CN110123920A - A kind of oral quick-dissolving film preparation and preparation method thereof for treatment of insomnia patients - Google Patents
A kind of oral quick-dissolving film preparation and preparation method thereof for treatment of insomnia patients Download PDFInfo
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Abstract
The easypro dormancy oral quick-dissolving film preparation and preparation method thereof that the present invention relates to a kind of for treatment of insomnia patients, specifically, the oral quick-dissolving film preparation its be prepared with the component of following weight percent meter: Chinese medical extract 20%~40%, filmogen 40%~60%, plasticizer 5%~15%, disintegrating agent 10%~20%, corrigent 1%~5%, colorant 0%~2%.The film can be improved the bioavilability of Chinese medicine, solves the disadvantage that most of oral solid formulation is taken at present and needs water, the mouthfeel of Chinese medicine is improved, and weaken stimulation of the Chinese medicine to stomach and intestine, to improve Chinese medicine in the compliance of specific crowd.
Description
Technical field
The present invention relates to traditional Chinese medicine preparation field more particularly to a kind of oral quick-dissolving film preparation for treating insomnia and its preparation sides
Method.
Background technique
Although insomnia refers to there is suitable sleep chance or environment in modern medicine, time and quality to sleep are still
It is so unsatisfactory for, and will affect the subjective experience of animation on daytime, main clinical manifestation is difficulty falling asleep, sleep maintenance barrier
Hinder, sleep quality decline and total sleep time are reduced.Vital function obstacle on daytime caused by having a sleepless night includes that fatigue is out of strength, sleepy kind
It is sleeping, mood is unsmooth, Somatic discomfort, cognitive disorder etc..The people in the U.S. existing 27.1% has insomnia according to statistics, and China also has 38%
People have insomnia.It is either old that the main population that insomnia occurs is distributed in study and work anxiety age bracket
People.The dormancy class preparation type that relaxes currently on the market mainly has tablet, also has and capsule is made.Tablets and capsules for children and
Old man patient is also easy to produce dysphagia and is not easy the problems such as taking.Therefore need to increase dosage form to meet the needs of different patients.
SHUMIAN JIAONANG is a kind of Chinese patent drug listed, national drug standard 0Z1052000, by semen ziziphi spinosae (stir-fry), Bupleurum Chinese (wine
Fry), Radix Paeoniae Alba (stir-frys), Flos Albiziae, cortex albiziae, bombyx batryticatus (stir-fry), cicada slough, rush be prepared, major function: soothing liver-qi stagnation, rather
Heart and tranquilizing mind.Insomnia caused by overtaxing one's nerves for liver depression, symptoms include: insomnia and dreamful sleep, mental depression or being irritable and getting angry easily, fullness and discomfort in chest and hypochondrium or chest
Diaphragm is unsmooth, and bitter taste is dizzy, and tongue side point is slightly red, whitish tongue or micro- Huang, veins string.
Oral quick-dissolving film preparation (oral fast dissolving film, OFDF) be by the chemicals of doses or
Diaphragm is made after being loaded into membrane material in the effective component of Chinese medical extract, can be in 1 min quickly without drinking-water after being placed on tongue
Dissolution, release drug.Oral quick-dissolving film preparation compared to other oral solid formulations for, have without being delivered with water, need not carry on a shoulder pole
The advantages such as the heart can choke or suck, and simple production process, and cost is relatively low；For oral liquid, divided dose
It is accurate and easy to carry, patient's medication compliance and convenience are substantially increased, children and gerontal patient are particularly suitable for.At present
Oral quick-dissolving film preparation is concentrated mainly on North America market, such as treats bagodryl hydrochloride, dextromethorphan and the treatment of children's cold cough
The meta-synephrine hydrochloride etc. of cold stuffy nasal obstruction.The country has no commercialized product, is in the state of grinding.
Oral quick-dissolving film preparation belongs to the solid pharmaceutical preparation of oral mucosa administration, and when use quickly dissolves in the oral cavity and discharges work
Property ingredient, bioavilability is high, and enteron aisle residual is few etc., but to prepare film forming agent difficulty more for Chinese medicine at present, especially in extract
Chinese medicine containing bitter ingredient or fibre composition, preparing film forming agent makes troubles to taking.
The present invention is unable to reach mark using the technology of existing oral quick-dissolving film preparation during developing easypro dormancy oral quick-dissolving film preparation
Alignment request, the present invention has carried out multiple improvement to the technical solution of existing oral quick-dissolving film preparation and has filtered out good formula thus
And component proportion, a kind of effectively easypro dormancy oral quick-dissolving film preparation is provided thus.
Summary of the invention
The purpose of the present invention is to provide one kind can in the oral cavity flash melt, absorb, conveniently take, patient's compliance
Good and preparation process is simple, low-cost easypro dormancy oral quick-dissolving film preparation and preparation method thereof.
The technical scheme is that a kind of easypro dormancy oral quick-dissolving film preparation, with the component system of following weight percent meter
It is standby to form:
Herbal extract 20%~30%
Filmogen 40%~60%
Plasticizer 5%~15%
Disintegrating agent 5%~10%
Corrigent 1%~5%
Colorant 0.5%~2%
Wherein, the herbal extract is by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), Radix Paeoniae Alba (stir-fry) 38
Part, 48 parts of Flos Albiziae, 48 parts of cortex albiziae, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, 1 part of rush, 8 taste medicinal materials add water to cook twice,
For the first time plus 14 times of amount water decoct 1 hour, and for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration,
Filtrate is concentrated into appropriate (relative density 1.05-1.10).
Wherein, the filmogen is PVA.
Wherein, the plasticizer is one or more of sorbierite, polyethylene glycol (PEG) and glycerol.
Wherein, the disintegrating agent is one or more of sodium carboxymethylcellulose (CMC), pre-paying starch, crospovidone.
Wherein, the corrigent is one or more of stevioside and citric acid.
Wherein, the colorant is titanium dioxide.
Preferably, wherein the filmogen is PVA, and plasticizer is glycerol, and disintegrating agent CMC, corrigent is stevioside,
Colorant is titanium dioxide.
In a preferred formula, easypro dormancy oral quick-dissolving film preparation of the invention, with the group of following weight percent meter
Divide and be prepared:
Herbal extract 25%
Polyvinyl alcohol (PVA) 52%
Glycerol 12%
Sodium carboxymethylcellulose (CMC) 8%
Stevioside 2%
Titanium dioxide (TiO2) 1%
Another object of the present invention is to provide the preparation methods of the easypro dormancy oral quick-dissolving film preparation comprising as follows
Step:
1) water is added under stirring in PVA, stirring and dissolving；
2) glycerol, CMC, stevioside, titanium dioxide are sequentially added in above-mentioned solution and is stirred evenly；
3) by easypro 65 parts of dormancy prescription Chinese medicinal materials semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), silk tree
Spend 48 parts, 48 parts of cortex albiziae, 30 parts of bombyx batryticatus (stir-fry), 1 part of 8 30 parts of cicada slough, rush taste medicinal material add water to cook twice, for the first time
14 times of amount water are added to decoct 1 hour, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is dense
It is reduced in right amount, relative density is that (1.05-1.10) resulting herbal extract stirs evenly, and is obtained containing drug solns；
4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
5) heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.It is of the present invention to relax
Dormancy oral quick-dissolving film preparation, formula and each component weight proportion are obtained by screening, and screening process is as follows:
The preparation of active pharmaceutical ingredient is screened:
The water of 14 times of amounts is added to decoct twice 8 taste medicinal materials in easypro dormancy prescription, 1 hour every time, collecting decoction staticly settled, filtration,
Filtrate is concentrated into right amount, and relative density is (1.05-1.10), concentrate, that is, active constituent 1.
Add the water of 14 times of amounts to decoct twice 8 taste medicinal materials in easypro dormancy prescription, decocts 1 hour for the first time, it is small to decoct 0.5 for the second time
When, collecting decoction staticly settles, and filtration, filtrate is concentrated into right amount, and relative density is (1.05-1.10), and concentrate is activity
Ingredient 2.
Add the water of 12 times of amounts to decoct twice 8 taste medicinal materials in easypro dormancy prescription, decocts 1 hour for the first time, it is small to decoct 0.5 for the second time
When, collecting decoction staticly settles, and filtration, filtrate is concentrated into right amount, and relative density is (1.05-1.10), and concentrate is activity
Ingredient 3.
Add the water of 16 times of amounts to decoct twice 8 taste medicinal materials in easypro dormancy prescription, decocts 1 hour for the first time, it is small to decoct 0.5 for the second time
When, collecting decoction staticly settles, and filtration, filtrate is concentrated into right amount, and relative density is (1.05-1.10), and concentrate is activity
Ingredient 4.
The assay that above-mentioned concentrate is carried out to Paeoniflorin, determines the preparation method of active pharmaceutical ingredient.
The screening of filmogen:
Film made of different filmogens is cut into 2.0cm × 3.0cm size, every piece of film (is drawn using tensile testing machine
Stretching speed is 25mm/min) longitudinal stretching, until film fracture, record reading calculates tensile strength and elongation.In film
The folding folding strength that film is measured to its fracture in the same position of agent, indicates resistance to the logarithm for being broken preceding twofold number
Folding degree.Test result is shown in Table.
The screening of plasticizer:
Filmogen is dissolved in the ethyl alcohol of certain mass score, magnetic agitation dissolves under certain temperature, in the molten of stirring and dissolving
Plasticizer is added in liquid, continues magnetic agitation dissolution, stands degassing, according to certain specification film on substrate, drying is cold
But, demoulding, carries out disintegration time and tensile strength test, and test result is shown in Table.Different plasticizer disintegration times and elasticity modulus
As a result
The screening of disintegrating agent:
Filmogen is dissolved in the ethyl alcohol of certain mass score, magnetic agitation dissolves under certain temperature, in the molten of stirring and dissolving
Plasticizer is added in liquid, continues magnetic agitation dissolution, adds disintegrating agent, continues magnetic agitation dissolution, stands de-
Gas, according to certain specification film on substrate, dry, cooling, demoulding carries out disintegration time test, and test result is shown in Table.
The disintegration time result of different disintegrating agents
The screening of corrigent:
Since the dosage form has better choice to children and gerontal patient, it is contemplated that their mouthfeel demand, in stevioside and
In citric acid, preferred stevioside can increase the compliance of patient.
The screening of colorant:
Since effective component extracts color is deeper in the prescription, and TIO2Covering power is high, stablizes, good weatherability, therefore preferably
For the colorant of this preparation.
The easypro dormancy oral quick-dissolving film preparation, characterized in that appearance uniform is smooth；Toughness is high, and folding number is more；Mechanicalness
Can be good, there are preferable tensile strength and percent elongation；Solution rate is fast, and the disintegration time in 37 DEG C of water is less than 30s, can be
Dissolution dispersion rapidly, discharges drug in oral cavity.
Specific embodiment
Embodiment 1
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 14gPVA to mix with water, sequentially adds sorbierite 4g, CMC3g, above-mentioned
Concentrate solution 7.5g, stevioside 0.6g, titanium dioxide 0.6g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 2
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring sequentially adds PEG4g, CMC3g, above-mentioned concentration to being completely dissolved after taking 15gPVA to mix with water
Solution 7.5g, stevioside 0.6g, titanium dioxide 0.3g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 3
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring sequentially adds glycerol 4g, CMC2g, above-mentioned concentration to being completely dissolved after taking 16gPVA to mix with water
Solution 7.5g, stevioside 0.6g, titanium dioxide 0.3g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 4
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 12gPVA to mix with water, sequentially add PEG6g, pregelatinized starch 4g, on
State concentrate solution 7.5g, stevioside 0.7g, titanium dioxide 0.5g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 5
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 11gPVA to mix with water, sequentially add glycerol 3g, crospovidone 4g,
Above-mentioned concentrate solution 7.5g, stevioside 1g, titanium dioxide 0.2g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 6
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 9gPVA to mix with water, sequentially add glycerol 9g, pregelatinized starch 3.5g,
Above-mentioned concentrate solution 8.5g, citric acid 0.5g, titanium dioxide 0.2g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 7
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 13gPVA to mix with water, sequentially adds PEG6g, CMC3.8g, above-mentioned dense
Contracting solution 7.5g, stevioside 0.4g, titanium dioxide 0.1g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
Embodiment 8
(1) by 65 parts of semen ziziphi spinosae (stir-fry), 38 parts of Bupleurum Chinese (parched with wine), 38 parts of Radix Paeoniae Alba (stir-fry), 48 parts of Flos Albiziae, cortex albiziae 48
1 part of 8 part, 30 parts of bombyx batryticatus (stir-fry), 30 parts of cicada slough, rush taste medicinal material add boiling twice, and for the first time plus 14 times of amount water decoctions 1 are small
When, for the second time plus 14 times of amount water decoct 0.5 hour, and collecting decoction staticly settles, filtration, and filtrate is concentrated into appropriate (relative density
1.05-1.10)；
(2) heating stirring is to being completely dissolved after taking 18gPVA to mix with water, sequentially add sorbierite 5.5g, CMC5g, on
State concentrate solution 7.5g, citric acid 0.7g, titanium dioxide 0.3g.It stirs evenly and rubber cement solution is made；
(3) it takes step (3) resulting and is added in above-mentioned steps (2) in rubber cement solution containing drug solns, stirred evenly；
(4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
Heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
The measurement of oral quick-dissolving film preparation property
Measuring method
Mechanical performance: measuring film mechanical performance mainly has 3 indexs: tensile strength, elongation and folding strength.By film
Agent is cut into 2.0cm × 3.0cm size, and every piece of film uses tensile testing machine (tensile speed 25mm/min) longitudinal stretching,
Until film fracture, record reading calculates tensile strength and elongation.It is folding to its fracture at the same position of film
To measure the folding strength of film, folding strength is indicated with the logarithm for being broken preceding twofold number.
Content: the paeoniflorin content in dormancy oral quick-dissolving film preparation of relaxing is measured using HPLC method.Chromatographic condition: chromatographic column is with ten
Eight alkyl silicon bonded silica gels are filler；With -0.1% phosphoric acid solution of acetonitrile (17:83) for mobile phase；Detection wavelength is 230nm；
Column temperature is 30 DEG C；10 μ l of sample volume is measured work.
| Lot number | Tensile strength/MPa | Elongation/% | Folding strength | Content/% |
| Embodiment 1 | 17.42 | 21.06 | 2.10 | 99.81 |
| Embodiment 2 | 16.25 | 19.94 | 1.97 | 100.13 |
| Embodiment 3 | 17.54 | 22.88 | 2.04 | 101.34 |
| Embodiment 4 | 15.46 | 21.68 | 1.82 | 100.06 |
| Embodiment 5 | 16.78 | 19.86 | 1.87 | 99.67 |
| Embodiment 6 | 16.78 | 18.92 | 2.06 | 101.30 |
| Embodiment 7 | 17.16 | 21.26 | 1.86 | 101.38 |
| Embodiment 8 | 15.36 | 19.74 | 1.99 | 99.96 |
Disintegration time
Film is put into the beaker equipped with 37 DEG C of purified water 50ml, is vortexed.It visually observes, when recording the disintegration of film
Between, each embodiment takes three pieces of films to be measured.The easypro dormancy oral quick-dissolving film preparation Mean disintegration time of embodiment 1-8 is shown in Table 2.
2 embodiment 1-8 of table relaxes dormancy oral quick-dissolving film preparation Mean disintegration time
To sum up, the present invention is relaxed, and dormancy oral quick-dissolving film preparation appearance uniform is complete, and uniform color, physics and chemical property are stablized,
Disintegration time is short.
The present invention passes through above-mentioned experiment, it is found that the most preferred formula of the present invention is as follows by weight percentage:
Herbal extract 25%
Polyvinyl alcohol (PVA) 52%
Glycerol 12%
Sodium carboxymethylcellulose (CMC) 8%
Stevioside 2%
Titanium dioxide (TiO2) 1%.
Claims (8)
1. a kind of easypro dormancy oral quick-dissolving film preparation for treatment of insomnia patients, which is characterized in that it is with following weight percent meter
Component is prepared:
Herbal extract 20%~30%
Filmogen 40%~60%
Plasticizer 5%~15%
Disintegrating agent 5%~10%
Corrigent 1%~5%
Colorant 0.5%~2%.
2. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the herbal extract is will to relax
Dormancy prescription Chinese medicinal materials add boiling twice, and for the first time plus 14 times of amount water decoct 1 hour, and for the second time plus 14 times of amount water decoct 0.5 hour,
Collecting decoction staticly settles, and filtration, filtrate is concentrated into relative density 1.05-1.10.
3. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the filmogen is polyvinyl alcohol
(PVA)。
4. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the plasticizer is sorbierite, gathers
One or more of ethylene glycol (PEG) and glycerol.
5. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the disintegrating agent is carboxymethyl cellulose
One or more of plain sodium (CMC), pre-paying starch, crospovidone.
6. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the corrigent is stevioside and lemon
One or more of lemon acid.
7. easypro dormancy oral quick-dissolving film preparation according to claim 1, which is characterized in that the colorant is titanium dioxide.
8. the preparation method of easypro dormancy oral quick-dissolving film preparation, feature described in a kind of any one of claims 1 to 7 claim
It is, the preparation method includes the following steps:
1) water is added under stirring in polyvinyl alcohol, stirring and dissolving；
2) plasticizer, disintegrating agent, corrigent, colorant are sequentially added in above-mentioned solution and is stirred evenly；
3) herbal extract described in claims 2~3 is added to stir evenly, obtains containing drug solns；
4) it deaerates, drug solns will be contained and be uniformly coated on glass plate；
5) heat drying, heat drying temperature are 30-60 DEG C, and cutting obtains the oral instant membrane.
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Cited By (2)
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| CN111450181A (en) * | 2020-04-23 | 2020-07-28 | 无锡济民可信山禾药业股份有限公司 | Sublingual tablet preparation for treating insomnia and preparation method thereof |
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| CN111297987A (en) * | 2019-12-26 | 2020-06-19 | 无锡济民可信山禾药业股份有限公司 | Preparation method of sleep-relieving dispersible tablet |
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Address after: 214028 Changjiang South Road, new Wu District, Wuxi, Jiangsu Province, No. 12 Applicant after: Wuxi Jiyu Shanhe Pharmaceutical Co.,Ltd. Address before: 214028 No. 12 Changjiang South Road, New District, Jiangsu, Wuxi Applicant before: WUXI JIMIN KEXIN SHANHE PHARMACEUTICAL Co.,Ltd. |
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