CN106474186A - A kind of preparation method improving DANHONG drug injection preparation stability - Google Patents
A kind of preparation method improving DANHONG drug injection preparation stability Download PDFInfo
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- CN106474186A CN106474186A CN201610968024.5A CN201610968024A CN106474186A CN 106474186 A CN106474186 A CN 106474186A CN 201610968024 A CN201610968024 A CN 201610968024A CN 106474186 A CN106474186 A CN 106474186A
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- danhong
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- citric acid
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- 239000008522 danhong Substances 0.000 title claims abstract description 54
- 238000002347 injection Methods 0.000 title claims abstract description 34
- 239000007924 injection Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 31
- 239000003814 drug Substances 0.000 title claims abstract description 26
- 229940079593 drug Drugs 0.000 title claims abstract description 23
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 99
- 239000000243 solution Substances 0.000 claims abstract description 33
- 239000001509 sodium citrate Substances 0.000 claims abstract description 24
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 24
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 14
- 239000008215 water for injection Substances 0.000 claims abstract description 10
- 238000005261 decarburization Methods 0.000 claims abstract description 7
- 239000000706 filtrate Substances 0.000 claims abstract description 7
- 239000012467 final product Substances 0.000 claims abstract description 7
- 230000001954 sterilising effect Effects 0.000 claims abstract description 7
- 238000001914 filtration Methods 0.000 claims description 6
- 230000003204 osmotic effect Effects 0.000 claims description 6
- 238000005352 clarification Methods 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 239000000811 xylitol Substances 0.000 claims description 4
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical group OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 4
- 229960002675 xylitol Drugs 0.000 claims description 4
- 235000010447 xylitol Nutrition 0.000 claims description 4
- 239000003610 charcoal Substances 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims description 2
- 239000000047 product Substances 0.000 abstract description 9
- 239000006184 cosolvent Substances 0.000 abstract description 6
- 230000015556 catabolic process Effects 0.000 abstract description 3
- 238000006731 degradation reaction Methods 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract description 3
- 238000007689 inspection Methods 0.000 abstract description 2
- 238000000034 method Methods 0.000 description 5
- 239000003002 pH adjusting agent Substances 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 229920001214 Polysorbate 60 Polymers 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 238000001556 precipitation Methods 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- -1 white block Substances 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 208000014644 Brain disease Diseases 0.000 description 1
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010008479 Chest Pain Diseases 0.000 description 1
- 201000006306 Cor pulmonale Diseases 0.000 description 1
- 208000032274 Encephalopathy 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
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 208000004186 Pulmonary Heart Disease Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 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
- 230000017531 blood circulation Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 229940126680 traditional chinese medicines Drugs 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/286—Carthamus (distaff thistle)
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
-
- 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
- A61K9/08—Solutions
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
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Abstract
The invention discloses a kind of preparation method improving DANHONG drug injection preparation stability, comprise the steps：1）Weigh extracting solution, citric acid and/or the sodium citrate of DANHONG；2）Join citric acid, liquor sodii citratises respectively；3）The extracting solution of DANHONG adds in 30 DEG C～40 DEG C of water for injection 500ml, stirs to after be completely dissolved, the activated carbon of addition, stirring, filters decarburization；4）The citric acid of gained filtrate configuration and/or liquor sodii citratises regulation pH value are .0～7.0, addition water for injection to 1000ml；5）It is filtered until clear, fill, sterilizing, obtain final product.The present invention can make this injection pH value more stable, DANHONG degradation material substantially reduces compared with prior art, in the case of avoiding increasing the cosolvent of clinical practice risk using other, improve the clarity of DANHONG ZHUSHEYE, can ensure that the visible foreign matters inspection of product meets the regulation of drug standard, be easy to clinical application and popularization.
Description
Technical field
A kind of the invention belongs to pharmaceutical technology field, in particular it relates to system improving DANHONG drug injection preparation stability
Preparation Method.
Background technology
Blood circulation promoting and blood stasis dispelling, TONGMAI SHULUO.For the thoracic obstruction caused by blood stasis impatency and apoplexy, card is shown in：Chest pain, uncomfortable in chest, cardiopalmus, mouth
Crooked, the sluggish speech of eye, numb limbs and tense tendons, activity is unfavorable to wait disease；Coronary heart diseases and angina pectoris, myocardial infarction, blood stasis type pulmonary heart disease, lack
Courageous and upright encephalopathy, cerebral thrombosiss.
Due to DANHONG dissolubility extreme difference in aqueous, therefore it is made into DANHONG hydrochlorate or DANHONG phosphate to increase
Its water solublity.Presently commercially available DANHONG ZHUSHEYE mainly has the phosphatic injection with small volume of DANHONG hydrochlorate, DANHONG, Yi Ji
DANHONG is extracted and is added the high-capacity injection that glucose or sodium chloride are made as osmotic pressure regulator in liquor.But in preparation
It is necessary to the pH value of medicinal liquid is adjusted to the certain limit of suitable human injection's administration during above-mentioned injection, current document report makes
PH value regulator is sodium hydroxide solution or uses hydrochloric acid solution, phosphoric acid solution, but adopts above-mentioned pH value regulator system
Standby DANHONG ZHUSHEYE easily separates out the precipitation such as tiny white point, white block, solution muddiness under the conditions of long-term storage and winter low temperature
Thing, causes the visible foreign matters check item of product unqualified.Prior art is to add polyoxyethylene sorbitan monoleate in the solution as cosolvent,
To solve product, the sedimentary problems such as small particles, white block, solution muddiness occur.But polyoxyethylene sorbitan monoleate is due to having haemolysis and fall
The effect of pressure, and easily become sour in storage and autoclaving process, lead to the injection clinical practice containing polyoxyethylene sorbitan monoleate
Risk is higher, makes troubles to clinical application and popularization.
Content of the invention
The technical problem to be solved is to provide a kind of preparation side improving DANHONG drug injection preparation stability
Method.This medicinal composition for injections adopts citric acid, sodium citrate as pH adjusting agent, and finds to adopt by creative work
When citric acid, sodium citrate are as pH adjusting agent, medicinal liquid pH value is more stable, and DANHONG degradation material drops significantly compared with prior art
Low, in the case of avoiding increasing the cosolvent of clinical practice risk using other, DANHONG ZHUSHEYE is satisfactorily addressed
The muddy problem of the tiny white point of easy precipitation, white block, solution under the conditions of long-term storage and winter low temperature.
The present invention solves the above problems and be employed technical scheme comprise that：A kind of raising DANHONG drug injection preparation stability
Preparation method, comprises the steps：
（1）Weigh extracting solution 0.1g～50g, citric acid and/or the sodium citrate 5mg～30mg of DANHONG；
（2）Citric acid, sodium citrate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
（3）The extracting solution of DANHONG adds in 30 DEG C～40 DEG C of water for injection 500ml, stirs to after be completely dissolved, the work of addition
Property charcoal, described activated carbon dosage be 0.2g/100ml, stir 15 minutes, filter decarburization；
（4）Step（3）Gained filtrate step（2）Configuration citric acid and/or liquor sodii citratises adjust pH value be 6.0～
8.0, add less than 40 DEG C（30 DEG C～40 DEG C）Water for injection to 1000ml；
（5）By step（4）Gained medical filtration, to clarification, fill, sterilizing, obtains final product.
Described step（1）Middle citric acid consumption is 5mg～18mg/100ml, sodium citrate consumption is 5mg～18mg/
100ml.
Described step（1）In also include osmotic pressure regulator 9.0g.
Described osmotic pressure regulator is xylitol.
Described DANHONG drug injection preparation formulation is injection.
In such scheme, add that citric acid and/or sodium citrate refer to add can be citric acid, in sodium citrate
Any one, or citric acid, sodium citrate are with arbitrary proportion proportioning；In step（2）In, the citric acid of addition, sodium citrate
One of, then make a kind of solution, such as include citric acid, two kinds of sodium citrate, be then configured to solution for standby respectively；DANHONG
Extracting solution, the consumption of osmotic pressure regulator can adopt the consumption of prior art, according to the consumption adjustment of prior art.
In sum, the invention has the beneficial effects as follows：The present invention pass through experimental studies have found that, in DANHONG drug injection preparation
In, during using citric acid, sodium citrate as pH adjusting agent, medicinal liquid pH value is more stable, and DANHONG degradation material is compared with prior art
Substantially reduce, in the case of avoiding increasing the cosolvent of clinical practice risk using other, DANHONG has been satisfactorily addressed
Injection adopts prior art products easily to separate out tiny white point, white block, the problem of solution muddiness, Ke Yibao in storage process
The visible foreign matters detection demonstrate,proving the holding injection that DANHONG ZHUSHEYE can be stable in storage process meets drug standard
Regulation, is easy to clinical application and popularization.
The present invention passes through creative work, the reason muddy to the tiny white point separating out in DANHONG ZHUSHEYE, white block, solution
It is analyzed and studies, determine that deposit is mainly raw material free alkali crystallize and a small amount of catabolite, above-mentioned reason can
Can be relevant with species sour, alkali used by the pH value of solution and pH adjusting agent.Sodium citrate is therefore used as pH adjusting agent, and
Citric acid is used as pH value counter regulation agent, in the case of avoiding increasing the cosolvent of clinical practice risk using other, with
Easily the tiny white point of precipitation, white block, solution are muddy under the conditions of long-term storage and winter low temperature to solve the problems, such as this product.
Specific embodiment
With reference to embodiment, the present invention is described in further detail, but embodiments of the present invention not limited to this.
Embodiment 1：
A kind of preparation method improving DANHONG drug injection preparation stability, comprises the steps：（1）Weigh crude drug with DANHONG
Extracting solution amount of calculation 5g, xylitol 9.0g, citric acid 1mgmg, sodium citrate 2.0mg；（2）Citric acid, sodium citrate are joined respectively
Make 10%～20% solution, standby；（3）Add in less than 40 DEG C of water for injection 500ml, stir to after be completely dissolved, plus
Enter 0.02%（g/ml）Activated carbon, stir 15 minutes, filter decarburization；（4）Filtrate citric acid or liquor sodii citratises adjust pH
It is worth for 3.0～7.0, add less than 40 DEG C of water for injection to 1000ml；（5）Medical filtration, to clarification, fill, sterilizing, obtains final product.
Specifically the composition of each component and its content are as follows for the present embodiment：
DANHONG extracting solution 5g
Xylitol 9.0g
Citric acid 1.0mg
Sodium citrate 2.0mg
Citric acid, sodium citrate are configured to 10%～20% solution respectively, standby.DANHONG extracting solution adds less than 40 DEG C of injection
With in water 500ml, stirring to after be completely dissolved, add 0.2% activated carbon（I.e. activated carbon dosage is 0.2g/100ml）, stirring
15 minutes, filter decarburization.Filtrate citric acid or liquor sodii citratises adjust pH value for 6.0～8.0, add less than 40 DEG C of note
Penetrate with water to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 2：
The present embodiment another embodiment, a kind of as follows, above-mentioned preparation improving DANHONG drug injection preparation stability
Method is prepared according to the following steps：
（1）Weigh crude drug with DANHONG amount of calculation 20g, citric acid 1mg～2.0g, sodium citrate 1mg～2.0g；（2）Citric acid,
Sodium citrate is configured to 10%～20% solution respectively, standby.（3）Add in less than 40 DEG C of water for injection 500ml, stir to
After being completely dissolved, add 0.2%（g/ml）Activated carbon, stir 15 minutes, filter decarburization；（4）Filtrate citric acid or citric acid
It is 6.0～8.0 that sodium solution adjusts pH value, adds less than 40 DEG C of water for injection to 1000ml；（5）Medical filtration, to clarifying, fills
Dress, sterilizing, obtain final product.
Specifically the composition of each component and its content are as follows for the present embodiment：
DANHONG extracting solution 20g
Citric acid 1.0mg
Sodium citrate 2.0mg
Citric acid, sodium citrate are configured to 10%～20% solution respectively, standby.Hydrochloric acid DANHONG adds less than 40 DEG C of injection
In water 500ml, stir to after be completely dissolved, add 0.2% activated carbon（I.e. activated carbon dosage is 0.2g/100ml）, stir 15
Minute, filter decarburization.Filtrate citric acid or liquor sodii citratises adjust pH value for 6.0～8.0, add less than 40 DEG C of injection
With water to 1000ml.Medical filtration, to clarification, fill, sterilizing, obtains final product.
Embodiment 3：
DANHONG ZHUSHEYE stability comparative test
Visible foreign matters detection using DANHONG ZHUSHEYE obtained by the present invention meets the regulation of drug standard, and solution-stabilized
Property very well, in the case of avoiding increasing the cosolvent of clinical practice risks using other, solve DANHONG ZHUSHEYE in storage
During easily occur small particles, white block, solution muddy the problems such as.Using the DANHONG ZHUSHEYE obtained by the present invention according to middle traditional Chinese medicines
The related request of allusion quotation two annex of version in 2005 Ⅺ Ⅹ C pharmaceutical preparation stability test guideline, has investigated respectively at 25 DEG C
Place to place for 24 months, 40 DEG C and place within 6 months, 60 DEG C 10 days, 0～5 DEG C of low temperature 20 days medicine stability of placement, result is above-mentioned
Under experimental condition, product quality is stable, and every Testing index all meets the regulation of this product quality standard.
The pharmacological results show：Using the stable DANHONG ZHUSHEYE obtained by the present invention no hemolytic, no anaphylaxis,
Nonirritant, meets the requirement of drug administration by injection.
According to the above results, the DANHONG drug injection preparation of the present invention can improve the clarity of DANHONG ZHUSHEYE,
Particularly in the case that DANHONG injection period of storage is longer, the visible foreign matters detection of holding injection that can be stable meets medicine
The regulation of quality standard, solves DANHONG medicine and little Bai using existing technical products in the case that period of storage is longer
The muddy problem of point, white block, solution, it is ensured that the visible foreign matters inspection of product meets the regulation of drug standard, is easy to
Clinical application and popularization.
As described above, just can preferably realize the present invention.
Claims (5)
1. a kind of preparation method improving DANHONG drug injection preparation stability is it is characterised in that comprise the steps：
（1）Weigh extracting solution 0.1g～50g, citric acid and/or the sodium citrate 5mg～30mg of DANHONG；
（2）Citric acid, sodium citrate are configured to the solution of 1g/100ml～10g/100ml respectively, standby；
（3）The extracting solution of DANHONG adds in 30 DEG C～40 DEG C of water for injection 500ml, stirs to after be completely dissolved, the work of addition
Property charcoal, described activated carbon dosage be 0.2g/100ml, stir 15 minutes, filter decarburization；
（4）Step（3）Gained filtrate step（2）Configuration citric acid and/or liquor sodii citratises adjust pH value be 6.0～
8.0, add 30 DEG C～40 DEG C of water for injection to 1000ml；
（5）By step（4）Gained medical filtration, to clarification, fill, sterilizing, obtains final product.
2. according to claim 1 a kind of improve DANHONG drug injection preparation stability preparation method it is characterised in that
Described step（1）Middle citric acid consumption is 5mg～18mg/100ml, sodium citrate consumption is 5mg～18mg/100ml.
3. according to claim 1 a kind of improve DANHONG drug injection preparation stability preparation method it is characterised in that
Described step（1）In also include osmotic pressure regulator 9.0g.
4. according to claim 3 a kind of improve DANHONG drug injection preparation stability preparation method it is characterised in that
Described osmotic pressure regulator is xylitol.
5. according to claim 1 a kind of improve DANHONG drug injection preparation stability preparation method it is characterised in that
Described DANHONG drug injection preparation formulation is injection.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008727A (en) * | 2010-12-07 | 2011-04-13 | 四川升和药业股份有限公司 | Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition |
| CN105106110A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
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- 2016-11-06 CN CN201610968024.5A patent/CN106474186A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008727A (en) * | 2010-12-07 | 2011-04-13 | 四川升和药业股份有限公司 | Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition |
| CN105106110A (en) * | 2015-09-23 | 2015-12-02 | 成都艾比科生物科技有限公司 | Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition |
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Application publication date: 20170308 |