CN107884529A - A kind of method and its application for determining fat emulsion formulation entrapment efficiency - Google Patents
A kind of method and its application for determining fat emulsion formulation entrapment efficiency Download PDFInfo
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Abstract
The present invention provides a kind of method for determining Fat Emulsion entrapment efficiency, the described method comprises the following steps：(1) weak-base anion-exchange resin is filled in column jecket, be dehydrated；(2) fat emulsion formulation of anion-containing medicine is added in column jecket, then eluted；(3) Fat Emulsion afforded is collected, the entrapment efficiency of fat emulsion formulation is calculated according to the dosage of the medicine of fat emulsion formulation before the content for the medicine being encapsulated in the fatty emulsion droplet afforded and elution.The method of the present invention solves the problems, such as that lipid emulsion droplet present in prior art and free drug separating degree are poor, measurement result is bigger than normal.This method degree of accuracy is high, reproducible, available for (the i.e. COO containing anion in the structures such as Alprostadil‑) medicine fat emulsion formulation formulation and technology research and quality control.
Description
Technical field
The invention belongs to Pharmaceutical Analysis technical field, is used to determine fat emulsion formulation entrapment efficiency more particularly to one kind
Method and this method in the encapsulated Fat Emulsion medicine of separation and the application in not encapsulated Fat Emulsion medicine.
Background technology
The method of measure fat emulsion formulation envelop rate mainly has following several at present：
First method is the envelop rate using ultrafiltration centrifugal determination fat emulsion formulation, and emulsion droplet is retained using milipore filter,
So as to be centrifuged out aqueous phase.Attempted during experiment using the super filter tube (3K, 5K, 10K) of Sai Duolisi and bohr measure Alprostadil liposome
The envelop rate of fat emulsion injection (its chemical constitution is as follows).But find in practice, different filter membranes is equal to Alprostadil
There is different degrees of suction-operated, that is to say, that the envelop rate of prostadil fatty emulsion injection is determined using this method to lead
Cause measurement result bigger than normal.
The chemical structural formula of Alprostadil is as follows：
Second method is the envelop rate using dialysis measure fat emulsion formulation.This method can handle larger amount of sample
Product, but larger amount of dialyzate and longer time are needed, and need constantly to change dialyzate.In addition, this method is uncomfortable
For being insoluble in the medicine of water.Inventor once using this method measure prostadil fatty emulsion injection envelop rate, but due to
The medicine specification (5 μ g/ml) is smaller, and is slightly soluble in water, it is necessary to give by free drug using substantial amounts of water, determines again afterwards
The concentration of free drug.Because the amount of dilution to free drug is very big, therefore using this round-about way measure envelop rate
When in the presence of certain limitation, the concentration of the Alprostadil in its dialyzate does not reach the test limit of liquid phase measurement.
The third method is the envelop rate using dextran microgel column measure drug-loaded liposome.Gathered by first removing Portugal
Water in sugared microgel column, then drug-loaded emulsion is loaded on dextran microgel column, centrifugation elution liposome；Then
Containing for the medicine that the total content concentration of medicine and dextran microgel column are encapsulated after eluting in drug-loaded emulsion is determined respectively
Concentration is measured, the total content concentration of medicine obtains in the content concn divided by Fat Emulsion of the medicine being encapsulated after glucan microtrabeculae is eluted
To the envelop rate of drug-loaded liposome.Inventor also once attempted to determine the encapsulating of prostadil fatty emulsion injection in this way
Rate, but when doing the Method validation of this method, find when using free Alprostadil loading, free Alprostadil
It is eluted, that is to say, that lipid emulsion droplet and free drug separating degree are poor, so can cause the measurement result of envelop rate not
Accurately.
The content of the invention
For problems of the prior art, the present invention provides a kind of side for determining fat emulsion formulation entrapment efficiency
Method, this method comprise the following steps：
(1) weak-base anion-exchange resin is filled in column jecket, be dehydrated；
(2) fat emulsion formulation of anion-containing medicine is added in column jecket, then eluted；
(3) collect the fatty emulsion droplet that affords, according to the medicament contg being encapsulated in the fatty emulsion droplet afforded with
And the drug dose of fat emulsion formulation calculates the entrapment efficiency in fat emulsion formulation before elution.
Calculation formula：
Preferably, in above-mentioned steps (1), the weak-base anion-exchange resin is DEAE Ago-Gels FF.
Preferably, in above-mentioned steps (1), the dehydration is centrifugal dehydration or vacuum suction dehydration.
Preferably, in above-mentioned steps (2), the anion-containing medicine is carboxylic medicine；It is it is highly preferred that described
The fat emulsion formulation of anion-containing medicine is alprostadil injection.
Preferably, in above-mentioned steps (2), the volume of the fat emulsion formulation for the anion-containing medicine being loaded into column jecket
For the 1%-100% of column volume, preferably 15%-25%.The fat emulsion formulation for the anion-containing medicine being loaded into column jecket
Volume cross conference and cause weak-base anion-exchange resin to overload, not encapsulated medicine is also eluted, and influences to separate
With measure effect.
Preferably, in above-mentioned steps (2), the elution is centrifugation elution or pressurization elution.It is highly preferred that the centrifugation
The condition of elution is the first centrifugation 1-10 minutes with 500-3000rpm, then carries out secondary elution with water；More preferably,
The condition of the centrifugation elution is the first centrifugation 2-8 minutes with 800-2000rpm, then carries out secondary elution with water；Enter
Preferably, the secondary elution is centrifugation elution or pressurization elution to one step；Still further preferably, the secondary elution carries out 1-
20 times, each water consumption is the 1-200%, preferably 10-50% of column volume.The number of secondary elution should not be excessive, otherwise removes
Cause beyond the Fat Emulsion for being encapsulated with medicine in column jecket is eluted, to also result in not encapsulated medicine and be also eluted down
Come, influence the accuracy of entrapment efficiency determination.
The method of the present invention is using the entrapment efficiency of weak-base anion-exchange resin post measure fat emulsion formulation, the party
Method contains anion (such as carboxy CO O suitable for chemical constitution-Deng) medicine, such as Alprostadil.Noted with Alprostadil
Penetrate exemplified by liquid, DEAE (diethyllaminoethyl) weak-base anion-exchange resin that this method uses can adsorb Alprostadil completely
The Alprostadil to dissociate in Fat Emulsion, and wrapped Alprostadil can quickly be eluted by water, with realizing free forefront
You are kept completely separate with wrapping up the lipid emulsion droplet of Alprostadil, so as to carry out the Accurate Determining of entrapment efficiency.
The method of the present invention solves that lipid emulsion droplet present in prior art and free drug separating degree be poor, measurement result
The problem of bigger than normal.This method degree of accuracy is high, reproducible, the fat available for the medicine containing anion in the structures such as Alprostadil
The formulation and technology research and quality control of fat emulsion formulation.
The present invention also provide it is a kind of by the fat emulsion formulation of anion-containing medicine be encapsulated medicine with it is not encapsulated
Medical separation method, this method comprises the following steps：
(a) weak-base anion-exchange resin is filled in column jecket, be dehydrated；
(b) fat emulsion formulation of anion-containing medicine is added in column jecket, then eluted, collect what is afforded
Fatty emulsion droplet.
Preferably, in above-mentioned steps (a), the weak-base anion-exchange resin exchanges for DEAE weakly-basic anions
Resin；It is highly preferred that the weak-base anion-exchange resin is DEAE Ago-Gels FF.
Preferably, in above-mentioned steps (a), the dehydration is centrifugal dehydration or vacuum suction dehydration.
Preferably, in above-mentioned steps (b), the anion-containing medicine is carboxylic medicine；It is it is highly preferred that described
The fat emulsion formulation of anion-containing medicine is alprostadil injection.
Preferably, in above-mentioned steps (b), the volume of the fat emulsion formulation for the anion-containing medicine being loaded into column jecket
For the 1%-100% of column volume, preferably 15%-25%.
Preferably, in above-mentioned steps (b), the elution is centrifugation elution or pressurization elution.It is highly preferred that the centrifugation
The condition of elution is the first centrifugation 1-10 minutes with 500-3000rpm, then carries out secondary elution with water；More preferably,
The condition of the centrifugation elution is the first centrifugation 2-8 minutes with 800-2000rpm, then carries out secondary elution with water；Enter
Preferably, the secondary elution is centrifugation elution or pressurization elution to one step；Still further preferably, the secondary elution carries out 1-
20 times, each water consumption is the 1-200%, preferably 10-50% of column volume.The number of secondary elution should not be excessive, otherwise removes
Cause beyond the Fat Emulsion for being encapsulated with medicine in column jecket is eluted, to also result in not encapsulated medicine and be also eluted down
Come, so as to influence the effect of separation.
Preferably, it is of the invention by the medicine being encapsulated in the fat emulsion formulation of anion-containing medicine and not encapsulated medicine
The method of thing separation is additionally included in after step (b), by medicament elution not encapsulated in column jecket.
The present invention also provides application of the weak-base anion-exchange resin in Fat Emulsion pharmaceutical preparation envelop rate is determined.It is excellent
Selection of land, the weak-base anion-exchange resin are DEAE weak-base anion-exchange resins；It is highly preferred that the alkalescent is cloudy
Ion exchange resin is DEAE Ago-Gels FF.
The present invention also provides weak-base anion-exchange resin quilt in the fat emulsion formulation for separating anion-containing medicine
The medicine of encapsulating and the application in not encapsulated medicine.Preferably, the weak-base anion-exchange resin is DEAE weak base
Property anion exchange resin；It is highly preferred that the weak-base anion-exchange resin is DEAE Ago-Gels FF.
Embodiment
Below by specific embodiment, the present invention will be described in more detail.Although it is directed to it should be appreciated that only listing
The embodiment of alprostadil injection, but in view of the property of weak-base anion-exchange resin in itself, method of the invention
Suitable for the fat emulsion formulation of other anion-containing medicines.
Embodiment 1
(1) DEAE weak-base anion-exchange resins are filled in 5ml syringe sleeves, centrifugal dehydration, form 5ml's
Dry post；
(2) alprostadil injection 1ml is loaded into syringe sleeve, 3 points is centrifuged with 1200rpm centrifugal speed
Clock；
(3) every time with 1ml water centrifugation elution, co-elute 7 times；The emulsion droplet eluted is collected into 10ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.Parallel test is three times, as a result as follows：
Embodiment 2
(1) DEAE weak-base anion-exchange resins are filled in 10ml syringe sleeves, centrifugal dehydration, form 10ml
Dry post；
(2) alprostadil injection 5ml is added in syringe sleeve, centrifuged 8 minutes with 2000rpm centrifugal speed；
(3) every time with 2ml water centrifugation elution, co-elute 5 times；The emulsion droplet eluted is collected into 20ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine, theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 3
(1) DEAE weak-base anion-exchange resins are filled in 50ml column jeckets, centrifugal dehydration, form the dry of 50ml
Post；
(2) alprostadil injection 1ml is added in column jecket, centrifuged 2 minutes with 3000rpm centrifugal speed；
(3) every time with 1ml water centrifugation elution, co-elute 20 times；The emulsion droplet eluted is collected into 25ml measuring bottles
And constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 4
(1) DEAE weak-base anion-exchange resins are filled in 100ml column jeckets, centrifugal dehydration, form the dry of 100ml
Post；
(2) alprostadil injection 1ml is added in column jecket, centrifuged 2 minutes with 500rpm centrifugal speed；
(3) every time with 1ml water centrifugation elution, co-elute 7 times；The emulsion droplet eluted is collected into 10ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 5
(1) DEAE weak-base anion-exchange resins are filled in 5ml column jeckets, centrifugal dehydration, form 5ml dry post；
(2) by alprostadil injection 0.5ml loadings, centrifuged 1 minute with 1500rpm centrifugal speed；
(3) every time with 4ml water centrifugation elution, co-elute 2 times；The emulsion droplet that collection elutes is transferred to 10ml measuring bottles
In and constant volume, measure obtain be encapsulated medicine content.Theoretical concentration alprostadil injection being diluted to after post, same to method
Measure, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 6
(1) DEAE weak-base anion-exchange resins are filled in 10ml column jeckets, centrifugal dehydration, form the dry of 10ml
Post；
(2) alprostadil injection 0.5ml is added in column jecket, centrifuged 5 minutes with 1000rpm centrifugal speed；
(3) every time with 0.5ml water centrifugation elution, co-elute 6 times；The emulsion droplet that collection elutes is transferred to 5ml amounts
In bottle and constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, together
Method determines, and then calculates the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 7
(1) DEAE weak-base anion-exchange resins are filled in 10ml column jeckets, centrifugal dehydration, form the dry of 10ml
Post；
(2) alprostadil injection 0.2ml is added in column jecket, with 2000rpm, centrifugal speed centrifuges 1 minute；
(3) every time with 0.2ml water centrifugation elution, co-elute 20 times；The emulsion droplet eluted is collected into 5ml measuring bottles
And constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 8
(1) DEAE weak-base anion-exchange resins are filled in 3ml column jeckets, centrifugal dehydration, form 3ml dry post；
(2) alprostadil injection 1ml is added in column jecket, centrifuged 2 minutes with 800rpm centrifugal speed；
(3) every time with 1ml water centrifugation elution, co-elute 8 times；The emulsion droplet eluted is collected into 10ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 9
(1) DEAE weak-base anion-exchange resins are filled in 5ml column jeckets, centrifugal dehydration, form 5ml dry post；
(2) alprostadil injection 2.5ml is added in column jecket, centrifuged 3 minutes with 1000rpm centrifugal speed；
(3) every time with 1ml water centrifugation elution, co-elute 7 times；The fatty emulsion droplet eluted is collected into 10ml measuring bottles
In and constant volume, measure obtain be encapsulated medicine content.Theoretical concentration alprostadil injection being diluted to after post, same to method
Measure, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Embodiment 10
(1) DEAE weak-base anion-exchange resins are filled in 4ml column jeckets, centrifugal dehydration, form 4ml dry post；
(2) alprostadil injection 1ml is added in column jecket, centrifuged 10 minutes with 500rpm centrifugal speed；
(3) every time with 8ml water centrifugation elution, co-elute 1 time；The emulsion droplet eluted is collected into 25ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.
Parallel test is three times, as a result as follows：
Comparative example 1 (dextran microgel column method)
(1) G50 sephadexes are filled in 5ml syringe sleeves, centrifugal dehydration, form 5.5ml dry post；
(2) alprostadil injection 0.5ml is loaded into syringe sleeve, 2 points is centrifuged with 1200rpm centrifugal speed
Clock；
(3) every time with 1ml water centrifugation elution, co-elute 2 times；The emulsion droplet eluted is collected into 5ml measuring bottles simultaneously
Constant volume, measure obtain being encapsulated the content of medicine.Theoretical concentration alprostadil injection being diluted to after post, surveyed with method
It is fixed, then calculate the envelop rate of alprostadil injection.Parallel test is three times, as a result as follows：
It can be seen that the envelop rate for filling to obtain with G50 sephadexes is lower.Method has been carried out with this G50 sephadex
Learn and investigate.Conclusion is：The independent loading of free drug, washing steps are slightly more, and free drug can be eluted, and as a result can cause to wrap
Envelope rate measurement result is higher.Thus, in order to control effective combination of free drug and pillar, reduce water washing time, but lead
The emulsion droplet rate of recovery is caused to decline, thus the measurement result of envelop rate is relatively low.Therefore compared with G50 sephadexes, DEAE anion
Exchanger resin has more preferable.
Comparative example 2 (ultrafiltration centrifugal process)
(1) alprostadil injection 0.5ml is added in 100k ultra-filtration centrifuge tubes, after trim rotor, 18000G centrifugations 20
Minute；
(2) aqueous solution for taking ultra-filtration centrifuge tube lower floor to filter directly determines.
Experiment is three times, as a result as follows：
It can be seen that the envelop rate obtained with ultrafiltration centrifugal process is very high.Methodological study, conclusion have been carried out to ultrafiltration centrifugal process
For：The free drug aqueous solution (micro ethanol hydrotropy) is centrifuged with different pore size material super filter tube, and free drug has absorption and made
With adsorption rate minimum 40% or so.Part free drug will not be eluted, and as a result cause entrapment efficiency determination result inclined
Height, influence the accuracy of result.Therefore compared with ultrafiltration centrifugal process, DEAE anion exchange resin has more preferable.
Claims (10)
1. a kind of method for determining fat emulsion formulation entrapment efficiency, the described method comprises the following steps：
(1) weak-base anion-exchange resin is filled in column jecket, be dehydrated；
(2) fat emulsion formulation of anion-containing medicine is added in column jecket, then eluted；
(3) Fat Emulsion afforded is collected, according to the content for the medicine being encapsulated in the fatty emulsion droplet afforded and is washed
The dosage of the medicine of fat emulsion formulation calculates the entrapment efficiency of fat emulsion formulation before de-；
Preferably, the weak-base anion-exchange resin is DEAE weak-base anion-exchange resins, more preferably DEAE fine jades
Sepharose FF；
Preferably, in step (1), the dehydration is centrifugal dehydration or vacuum suction dehydration；
Preferably, in step (2), the fat emulsion formulation of the anion-containing medicine is alprostadil injection；
Preferably, in step (2), the volume of the fat emulsion formulation for the anion-containing medicine being loaded into column jecket is column volume
1%-100%, preferably 15%-25%.
2. according to the method for claim 1, it is characterised in that in step (2), the elution is centrifugation elution or pressurization
Elution.
3. according to the method for claim 2, it is characterised in that the condition of the centrifugation elution is first with 500-3000rpm
Centrifugation 1-10 minutes, then carry out secondary elution with water；It is highly preferred that the condition of the centrifugation elution is first with 800-
2000rpm centrifugation 2-8 minutes, then carry out secondary elution with water.
4. according to the method for claim 3, it is characterised in that the secondary elution is centrifugation elution or pressurization elution；It is excellent
Selection of land, the secondary elution are carried out 1-20 times, and each water consumption is the 1-200%, more preferably 10-50% of column volume.
It is 5. a kind of by the medicine being encapsulated in the fat emulsion formulation of anion-containing medicine and not encapsulated medical separation
Method, this method comprise the following steps：
(a) weak-base anion-exchange resin is filled in column jecket, be dehydrated；
(b) fat emulsion formulation of anion-containing medicine is added in column jecket, then eluted, collect the fat afforded
Emulsion droplet；
Preferably, in step (a), the weak-base anion-exchange resin is DEAE weak-base anion-exchange resins；More
Preferably, the weak-base anion-exchange resin is DEAE Ago-Gels FF.
Preferably, in step (a), the dehydration is centrifugal dehydration or vacuum suction dehydration；
Preferably, in step (b), the fat emulsion formulation of the anion-containing medicine is alprostadil injection；
Preferably, in step (b), the volume of the fat emulsion formulation for the anion-containing medicine being loaded into column jecket is column volume
1%-100%；Preferably 15%-25%.
6. according to the method for claim 5, it is characterised in that in above-mentioned steps (b), it is described elution for centrifugation elution or
Pressurization elution.
7. according to the method for claim 5, it is characterised in that the condition of the centrifugation elution is first with 500-3000rpm
Centrifugation 1-10 minutes, then carry out secondary elution with water；Preferably, the condition of the centrifugation elution is first with 800-
2000rpm centrifugation 2-8 minutes, then carry out secondary elution with water；It is highly preferred that the secondary elution is centrifugation elution
Or pressurization elution；More preferably, the secondary elution is carried out 1-20 times, and each water consumption is the 1-200% of column volume, is preferably
10-50%.
8. according to the method for claim 5, it is characterised in that methods described is additionally included in after step (b), by column jecket
Not encapsulated medicament elution.
9. weak-base anion-exchange resin answering in the entrapment efficiency of fat emulsion formulation of anion-containing medicine is determined
With；Preferably, the weak-base anion-exchange resin is DEAE weak-base anion-exchange resins；It is it is highly preferred that described weak
Alkalescence anion-exchange resin is DEAE Ago-Gels FF.
10. the medicine that weak-base anion-exchange resin is encapsulated in the fat emulsion formulation for separating anion-containing medicine with not
Application in encapsulated medicine；Preferably, the weak-base anion-exchange resin is that DEAE weakly-basic anions exchange tree
Fat；It is highly preferred that the weak-base anion-exchange resin is DEAE Ago-Gels FF.
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| CN107884529B (en) | 2020-12-08 |
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