CN104906282B - A kind of soft capsule preparation and preparation method thereof of anti-flu compound Chinese medicine extract phosphatide complexes - Google Patents
A kind of soft capsule preparation and preparation method thereof of anti-flu compound Chinese medicine extract phosphatide complexes Download PDFInfo
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Abstract
The invention discloses a kind of soft capsule preparations and preparation method thereof of anti-flu compound Chinese medicine extract phosphatide complexes.The compound is by campanulaceae, ramulus cinnamomi, Rhizoma Et Radix Notopterygii, Chinese ephedra, radix scutellariae, pueraria lobata, semen armeniacae amarae, the root of Dahurain angelica, Radix Angelicae Sinensis, radix saposhnikoviae, the root of Dahurain angelica, Rhizoma Chuanxiong, rhizoma acori graminei, 14 taste Chinese medicinal composition of peppermint, after an ethyl alcohol extracts, phosphatide is added and is prepared as compound Chinese medicine extract phosphatide complexes.The present invention passes through phosphatide complexes technology, hence it is evident that improves the water dispersible of 14 taste Chinese medical extracts and fat-soluble, proper auxiliary materials are added on this basis and are prepared into soft capsule preparation, said preparation dissolution rate is high, bioavilability is high, and quality is stablized, and has effects that dispelling wind and heat, analgesia removing toxic substances；The preparation method simple process is reasonable, and yield is high, with short production cycle, is suitable for large-scale production.
Description
Technical field
The present invention relates to it is anti-flu compound Chinese medicine extract phosphatide complexes soft capsule preparation and preparation method thereof,
Belong to Chinese medicine phosphatide complexes and its preparation technique field.
Technical background
Flu, cardinal symptom is headache, fever, nasal obstruction, runny nose etc., although being a kind of common disease, to the life of people
Living and work brings serious influence, while easily causing many complication, threatens to life zone.Currently, on domestic market
The Chinese materia medica preparation dosage form of common treatment flu falls behind, and simple process, the method taken mostly is simply extracted to Chinese medicine
The dosage forms such as capsule, tablet, powder, pill and oral solution are directly prepared into after obtaining Chinese medical extract.Such preparation process is past
Toward the whole drug effects that cannot play Chinese medical extract, causes Chinese materia medica preparation dose big, work the defects of slow.
Phosphatide complexes are the novel forms received significant attention in recent years, are a kind of drug delivery systems using phosphatide as carrier
System.Many studies have shown that having special affinity between the natural component and phosphatide of many types, mainly it is considered with hydrogen bond
It combines.The biological nature and physicochemical property of phosphatide complexes have different degrees of change compared with ultimate constituent, have stronger moisture
Property and fat-soluble is dissipated, the absorption of natural component in vivo can be effectively improved, significantly improve its bioavilability.
The present invention is compound by compound Chinese medicine extract and phosphatide using phosphatide complexes technology and forms carrier system, and will
Extraction process and phosphatide recombination process are combined together, and the phosphatide complexes of preparation improve the lipophilicity and water dispersion of ultimate constituent
Property, reduce production process.It is prepared into soft capsule preparation on this basis, phosphatide complexes quality can not only be kept to stablize,
Patient compliance is improved, while can preferably prevent volatile ingredients from lossing, therefore compound Chinese medicine extract phosphatide is compound
Object is prepared into soft capsule preparation, and preparation process advantages of simple, yield is high, with short production cycle, while being conducive to improve its treatment sense
The effect emitted.
Summary of the invention
The present invention provides a kind of soft capsule preparation of anti-flu compound Chinese medicine extract phosphatide complexes and its preparation sides
Method, the composition component weight proportion composition are as follows:
6 parts of Rhizoma Et Radix Notopterygii
6 parts of the root of Dahurain angelica
12 parts of semen armeniacae amarae
12 parts of Chinese ephedra
9 parts of ramulus cinnamomi
9 parts of ching-chieh
6 parts of radix saposhnikoviae
6 parts of Rhizoma Chuanxiong
3 parts of rhizoma acori graminei
9 parts of pueraria lobata
3 parts of peppermint
6 parts of Radix Angelicae Sinensis
12 parts of radix scutellariae
6 parts of campanulaceae
Phosphatidase 2 ~ 6 part
The soft capsule preparation of anti-flu compound Chinese medicine extract phosphatide complexes of the present invention is by softgel shell and content
Object composition, technical solution are as follows:
1. dry: medicinal material being dried using band drier, Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 ~ 60 DEG C of maximum temperature is dried, other medicinal materials set 70 ~ 80 DEG C of drying temperature, 200 ~ 300 revs/min of setting speed, need to
Dry medicinal material is set on band drier conveyer belt, is dried.
2. volatile oil extracting: according to ratio given herein above, 3 will be added in the ching-chieh of recipe quantity, peppermint investment extractor
The drinking water of ~ 5 times of medicinal material total amounts extracts 3 ~ 4 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.
3. primary extract: by the net medicinal material investment extractor of remaining 12 taste of recipe quantity, configuring 80% ethyl alcohol, measure medicinal material
80% ethyl alcohol of 6 times of amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
It opens, refluxing extraction 2 hours (70 ~ 80 DEG C of temperature in control tank).
4. back flow reaction: measuring 5 times of 80% ethyl alcohol of medicinal material again and squeeze into extractor, and put into recipe quantity phosphatide, will extract
Tank interlayer steam valve is opened, while corresponding return valve being opened, and (controls temperature 70 ~ 80 in tank within back flow reaction 1 ~ 3 hour
DEG C).
5. concentration: closing and extract jacket steam valve, the pipeline valve that extractor is connected with inspissator is opened, and will be extracted
Liquid is put into inspissator, combined extract, stops recycling when recycling ethyl alcohol to no alcohol taste.Recovered liquid merges with medical fluid after leaching
Afterwards, continuing to be concentrated under reduced pressure into relative density is 1.30 ~ 1.50(50 DEG C) thick paste.
6. vacuum drying: medicinal extract is respectively charged into clean basin, it is dry with vacuum oven, drying temperature 70 ~
80 DEG C, 0.04 ~ 0.06Mpa of vacuum degree, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken out, is cooled, is weighed.
7. by the crushing unit co-grinding of the dry cream after drying, 100 mesh of disintegrator sieving net.Be added gained volatile oil and
Corresponding auxiliary material mixes, soft capsule preparation is made.
The soft capsule preparation of above-mentioned anti-flu compound Chinese medicine extract phosphatide complexes, it is characterised in that: 14 taste Chinese medicines
Total amount of feeding and phosphatide mass ratio be 52.5:1 ~ 17.5:1；Content accounts for 30% ~ 70%, and corresponding auxiliary material accounts for 70% ~ 30%,
Optimum proportioning range is 1:0.5 ~ 1:2；Auxiliary material can be one of surfactant, preservative, suspending agent, antioxidant or several
Kind；Gelatin and glycerol proportion are 1:1 ~ 5:1 in soft capsule shell.
The surfactant is one or more of polyethylene glycols, tween, propylene glycol, water, vegetable oil；Suspending agent
For one or more of xanthan gum, oily wax, beeswax, hydroxypropyl methyl cellulose；Antioxidant be ascorbic acid, malic acid,
One or more of succinic acid, ethylenediamine tetra-acetic acid；Preservative be glycerine, benzoic acid, sorbic acid, benzyl alcohol, to hydroxyl
One or more of butyl benzoate.
Compound Chinese medicine extract phosphatide complexes and auxiliary material mixture be wrapped in soft capsule shell by the present invention to be made
Medicine soft capsule preparation.Phosphatide is added during refluxing extraction in the present invention, to 14 taste Chinese medicines carry out ethyl alcohol extraction, while phosphatide with
Chinese medical extract reacts, and forms Chinese medicine phosphatide complexes, improves the water dispersible of Chinese medical extract and fat-soluble.In this base
Proper auxiliary materials are added on plinth and are prepared into soft capsule preparation, said preparation dissolution rate is high, and bioavilability is high, and quality is stablized, and overcomes
The defect of existing preparation；The preparation method simple process is reasonable, and yield is high, with short production cycle, is suitable for large-scale production.
Specific embodiment
To facilitate the understanding of the present invention, especially exemplified by following embodiment.Its act on be understood to be to explaination of the invention and
It is non-to any type of limitation of the invention.
Embodiment 1
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 DEG C of maximum temperature is dried, other medicinal materials set 70 DEG C of drying temperature, 200 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 3 times of medicinal material total amounts is added, extracts 3 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (temperature 70 C in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 20g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 3 hours
Temperature 70 C in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.30(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 70 DEG C of drying temperature, vacuum degree 0.04Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 2
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 60 DEG C of maximum temperature is dried, other medicinal materials set 80 DEG C of drying temperature, 300 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 5 times of medicinal material total amounts is added, extracts 4 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (80 DEG C of temperature in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 10g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 3 hours
80 DEG C of temperature in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.50(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 80 DEG C of drying temperature, vacuum degree 0.06Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 3
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 DEG C of maximum temperature is dried, other medicinal materials set 70 DEG C of drying temperature, 200 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 4 times of medicinal material total amounts is added, extracts 3 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (temperature 70 C in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 30g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 3 hours
Temperature 70 C in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.40(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 70 DEG C of drying temperature, vacuum degree 0.05Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 4
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 60 DEG C of maximum temperature is dried, other medicinal materials set 80 DEG C of drying temperature, 300 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 3 times of medicinal material total amounts is added, extracts 4 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (80 DEG C of temperature in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 20g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 1 hour
80 DEG C of temperature in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.30(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 80 DEG C of drying temperature, vacuum degree 0.04Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 5
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 DEG C of maximum temperature is dried, other medicinal materials set 70 DEG C of drying temperature, 200 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 5 times of medicinal material total amounts is added, extracts 3 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (temperature 70 C in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 10g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 1 hour
Temperature 70 C in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.50(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 70 DEG C of drying temperature, vacuum degree 0.06Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 6
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 60 DEG C of maximum temperature is dried, other medicinal materials set 80 DEG C of drying temperature, 300 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 4 times of medicinal material total amounts is added, extracts 4 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (80 DEG C of temperature in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 30g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 1 hour
80 DEG C of temperature in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.40(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 80 DEG C of drying temperature, vacuum degree 0.05Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 7
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 DEG C of maximum temperature is dried, other medicinal materials set 70 DEG C of drying temperature, 200 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 3 times of medicinal material total amounts is added, extracts 3 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (temperature 70 C in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 20g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 2 hours
Temperature 70 C in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.30(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 70 DEG C of drying temperature, vacuum degree 0.04Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 8
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 60 DEG C of maximum temperature is dried, other medicinal materials set 80 DEG C of drying temperature, 300 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 5 times of medicinal material total amounts is added, extracts 4 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (80 DEG C of temperature in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 10g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 2 hours
80 DEG C of temperature in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.50(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 80 DEG C of drying temperature, vacuum degree 0.06Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 9
The preparation of phosphatide complexes dry cream: being dried medicinal material, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong are set
Surely 50 DEG C of maximum temperature is dried, other medicinal materials set 70 DEG C of drying temperature, 200 revs/min of setting speed, need to dry medicinal material and set
On band drier conveyer belt, it is dried.It, will be in 45g ching-chieh, 15g peppermint investment extractor according to ratio given herein above
The drinking water of 4 times of medicinal material total amounts is added, extracts 3 hours (boiling starts timing), while opening and collecting volatile oil device, uses water
Vapor distillation method extracts volatile oil.By in the net medicinal material investment extractor of remaining 12 taste of recipe quantity, 80% ethyl alcohol is configured, medicine is measured
80% ethyl alcohol of 6 times of material amounts, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while by corresponding return valve
Door is opened, and refluxing extraction 2 hours (temperature 70 C in control tank).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and is thrown
Enter 30g phosphatide, extractor jacket steam valve is opened, while corresponding return valve being opened, back flow reaction (control in 2 hours
Temperature 70 C in tank).Combined extract stops recycling when recycling ethyl alcohol to no alcohol taste.After recovered liquid merges with medical fluid after leaching,
Continuing to be concentrated under reduced pressure into relative density is 1.40(50 DEG C) thick paste.Medicinal extract is respectively charged into clean basin, uses vacuum
Drying box is dry, and 70 DEG C of drying temperature, vacuum degree 0.05Mpa, medicinal extract becomes dry cream, dry to stop, and dried dry cream is taken
Out, it cools, weighs.
Embodiment 10
The preparation of common dry cream: whole preparation process is added without phosphatide, and other methods are identical with embodiment 1.To medicine
Material is dried, and Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong set dry 50 DEG C of maximum temperature, and other medicinal material settings are dry
Dry temperature 70 C, need to dry medicinal material and set on band drier conveyer belt, be dried by 200 revs/min of setting speed.According to
Ratio given herein above will be added the drinking water of 3 times of medicinal material total amounts, it is small to extract 3 in 45g ching-chieh, 15g peppermint investment extractor
When (boiling start timing), while opening and collecting volatile oil device, extract volatile oil with steam distillation.By recipe quantity residue
12 tastes net medicinal material investment extractor in, configure 80% ethyl alcohol, measure 80% ethyl alcohol of 6 times of medicinal material amounts, ethyl alcohol is put into extractor
It is interior, extractor jacket steam valve is opened, while corresponding return valve being opened, (controls temperature in tank within refluxing extraction 2 hours
70 DEG C).5 times of 80% ethyl alcohol of medicinal material is measured again to squeeze into extractor, and extractor jacket steam valve is opened, while will return accordingly
It flows valve to open, back flow reaction 3 hours (temperature 70 C in control tank).Combined extract stops when recycling ethyl alcohol to no alcohol taste
Recycling.After recovered liquid merges with medical fluid after leaching, continuing to be concentrated under reduced pressure into relative density is 1.30(50 DEG C) thick paste.By medicinal extract
It is respectively charged into clean basin, dry with vacuum oven, 70 DEG C of drying temperature, vacuum degree 0.04Mpa, medicinal extract becomes dry
Cream, it is dry to stop, dried dry cream is taken out, is cooled, is weighed.
Embodiment 11
The preparation of soft capsule: the dry cream crushing unit co-grinding by embodiment 1 and embodiment 10 after dry respectively, powder
Broken 100 mesh of machine sieve.Gained volatile oil, the soybean oil containing beeswax is added, mixes, be made soft capsule preparation 300 to get.Medicine
Object and auxiliary material parts by weight are as shown in table 1:
1 drug of table and auxiliary material parts by weight form table
Form parts by weight
Drug (pressing total medicinal powder meter) 5
Beeswax 0.5
Soybean oil 4
Softgel shell prescription: gelatin 15g, glycerol 15g, water 30g, titanium dioxide 0.2g.
Embodiment 12
The preparation of soft capsule: the dry cream crushing unit co-grinding by embodiment 1 and embodiment 10 after dry respectively, powder
Broken 100 mesh of machine sieve.Gained volatile oil, the soybean oil containing beeswax is added, mixes, be made soft capsule preparation 300 to get.Medicine
Object and auxiliary material parts by weight are as shown in table 2:
2 drug of table and auxiliary material parts by weight form table
Form parts by weight
Drug (pressing total medicinal powder meter) 5
Polyethylene glycol 400 5.5
Glycerine 0.5
Ascorbic acid 0.02
Beeswax 0.02
Tween 80 0.1
Softgel shell prescription: gelatin 25g, glycerol 12g, water 25g, titanium dioxide 0.1g.
Embodiment 13
The preparation of soft capsule: the dry cream crushing unit co-grinding by embodiment 1 and embodiment 10 after dry respectively, powder
Broken 100 mesh of machine sieve.Gained volatile oil, the soybean oil containing beeswax is added, mixes, be made soft capsule preparation 300 to get.Medicine
Object and auxiliary material parts by weight are as shown in table 3:
3 drug of table and auxiliary material parts by weight form table
Form parts by weight
Drug (pressing total medicinal powder meter) 5
Soybean oil 5.2
Glycerine 0.7
Sorbic acid 0.12
Butyl p-hydroxybenzoate 0.12
Softgel shell prescription: gelatin 50g, glycerol 10g, water 30g, titanium dioxide 0.15g.
Embodiment 14
The present embodiment is using anti-flu compound Chinese medicine extract phosphatide complexes soft capsule prepared by embodiment 13 and general
Logical compounded anti-cold compound Chinese medicine extract soft capsule, carries out disintegration time limited experiment, and 10 wherein qualified measurements is arbitrarily taken to collapse
The time limit is solved, using marketed tablet as control, the results are shown in Table 4.
4 disintegration time mensuration result of table
Group disintegration time limited (minute)
Phosphatide complexes soft capsule 12.5 ± 0.6
Common soft capsule 17.3 ± 1.1
Marketed tablet 31 ± 1.4
Embodiment 15
The present embodiment is using anti-flu compound Chinese medicine extract phosphatide complexes soft capsule prepared by embodiment 13 and general
Logical compounded anti-cold compound Chinese medicine extract soft capsule, carries out anti-inflammatory effect research:
Experimental animal, using 4 week old female KM system mouse, 20 ± 2g of weight, raising is alternately followed in 12h day/night
In the environment of ring, 20 ± 1 DEG C of temperature, humidity 55 ± 10%, rate of ventilation 20 ± 2 times/when, the pellet of feeding standard, freely
It ingests and drinks water.50 female mices are randomly divided into the 5 groups: 1st group as blank control group；2nd group be model group, blank group and
Model group stomach-filling same amount of normal saline；3rd group is phosphatide complexes soft capsule group (4g crude drug/kg)；4th group is common soft capsule
Group (4g crude drug/kg)；5th group is positive controls, gives aspirin 50mg/kg.
After last dose 30min, 0.02mL dimethylbenzene is uniformly applied to the left auricle two sides of mouse and causes inflammation by etherization,
Auris dextra is not painted with control, and the left auricle of blank control group applies physiological saline.Neck execution animal is taken off after causing inflammation 1h, with beating for diameter 6mm
Two ear of every mouse or so is laid round auricle, electronic balance weighing, auricle swelling degree (mg)=left auricle at same position respectively by hole device
Quality-auris dextra tablet quality.
The influence (x ± s, n=10) of 5 each group paraxylene of table cause mice auricle swelling
Compared with blank group,##P<0.01；Compared with model group, P < 0.01 * P < 0.05, * *；n=10
Compared to the blank group, the left ear of model group subtracts auris dextra weight and dramatically increases (P < 0.01) for this experiment.With model group phase
Than, phosphatide complexes soft capsule group and common soft capsule group can significantly mitigate mice auricle swelling caused by dimethylbenzene (P <
0.05), anti-inflammatory effect is preferable, and wherein the former effect is better than the latter.Phosphatide complexes soft capsule group and positive control medicine Ah Si
Forest form ratio, antiphlogistic effects are close.This experiment shows anti-flu compound Chinese medicine extract phosphatide complexes soft capsule of the invention
With preferable antiphlogistic effects.
Embodiment 16
The present embodiment is using anti-flu compound Chinese medicine extract phosphatide complexes soft capsule prepared by embodiment 13 and general
Logical compounded anti-cold compound Chinese medicine extract soft capsule, carries out refrigeration function research:
Experimental animal, using 4 week old rabbit, 20 ± 2g of weight is raised in the environment of 12h day/night alternate cycles,
20 ± 1 DEG C of temperature, humidity 55 ± 10%, rate of ventilation 20 ± 2 times/when, the pellet of feeding standard freely ingests and drinks water.
By 32 rabbit, 18 DEG C of measurement anus temperature, measure 1 time every 1h, survey 5 times altogether at room temperature.5 times mean body temperature difference is no more than 0.5
DEG C rabbit be qualified rabbit.Qualified rabbit is randomly divided into 3 groups, every group 8.4 groups are respectively positive controls aspirin
(4g is raw for (50mg/kg), negative control group (physiological saline 10mL/kg), phosphatide complexes soft capsule group and common soft capsule group
Medicine/kg).After every rabbit injection the first and second triple vaccine of typhoid fever 10mL/kg, it is administered immediately by above-mentioned administration mode.As a result
It has been shown that, vaccinates in 1 ~ 6h, administration group is compared with saline control group, and there were significant differences, wherein phosphatide complexes flexible glue
Capsule group is similar to the effect of positive control drug aspirin, is better than common soft capsule group.This experiment shows that anti-flu of the invention is multiple
Square Chinese medical extract phosphatide complexes soft capsule has preferable antipyretic response.
Claims (5)
1. a kind of preparation method of the soft capsule preparation of anti-flu compound Chinese medicine extract phosphatide complexes, the anti-flu compound
The soft capsule preparation of Chinese medical extract phosphatide complexes, including the following raw material medicine ingredient: Rhizoma Et Radix Notopterygii, the root of Dahurain angelica, semen armeniacae amarae, Chinese ephedra, osmanthus
Branch, ching-chieh, radix saposhnikoviae, Rhizoma Chuanxiong, rhizoma acori graminei, pueraria lobata, peppermint, Radix Angelicae Sinensis, radix scutellariae, campanulaceae；In addition, also there is phosphatide in the capsule,
The phosphatide can be one or more of soybean lecithin, egg yolk lecithin, phosphatidyl choline, phosphatidyl-ethanolamine；In 14 tastes
The total amount of feeding of medicine and the mass ratio of phosphatide are 52.5:1~17.5:1；The weight proportion composition of the bulk pharmaceutical chemicals is as follows: Rhizoma Et Radix Notopterygii 6
Part, 6 parts of the root of Dahurain angelica, 12 parts of semen armeniacae amarae, 12 parts of Chinese ephedra, 9 parts of ramulus cinnamomi, 9 parts of ching-chieh, 6 parts of radix saposhnikoviae, 6 parts of Rhizoma Chuanxiong, 3 parts of rhizoma acori graminei, Pueraria lobota
9 parts of root, 3 parts of peppermint, 6 parts of Radix Angelicae Sinensis, 12 parts of radix scutellariae, 6 parts of campanulaceae, phosphatidase 2~6 part；
It is characterized in that, the preparation method the following steps are included:
(1) dry: medicinal material to be dried using band drier, Radix Angelicae Sinensis, the root of Dahurain angelica, rhizoma acori graminei, radix saposhnikoviae, Rhizoma Chuanxiong setting are dry
50~60 DEG C of dry maximum temperature, other medicinal materials set 70~80 DEG C of drying temperature, 200~300 revs/min of setting speed, need to
Dry medicinal material is set on band drier conveyer belt, is dried；
(2) volatile oil extracting: drinking for 3~5 times of medicinal material total amounts will be added in the ching-chieh of recipe quantity, peppermint investment extractor
Water extracts 3~4 hours, while opening and collecting volatile oil device, extracts volatile oil with steam distillation；
(3) primary to extract: by the net medicinal material investment extractor of remaining 12 taste of recipe quantity, to configure 80% ethyl alcohol, measure 6 times of medicinal material
80% ethyl alcohol of amount, ethyl alcohol is put into extractor, extractor jacket steam valve is opened, while corresponding return valve being beaten
It opens, refluxing extraction 2 hours；
(4) back flow reaction: 5 times of 80% ethyl alcohol of medicinal material is measured again and is squeezed into extractor, and puts into recipe quantity phosphatide, extractor is pressed from both sides
Layer steam valve is opened, while corresponding return valve being opened, back flow reaction 1~3 hour；
(5) it is concentrated: closing and extract jacket steam valve, the pipeline valve that extractor is connected with inspissator is opened, and extracting solution is put
Enter in inspissator, combined extract, stops recycling when recycling ethyl alcohol to no alcohol taste, after recovered liquid merges with medical fluid after leaching, after
The continuous thick paste for being concentrated under reduced pressure into relative density and being 1.30~1.50；
(6) it is dried in vacuo: medicinal extract being respectively charged into clean basin, drying temperature 50~60 dry with vacuum oven
DEG C, 0.04~0.06Mpa of vacuum degree, medicinal extract becomes dry cream, and it is dry to stop, dried dry cream is taken out, is cooled, is weighed；
(7) volatile oil obtained by step (2) is added with unit co-grinding, 100 mesh of disintegrator sieving net is crushed in the dry cream after drying
And corresponding auxiliary material, it mixes, soft capsule preparation is made.
2. preparation method as described in claim 1, it is characterised in that: auxiliary material is surfactant, preservative, suspending agent, resists
One or more of oxidant.
3. preparation method as claimed in claim 2, it is characterised in that: content accounts for 30%~70%, and corresponding auxiliary material accounts for 70%
~30%, ratio range is 1:0.5~1:2.
4. preparation method as claimed in claim 3, it is characterised in that: gelatin and glycerol proportion are 1:1~5 in soft capsule shell:
1。
5. preparation method as claimed in claim 4, it is characterised in that: the surfactant is polyethylene glycols, tween, third
One or more of glycol, water, vegetable oil；Suspending agent is xanthan gum, oily wax, beeswax, one in hydroxypropyl methyl cellulose
Kind is several；Antioxidant is one or more of ascorbic acid, malic acid, succinic acid, ethylenediamine tetra-acetic acid；Preservative is
One or more of glycerine, benzoic acid, sorbic acid, benzyl alcohol, butyl p-hydroxybenzoate.
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Denomination of invention: A soft capsule preparation of phospholipid complex of anti cold compound traditional Chinese medicine extract and its preparation method Effective date of registration: 20220713 Granted publication date: 20190830 Pledgee: Tonghua Branch of China Everbright Bank Co.,Ltd. Pledgor: JILIN TONGHUA BOXIANG PHARMACEUTICAL Co.,Ltd. Registration number: Y2022220000033 |
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