CN107158178A - A kind of preparation technology of soft capsule for treating common cold - Google Patents

A kind of preparation technology of soft capsule for treating common cold Download PDF

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Publication number
CN107158178A
CN107158178A CN201710499345.XA CN201710499345A CN107158178A CN 107158178 A CN107158178 A CN 107158178A CN 201710499345 A CN201710499345 A CN 201710499345A CN 107158178 A CN107158178 A CN 107158178A
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Prior art keywords
root
soft capsule
glue
common cold
raw material
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张金云
樊流昌
王延涛
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Luoyang Junshan Pharmaceutical Co Ltd
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Luoyang Junshan Pharmaceutical Co Ltd
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Priority to CN201710499345.XA priority Critical patent/CN107158178A/en
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538—Schizonepeta
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
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Abstract

The invention belongs to field of traditional Chinese, a kind of preparation technology of soft capsule for treating common cold is proposed.A kind of preparation technology of the soft capsule for treating common cold proposed includes preparation and extraction, decoction, the preparation of glue and pelleting, sizing, drying, the technology of the package of raw material；Ching-chieh in raw material, peppermint are extracted into volatile oil, and leaching decoction；Notopterygium root in raw material, Chinese ephedra, cassia twig, the windproof, root of Dahurain angelica, Ligusticum wallichii, grass-leaved sweetflag, the root of kudzu vine, semen armeniacae amarae, Radix Angelicae Sinensis, radix scutellariae, balloonflower root are extracted, concentrate, dry, crush to obtain extract powder；Extract powder and volatile oil are dissolved in the drug solns that homogeneous is obtained in water-soluble base；Prepare glue；By glue and drug solns with 1~1.2:1 ratio is produced in being pressed into soft capsule on rolling pattern pellet processing machine through shaping, washing ball, drying, packaging.Solution is made in content by the present invention, not only rapid-action, and steady quality, there is the longer shelf-life.

Description

A kind of preparation technology of soft capsule for treating common cold
Technical field
The invention belongs to field of traditional Chinese, and in particular to a kind of preparation technology of soft capsule for treating common cold.
Background technology
Soft capsule for treating common cold standard is that the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation the 6th records kind, and soft capsule for treating common cold is Flu class non-prescribed medicine, is mainly used in Chinese medical discrimination and belongs to wind-cold syndrome class, and the infection of the upper respiratory tract for belonging to modern medicine is primary symptom person； It is by Chinese ephedra, cassia twig, ching-chieh, radix scutellariae, semen armeniacae amarae, notopterygium root, Ligusticum wallichii, the windproof, root of Dahurain angelica, grass-leaved sweetflag, the root of kudzu vine, peppermint, Radix Angelicae Sinensis, tangerine The compound preparation of the 14 taste pure Chinese medicines such as stalk composition；Clinically burnt for treating caused headache body of catching cold, runny nose of having a stuffy nose, evil Tremble with fear lossless, skeletal pain, abscess of throat has good curative effect, can be as the standing medicine of influenza be prevented and treated, in being current Chinese medicine preparation The traditional famous-brand and high-quality OTC Chinese patent drugs being popular.
But country increased sampling observation dynamics in recent years, quality bulletin is carried out to substandard product, it is found that soft capsule for treating common cold is multiple Many producers appear on the list of successful candidates.Defective item is generally [character] item, and one of reason is extract powder sedimentation, plant in content suspension Oil is layered with extract powder, or even extract powder moisture absorption caking, is bonded on softgel shell inwall, is squeezed and do not come out, hard by means of the point such as blade Instrument could be scraped off from softgel shell；The two of reason be that gelatin viscosity is inadequate or extract particles are excessive or pellet processing machine debugging less than Position, causes soft capsule oil leak.
The standard is revised for the nineties in last century, with development in science and technology, the continuous improvement of pharmaceutical technology level, the defect of standard Constantly it is exposed, is progressively realized.
Why soft capsule dosage form is better than other oral solid formulations, and one of reason is due to that can be wrapped in liquid medicine In softgel shell, rear softgel shell dissolving is taken, medicine can directly be absorbed, so than tablet, hard capsule, granule is rapid-action, and molten The absorption of liquid will be faster than suspension.Therefore solution should be made as much as possible for extract.
State Food and Drug Administration prints and distributes within 2008《Treatment principle on printing and distributing Chinese medicine technique relevant issues Deng the notice of 5 drug evaluation technical standards》State's food medicine prison note [2008] 287, its annex 3：" Chinese medicine dosage changing form kind formulation Select rational technical requirements " in clear stipulaties " preparation based on water soluble ingredient should not typically be changed to use oil-soluble The soft capsule that matrix is made ".
And national ten Duo Ge soft capsule for treating common cold manufacturer（All studied and declare before 2008）, use Prescription and preparation method in soft capsule for treating common cold ministry standard, content matrix is vegetable oil, has soybean oil, corn essential oil etc., helps Suspension is beeswax, lecithin etc.；Soft capsule for treating common cold ministry standard prescription and preparation method are as follows：
[prescription] notopterygium root 30g, Chinese ephedra 60g, cassia twig 45g, ching-chieh 45g, windproof 30g, root of Dahurain angelica 30g, Ligusticum wallichii 30g, grass-leaved sweetflag 15g, root of kudzu vine 45g, peppermint 15g, semen armeniacae amarae 60g, Radix Angelicae Sinensis 30g, radix scutellariae 60g, balloonflower root 30g.
14 tastes more than [preparation method], ching-chieh, peppermint extract volatile oil, and leaching decoction；The taste of remaining notopterygium root etc. 12, is used 80% ethanol is heated to reflux secondary, and 2 hours for the first time, second 1 hour, filtration, merging filtrate reclaimed ethanol to without alcohol taste, with Above-mentioned filtrate merges, and it is 1.30 to be concentrated into relative density（50 DEG C of heat are surveyed）Thick paste, be dried under reduced pressure, be ground into fine powder, add and plant Thing is oily and above-mentioned volatile oil, mixes, soft capsule is made, produces.
As can be seen here, above medicinal material is extracted obtains outside a small amount of volatile oil, and most of is water-soluble extractive.According to present Country, which evaluates technical requirements, should use water-soluble base, so existing standard vegetable oil is unreasonable as matrix, one is to work Slowly, two be that extract powder free settling is layered in suspension in storage process, and pill is layered therebetween causes product filling uneven, contains Amount is inaccurate, is layered in long-term storage, sedimentation is built up, or even the moisture absorption condenses, and sticks inside capsule wall, causes market to inspect [property by random samples Shape] item is unqualified.
The reason for soft capsule oil leak, one is, the viscosity of glue and quality and glue with gelatin relevant with the viscosity of glue Composition it is relevant；Two be to adjust not in place with pelleting mould, makes jointing line actual adhesion face too narrow, or extract was expected Greatly, sprinkler body is asynchronous with upper and lower mould corresponding, extract particles is embedded in jointing line and causes oil seepage phenomena.Mould regulation is production Operational issue, relatively good solution, as long as debugging is in place.Therefore, Leakage is solved, need to also be from the quality control for studying gelatin The composition of system and glue is set about.
The content of the invention
To solve the quality problems that existing soft capsule for treating common cold is present, the purpose of the present invention is to propose to a kind of soft capsule for treating common cold Preparation technology.
The present invention adopts the following technical scheme that to complete above-mentioned purpose：
A kind of preparation technology of soft capsule for treating common cold, described preparation technology includes the preparation and extraction of raw material, decoction, glue Prepare and pelleting, sizing, drying, technology of the package；Ching-chieh in raw material, peppermint are extracted into volatile oil, and leaching decoction；Will Notopterygium root, Chinese ephedra, cassia twig in raw material, the windproof, root of Dahurain angelica, Ligusticum wallichii, grass-leaved sweetflag, the root of kudzu vine, semen armeniacae amarae, Radix Angelicae Sinensis, radix scutellariae, balloonflower root use 80% Ethanol is heated to reflux secondary, filtration merging filtrate, reclaims ethanol to without alcohol taste, merges with decoction, is concentrated to give medicinal extract, and decompression is dry It is dry, it is ground into extract powder；Using described extract powder and volatile oil as extract and content matrix with 1:1.5~2 ratio Mixing, and extract is substantially dissolved in the content drug solns that content Medium Culture obtains homogeneous；Described content matrix For the water-soluble base being made up of polyethylene glycol 400,1,2 propane diols, glycerine, its mass ratio is：Polyethylene glycol 400:1,2 the third two Alcohol:Glycerine=1：0.1~0.2：0.1~0.2；Wherein, 1,2 propane diols and glycerine are used as the cosolvent to dissolve extract powder；Match somebody with somebody Glue liquid；By the glue and content drug solns with 1~1.2:1 ratio in rolling pattern pellet processing machine on be pressed into soft capsule, Produced through shaping, washing ball, drying, packaging.
The composition and ratio of the glue：It is made up of gelatin, glycerine, water, ethyl hydroxy benzoate, food coloring；Its mass ratio is： Gelatin:Glycerine:Water:Ethyl hydroxy benzoate:Food coloring=1:0.3~0.5:0.9~1.1:0.001:0.003；Described gelatin is used The gelatine of subtraction production, it freezes power viscosity in 190~200Bloomg.
Described raw material includes notopterygium root, Chinese ephedra, cassia twig, ching-chieh, the windproof, root of Dahurain angelica, Ligusticum wallichii, grass-leaved sweetflag, the root of kudzu vine, thin Lotus, semen armeniacae amarae, Radix Angelicae Sinensis, radix scutellariae, balloonflower root.
A kind of preparation technology of soft capsule for treating common cold proposed by the present invention, its content matrix is used by polyethylene glycol 400,1, The water-soluble base of 2 propane diols, glycerine composition, extract powder is made up of many components, and measures larger, and dissolving is difficult, from 1,2 the third two Alcohol and glycerine add the solubility for improving extract powder as cosolvent；By polyethylene glycol 400,1, what 2 propane diols, glycerine were constituted Extract can be completely dissolved to form drug solns by water-soluble base；Because polyethylene glycol 400 also has water imbibition, easily by rubber Water be transferred in content drug solns, the addition of 1,2 propane diols and glycerine can substantially hinder moisture in rubber to content Shifted in drug solns, the biphase equilibrium between regulation content drug solns and softgel shell makes product quality stable, there is longer guarantee the quality Phase；It is more rapid-action for the soft capsule for treating common cold of suspension than content using soft capsule for treating common cold produced by the present invention；In pelletizing process not Layering occurs, filling decoction is uniform, and content is accurate；By extract be made solution also avoid suspension is made when medicinal powder particle Excessive, medicinal powder particle is embedded in jointing line during pelleting, causes oil seepage phenomena；Gelatin is the glue in the skin of animal, bone, tendon and ligament Obtained product is purified after the former incomplete sour water solution of albumen, basic hydrolysis or enzyme degraded, or is above-mentioned three kinds different gelatin products Mixture, the gelatine viscosity for finding to use alkaline process to produce is investigated through many experiments best；Therefore, gelatin use used subtracts in glue The gelatine of method production, it freezes the internal control of power viscosity in 190~200Bloomg, the viscosity of glue is ensure that well, so as to avoid soft The oil seepage phenomena of capsule.Investigated through long-time stability, the steady quality in storage process, do not occur being layered, there is no medicinal extract Powder builds up caking phenomenon, oil seepage phenomena does not also occur.
Specific implementation method
The present invention is illustrated in conjunction with specific embodiments：
A kind of preparation technology of soft capsule for treating common cold, described preparation technology includes the proportioning of raw material, the extraction of raw material, decoction Preparation, the preparation of glue, pelleting, shape, wash ball, drying, packaging；The proportioning of raw material, the extraction of raw material and pelleting in this document, Shape, wash ball, drying, packaging use prior art, do not do excessive explanation herein；Example 1 below -3 provides three kinds Preparation technology；
Embodiment 1
1st, raw material prescription ratio：Notopterygium root 15kg, Chinese ephedra 30kg, cassia twig 22.5kg, ching-chieh 22.5kg, windproof 15kg, the root of Dahurain angelica 15kg, Ligusticum wallichii 15kg, grass-leaved sweetflag 7.5kg, root of kudzu vine 22.5kg, peppermint 7.5kg, semen armeniacae amarae 30kg, Radix Angelicae Sinensis 15kg, radix scutellariae 30kg, Balloonflower root 15kg；
2nd, extract：Ching-chieh, peppermint are extracted into volatile oil, and leaching decoction；The taste of remaining notopterygium root etc. 12, is heated with 80% ethanol Backflow is secondary, 2 hours for the first time, second 1 hour, filtration, merging filtrate, reclaims ethanol to without alcohol taste, is closed with above-mentioned filtrate And, it is 1.30 to be concentrated into relative density（50 DEG C of heat are surveyed）Thick paste, be dried under reduced pressure, be ground into fine powder, it is standby；
3rd, content drug solns prescription ratio：Volatile oil 0.29kg, extract powder 24.94kg, polyethylene glycol 400 29.12kg, 1,2 Propane diols 2.91kg, glycerine 5.82kg；
4th, prepared by content drug solns：By PVOH 400,1,2 propane diols, glycerine, sequentially add during dispensing fills, then add and carry The volatile oil and extract powder taken, stirs to whole dissolvings, solution is made, standby；
5th, glue prescription ratio：By gelatin 26.24kg, glycerine 7.87kg, water 28.86kg, ethyl hydroxy benzoate 0.026kg, edible color Plain 0.079kg compositions；Wherein gelatin uses the gelatine that subtraction is produced, and it is 192Bloomg that it, which freezes power viscosity,；
6th, prepared by glue：Gelatin, glycerine, water, food coloring are added in Agitation Tank, after ethyl hydroxy benzoate is first dissolved with ethanol in proper amount Add, heating melting stirring 2 hours, turn off steam valve when temperature rises to 80 DEG C.Vacuum system is opened, vacuum should be kept - 0.04 to -0.06Mpa, temperature is kept for 70-80 DEG C, is vacuumized while stirring 1.5-2 hours.Glue is crossed into 100 mesh after end In screen cloth injection heat-preserving container, 50 DEG C of insulations place froth breaking overnight standby；
7th, by above-mentioned glue and content drug solns in being pressed into soft capsule on rolling pattern pellet processing machine, through shape, wash ball, drying, Packaging is produced.
Embodiment 2
1st, raw material prescription ratio：Notopterygium root 15kg, Chinese ephedra 30kg, cassia twig 22.5kg, ching-chieh 22.5kg, windproof 15kg, the root of Dahurain angelica 15kg, Ligusticum wallichii 15kg, grass-leaved sweetflag 7.5kg, root of kudzu vine 22.5kg, peppermint 7.5kg, semen armeniacae amarae 30kg, Radix Angelicae Sinensis 15kg, radix scutellariae 30kg, Balloonflower root 15kg；
2nd, extract：Ching-chieh, peppermint are extracted into volatile oil, and leaching decoction；The taste of remaining notopterygium root etc. 12, is heated with 80% ethanol Backflow is secondary, 2 hours for the first time, second 1 hour, filtration, merging filtrate, reclaims ethanol to without alcohol taste, is closed with above-mentioned filtrate And, it is 1.30 to be concentrated into relative density（50 DEG C of heat are surveyed）Thick paste, be dried under reduced pressure, be ground into fine powder, it is standby；
3rd, content drug solns prescription ratio：Volatile oil 0.31kg, extract powder 25.64kg, polyethylene glycol 400 34.93kg, 1,2 Propane diols 5.24kg, glycerine 5.24kg；
4th, prepared by content drug solns：By PVOH 400,1,2 propane diols, glycerine are sequentially added in dispensing filling, are then added and are carried The volatile oil and extract powder taken, stirs to whole dissolvings, solution is made, standby；
5th, glue prescription ratio：By gelatin 32.65kg, glycerine 13.06kg, water 32.65kg, ethyl hydroxy benzoate 0.033kg, edible color Plain 0.098kg compositions.Wherein gelatin uses the gelatine that subtraction is produced, and it is 199Bloomg that it, which freezes power viscosity,；
6th, prepared by glue：Gelatin, glycerine, water, food coloring are added in Agitation Tank, after ethyl hydroxy benzoate is first dissolved with ethanol in proper amount Add, heating melting stirring 2 hours, turn off steam valve when temperature rises to 80 DEG C.Vacuum system is opened, vacuum should be kept - 0.04 to -0.06Mpa, temperature is kept for 70-80 DEG C, is vacuumized while stirring 1.5-2 hours.Glue is crossed into 100 mesh after end In screen cloth injection heat-preserving container, 50 DEG C of insulations place froth breaking overnight standby；
7th, by above-mentioned glue and decoction in being pressed into soft capsule on rolling pattern pellet processing machine, produced through shaping, washing ball, drying, packaging.
Embodiment 3
1st, raw material prescription ratio：Notopterygium root 15kg, Chinese ephedra 30kg, cassia twig 22.5kg, ching-chieh 22.5kg, windproof 15kg, the root of Dahurain angelica 15kg, Ligusticum wallichii 15kg, grass-leaved sweetflag 7.5kg, root of kudzu vine 22.5kg, peppermint 7.5kg, semen armeniacae amarae 30kg, Radix Angelicae Sinensis 15kg, radix scutellariae 30kg, Balloonflower root 15kg；
2nd, extract：Ching-chieh, peppermint are extracted into volatile oil, and leaching decoction；The taste of remaining notopterygium root etc. 12, is heated with 80% ethanol Backflow is secondary, 2 hours for the first time, second 1 hour, filtration, merging filtrate, reclaims ethanol to without alcohol taste, is closed with above-mentioned filtrate And, it is 1.30 to be concentrated into relative density（50 DEG C of heat are surveyed）Thick paste, be dried under reduced pressure, be ground into fine powder, it is standby；
3rd, content drug solns prescription ratio：Volatile oil 0.28kg, extract powder 26.12kg, polyethylene glycol 400 40.62kg, 1,2 Propane diols 8.12kg, glycerine 4.06kg；
4th, prepared by content drug solns：By PVOH 400,1,2 propane diols, glycerine are sequentially added in dispensing filling, are then added and are carried The volatile oil and extract powder taken, stirs to whole dissolvings, solution is made, standby；
5th, glue prescription ratio：By gelatin 39.53kg, glycerine 19.77kg, water 35.58kg, ethyl hydroxy benzoate 0.04kg, edible color Plain 0.12kg compositions；Wherein gelatin uses the gelatine that subtraction is produced, and it is 196Bloomg that it, which freezes power viscosity,；
6th, prepared by glue：Gelatin, glycerine, water, food coloring are added in Agitation Tank, after ethyl hydroxy benzoate is first dissolved with ethanol in proper amount Add, heating melting stirring 2 hours, turn off steam valve when temperature rises to 80 DEG C.Vacuum system is opened, vacuum should be kept - 0.04 to -0.06Mpa, temperature is kept for 70-80 DEG C, is vacuumized while stirring 1.5-2 hours.Glue is crossed into 100 mesh after end In screen cloth injection heat-preserving container, 50 DEG C of insulations place froth breaking overnight standby；
7th, by above-mentioned glue and decoction in being pressed into soft capsule on rolling pattern pellet processing machine, produced through shaping, washing ball, drying, packaging.
Product stability is tested
We choose the sample of embodiment 1,2,3, the accelerated test for carry out 6 months to it and the long-term stable experiment of 6 months, Further to verify the feasibility of the moulding process and the stability of product quality.
It is specific to investigate method：Take example, simulation listing packaging, respectively in 40 ± 2 DEG C of temperature, relative humidity 75% Under the conditions of taken a sample to check 0,1,2,3, June；In 25 DEG C ± 2 DEG C of room temperature, placed under the conditions of relative humidity 60% ± 10%, in 0,1, 2nd, 3, take a sample to check June, inspection project is appearance character, discriminating, acidity, disintegration time limited, differential difference, assay, micro- life Thing limit（It the results are shown in Table 1-6）
Conclusion：The sample of soft capsule for treating common cold embodiment 1,2,3 is under the conditions of accelerated stability test condition and long-term stable experiment Place, and above-mentioned project of taking a sample to check 0,1,2,3, June, as a result, do not change significantly, particularly no oil leak, extraction Thing precipitation, aggregation caking phenomenon, meet regulation.
Subordinate list 1
Soft capsule for treating common cold accelerated test is reported
The sample of embodiment 1：Soft capsule for treating common cold
Subordinate list 2
Soft capsule for treating common cold long-term stable experiment is reported
The sample of example 1：Soft capsule for treating common cold
Subordinate list 3
Soft capsule for treating common cold accelerated test is reported
The sample of example 2：Soft capsule for treating common cold
Subordinate list 4
Soft capsule for treating common cold long-term stable experiment is reported
The sample of example 2：Soft capsule for treating common cold
Subordinate list 5
Soft capsule for treating common cold accelerated test is reported
The sample of example 3：Soft capsule for treating common cold
Subordinate list 6
Soft capsule for treating common cold long-term stable experiment is reported
The sample of example 3：Soft capsule for treating common cold

Claims (3)

1. a kind of preparation technology of soft capsule for treating common cold, described preparation technology includes the preparation and extraction of raw material, decoction, glue Preparation and pelleting, sizing, drying, technology of the package；Ching-chieh in raw material, peppermint are extracted into volatile oil, and leaching decoction； Notopterygium root in raw material, Chinese ephedra, cassia twig, the windproof, root of Dahurain angelica, Ligusticum wallichii, grass-leaved sweetflag, the root of kudzu vine, semen armeniacae amarae, Radix Angelicae Sinensis, radix scutellariae, balloonflower root are used 80% ethanol is heated to reflux secondary, filtration merging filtrate, reclaims ethanol to without alcohol taste, merges with decoction, be concentrated to give medicinal extract, depressurizes It dry, pulverize into extract powder；It is characterized in that：Using described extract powder and volatile oil as extract and content matrix with 1: 1.5~2 ratio mixing, and extract is substantially dissolved in the content drug solns that content Medium Culture obtains homogeneous；It is described Content matrix be 2 propane diols, the water-soluble base of glycerine composition by polyethylene glycol 400,1, its mass ratio is：Poly- second two Alcohol 400:1,2 propane diols:Glycerine=1：0.1~0.2：0.1~0.2；Wherein, 1,2 propane diols and glycerine are as to dissolve medicinal extract The cosolvent of powder；Prepare glue；By the glue and content drug solns with 1~1.2:1 ratio is on rolling pattern pellet processing machine Soft capsule is pressed into, is produced through shaping, washing ball, drying, packaging.
2. a kind of preparation technology of soft capsule for treating common cold as claimed in claim 1, it is characterised in that：The composition and ratio of the glue Example：It is made up of gelatin, glycerine, water, ethyl hydroxy benzoate, food coloring；Its mass ratio is：Gelatin:Glycerine:Water:Ethyl hydroxy benzoate:It is edible Pigment=1:0.3~0.5:0.9~1.1:0.001:0.003；Described gelatin uses the gelatine that subtraction is produced, and it freezes power viscosity In 190~200Bloomg.
3. a kind of preparation technology of soft capsule for treating common cold as claimed in claim 1, it is characterised in that：Described raw material includes Qiang Work, Chinese ephedra, cassia twig, ching-chieh, the windproof, root of Dahurain angelica, Ligusticum wallichii, grass-leaved sweetflag, the root of kudzu vine, peppermint, semen armeniacae amarae, Radix Angelicae Sinensis, radix scutellariae, balloonflower root.
CN201710499345.XA 2017-06-27 2017-06-27 A kind of preparation technology of soft capsule for treating common cold Pending CN107158178A (en)

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Application publication date: 20170915