CN107970294A - A kind of preparation method of Maxingshigan injecta - Google Patents
A kind of preparation method of Maxingshigan injecta Download PDFInfo
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Abstract
The invention belongs to technical field of traditional Chinese medicine pharmacy, specifically discloses a kind of preparation method of Maxingshigan injecta, and main constituents are:Each material in mass, 400~600 parts of gypsum, 400~600 parts of Chinese ephedra, 400~600 parts of semen armeniacae amarae, 400~600 parts of radix glycyrrhizae;First take the Chinese ephedra of crushing, semen armeniacae amarae, three taste medicinal material of radix glycyrrhizae to add water ultrasonic, it is rear add the gypsum crushed and close decoct, filtration, merging filtrate;It is concentrated under reduced pressure, adds fining agent, stirs, refrigeration;Centrifugation, supernatant are concentrated under reduced pressure, filtrate dosing activated carbon decolorizing, refrigeration, Tween 80 are added under stirring condition, propane diols, injects water to 1000ml, embedding, sterilizing, you can.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, and in particular to a kind of Maxingshigan injecta for animals and its preparation side
Method.
Technical background
Maxingshigan prescription is a kind of traditional prescriptions of traditional Chinese medicine, from Han dynasty Zhang Zhongjing《The Treatise on Fevrile Diseases》, by Chinese ephedra, hardship
Almond, radix glycyrrhizae, gypsum etc. form, have it is pungent it is cool lead off, clearing lung, relieving asthma the effect of, cure mainly the flourishing pneumonia of lung heat and heat evil and violate
The asthma of lung.Clinical practice verification through centuries, this side is used to prevent people and animals' breathing problem, curative for effect, safe and non-toxic
Side effect, but there are the problems such as Chinese medicine is bitter to the taste, administration is inconvenient.
At present, field of veterinary there is Maxingshigan to dissipate, Maxingshigan piece, Maxingshigan oral liquid, Maxingshigan particle with fiber crops
The special livestock formulations such as the sweet parenteral solution of apricot stone, wherein, 2015 editions《Chinese veterinary pharmacopoeia》Two include be used for horse, ox, sheep, pig, rabbit,
The traditional Chinese medicine powder Maxingshigan of fowl lung heat cough and asthma dissipate with conventional tablet Maxingshigan piece, by Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, stone
Cream four traditional Chinese medicine material directly crushes preparation, acrid flavour, hardship, puckery, and palatability is poor;《Provincial standard rises national standard》Second receipts
Maxingshigan particle, Maxingshigan oral liquid and the Maxingshigan injecta of record are by Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum
What four traditional Chinese medicine material was prepared through decocting, for chicken lung heat cough and asthma, although can effectively improve palatability, due to the activity of Chinese medicine
Component by cell membrane due to being wrapped up, the shortcomings that traditional decoction extraction method main active recovery rate is low.
The content of the invention
For the shortcoming of existing extraction process, the present invention provides one kind improve palatability, improve chief active into
The preparation method of the Maxingshigan injecta of point recovery rate, solves that traditional powder, the palatability of tablet be poor and existing particle
The problem of agent, oral liquid, low parenteral solution recovery rate.Invention is used first to be ultrasonically treated and decocted afterwards, and ZTC1+1 then will be used natural
The method of fining agent removal of impurities, solves the problems such as existing extraction process recovery rate is low, product quality is bad, and simple process is easy,
Beneficial to industrialized production.
A kind of Maxingshigan injecta for animals of the present invention and preparation method thereof, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum crush, sieving for standby;
(2) extract:In terms of mass fraction, 400~600 parts of step (1) epheday intermedia, 400~600 parts of semen armeniacae amarae, radix glycyrrhizae are taken
400~600 parts, three taste medicinal materials press solid-liquid ratio 1:8~16, which add water, is ultrasonically treated, and rear 400~600 parts of the land plaster that adds decocts 2
~3 times, 1~2h, filtration, merging every time obtains extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure to obtain concentrate, 55~75 DEG C of whens add concentrate
The ZTC1+1 natural clarifying agent component A solution of volume 2%~8%, component A concentration of polymer solution are 0.25%~1%, stirring
Time is 10~30min, adds the ZTC1+1 natural clarifying agent B component solution of the volume of the concentrated liquid 1%~4%, and B component is molten
Liquid mass concentration is 0.25%~1%, and mixing time is 10~30min, and 10~14h of refrigeration must refrigerate liquid;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant to be concentrated under reduced pressure
To every 1mL concentrates 3~5g containing crude drug amount, decoloration, refrigerates 22~24h, adds Tween-80 under stirring condition, propane diols, adds
Enter water for injection, embedding, sterilizing, up to Maxingshigan injecta.
Compared with prior art, the advantage of the invention is that:
1. first being decocted after ultrasound, the unique extreme physical characteristic of ultrasonic wave, can promote plant tissue broken wall or deformation, make
Effective components of Chinese medicinal extraction is more abundant, improves recovery rate;
It is natural clear 2. the fining agent ZTC1+1 models II~IV that the present invention selects, are made of A and two components of B
Agent, it is safe without particular/special requirement, noresidue to solution ph in use.Clarification rate of flocculating is up to more than 90%;
3. using ZTC1+1 natural clarifying agents processing rear decoloring, the clarity of solution can be improved, while avoid former method second
The problems such as dissolvent residual, removal of impurities are not thorough in alcohol removal of impurities;
4. replacing ethanol to carry out purification and impurity removal using natural clarifying agent, the consumption of organic solvent is avoided, it is cost-effective.
Every 1 ton of crude drug is only cost with 600~800 yuan.
5. method is easy, easily promotes, greatly improve the efficiency, and simple process and be easy to be amplified to industrialized production,
Raw material availability can be greatly improved at the same time.
Embodiment
A kind of Maxingshigan injecta for animals of the present invention and preparation method thereof, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum crush, sieving for standby;
(2) extract:In terms of mass fraction, 400~600 parts of step (1) epheday intermedia, 400~600 parts of semen armeniacae amarae, radix glycyrrhizae are taken
400~600 parts, three taste medicinal materials press solid-liquid ratio 1:8~16, which add water, is ultrasonically treated, and rear 400~600 parts of the land plaster that adds decocts 2
~3 times, 1~2h, filtration, merging every time obtains extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure to obtain concentrate, 55~75 DEG C of whens add concentrate
The ZTC1+1 natural clarifying agent component A solution of volume 2%~8%, component A concentration of polymer solution are 0.25%~1%, stirring
Time is 10~30min, adds the ZTC1+1 natural clarifying agent B component solution of the volume of the concentrated liquid 1%~4%, and B component is molten
Liquid mass concentration is 0.25%~1%, and mixing time is 10~30min, and 10~14h of refrigeration must refrigerate liquid;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant to be concentrated under reduced pressure
To every 1mL concentrates 3~5g containing crude drug amount, decoloration, refrigerates 22~24h, adds Tween-80 under stirring condition, propane diols, adds
Enter water for injection, embedding, high pressure or flowing steam sterilization, up to Maxingshigan injecta.
Removing of the conventional alcohol precipitation impurity removal process for impurity is more general, does not possess specific aim, is removing various impurity
While amino acid, polypeptide, polysaccharide of needs etc. also been removed beneficial to component.Fining agent high selectivity, but due to impuritiess
The complexity and diversity of type, inappropriate fining agent can not play good impurity removal effect, and the present invention is using ultrasound
Step promotes plant tissue broken wall or deformation, extracts effective components of Chinese medicinal more abundant, impurity is mainly in the system after ultrasound
Tannin, protein, with reference to ZTC natural clarifying agents, are effectively removed for tannin, protein, realize to only having to impurity
Effect is removed and retained beneficial to component, while can remove the colloidal substance in extracting solution, is separated beneficial to subsequent filter, is finally carried
The stability of high injection, and ephedrine hydrochloride retention rate improves more than 30% compared with traditional handicraft.
Preferably, it is 40~100 mesh that step (1) epheday intermedia, semen armeniacae amarae, radix glycyrrhizae, gypsum, which are crushed to granularity, is used in combination
500 mesh food-grade filter clothes wrap up.
Preferably, a length of 1~2h when being ultrasonically treated in step (2).
Preferably, extracting solution is concentrated under reduced pressure into quality and volume ratio (is counted) using crude drug as 1g in step (3):4~10ml;Step
Suddenly ZTC1+1 natural clarifying agents model II~IV in (3).
Preferably, the ratio between the addition quality of Tween-80 and the volume of the concentrated liquid described in step (4) are 0.02~0.08g/
The ratio between mL, the addition quality and the volume of the concentrated liquid of the propane diols is 0.02~0.08g/mL.
Preferably, step (4) decoloration uses dosing activated carbon decolorizing, and the sterilizing is steamed using high pressure or circulation
Vapour sterilizes.
For the ease of understanding the present invention, present invention work more comprehensively, is meticulously described below in conjunction with embodiment, but this
The protection domain of invention is not limited to embodiment in detail below.
Unless otherwise defined, all technical terms used hereinafter with those skilled in the art are normally understood contains
Justice is identical.Technical term used herein is intended merely to the purpose of description specific embodiment, is not intended to and limits this hair
Bright protection domain.
Unless otherwise specified, various raw material, reagent, the instrument and equipment etc. used in the present invention can pass through
Market is commercially available or can be prepared by existing method.
Raw material sources:ZTC1+1 natural clarifying agents model II~IV used in following embodiments, purchased from the positive day in Beijing into
Clarification technique Co., Ltd, wherein component A are white powder particle, and B component is faint yellow or white powder.Preparation method:
Component A solution:White powder particle, adds water stirring that the solution that concentration is 5wt% is made (when swelling 24 is small) standby
With.
B component solution:Faint yellow or white powder, first plus water stirs, and then adds the glacial acetic acid (matter used in glacial acetic acid
Amount is identical with fining agent B component powder) it is stirred for, when swelling 24 is small, the solution for standby that B component concentration is 1wt% is made.
Spare component A and B component solution is diluted with water to obtain required concentration in use.
Embodiment 1
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 40,60,40,80 mesh,
Gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 400g, semen armeniacae amarae 600g, radix glycyrrhizae 500g, three taste medicines are taken
Material presses solid-liquid ratio 1:8, which add water, is ultrasonically treated 2h, and rear 500 parts of the land plaster that adds decocts 2 times, each 2h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
4ml, the II type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 2%, component A solution quality are added at 75 DEG C
Percentage concentration is 0.25%, mixing time 30min, adds the II type B of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 4%
Component solution, B component solution quality percentage concentration are 1%, mixing time 10min, refrigerate 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 3g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 2% times of quality of body volume, the propane diols of 4% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, flowing steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 0.61mg/ml.
Embodiment 2
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 60,60,80,100
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 500g, semen armeniacae amarae 500g, radix glycyrrhizae 600g, three taste medicines are taken
Material presses solid-liquid ratio 1:12, which add water, is ultrasonically treated 1h, and rear 400 parts of the land plaster that adds decocts 3 times, each 1h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
6ml, the III type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 8%, component A solution quality are added at 75 DEG C
Percentage concentration is 0.5%, mixing time 10min, adds the III type B groups of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 2%
Divide solution, B component solution quality percentage concentration is 0.75%, mixing time 10min, refrigerates 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 5g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 8% times of quality of body volume, the propane diols of 2% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, high pressure steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 0.95mg/ml.
Embodiment 3
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 80,60,100,40
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 600g, semen armeniacae amarae 400g, radix glycyrrhizae 400g, three taste medicines are taken
Material presses solid-liquid ratio 1:16, which add water, is ultrasonically treated 1h, and rear 600 parts of the land plaster that adds decocts 2 times, each 2h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
8ml, the II type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 4%, component A solution quality are added at 55 DEG C
Percentage concentration is 0.75%, mixing time 30min, adds the II type B of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 2%
Component solution, B component solution quality percentage concentration are 0.25%, mixing time 30min, refrigerate 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 4g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 2% times of quality of body volume, the propane diols of 4% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, high pressure steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 1.63mg/ml.
Embodiment 4
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 100,60,80,60
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 400g, semen armeniacae amarae 500g, radix glycyrrhizae 500g, three taste medicines are taken
Material presses solid-liquid ratio 1:8, which add water, is ultrasonically treated 2h, and rear 600 parts of the land plaster that adds decocts 3 times, each 2h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
10ml, the II type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 4%, component A solution matter are added at 75 DEG C
It is 1%, mixing time 20min to measure percentage concentration, adds the II type B groups of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 4%
Divide solution, B component solution quality percentage concentration is 0.5%, mixing time 10min, refrigerates 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 3g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 4% times of quality of body volume, the propane diols of 4% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, flowing steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 1.75mg/ml.
Embodiment 5
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 40,60,80,60 mesh,
Gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 500g, semen armeniacae amarae 600g, radix glycyrrhizae 400g, three taste medicines are taken
Material presses solid-liquid ratio 1:16, which add water, is ultrasonically treated 1h, and rear 500 parts of the land plaster that adds decocts 3 times, each 2h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
6ml, the III type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 6%, component A solution quality are added at 75 DEG C
Percentage concentration is 1%, mixing time 30min, adds the III type B component of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 3%
Solution, B component solution quality percentage concentration are 1%, mixing time 20min, refrigerate 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 5g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 2% times of quality of body volume, the propane diols of 2% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, high pressure steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 1.12mg/ml.
Embodiment 6
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 60,100,80,80
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 600g, semen armeniacae amarae 600g, radix glycyrrhizae 400g, three taste medicinal materials are taken
By solid-liquid ratio 1:12, which add water, is ultrasonically treated 2h, and rear 400 parts of the land plaster that adds decocts 2 times, each 2h, and filtration, merging is carried
Take liquid;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
4ml, the III type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 4%, component A solution quality are added at 55 DEG C
Percentage concentration is 0.75%, mixing time 30min, adds the III type B of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 1%
Component solution, B component solution quality percentage concentration are 0.75%, mixing time 10min, refrigerate 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 3g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 4% times of quality of body volume, the propane diols of 3% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, flowing steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 0.71mg/ml.
Embodiment 7
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 80,60,40,100
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 500g, semen armeniacae amarae 600g, radix glycyrrhizae 400g, three taste medicines are taken
Material presses solid-liquid ratio 1:8, which add water, is ultrasonically treated 1h, and rear 500 parts of the land plaster that adds decocts 3 times, each 1h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
8ml, the IV type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 8%, component A solution quality are added at 75 DEG C
Percentage concentration is 0.5%, mixing time 10min, adds the IV type B groups of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 2%
Divide solution, B component solution quality percentage concentration is 0.5%, mixing time 20min, refrigerates 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 5g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 2% times of quality of body volume, the propane diols of 4% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, high pressure steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 1.91mg/ml.
Embodiment 8
A kind of Maxingshigan injecta for animals and preparation method thereof is present embodiments provided, step is as follows:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum are crushed and sieved, respectively into 100,60,80,40
Mesh, gypsum is wrapped up with 500 mesh food-grade filter clothes, spare;
(2) extract:In terms of mass fraction, step (1) epheday intermedia 500g, semen armeniacae amarae 500g, radix glycyrrhizae 500g, three taste medicines are taken
Material presses solid-liquid ratio 1:12, which add water, is ultrasonically treated 2h, and rear 500 parts of the land plaster that adds decocts 2 times, each 2h, and filtration, merging obtains
Extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure into quality volume ratio (is counted) using crude drug as 1g:
10ml, the II type component A solution of ZTC1+1 natural clarifying agents of concentrate liquid volume 4%, component A solution matter are added at 55 DEG C
It is 0.5%, mixing time 30min to measure percentage concentration, adds the II type B of ZTC1+1 natural clarifying agents of the volume of the concentrated liquid 2%
Component solution, B component solution quality percentage concentration are 1%, mixing time 10min, refrigerate 12h;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant, decompression is dense
It is reduced to quality and volume ratio (is counted) using crude drug as 4g:1ml, adds medical active carbon decoloring, refrigerates 24h, liquid is added under stirring condition
The Tween-80 of 8% times of quality of body volume, the propane diols of 8% times of quality of liquid volume, adds water for injection to 1000ml, fills
Envelope, high pressure steam sterilization, to obtain the final product.According to《Provincial standard rises national standard》Second Maxingshigan injecta assay
Method, Determination of ephedrine hydrochloride 2.27mg/ml.
Embodiment 9
By recovery rate, impurity-eliminating effect, the extracting solution of 1 extraction process of embodiment and traditional handicraft and other existing process
Stability, extracting solution active principle etc. have carried out contrast experiment, and experimental result is as follows.
(1) result is extracted:《Provincial standard rises national standard》Second (traditional handicraft) is made with the embodiment of the present invention 1
Extracting method recovery rate is shown in Table 1 in standby technique.
1 Different Extraction Method recovery rate of table compares
(2) impurity-eliminating effect:《Provincial standard rises national standard》(Anhui Lu Rong gives birth to for second (traditional handicraft), chitosan
Thing Science and Technology Ltd.), it is prepared by 101 fruit juice clarifiers (Anhui Lu Rong bio tech ltd) and the embodiment of the present invention 1
Impurity-removing method impurity-eliminating effect is shown in Table 2 in technique.
The different impurity-removing method impurity-eliminating effects of table 2 compare
(3) parenteral solution stability:Influence of the different cosolvents to parenteral solution stability is shown in Table 3.
Influence of the different cosolvents of table 3 to parenteral solution stability
(4) parenteral solution detects:According to《Provincial standard rises national standard》The detection side of second Maxingshigan injecta
Method, Different Preparation testing result are shown in Table 4.
The testing result of 4 Different Preparation of table
As shown in Table 1, first extracted after ultrasound, the embodiment of the present invention 1 improves 29.22% compared with traditional handicraft recovery rate;By
Table 2 is understood, is improved in the embodiment of the present invention 1 using fining agent ZTC1+1 removal of impurities ephedrine hydrochloride retention rates compared with traditional handicraft
30.02%;As shown in Table 3, the embodiment of the present invention 1 using Tween-80, that mixed with propylene glycol use helps to improve parenteral solution is steady
It is qualitative;As shown in Table 4, Maxingshigan injecta preparation process active principle ephedrine hydrochloride used by the embodiment of the present invention 1
Content improve 0.30mg/mL compared with traditional handicraft.
Claims (6)
1. a kind of preparation method of Maxingshigan injecta, including:
(1) raw material pre-treatment:Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum crush, sieving for standby;
(2) extract:In terms of mass fraction, 400~600 parts of step (1) epheday intermedia is taken, 400~600 parts of semen armeniacae amarae, radix glycyrrhizae 400~
600 parts, three taste medicinal materials press solid-liquid ratio 1:8~16, which add water, is ultrasonically treated, rear to add the decoction 2~3 times of 400~600 parts of gypsum, often
Secondary 1~2h, filtering, merging obtain extracting solution;
(3) concentration and removal:Extracting solution in step (2) is concentrated under reduced pressure to obtain concentrate, 55~75 DEG C of whens add the volume of the concentrated liquid
2%~8% ZTC1+1 natural clarifying agent component A solution, component A concentration of polymer solution are 0.25%~1%, and mixing time is
10~30min, adds the ZTC1+1 natural clarifying agent B component solution of the volume of the concentrated liquid 1%~4%, and B component solution quality is dense
Spend for 0.25%~1%, mixing time is 10~30min, and 10~14h of refrigeration must refrigerate liquid;
(4) prepared by concentration, parenteral solution:By refrigeration liquid centrifugation in step (3), sediment is removed, takes supernatant to be concentrated under reduced pressure into often
1mL concentrates 3~5g containing crude drug amount, decoloration, refrigerates 22~24h, Tween-80 is added under stirring condition, propane diols, adds injection
With water, embedding, sterilizing, up to Maxingshigan injecta.
A kind of 2. preparation method of Maxingshigan injecta as claimed in claim 1, it is characterised in that:Described in step (1)
It is 40~100 mesh that Chinese ephedra, semen armeniacae amarae, radix glycyrrhizae, gypsum, which are crushed to granularity, and is wrapped up with 500 mesh food-grade filter clothes.
A kind of 3. preparation method of Maxingshigan injecta as claimed in claim 1, it is characterised in that:Described in step (2)
A length of 1~2h during supersound process.
A kind of 4. preparation method of Maxingshigan injecta as claimed in claim 1, it is characterised in that:Extraction in step (3)
Liquid is concentrated under reduced pressure into every 4~10mL concentrates 1g containing crude drug amount;ZTC1+1 natural clarifying agents model II~IV in step (3).
A kind of 5. preparation method of Maxingshigan injecta as claimed in claim 1, it is characterised in that:Described in step (4)
The ratio between addition quality and the volume of the concentrated liquid of Tween-80 are 0.02~0.08g/mL, and the addition quality of the propane diols is with concentrating
The ratio between liquid product is 0.02~0.08g/mL.
A kind of 6. preparation method of Maxingshigan injecta as claimed in claim 1, it is characterised in that:Step (4) is described de-
Color uses dosing activated carbon decolorizing, and the sterilizing uses high pressure or flowing steam sterilization.
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CN114588659A (en) * | 2022-04-02 | 2022-06-07 | 慈诺中医药科技(山东)集团有限公司 | Method for extracting micromolecular nondestructive traditional Chinese medicine |
CN116115676A (en) * | 2022-12-01 | 2023-05-16 | 湖州市中医院 | Traditional Chinese medicine composition for relieving asthma acute attack and verification method thereof |
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CN101843682A (en) * | 2010-06-08 | 2010-09-29 | 江西中成药业集团有限公司 | Maxingshigan injecta and preparation method thereof |
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CN101843682A (en) * | 2010-06-08 | 2010-09-29 | 江西中成药业集团有限公司 | Maxingshigan injecta and preparation method thereof |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN114588659A (en) * | 2022-04-02 | 2022-06-07 | 慈诺中医药科技(山东)集团有限公司 | Method for extracting micromolecular nondestructive traditional Chinese medicine |
CN116115676A (en) * | 2022-12-01 | 2023-05-16 | 湖州市中医院 | Traditional Chinese medicine composition for relieving asthma acute attack and verification method thereof |
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