CN107661369A - A kind of method for improving FUFANG DANGGUI ZHUSHEYE security - Google Patents

A kind of method for improving FUFANG DANGGUI ZHUSHEYE security Download PDF

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CN107661369A
CN107661369A CN201610995291.1A CN201610995291A CN107661369A CN 107661369 A CN107661369 A CN 107661369A CN 201610995291 A CN201610995291 A CN 201610995291A CN 107661369 A CN107661369 A CN 107661369A
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relative density
filtrate
concentrated
filtration
security
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张蛟
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Chengdu Shengshi Guanghua Biological Technology Co Ltd
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Chengdu Shengshi Guanghua Biological Technology Co Ltd
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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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481—Astragalus (milkvetch)
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The invention discloses a kind of method for improving FUFANG DANGGUI ZHUSHEYE security.Mainly injection pharmaceutical composition is made from angelica extract, Astragalus Root P.E, Notogineng Extract and methyl methacrylate in this method.The inventive method uses the cosolvent Phenoxyethanol that security is more preferable, potential safety hazard and influence product quality in the more obvious cosolvent replacement FUFANG DANGGUI ZHUSHEYE of solubilization-aid effect be present, the security of methyl methacrylate is higher than Phenoxyethanol and dosage is lower, adverse reaction occurs for medicine probability and risk are reduced, improves the security of clinical application.

Description

A kind of method for improving FUFANG DANGGUI ZHUSHEYE security
Technical field
The invention belongs to pharmaceutical technology field, in particular it relates to a kind of method for improving FUFANG DANGGUI ZHUSHEYE security.
Background technology
FUFANG DANGGUI ZHUSHEYE standard is recorded issues the drug standards (Traditional Chinese medicine historical preparation) in the Ministry of Public Health, bulk drug be Radix Angelicae Sinensis, The Radix Astragali, pseudo-ginseng, belong to traditional Chinese medicine injection.With invigorate blood circulation, the effect of stasis-dispelling and pain-killing.It is clinically used for treating dysmenorrhoea, Amenorrhea, falls Flutter damage, arthralgia pain due to rheumatism etc..
FUFANG DANGGUI ZHUSHEYE in China in wide clinical application for many years, clinical efficacy has obtained the good of doctor and patient Comment.But in recent years, the Reporting of harms of traditional Chinese medicine injection clinical practice is on the rise, have impact on Chinese Medicine characteristic The development of traditional Chinese medicine injection.Adverse reaction of the domestic experts and scholars to traditional Chinese medicine injection has carried out numerous studies, document report its The cosolvent Phenoxyethanol of the presence potential safety hazard added in the generation of adverse reaction and traditional Chinese medicine injection has very big relation.By In traditional Chinese medicine injection complicated component, clarity, pH value of solution are influenceed with easily occurring solute precipitation in autoclaving process storing The problems such as value is decreased obviously, therefore add Phenoxyethanol in such parenteral solution and make cosolvent, add helping for other cosolvents Molten effect then unobvious.But Phenoxyethanol is being stored and easily become sour in autoclaving process, led because process for refining is immature Cause impurity content high, it is difficult to reach injection standard, Phenoxyethanol inherently has stronger hemolytic and anaphylaxis, applied The probability and risk that adverse reaction occurs are added in parenteral solution.In addition, traditional Chinese medicine injection is gone back in itself in sterilizing and storage process The problem of solution ph is decreased obviously be present, and Phenoxyethanol easily becomes sour, and more accelerates the decline of the pH value of decoction.At present Also Phenoxyethanol is added in the FUFANG DANGGUI ZHUSHEYE of domestic production and makees cosolvent, is faced with the problem of same.
In view of the foregoing, the benzene oxygen that security is more preferable, the more obvious cosolvent of solubilization-aid effect replaces security difference is found Ethanol is the parenteral solution urgent problem.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of method for improving FUFANG DANGGUI ZHUSHEYE security.
Technical scheme is used by the present invention solves above-mentioned technical problem：
A kind of method for improving FUFANG DANGGUI ZHUSHEYE security, comprises the steps：
(1) 50~120g of FUFANG DANGGUI ZHUSHEYE raw medicinal material Radix Angelicae Sinensis, 50~120g of the Radix Astragali, 50~120g of pseudo-ginseng, hydrotropy Agent 0.005g~2.0g；The cosolvent is mainly methyl methacrylate；
(2) Radix Angelicae Sinensis, the Radix Astragali, which add, is hydrated and decocts secondary, merges decocting liquid twice, filtration, filtrate decompression is concentrated into relative density For 1.27~1.30, let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, decompression filtrate recycling ethanol simultaneously concentrates It is 1.30 to relative density, adds 3 times of amount water, be sufficiently stirred, refrigerate 48 hours, filtration, filtrate decompression is concentrated into relative density about For 1.15, decoction is standby；Pseudo-ginseng adds water to cook secondary, collecting decoction, filtration, filtrate be concentrated into relative density for 1.25~ 1.30, let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, and it is 1.20 that filtrate decompression, which is concentrated into relative density, It is 70% to add ethanol to make containing amount of alcohol, stands overnight, filters, and it is 1.30 that filtrate, which is concentrated into relative density, adds 3 times of amount water, fully Stirring, refrigerate 48 hours, filtration, it is 1.15 that filtrate, which is concentrated into relative density, is merged with above-mentioned decoction, adds 2 times of amount water, fully stirs Mix, refrigerate 24 hours, filtration, filtrate adds cosolvent and water for injection is configured to 1000ml solution, stirs evenly；
(3) solution ph is adjusted to 6.5~8.5 with 20% sodium hydroxide solution；
(4) above-mentioned solution is filtered through miillpore filter；
(5) it is filling, sterilizing, produce.
In order to which the method for the present invention is better achieved, further, in the step (1), raw medicinal material Radix Angelicae Sinensis 100g, Huang Stilbene 100g, pseudo-ginseng 100g.
In order to which the method for the present invention is better achieved, further, in the step (1), the cosolvent also includes 1.5 ~3.0g Phenoxyethanols.
In order to which the method for the present invention is better achieved, further, in the step (2), Radix Angelicae Sinensis, the Radix Astragali add decocting every time The time boiled, the time that pseudo-ginseng adds water to cook every time was 1 hour every time for 2 hours every time.
In order to which the method for the present invention is better achieved, further, in the step (2), the relative density of each filtrate is equal For 80 DEG C when relative density.
For the present invention by substantial amounts of experimental study, it is that Phenoxyethanol preferably substitutes production to find a kind of methyl methacrylate Product.The pharmacological toxicology experimental data of document report shows that its toxicity is significantly lower than Phenoxyethanol.We pass through substantial amounts of real in addition Test research and find that the amount ratio Phenoxyethanol of methyl methacrylate is low when reaching identical solubilization-aid effect, more improves medicine The security of thing.
The pharmacological toxicology experimental data of document report shows that the security of methyl methacrylate is higher than Phenoxyethanol, its poison Property is significantly lower than Phenoxyethanol (see the table below 1-3).Use (0.5g/100ml) first of equivalent respectively in FUFANG DANGGUI ZHUSHEYE Base methyl acrylate and Phenoxyethanol, safety experiment comparative study result show, use (0.5g/100ml) methyl of equivalent Methyl acrylate group obvious ratio in terms of hemolytic, excitant, anaphylaxis and the toxicity such as reduce blood pressure uses benzene oxygen second Alcohol group is low, passes through the probability and wind of the invention for considerably reducing FUFANG DANGGUI ZHUSHEYE and adverse reaction occurring in clinical practice Danger, improve the security of clinical application.
To sum up, the beneficial effects of the invention are as follows：There is provided that a kind of security is more preferable, the more obvious cosolvent of solubilization-aid effect is replaced Potential safety hazard in FUFANG DANGGUI ZHUSHEYE be present and influence the cosolvent Phenoxyethanol of product quality；The peace of methyl methacrylate Full property is higher than Phenoxyethanol and dosage is lower, reduces adverse reaction occurs for medicine probability and risk, improves clinical application Security.
Embodiment
Embodiment 1
Preparation method：Radix Angelicae Sinensis, the Radix Astragali add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was concentrated into Relative density is 1.27~1.30 (80 DEG C), is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression It is 1.30 (80 DEG C) to reclaim ethanol and be concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate It is about 1.15 (80 DEG C) to be concentrated under reduced pressure into relative density, and decoction is standby；Pseudo-ginseng add water to cook it is secondary, 1 hour every time, merge decoct Liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, is stood Overnight, filtration, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood overnight, Filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate is dense It is 1.15 (80 DEG C) to be reduced to relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filter, filter Liquid addition methyl methacrylate makees cosolvent and water for injection is configured to 1000ml solution.Stir evenly.It is molten with 20% sodium hydroxide Liquid adjusts solution ph to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.It is filling, sterilizing, produce.
Embodiment 2
Preparation method：Radix Angelicae Sinensis, the Radix Astragali add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was concentrated into Relative density is 1.27~1.30 (80 DEG C), is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression It is 1.30 (80 DEG C) to reclaim ethanol and be concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate It is about 1.15 (80 DEG C) to be concentrated under reduced pressure into relative density, and decoction is standby；Pseudo-ginseng add water to cook it is secondary, 1 hour every time, merge decoct Liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, is stood Overnight, filtration, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood overnight, Filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate is dense It is 1.15 (80 DEG C) to be reduced to relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filter, filter Liquid adds methyl methacrylate and Phenoxyethanol makees cosolvent and water for injection is configured to 1000ml solution.Stir evenly.With 20% Sodium hydroxide solution adjusts solution ph to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.It is filling, sterilizing, produce.
Embodiment 3
Preparation method：Radix Angelicae Sinensis, the Radix Astragali add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate decompression was concentrated into Relative density is 1.27~1.30 (80 DEG C), is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression It is 1.30 (80 DEG C) to reclaim ethanol and be concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate It is about 1.15 (80 DEG C) to be concentrated under reduced pressure into relative density, and decoction is standby；Pseudo-ginseng add water to cook it is secondary, 1 hour every time, merge decoct Liquid, filtration, it is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, is stood Overnight, filtration, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, is stood overnight, Filtration, it is 1.30 (80 DEG C) that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate is dense It is 1.15 (80 DEG C) to be reduced to relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filter, filter Liquid addition methyl methacrylate makees cosolvent and water for injection is configured to solution.Stir evenly.Adjusted with 20% sodium hydroxide solution Solution ph is to 6.5-8.5.Above-mentioned solution is filtered through miillpore filter.1000 are distributed into, freeze-drying, is produced.
Embodiment 4：
Angelica extract, Astragalus Root P.E, Notogineng Extract and the methyl methacrylate of the present invention is manufactured for injection What pharmaceutical composition can be achieved through the following technical solutions：
(1) FUFANG DANGGUI ZHUSHEYE raw medicinal material Radix Angelicae Sinensis 100g, Radix Astragali 100g, pseudo-ginseng 100g, methyl methacrylate 2.0g；
(2) Radix Angelicae Sinensis, the Radix Astragali add water to cook secondary, 2 hours every time, collecting decoction, and filtration, filtrate decompression is concentrated into relatively close Spend for 1.27~1.30 (80 DEG C), let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, filtrate decompression recovery second Alcohol and to be concentrated into relative density be 1.30 (80 DEG C), adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, and filtrate decompression is dense It is about 1.15 (80 DEG C) to be reduced to relative density, and decoction is standby；Pseudo-ginseng add water to cook it is secondary, 1 hour every time, collecting decoction, filtration, It is 1.25~1.30 (80 DEG C) that filtrate, which is concentrated into relative density, is let cool, and it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters Cross, it is 1.20 (80 DEG C) that filtrate decompression, which is concentrated into relative density, and it is 70% to add ethanol to make containing amount of alcohol, stands overnight, filters, filter It is 1.30 (80 DEG C) that liquid, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate is concentrated into phase It is 1.15 (80 DEG C) to density, merges with above-mentioned decoction, adds 2 times of amount water, be sufficiently stirred, refrigerate 24 hours, filtration, filtrate adds Methyl methacrylate makees cosolvent and water for injection is configured to 1000ml solution.Stir evenly；
(3) solution ph is adjusted to 6.5-8.5 with 20% sodium hydroxide solution；
(4) above-mentioned solution is filtered through miillpore filter；
(5) it is filling, sterilizing, produce.
In the present invention, cosolvent can be methyl methacrylate, and its dosage is appointing in 0.005g~5.0g/100ml Meaning value, such as 0.005g/100ml, 0.01g/100ml, 0.05g/100ml, 1.0g/100ml, 5.0g/100ml；Cosolvent It can be made up of methyl methacrylate and Phenoxyethanol, its usage ratio is 0.005g~5.0g/100ml：0.001g~ 2.0g/100ml。
After the present invention uses methyl methacrylate as cosolvent, its security is more preferable, solubilization-aid effect is more obviously excellent In Phenoxyethanol, specific data are referring to following table：
The methyl methacrylate of table 1 and Phenoxyethanol LD50Toxicity test data compare
Table 2 is injected intravenously methyl methacrylate compared with haemolysis after Phenoxyethanol and serum histamine levels
Table 3 is injected intravenously methyl methacrylate compared with being depressured level after Phenoxyethanol
In addition, the present invention by experimental studies have found that, in FUFANG DANGGUI ZHUSHEYE, first when reaching identical solubilization-aid effect The dosage of base methyl acrylate is substantially lower than Phenoxyethanol, more improves Drug safety.Methyl-prop in pharmaceutical composition The dosage of e pioic acid methyl ester is 0.005g-5.0g/100ml, preferable amount 0.05g-1.0g/100ml.May be used also in pharmaceutical composition Combined using methyl methacrylate with Phenoxyethanol by different proportion and make cosolvent to reduce Phenoxyethanol dosage, metering system The usage ratio of sour methyl esters and Phenoxyethanol is 0.005g-5.0g/100ml：0.001g-2.0g/100ml.
The present invention by experimental studies have found that, the methyl methacrylate of isoconcentration and Phenoxyethanol solution comparative study are molten The pH value change of liquid, the results showed that methyl methacrylate does not cause the pH value of parenteral solution to decline in itself, and the stability of solution is more Good (see the table below 4), the stability of medicine is added, be advantageous to improve the security of clinical application.
The methyl methacrylate and Phenoxyethanol solution ph comparative study result of the isoconcentration of table 4
The final product quality that the FUFANG DANGGUI ZHUSHEYE of table 5 adds different cosolvents investigates result
The FUFANG DANGGUI ZHUSHEYE methyl methacrylate of table 6 makees 25 DEG C of study on the stability results of cosolvent
The FUFANG DANGGUI ZHUSHEYE of table 7 and 60 DEG C of study on the stability results of methyl methacrylate
Time 0 day 5 days 10 days 20 days
Character Brown clear liquid Brown clear liquid Brown clear liquid Brown clear liquid
Visible foreign matters Meet regulation Meet regulation Meet regulation Meet regulation
PH value 6.41 5.86 5.78 5.65
It is sterile It is qualified It is qualified It is qualified It is qualified
Pyrogen It is qualified It is qualified It is qualified It is qualified
Content (μ g) 21.5 21.5 21.3 21.3
60 DEG C of study on the stability results of the FUFANG DANGGUI ZHUSHEYE of table 8 and 0.5% Phenoxyethanol
Time 0 day 5 days 10 days 20 days
Character Brown clear liquid Brown clear liquid Brown clear liquid Brown clear liquid
Visible foreign matters Meet regulation Meet regulation Meet regulation Meet regulation
PH value 6.37 5.81 5.70 5.60
It is sterile It is qualified It is qualified It is qualified It is qualified
Pyrogen It is qualified It is qualified It is qualified It is qualified
Content (μ g) 21.2 21.0 21.0 21.1

Claims (5)

  1. A kind of 1. method for improving FUFANG DANGGUI ZHUSHEYE security, it is characterised in that comprise the steps：
    （1）50 ~ 120g of FUFANG DANGGUI ZHUSHEYE raw medicinal material Radix Angelicae Sinensis, 50 ~ 120g of the Radix Astragali, 50 ~ 120g of pseudo-ginseng, cosolvent 0.005g ~2.0g；The cosolvent is mainly methyl methacrylate；
    （2）Radix Angelicae Sinensis, the Radix Astragali, which add, to be hydrated and decocts secondary, merges decocting liquid twice, filtration, filtrate decompression is concentrated into relative density and is 1.27~1.30, let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, decompression filtrate recycling ethanol is simultaneously concentrated into Relative density is 1.30, adds 3 times of amount water, is sufficiently stirred, refrigerates 48 hours, filtration, filtrate decompression is concentrated into relative density and is about 1.15, decoction is standby；Pseudo-ginseng adds water to cook secondary, collecting decoction, filtration, and it is 1.25~1.30 that filtrate, which is concentrated into relative density, Let cool, it is 65% to add ethanol to make containing amount of alcohol, stands overnight, filters, it is 1.20 that filtrate decompression, which is concentrated into relative density, adds ethanol It is 70% to make containing amount of alcohol, is stood overnight, and is filtered, and it is 1.30 that filtrate, which is concentrated into relative density, adds 3 times of amount water, is sufficiently stirred, cold Hide 48 hours, filtration, it is 1.15 that filtrate, which is concentrated into relative density, is merged with above-mentioned decoction, adds 2 times of amount water, is sufficiently stirred, refrigerates 24 hours, filtration, filtrate added cosolvent and water for injection is configured to 1000ml solution, stirs evenly；
    （3）Solution ph is adjusted to 6.5 ~ 8.5 with 20% sodium hydroxide solution；
    （4）Above-mentioned solution is filtered through miillpore filter；
    （5）It is filling, sterilizing, produce.
  2. A kind of 2. method for improving FUFANG DANGGUI ZHUSHEYE security according to claim 1, it is characterised in that the step Suddenly（1）In, raw medicinal material Radix Angelicae Sinensis 100g, Radix Astragali 100g, pseudo-ginseng 100g.
  3. A kind of 3. method for improving FUFANG DANGGUI ZHUSHEYE security according to claim 1, it is characterised in that the step Suddenly（1）In, the cosolvent also includes 1.5 ~ 3.0g Phenoxyethanols.
  4. A kind of 4. method for improving FUFANG DANGGUI ZHUSHEYE security according to claim 1, it is characterised in that the step Suddenly（2）In, the time that Radix Angelicae Sinensis, the Radix Astragali add water to cook every time, the time that pseudo-ginseng adds water to cook every time was every time 1 for 2 hours every time Hour.
  5. A kind of 5. method for improving FUFANG DANGGUI ZHUSHEYE security according to claim 1, it is characterised in that the step Suddenly（2）In, the relative density when relative density of each filtrate is 80 DEG C.
CN201610995291.1A 2016-11-11 2016-11-11 A kind of method for improving FUFANG DANGGUI ZHUSHEYE security Withdrawn CN107661369A (en)

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CN110339244A (en) * 2019-08-12 2019-10-18 段江琪 A kind of drug and preparation method for treating pain and rheumatism

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110339244A (en) * 2019-08-12 2019-10-18 段江琪 A kind of drug and preparation method for treating pain and rheumatism

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