CN106109845B - For treating the Resina Draconis spray and its inspection and preparation method of pressure sore - Google Patents
For treating the Resina Draconis spray and its inspection and preparation method of pressure sore Download PDFInfo
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Abstract
The present invention relates to a kind of Resina Draconis sprays and preparation method thereof for treating pressure sore.The Resina Draconis spray includes dragon's blood extract, the PVP K30 as film forming agent, second alcohol and water etc..Said preparation dosage form is simple, easy-to-use, and bioavilability is high, has significant therapeutic effect for pressure sore.For treating the method for inspection of the Resina Draconis spray of pressure sore, this method is simple the present invention relates to a kind of, convenient, has preferable operability, can with accurate detection and control treatment pressure sore Resina Draconis spray quality.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine preparation, and in particular to a kind of Resina Draconis spray for treating pressure sore and its
Inspection and preparation method.
Background technique
Resina Draconis is the resin constituents that swordleaf dragon tree generates under the influence of certain factors, restrains myogenic definite effect.
It is recorded in the ancient books such as " Liu Juanzi Guiyi Fang, Liu Juanzi ", Golden Mirror of Medicine in the myogenic class recipe for treating wound mouth of bursting, Resina Draconis
Frequency of use highest.In modern clinical practice, Resina Draconis is also frequently utilized for ulcer caused by a variety of diseases, Resina Draconis and its
His antibacterials or physical therapy means share the cure rate that can greatly improve pressure sore.But Resina Draconis is in clinical treatment and nursing
In application mode it is but more original, be generally modulated into paste using physiological saline, vinegar, honey or alcohol or directly to dissipate
The form of agent is overlying on the surface of a wound.This usage mode becomes easily infected by clothing, sheet etc. over the course for the treatment of, leads to the stream of drug
It loses；Cause in wrapping that patient's is handicapped using medical dressing, secondary injury is caused to the surface of a wound when replacing drug.In addition to
Disadvantages mentioned above, Resina Draconis is not soluble in water, and low bioavilability is also to influence its important limitation used.
Therefore, to solve the above-mentioned problems, it is simple, easy-to-use to need to research and develop a kind of dosage form, and bioavilability
The high dragon's blood medicine preparation for being used to treat pressure sore.
Summary of the invention
An object of the present invention be in view of the problems of the existing technology provide it is a kind of for treating the Resina Draconis of pressure sore
Spray.This preparation formulation is simple, easy-to-use, and bioavilability is high.
It is a kind of for treating the method for inspection of the Resina Draconis spray of pressure sore the second object of the present invention is to provide, utilize this
Method can preferably control the quality of the Resina Draconis spray for the treatment of pressure sore.
The third object of the present invention is to provide a kind of for treating the preparation method of the Resina Draconis spray of pressure sore.
For this purpose, the present invention provides first aspect provide it is a kind of for treating the Resina Draconis spray of pressure sore, it includes
Dragon's blood extract, film forming agent, second alcohol and water.
In the present invention, the preferably described film forming agent is PVP K30.
In some embodiments of the invention, in the spray, by the total weight of spray, dragon's blood extract
Content be 0.6wt%-3wt%.
In other embodiments of the invention, in the spray, by the total weight of spray, the film forming
The content of agent is 2wt%-8wt%；It is preferred that the content of the film forming agent is 4wt%-8wt%.
In other embodiment of the invention, in the spray, by the total volume meter of spray, the ethyl alcohol
Content is 60v%-80v%.
According to the present invention, also contain bacteriostatic agent in the spray.
In some embodiments of the invention, in the spray, by the total weight of spray, the content of bacteriostatic agent
For 0.5wt%-4.5wt%.
In the present invention, the bacteriostatic agent includes one or more of gluconic acid chlorhexidine, benzalkonium bromide and glutaraldehyde.
It according to the present invention, further include the ingredient that relieves the pain in the spray.
In some embodiments of the invention, in the spray, by the total weight of spray, the ingredient that relieves the pain
Content be 0.1wt%-1.0wt%.
In the present invention, the ingredient that relieves the pain includes one or more of borneol, menthol and eucalyptus oil.
Second aspect of the present invention provides the method for inspection of spray described in first aspect present invention, uses efficient liquid phase
Chromatography identifies sample to be tested, including uses photodiode array detector and WatersC18 chromatographic column, with second
Nitrile: triethylamine-phosphate buffer is mobile phase, carries out gradient elution to sample to be tested in the case where wavelength is 259nm and/or 275nm,
And the high-efficient liquid phase chromatogram of sample to be tested is inspected using the finger-print of Resina Draconis spray as control.
According to the method for the present invention, when in the high performance liquid chromatography of sample to be tested in the finger-print phase with Resina Draconis spray
Identical characteristic absorption peak is shown on the position answered, then illustrates that sample to be tested is Resina Draconis spray.
In some embodiments of the invention, the characteristic absorption peak appears in 4.220,5.665,10.500,14.311
And at 16.033 minutes.
In other embodiments of the invention, the condition of the gradient elution are as follows: flow velocity 0.6-1.0mL/min, into
Sample amount is 5-10 μ L.
In the present invention, the pH value of preferable mobile phase is 3.2-5.0.
Third aspect present invention provides a kind of preparation method of spray described in first aspect present invention comprising:
Resina Draconis solution is mixed with film forming agent solution, Resina Draconis spray precursor mixture is made by step C；
Distilled water is added into Resina Draconis spray precursor mixture, Resina Draconis spray is made after mixing by step D；
Wherein, the Resina Draconis solution is the ethanol solution of Resina Draconis；The film forming agent solution is that the ethyl alcohol of film forming agent is molten
Liquid.
According to the present invention, in the Resina Draconis spray precursor mixture, the Resina Draconis solution and film forming agent solution
Volume ratio be (1-3): 1.
In some embodiments of the invention, the concentration of dragon's blood extract is 120-150mg/ in the Resina Draconis solution
mL。
In other embodiments of the invention, the concentration of film forming agent is 5%-10% (w/v) in the agent solution that forms a film.
In some embodiments of the invention, in the Resina Draconis spray, by the total weight of spray, Resina Draconis
The content of extract is 0.6wt%-3wt%.
In some embodiments of the invention, in the Resina Draconis spray, by the total weight of spray, it is described at
The content of film is 2wt%-8wt%；It is preferred that the content of the film forming agent is 4wt%-8wt%.
In some embodiments of the invention, in the Resina Draconis spray, by the total volume meter of spray, the second
The content of alcohol is 60v%-80v%.
Detailed description of the invention
Illustrate the present invention below in conjunction with attached drawing.
Fig. 1 shows the fingerprint image spectrogram of Resina Draconis film spray in the present invention.
Fig. 2 shows gluconic acid chlorhexidine standard items ultra performance liquid chromatography figures.
Fig. 3 shows Resina Draconis standard items ultra high efficiency liquid liquid chromatogram.
Fig. 4 shows each group rat pressure sore wound healing situation after the experiment of Resina Draconis film aerosol therapy pressure sore rat model.
Specific embodiment
To be readily appreciated that the present invention, the present invention is described more detail below.
As previously mentioned, Resina Draconis is more original in clinical treatment and nursing at present, so that it holds over the course for the treatment of
Easily contamination clothing, sheet etc., lead to the loss of drug；Meanwhile causing that patient's is handicapped when wrapping up using medical dressing, more
Secondary injury then is caused to the surface of a wound when dressing object；Especially the water of Resina Draconis does not dissolve in property, causes its bioavilability low, becomes
Influence its important limitation used.
In view of the above-mentioned problems, finding present inventor has performed a large amount of experimental study by dragon's blood extract and polyethylene
Pyrrolidones K30 compounding is mixed with alcohols solvent can be made a kind of bioavilability height, film forming, good permeability, and curative effect
The significant Resina Draconis spray for being used to treat traumatic surface.The present invention is based on what above-mentioned discovery was made.
Therefore, the present invention provides provided for treating the Resina Draconis spray of pressure sore, and also known as Resina Draconis film sprays
Mist agent, it includes dragon's blood extract, film forming agent, second alcohol and waters, wherein and the film forming agent is PVP K30, and
Second alcohol and water is used as carrier.
This preparation belongs to solution-type non-quantitation spray, while having both the property of plastics, after being sprayed on affected part, with solvent
Evaporation can form film protection affected part, and slow release drug plays therapeutic effect.Present invention is also beneficial in that forming a film
While, Resina Draconis and PVP K30 can form solid dispersions, increase the dissolution rate of Resina Draconis.
Term " PVP K30 " (PVP-K30) of the present invention refers to that K value is 30 polyvinylpyrrolidine
Ketone.PVP is divided into level Four by its average molecular weight size, is traditionally often indicated with K value, and different K values respectively represents corresponding PVP
Average molecular weight range.K value is actually characteristic value related with the relative viscosity of PVP aqueous solution, and viscosity is poly- with height
The related physical quantity of object molecular weight, therefore the average molecular weight of PVP can be characterized with K value.Usual K value is bigger, and viscosity is got over
Greatly, cementability is stronger.
In some embodiments of the invention, in the spray, by the total weight of spray, dragon's blood extract
Content be 0.6wt%-3wt%, preferably the content of dragon's blood extract be 0.6wt%；The content of film forming agent is 2wt%-
8wt%, the preferably content of film forming agent are 4wt%-8wt%, and the content of further preferred film forming agent is 4wt%；The content of ethyl alcohol
For 60v%-80v%, the content of preferred alcohol is 80v%.
Some preferred embodiments according to the present invention also contain bacteriostatic agent in the spray.Of the invention some
In embodiment, in the spray, for example, pressing the total weight of spray, the content of bacteriostatic agent is 0.5wt%-
4.5wt%, the preferably content of bacteriostatic agent are 2wt%-4.5wt%, and the content of further preferred bacteriostatic agent is 2wt%.
In the present invention, the bacteriostatic agent includes one or more of gluconic acid chlorhexidine, benzalkonium bromide and glutaraldehyde；
It is preferred that the bacteriostatic agent is gluconic acid chlorhexidine.
According to certain embodiments of the present invention, further include the ingredient that relieves the pain in the spray, the ingredient it also will be understood that
To reduce ethyl alcohol irritation component.This become predominantly can produce refrigerant sense have relieve the pain effect some natural drugs at
Point comprising one or more of borneol, menthol and eucalyptus oil.
In some embodiments of the invention, in the spray, by the total weight of spray, the ingredient that relieves the pain
Content be 0.1wt%-1.0wt%, the content of the preferably described ingredient that relieves the pain is 0.1wt%.
In the present invention, the preferably described ethyl alcohol is dehydrated alcohol.
Heretofore described " water " word refers to distilled water and ultrapure water in the case where being not particularly illustrated and specifying.
In order to control the quality of Resina Draconis spray, inventor is by distinguishing 10 batch Resina Draconis sprays in wavelength
Peak is shared for the map similitude under 259nm or 275nm to be compared, and has made the finger-print of two width Resina Draconis sprays,
The characteristic absorption peak appearance position of Resina Draconis spray is identical in two width maps, and only absorption peak strength is variant, for example, in wave
The absorption peak of bacteriostatic agent (gluconic acid chlorhexidine) is stronger in the finger-print of acquisition under a length of 259nm, and Resina Draconis extracts
The absorption peak of object is relatively weak；And wavelength be 275nm under acquisition finger-print in dragon's blood extract absorption peak compared with
By force, the absorption peak of bacteriostatic agent (gluconic acid chlorhexidine) is relatively weak.It may be used to characterize dragon's blood in this two width finger-print
All ingredient and its relative amount with UV absorption, especially important goal ingredient are exhausted in spray, this is based on, it can be right
Resina Draconis spray sample carries out Testing and appraisal, and is monitored to the quality of Resina Draconis spray.
It is particularly preferred that the finger-print of the acquisition in the case where wavelength is 275nm can preferably be used to characterize Resina Draconis
All ingredient and its relative amount with UV absorption, especially important goal ingredient in spray.It, can be more preferable based on this
Ground carries out Testing and appraisal to Resina Draconis spray sample, and is monitored to the quality of Resina Draconis spray, and the finger-print is such as
Shown in Fig. 1.
Therefore, the method for inspection of Resina Draconis spray involved in second aspect of the present invention, uses high performance liquid chromatography
Method identifies sample to be tested, including using photodiode array detector and WatersC18 chromatographic column (4.6mm ×
250mm, 5 μm), it is 3.2-5.0 with pH value, the acetonitrile that preferable ph is 3.2: triethylamine-phosphate buffer is mobile phase, in wave
Under a length of 259nm and/or 275nm, gradient elution preferably is carried out to sample to be tested in the case where wavelength is 275nm, and spray with Resina Draconis
The finger-print of mist agent inspects the high-efficient liquid phase chromatogram of sample to be tested as control.
In some embodiments of the invention, for example, the condition of the gradient elution are as follows: flow velocity 0.6-1.0mL/min,
Preferable flow rate is 0.6mL/min；Sample volume is 5-10 μ L, and preferably sample volume is 10 μ L.
According to the method for the present invention, when in the high performance liquid chromatography of sample to be tested in the finger-print phase with Resina Draconis spray
Identical characteristic absorption peak is shown on the position answered, then illustrates that sample to be tested is Resina Draconis spray.It is preferably described in the present invention
The finger-print of Resina Draconis spray as shown in Figure 1, it will be seen from figure 1 that Resina Draconis spray of the present invention feature
Absorption peak is present in 4.220,5.665,10.500,14.311 and 16.033 minutes, and the spy at 16.033 minutes
Sign absorption peak shows extremely strong absorption intensity.
The preparation method of Resina Draconis spray involved in third aspect present invention includes:
Step B prepares Resina Draconis solution and film forming agent solution using ethyl alcohol as solvent respectively；
Resina Draconis solution is slowly added into the agent solution that forms a film according to certain volume ratio, vibrates, mixing by step C
Resina Draconis spray precursor mixture is made after uniformly；
Step D instills distilled water into Resina Draconis spray precursor mixture while stirring, and Resina Draconis spray is made after mixing
Mist agent.
According to the present invention, in the Resina Draconis spray precursor mixture, the Resina Draconis solution and film forming agent solution
Volume ratio be (1-3): 1, the preferably described Resina Draconis solution and film forming agent solution volume ratio be 1:1.
In some embodiments of the invention, the concentration of dragon's blood extract is 120-150mg/ in the Resina Draconis solution
ML, the concentration of dragon's blood extract is 150mg/mL in the preferably described Resina Draconis solution.
In other embodiments of the invention, the concentration of film forming agent is 5%-10% (w/v) in the agent solution that forms a film, preferably
The concentration of film forming agent is 10% (w/v) in film forming agent solution.
The ethanol solution that term " Resina Draconis solution " of the present invention refers to Resina Draconis, is dissolved in second by dragon's blood extract
It is obtained in alcohol.
The ethanol solution that term " film forming agent solution " of the present invention refers to film forming agent, is dissolved in ethyl alcohol by film forming agent
It obtains.
In some embodiments of the invention, in the spray, by the total weight of spray, dragon's blood extract
Content be 0.6wt%-3wt%, the content of dragon's blood extract is 0.6wt%；By the total weight of spray, the film forming
The content of agent is 2wt%-8wt%, and the content of the preferably described film forming agent is 4wt%-8wt%, the further preferred film forming agent
Content be 4wt%；By the total volume meter of spray, the content of the ethyl alcohol is 60v%-80v%, and the preferably described ethyl alcohol contains
Amount is 80v%.
Resina Draconis spray provided by the present invention for treating pressure sore includes dragon's blood extract, as film forming agent
PVP K30, second alcohol and water etc..Said preparation dosage form is simple, easy-to-use, and bioavilability is high, for pressure sore
With significant therapeutic effect.The method of inspection of the Resina Draconis spray provided by the present invention for being used to treat pressure sore, simply, side
Just, there is preferable operability, can preferably detect and control the quality of the Resina Draconis spray for the treatment of pressure sore.
Embodiment
To keep the present invention easier to understand, this hair is further described below in conjunction with drawings and examples
Bright, these embodiments only serve illustrative, it is not limited to application range of the invention, unmentioned tool in the following example
Body experimental method is usually carried out according to routine experiment method.
Embodiment 1: Resina Draconis spray optimum preparation condition.
In order to confirm the optimal proportion of Resina Draconis spray, inventor devises orthogonal experiment optimization Resina Draconis spray
Preparation process, the factor level table of orthogonal test are shown in Table 1, and orthogonal experiments are shown in Table 2, and the results of analysis of variance is shown in Table 3.
1 factor level table of table
2 film spray preparation process orthogonal arrage of table
As shown in Table 2, the factor sequence of operation of Resina Draconis film spray film formation time and viscosity is influenced successively are as follows: C > A >
B, D are void item.
The analysis of variance table of 3 preparation process of table
| Soruces of variation | SS | f | F | P |
| A | 20816.67 | 2 | 19.42 | <0.05 |
| B | 2985.5 | 2 | 2.78 | >0.05 |
| C | 23035.92 | 2 | 21.48 | <0.05 |
| D (error) | 1072.17 | 2 | 1.00 |
Note: F0.05(2,2)=19.00；F0.01(2,2)=99.00
By 3 variance analysis of table it is found that A have significant difference, while root with the C influences to Resina Draconis film spray
According to GB27951-2011 " skin antiseptic hygienic requirements " and the drug effect demand of sterilization is combined to determine gluconic acid chlorhexidine dosage
For 2wt%, the final preparation optimal set for determining Resina Draconis film spray becomes: A3B3C1, PVPk30 (film forming agent) concentration is
4wt%, concentration of alcohol 80v%, gluconic acid chlorhexidine concentration are 2wt%.
The final of Resina Draconis film spray is determined by the above experimental result the preparation method comprises the following steps:
(1) 10% (w/v) PVPk30 solution and 150mgmL are prepared by solvent of ethyl alcohol-1Resina Draconis solution.
(2) 40mL Resina Draconis solution is slowly added into same volume PVPk30 solution, vibrates, is allowed to uniformly mixed, dragon
Dragon's blood spray precursor mixture.
(3) 20mL distilled water is instilled into Resina Draconis spray precursor mixture while stirring, dragon is made after mixing
Dragon's blood spray.
The concentration of Resina Draconis is 60mgmL in obtained Resina Draconis spray-1The volume of (i.e. 0.6wt%), ethyl alcohol are dense
Degree is 80v%, and the concentration of PVPk30 is 4w%.
Embodiment 2:
In order to control the quality of Resina Draconis film spray, inventor passes through to 10 batch Resina Draconis film spray map phases
The comparison that peak is shared like property depicts Resina Draconis film spray finger-print, sees Fig. 1.Experiment condition is as follows:
Instrument and reagent
High performance liquid chromatograph model are as follows: UPLC (Waters Aquity H-Class, PDA detector)；Electronic balance
(METTLER TOLEDO, model: AB265-S)；Chlorhexidine digfluconate (sigma company, lot number:
LRAA1627, specification: 1g/mL)；Lourerin B (National Institute for Food and Drugs Control, lot number: 111558-201407)；Ethyl alcohol
(Beijing Chemical Plant, lot number: 20150504)；Acetonitrile (Fisher Scientific, lot number: 134145)；Triethylamine (traditional Chinese medicines collection
Chemical reagent Co., Ltd, group, lot number: 20131104)；Phosphoric acid (development in science and technology Co., Ltd is recovered in Tianjin, lot number:
20120403)。
Chromatographic condition: UPLC (Waters Aquity H-Class, PDA detector), chromatographic column: WatersC18 chromatographic column
(4.6mm × 250mm, 5 μm), mobile phase: acetonitrile: (elution requirement is shown in Table triethylamine-phosphate buffer (pH3.2) gradient elution
4), Detection wavelength: 259nm, 275nm dual wavelength, flow velocity: 0.6mL/min, sample volume: 10uL.
4 condition of gradient elution of table
Gluconic acid chlorhexidine standard items ultra performance liquid chromatography figure is as shown in Figure 2.
Lourerin B standard items ultra high efficiency liquid liquid chromatogram is as shown in Figure 3.
Embodiment 3: the solubilization of film forming agent (PVP K30) to dragon's blood medicine is investigated.
Take 1mL to contain film forming agent (PVP K30) Resina Draconis spray (wherein, Resina Draconis solution at
The volume ratio of film solution is 1:1) in 2.0mL centrifuge tube, 50 DEG C of vacuum drying；It prepares simultaneously and is free of film forming agent (polyethylene
Pyrrolidones K30) Resina Draconis spray sample do same treatment.1mL physiological saline, ultrasonic 15min are added in centrifuge tube
Afterwards, with TU1900 ultraviolet specrophotometer (Beijing Puxi General Instrument Co., Ltd), at 510nm, using rutin as
Reference substance makes standard curve, determines flavones ingredient in Resina Draconis film spray and dissolves out releasing effect, each sample repeats 3
It is secondary.
The result shows that wherein general flavone the amount of dissolution is 7.516mg to 1mL Resina Draconis film spray, and same volume is without containing poly-
The sample general flavone the amount of dissolution of vinylpyrrolidone K30 is 3.914mg, it was demonstrated that in Resina Draconis film spray, dragon's blood flavone
Active constituent is easier to dissolve out, and bioavilability improves.
Embodiment 4: Resina Draconis film aerosol therapy pressure sore rat model experiment.
Rat II phase pressure sore model is replicated using the method for ischemia-reperfusion, is divided into excipient group, sun to medicine group, Resina Draconis
Film spray group and model group use film forming agent (PVP K30) ethanol solution, Mupirocin Ointment, Resina Draconis film respectively
Spray and physiological saline are administered intervention.It is taken twice daily, successive administration 10 days.After administration, pan paper is used
It is covered on the pressure sore surface of a wound, depicts surface of a wound area, weighed weighing paper weight, compared with master mould surface of a wound area weighs paper weight
Compared with calculating healing rate.
Each group rat pressure sore wound healing situation such as Fig. 4 institute after the experiment of Resina Draconis film aerosol therapy pressure sore rat model
Show.
The average rehabilitation rate of Resina Draconis film spray group is greater than sun to medicine group (Mupirocin Ointment) 57.99%, model for 84.02%
It is preferable to show that Resina Draconis film spray has rat II phase pressure sore 20% or so for the rehabilitation rate of group and film forming agent group
Therapeutic effect.
It should be noted that embodiment described above for explaining only the invention, is not constituted to of the invention any
Limitation.By referring to exemplary embodiments, invention has been described, it should be appreciated that word used in it is descriptive
With explanatory vocabulary, rather than limited vocabulary.The present invention can be made within the scope of the claims by regulation
Modification, and the present invention is revised in without departing substantially from scope and spirit of the present invention.Although the present invention described in it relates to
And specific method, material and embodiment, it is not intended that the present invention is limited to particular case disclosed in it, on the contrary, this hair
It is bright to can be extended to other all methods and applications with the same function.
Claims (22)
1. it is a kind of for treating the Resina Draconis spray of pressure sore, it is made of dragon's blood extract, film forming agent, second alcohol and water,
In, the film forming agent is PVP K30,
Wherein, by the total weight of spray, the content of the dragon's blood extract is 0.6wt%-3wt%, the film forming agent
Content be 2wt%-8wt%, the content of the ethyl alcohol is 60v%-80v%.
2. spray according to claim 1, which is characterized in that in the spray, by the total weight of spray,
The content of film forming agent is 4wt%-8wt%.
3. a kind of for treating the Resina Draconis spray of pressure sore, by bacteriostatic agent and dragon's blood extract described in claim 1,
Film forming agent, ethyl alcohol, water and composition, wherein the film forming agent is PVP K30.
4. spray according to claim 3, which is characterized in that in the spray, by the total weight of spray,
The content of bacteriostatic agent is 0.5wt%-4.5wt%.
5. spray according to claim 3, which is characterized in that in the spray, by the total weight of spray,
The content of bacteriostatic agent is 2wt%-4.5wt%.
6. spray according to claim 3, which is characterized in that in the spray, the bacteriostatic agent includes grape
One or more of saccharic acid chlorhexidine, benzalkonium bromide and glutaraldehyde.
7. spray according to claim 3, which is characterized in that further include the ingredient that relieves the pain in the spray.
8. spray according to claim 7, which is characterized in that in the spray, by the total weight of spray,
The content of the ingredient that relieves the pain is 0.1wt%-1.0wt%.
9. spray according to claim 7, which is characterized in that in the spray, the ingredient that relieves the pain includes ice
One or more of piece, menthol and eucalyptus oil.
10. a kind of method of inspection of spray described in any one of claims 1 or 2 or 3-9, uses high-efficient liquid phase color
Spectrometry identifies sample to be tested, including uses photodiode array detector and WatersC18 chromatographic column, with acetonitrile:
Triethylamine-phosphate buffer is mobile phase, carries out gradient elution to sample to be tested under 259nm and 275nm dual wavelength, and with dragon
The finger-print of dragon's blood spray inspects the high-efficient liquid phase chromatogram of sample to be tested as control.
11. the method for inspection according to claim 10, which is characterized in that when in the high performance liquid chromatography of sample to be tested with
The finger-print of Resina Draconis spray shows identical characteristic absorption peak on corresponding position, then illustrates that sample to be tested is Resina Draconis
Spray.
12. the method for inspection according to claim 11, which is characterized in that the characteristic absorption peak appears in 4.220,
5.665, at 10.500,14.311 and 16.033 minutes.
13. the method for inspection according to claim 10, which is characterized in that the condition of the gradient elution are as follows: flow velocity is
0.6-1.0mL/min, sample volume 5-10uL.
14. the method for inspection according to claim 13, which is characterized in that the condition of the gradient elution are as follows: mobile phase
PH value is 3.2-5.0.
15. a kind of preparation method of spray according to claim 1 or 2 comprising:
Resina Draconis solution is mixed with film forming agent solution, Resina Draconis spray precursor mixture is made by step C；
Distilled water is added into Resina Draconis spray precursor mixture, Resina Draconis spray is made after mixing by step D；
Wherein, the Resina Draconis solution is the ethanol solution of Resina Draconis；The film forming agent solution is the ethanol solution of film forming agent.
16. preparation method according to claim 15, which is characterized in that in the Resina Draconis spray precursor mixture
In, the volume ratio of the Resina Draconis solution and film forming agent solution is (1-3): 1.
17. preparation method according to claim 16, which is characterized in that in the Resina Draconis spray precursor mixture
In, the concentration of dragon's blood extract is 120-150mg/mL in the Resina Draconis solution.
18. preparation method according to claim 16, which is characterized in that in the Resina Draconis spray precursor mixture
In, the concentration of film forming agent is 5%-10% (w/v) in the agent solution that forms a film.
19. preparation method according to claim 15, which is characterized in that in the spray, by the gross weight of spray
Meter, the content of dragon's blood extract are 0.6wt%-3wt%.
20. preparation method according to claim 19, which is characterized in that in the spray, by the gross weight of spray
Meter, the content of the film forming agent are 2wt%-8wt%.
21. preparation method according to claim 19, which is characterized in that in the spray, the film forming agent contains
Amount is 4wt%-8wt%.
22. preparation method according to claim 19, which is characterized in that in the spray, by the totality of spray
Product meter, the content of the ethyl alcohol are 60v%-80v%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610292880.3A CN106109845B (en) | 2016-05-05 | 2016-05-05 | For treating the Resina Draconis spray and its inspection and preparation method of pressure sore |
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| CN106109845B true CN106109845B (en) | 2019-07-26 |
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| CN108051509B (en) * | 2017-11-21 | 2020-06-23 | 陈溉 | Detection method of characteristic spectrum of medicine for treating bedsore and application thereof |
| CN114504567B (en) * | 2022-03-01 | 2023-10-20 | 云南云河药业股份有限公司 | Dragon blood liquid adhesive bandage and preparation method thereof |
Citations (6)
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|---|---|---|---|---|
| CN1552406A (en) * | 2003-06-06 | 2004-12-08 | 陈才义 | Preparation of water soluble dragon's blood as medicine |
| CN1788740A (en) * | 2004-12-13 | 2006-06-21 | 北京东方凯恩医药科技有限公司 | Externally-used pain-relieving spray |
| CN101007072A (en) * | 2007-01-18 | 2007-08-01 | 天津红日药业股份有限公司 | Quality-control method of a traditional Chinese medicine 'Xuebijing' injection |
| CN103115973A (en) * | 2013-01-25 | 2013-05-22 | 山东大学 | Method for judging consistency of traditional Chinese medicine batches |
| CN103191284A (en) * | 2013-03-21 | 2013-07-10 | 中国医学科学院药用植物研究所云南分所 | Dragon blood spraying film agent applied to superficial wound and preparation technology thereof |
| CN103698420A (en) * | 2013-12-04 | 2014-04-02 | 江苏康缘药业股份有限公司 | Resina draconis detecting method |
-
2016
- 2016-05-05 CN CN201610292880.3A patent/CN106109845B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1552406A (en) * | 2003-06-06 | 2004-12-08 | 陈才义 | Preparation of water soluble dragon's blood as medicine |
| CN1788740A (en) * | 2004-12-13 | 2006-06-21 | 北京东方凯恩医药科技有限公司 | Externally-used pain-relieving spray |
| CN101007072A (en) * | 2007-01-18 | 2007-08-01 | 天津红日药业股份有限公司 | Quality-control method of a traditional Chinese medicine 'Xuebijing' injection |
| CN103115973A (en) * | 2013-01-25 | 2013-05-22 | 山东大学 | Method for judging consistency of traditional Chinese medicine batches |
| CN103191284A (en) * | 2013-03-21 | 2013-07-10 | 中国医学科学院药用植物研究所云南分所 | Dragon blood spraying film agent applied to superficial wound and preparation technology thereof |
| CN103698420A (en) * | 2013-12-04 | 2014-04-02 | 江苏康缘药业股份有限公司 | Resina draconis detecting method |
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