 is:Breviscapinun, mannitol, hydroxyl second
Base starch 130/0.4, water for injection.
A) above-mentioned mannitol is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirring temperature
Spend for 80 DEG C, to whole dissolvings, then be separately added into HES 130/0.4 and Breviscapinun, keep 80 DEG C of temperature to continue to stir
Mix to whole dissolvings, with appropriate water for injection constant volume, the rear pH value for adjusting solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 30 minutes time;
C) inspection by sampling, determine loading amount and pour into cleaned and sterilization cillin bottle, vacuum refrigeration is put into after half tamponade
Drying machine;
(3) lyophilized technique:Cillin bottle equipped with decoction opens machine after being put into vacuum freeze drier, in 55-60 minutes
Interior fast cooling is kept for subzero 45 DEG C start to vacuumize after 60 minutes, vacuum is evacuated to below 10 pas and maintained to subzero 45 DEG C
To product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, is gradually risen within 110-120 minutes
Temperature is to 0 DEG C, and temperature is maintained 180 minutes at 0 DEG C, then 32~33 DEG C are gradually heating within 300-310 minutes, at 32~33 DEG C
At a temperature of maintain 5 hours after shut down, product outlet Zha Gai, the whole used time be no more than 15 hours.
The breviscapine frozen dry powder for injection agent preparation technology of the present invention is simple, and product quality is excellent, than alone mannitol
Auxiliary material production breviscapine frozen dry powder for injection agent is done to reduce production freeze-drying time 8 hours, averagely reduce by 6 DEG C of drying temperature,
Therefore energy consumption is greatly reduced, improves productivity ratio, and finished product clarity and solution colour qualification rate increase.
Embodiment:
In order that the technical means, the inventive features, the objects and the advantages of the present invention are easy to understand, tie below
Specific embodiment is closed, the present invention is expanded on further.
For the uniformity of guarantee test result, the embodiment of the present invention has used the raw material, auxiliary material, cillin bottle of same batch
And plug, and employ consistent production technology and prepare breviscapine frozen dry powder for injection agent.
Embodiment one, breviscapine frozen dry powder for injection agent, in terms of 1000 bottles
Prescription (specification:10mg/ bottles):
Preparation technology:
A) mannitol of recipe quantity is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirred
Temperature is 80 DEG C, to whole dissolvings, then is separately added into the HES 130/0.4 of recipe quantity and the Breviscapinun of recipe quantity,
Keep 80 DEG C of temperature to continue stirring to whole dissolvings, 2000ml is settled to water for injection, adjust the pH value of solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 30 minutes time;
C) inspection by sampling, the cillin bottle equipped with decoction open machine after being put into vacuum freeze drier, within 55-60 minutes
Fast cooling is kept for subzero 45 DEG C start to vacuumize after 60 minutes, vacuum is evacuated to below 10 pas and maintained extremely to subzero 45 DEG C
Product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated up within 110-120 minutes
To 0 DEG C, temperature is maintained 180 minutes at 0 DEG C, then 32~33 DEG C are gradually heating within 300-310 minutes, in 32~33 DEG C of temperature
The lower maintenance of degree is shut down after 3 hours, and product outlet Zha Gai, the whole used time is no more than 15 hours.
Embodiment two, breviscapine frozen dry powder for injection agent, in terms of 1000 bottles
Prescription (specification:10mg/ bottles):
Preparation technology:
A) mannitol of recipe quantity is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirred
Temperature is 80 DEG C, to whole dissolvings, then is separately added into the HES 130/0.4 of recipe quantity and the Breviscapinun of recipe quantity,
Keep 80 DEG C of temperature to continue stirring to whole dissolvings, 2000ml is settled to water for injection, adjust the pH value of solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 30 minutes time.
C) inspection by sampling, the cillin bottle equipped with decoction open machine after being put into vacuum freeze drier, within 55-60 minutes
Fast cooling is kept for subzero 45 DEG C start to vacuumize after 60 minutes, vacuum is evacuated to below 10 pas and maintained extremely to subzero 45 DEG C
Product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated up within 110-120 minutes
To 0 DEG C, temperature is maintained 180 minutes at 0 DEG C, then 32~33 DEG C are gradually heating within 300-310 minutes, in 32~33 DEG C of temperature
The lower maintenance of degree is shut down after 3 hours, and product outlet Zha Gai, the whole used time is no more than 15 hours.
Experimental study data
To prove the superiority of the present invention, our breviscapine frozen dry powder for injection agent and its system by double accessory formulas
Breviscapine frozen dry powder for injection agent and its preparation technology and product quality of the standby technique with existing single auxiliary material have been carried out pair
Than research:
First, different auxiliary material formula process study
Experiment 1:
Prescription (specification:10mg/ bottles, in terms of 1000 bottles):
Preparation technology:
A) mannitol of recipe quantity is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirred
Temperature is 80 DEG C, to whole dissolvings, then is separately added into the HES 130/0.4 of recipe quantity and the Breviscapinun of recipe quantity,
Keep 80 DEG C of temperature to continue stirring to whole dissolvings, 2000ml is settled to water for injection, adjust the pH value of solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 30 minutes time;
C) inspection by sampling, the cillin bottle equipped with decoction open machine after being put into vacuum freeze drier, within 55-60 minutes
Fast cooling is kept for subzero 45 DEG C start to vacuumize after 60 minutes, vacuum is evacuated to below 10 pas and maintained extremely to subzero 45 DEG C
Product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated up within 110-120 minutes
To 0 DEG C, temperature is maintained 180 minutes at 0 DEG C, then 32~33 DEG C are gradually heating within 300-310 minutes, in 32~33 DEG C of temperature
The lower maintenance of degree is shut down after 3 hours, and product outlet Zha Gai, the whole used time is no more than 15 hours.
Experiment 2:
Prescription:(specification:10mg/ bottles, in terms of 1000 bottles):
Preparation technology:
A) mannitol of recipe quantity is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirred
Temperature is 80 DEG C, to whole dissolvings, then is separately added into the HES 130/0.4 of recipe quantity and the Breviscapinun of recipe quantity,
Keep 80 DEG C of temperature to continue stirring to whole dissolvings, 2000ml is settled to water for injection, adjust the pH value of solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 30 minutes time;
C) inspection by sampling, the cillin bottle equipped with decoction open machine after being put into vacuum freeze drier, within 55-60 minutes
Fast cooling is kept for subzero 45 DEG C start to vacuumize after 60 minutes, vacuum is evacuated to below 10 pas and maintained extremely to subzero 45 DEG C
Product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated up within 110-120 minutes
To 0 DEG C, temperature is maintained 180 minutes at 0 DEG C, then 32~33 DEG C are gradually heating within 300-310 minutes, in 32~33 DEG C of temperature
The lower maintenance of degree is shut down after 3 hours, and product outlet Zha Gai, the whole used time is no more than 15 hours.
Experiment 3:
Prescription:(specification:10mg/ bottles, in terms of 1000 bottles):
Preparation technology:
The mannitol of recipe quantity is dissolved in water for injection, is placed in water bath with thermostatic control magnetic stirring apparatus and stirs, stirring temperature
Spend for 80 DEG C, to whole dissolvings, add the Breviscapinun of recipe quantity, keep 80 DEG C of temperature to continue stirring to whole dissolvings, use
Water for injection is settled to 2000ml, adjusts the pH value of solution to 6.0.
B) above-mentioned solution successively passes through 0.45 μm and 0.22 μm of filter membrane circulating filtration, 33 minutes time;
C) inspection by sampling, determine loading amount and pour into cleaned and sterilization cillin bottle, vacuum refrigeration is put into after half tamponade
Drying machine, machine is opened, fast cooling starts to take out very to subzero 45 DEG C after keeping subzero 45 DEG C of freezings 180 within 55-60 minutes
Sky, vacuum are evacuated to below 10 pas and maintained, and vacuum freeze drier heating function is opened while starting to vacuumize,
0 DEG C is gradually heating in 180-190 minutes, temperature maintains 300 minutes at 0 DEG C, then is gradually heating within 300-310 minutes
38~39 DEG C, product outlet Zha Gai after 6 hours drying times is maintained at a temperature of 38~39 DEG C, whole vacuum is freezed and keeps 10
Below pa, whole freeze-drying time is no more than 23 hours.
Product checking result:The product water content 1.36% of experiment 1, outward appearance, quality all meet Chinese Pharmacopoeia requirement.Experiment
2 product water content 19.05%, does not meet Chinese Pharmacopoeia requirement.The product water content 1.19% of experiment 3, outward appearance, quality all accord with
Close Chinese Pharmacopoeia requirement.Thus prove the lyophilized powder injection of breviscapinum of single accessory formula in 32~33 DEG C of drying temperature, jelly
It is that can not produce qualified breviscapine frozen dry powder for injection agent product that the dry whole used time, which was no more than in 15 hours,.
2nd, commercially available single auxiliary material breviscapine frozen dry powder for injection agent and the double auxiliary material Breviscapines of self-control freeze
The quality research of powder-injection
Commercially available prod and homemade three batches of products are carried out quality versus's research by us, and its result is as follows:
Note:The preparation technology of own product 1, own product 2 and own product 3 and experiment are 1 identical, make by oneself in three batches of products main ingredient with
The weight ratio of auxiliary material is 100:110, the weight ratio of auxiliary material mannitol and HES 130/0.4 is 100 in own product 1:
70, the weight ratio of auxiliary material mannitol and HES 130/0.4 is 100 in own product 2:80, auxiliary material mannitol in own product 3
Weight ratio with HES 130/0.4 is 100:90.
The studies above proves:Double commercially available single auxiliary material injection lamps of auxiliary material breviscapine frozen dry powder for injection agent mass ratio
Small cup florigen freeze drying powder injection quality is more excellent on appearance character and clarity.
General principle, principal character and the advantages of the present invention of the present invention has been shown and described above.The technology of the industry
For personnel it should be appreciated that the present invention is not limited to the above embodiments, that described in above-described embodiment and specification is only the present invention
Preference, be not intended to limit the present invention, without departing from the spirit and scope of the present invention, the present invention also have it is various
Changes and improvements, these changes and improvements all fall within the protetion scope of the claimed invention.The claimed scope of the invention is by institute
Attached claims and its equivalent thereof.
Claims (2)
1. a kind of double auxiliary material breviscapine frozen dry powder for injection agent, it is characterised in that including main ingredient and auxiliary material, main ingredient is oil lamp
Florigen, auxiliary material are mannitol and HES 130/0.4, and the medicament is prepared into injection freeze-dried powder with above-mentioned main ingredient and auxiliary material
The weight ratio of injection, wherein main ingredient and auxiliary material is 100:100-100:120, the weight of mannitol and HES 130/0.4
Than for 100:70-100:90.
A kind of 2. double auxiliary material breviscapine frozen dry powder for injection agent according to claim 1, it is characterised in that main ingredient with
The preferred weight ratio of auxiliary material is 100:110, the preferred weight ratio of mannitol and HES 130/0.4 is 100:80.
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CN201711079984.7A CN107744505A (en) | 2017-11-06 | 2017-11-06 | A kind of double auxiliary material breviscapine frozen dry powder for injection agent |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109453124A (en) * | 2018-11-23 | 2019-03-12 | 深圳市维琪医药研发有限公司 | A kind of lamp-dish flower acetic lyophilized preparation and preparation method thereof of RGD class peptide modification |
-
2017
- 2017-11-06 CN CN201711079984.7A patent/CN107744505A/en not_active Withdrawn
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109453124A (en) * | 2018-11-23 | 2019-03-12 | 深圳市维琪医药研发有限公司 | A kind of lamp-dish flower acetic lyophilized preparation and preparation method thereof of RGD class peptide modification |
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