CN106420656B - A kind of trollflower effervescent tablet and preparation method thereof - Google Patents

A kind of trollflower effervescent tablet and preparation method thereof Download PDF

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CN106420656B
CN106420656B CN201611055830.XA CN201611055830A CN106420656B CN 106420656 B CN106420656 B CN 106420656B CN 201611055830 A CN201611055830 A CN 201611055830A CN 106420656 B CN106420656 B CN 106420656B
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trollflower
effervescent tablet
trollflower effervescent
ethyl alcohol
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CN106420656A (en
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高旭华
高仪
王飞
王一飞
廖晓凤
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Guangdong Dapeng Medicine Technology Co Ltd
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Guangdong Dapeng Medicine Technology Co Ltd
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    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
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    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention belongs to field of medicaments, and in particular to a kind of trollflower effervescent tablet and preparation method thereof.Trollflower effervescent tablet provided by the invention is mainly made of lily feet pollen, Coixol, syringic acid, sorbierite, xanthans, sodium citrate and sodium bicarbonate.Trollflower effervescent tablet formula provided by the invention rationally, science, the effect of mutually coordinated of each component is clearing heat and detoxicating, promoting blood circulation and removing blood stasis and anti-inflammatory analgesic, there is significant improvement result to idiopathic pulmonary fibrosis disease, can greatly mitigate the pain of idiopathic pulmonary fibrosis.And trollflower effervescent tablet provided by the invention has stable quality, safe, and the low advantage of production cost is conducive to the promotion and application of the effervescent tablet.

Description

A kind of trollflower effervescent tablet and preparation method thereof
Technical field
The invention belongs to field of medicaments, and in particular to a kind of trollflower effervescent tablet and preparation method thereof.
Background technology
Trollflower is the flower of Ranunculaceae herbaceos perennial China trollflower (Trollius chinensis Bge.), Alias gold pimple, globe-flower are grown on the hillside grass of the regional height above sea level 1000-2200m such as northern Hebei, Shanxi, Southern Nei Mongol Under slope, sparse woods or in the thick grass of marsh.Trollflower is used as medicine with flower, and cool in nature, bitter has clearing heat and detoxicating, antibacterial anti-inflammatory function, to pneumonia Diplococcus, Pseudomonas aeruginosa, micrococcus catarrhalis etc. have compared with high inhibition act on, to acute and chronic tonsillitis, pharyngitis, otitis media acuta, The diseases such as conjunctivitis and the infection of the upper respiratory tract have preferable therapeutic effect.Trollflower contains abundant nutriment, contains Huang Ketones component orientoside, Vitexina, also contain alkaloid, resin, palmitic acid, cumarin and its glycosides, sugar and polysaccharide, volatile oil, Tannin and a variety of phytosterin compounds.Trollflower it is not only pharmaceutically acceptable but also can tea use, also larger ornamental value, therefore, people couple The application of trollflower is more and more extensive.
Chinese patent CN1073360C discloses a kind of Trollflower health-care tea, and the health protection tea is by trollflower, lotus flower, fat big Sea, Radix Ophiopogonis, plantain seed, hawthorn, malt, sea-buckthorn and sugar composition, the Trollflower health-care tea being prepared, which can be used for treating, exhales It inhales road and infects, lower part of the body edema patient hoarse with noise, be a kind of ideal health beverages.
Chinese patent application 201510899748.4 discloses a kind of Trollflower beverage and preparation method thereof, the trollflower Beverage is mainly by trollflower, fructose syrup, Radix Glycyrrhizae, jujube, honey, concentrated lemon juice, concentrated lemon juice sodium, concentrated orange juice, D- Sodium ascorbate, thickener, salt and pure appropriate amount of water.The Trollflower beverage being prepared has certain blood pressure lowering, drop blood Sugar, reducing blood lipid, it is anti-oxidant, enhance human immunity, adjust function of human body balance, beautifying face and moistering lotion health-care efficacy, be a kind of ideal Functional beverage.
Effervescent agent be it is a kind of chance water can release great amount of carbon dioxide gas and reach fater disintegration effect novel troche.It should Dosage form has rapid dissolving, absorbs soon, and bioavilability is high, and carries, is easy to use, the advantages of being evenly distributed in water, has both The characteristics of solid pharmaceutical preparation and liquid preparation, be a kind of ideal tablet.
Chinese patent CN1315500C discloses a kind of trollflower effervescent tablet and preparation method thereof, and the effervescent tablet is by lily feet Flower leaching powder, sour agent, alkaline agent, corrigent, filler and lubricant composition.The preparation method of trollflower leaching powder is:Take lily feet Flower plus 12 times amount water decoct three times, collecting decoction, be dried under reduced pressure to get.The trollflower effervescent tablet being prepared has biology profit Expenditure is high, and work rapid, convenient to take, in good taste and transport, advantage easy to carry.
However, that there are stability in transportational process is poor for current trollflower effervescent tablet, active ingredient degradation is fast, shape It is imperfect, the defects of loss of gloss, seriously affect the presentation quality of the trollflower effervescent tablet.
Invention content
In order to solve defect existing for trollflower effervescent tablet in the prior art, the purpose of the present invention is to provide a kind of lily feets Flower effervescent tablet and preparation method thereof, the trollflower effervescent tablet have it is in good taste, stable quality, convenient for taking the advantages of.
The present invention provides a kind of trollflower effervescent tablets, including following component and its parts by weight:
40-60 parts of lily feet pollen, 20-30 parts of Coixol, 10-22 parts of syringic acid, 15-30 parts of sorbierite, xanthans 8-12 8-12 parts of part, 2-6 parts of sodium citrate and sodium bicarbonate.
Further, the trollflower effervescent tablet includes following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 22 parts of sorbierite, 10 parts of xanthans, 4 parts of sodium citrate With 10 parts of sodium bicarbonate.
Further, the preparation method of the lily feet pollen is:Fresh trollflower is cleaned, it is dense to be put into percent by volume Degree is in the ethyl alcohol of 75-85%, and the additive amount of the ethyl alcohol is 8-12 times of the trollflower weight, refluxing extraction 45- 60min, filtering, obtains extracting solution, and extracting solution is recovered under reduced pressure ethyl alcohol and concentrated extracting solution, it is dry to get.
Further, the Extracting temperature is 75-85 DEG C, and preferred Extracting temperature is 76-80 DEG C.
Further, the drying temperature is 45-55 DEG C.
In addition, the present invention also provides a kind of preparation method of trollflower effervescent tablet, include the following steps:
S1 cleans fresh trollflower, is put into the ethyl alcohol that concentration of volume percent is 75-85%, the ethyl alcohol adds Dosage is 8-12 times of the trollflower weight, and refluxing extraction 45-60min is filtered, obtained extracting solution, extracting solution is recovered under reduced pressure Ethyl alcohol and concentrated extracting solution, it is dry, obtain lily feet pollen;
The lily feet pollen that step S1 is obtained is sufficiently stirred by S2 with Coixol and syringic acid, obtains mixture;
Step S2 is obtained mixture and is uniformly mixed with sorbierite, xanthans, sodium citrate and sodium bicarbonate by S3, opposite Humidity be 20-30% environment in carry out tabletting to get.
Further, Extracting temperature is 75-85 DEG C in the step S1, and preferred Extracting temperature is 76-80 DEG C.
Further, drying temperature is 45-55 DEG C in the step S1.
In addition to this, the present invention also provides the trollflower effervescent tablets to prepare auxiliary treatment idiopathic pulmonary fibrosis Application in drug.
Trollflower (Trollius chinensis Bunge) in trollflower effervescent tablet provided by the invention has heat-clearing The effect of removing toxic substances, antibacterial anti-inflammatory, for treating chronic tonsillitis, the diseases such as otitis media acuta, acute conjunctivitis;Syringic acid Entitled 3, the 5- dimethoxy-4 's-hydroxybenzoic acid of chemistry, No. CAS is 530-57-4;The chemical formula of Coixol is C8H7NO3, English Entitled Coixol, No. CAS is 532-91-2.Trollflower effervescent tablet formula provided by the invention rationally, science, each component mutually assists The effect of having adjusted clearing heat and detoxicating, promoting blood circulation and removing blood stasis and anti-inflammatory analgesic has significant improvement result to idiopathic pulmonary fibrosis disease, can Greatly to mitigate the pain of idiopathic pulmonary fibrosis.
Trollflower effervescent tablet provided by the invention can significantly reduce the paragonimus cyst of idiopathic pulmonary fibrosis model, and It reduces the effect of paragonimus cyst and the effect of pirfenidone capsule is good.Meanwhile trollflower effervescent tablet provided by the invention can be with The significant LN contents for reducing idiopathic pulmonary fibrosis model illustrate that trollflower effervescent tablet provided by the invention is fine to idiopathic lung Dimensionization has significant improvement result.
Further, trollflower effervescent tablet provided by the invention can significantly improve idiopathic pulmonary fibrosis rat model Pulmonary alveolitis, macrophage foam cell formation sample change, fibrocyte activation and the symptoms such as collagen fiber hyperplasia, to idiopathic pulmonary fibrosis With good improvement result, it is more advantageous to the rehabilitation of idiopathic pulmonary fibrosis.
Further, the trollflower effervescent tablet that prepared by the present invention is in (25 ± 2) DEG C, the condition of relative humidity (60 ± 10) % Lower to place 18 months, character is bright and clean, and weight differential meets regulation, and disintegration time and average gas release are substantially unchanged, have Higher stability illustrates pears alcohol, xanthans and mutually coordinated of sodium citrate in trollflower effervescent tablet provided by the invention The stability action for enhancing trollflower effervescent tablet can greatly improve the stability of trollflower effervescent tablet, improve trollflower bubble Rise the presentation quality of piece.
In addition, the alkaline disintegrant of effervescent tablet prepared by the present invention is sodium carbonate, acid disintegrant is sodium citrate and fourth Fragrant acid, it is possible to reduce the dosage of auxiliary material reduces production cost.
In addition to this, trollflower effervescent tablet provided by the invention can be also used for cold, fever, abscess of throat, aphtha, tooth Gum swells and ache, red eye, swell pain, acute myringitis, the symptoms such as acute lymphangitis.
Compared with prior art, trollflower effervescent tablet provided by the invention has the advantage that:
(1) mutually coordinated of trollflower effervescent tablet each component provided by the invention is clearing heat and detoxicating, promoting blood circulation and removing blood stasis and anti-inflammatory town The effect of pain, has significant improvement result to idiopathic pulmonary fibrosis;
(2) trollflower effervescent tablet provided by the invention has stable quality, safe, and the low advantage of production cost has Conducive to the promotion and application of the effervescent tablet.
Specific implementation mode
The following describes the present invention further through the description of specific embodiments, but this is not the limit to the present invention System, those skilled in the art's basic thought according to the present invention can make various modifications or improvements, but without departing from this The basic thought of invention, is all within the scope of the present invention.
Embodiment 1, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
40 parts of lily feet pollen, 20 parts of Coixol, 10 parts of syringic acid, 15 parts of sorbierite, 8 parts of xanthans, 2 parts of sodium citrate and 8 parts of sodium bicarbonate.
Preparation method:
S1 cleans fresh trollflower, is put into the ethyl alcohol that concentration of volume percent is 75%, the addition of the ethyl alcohol Amount is 8 times of the trollflower weight, and refluxing extraction 45min, the Extracting temperature is 75 DEG C of filterings, obtains extracting solution, will extract Ethyl alcohol and concentrated extracting solution is recovered under reduced pressure in liquid, dry, and the drying temperature is 45 DEG C, obtains lily feet pollen;
The lily feet pollen that step S1 is obtained is sufficiently stirred by S2 with Coixol and syringic acid, obtains mixture;
Step S2 is obtained mixture and is uniformly mixed with sorbierite, xanthans, sodium citrate and sodium bicarbonate by S3, opposite Humidity be 20% environment in carry out tabletting to get.
Embodiment 2, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 22 parts of sorbierite, 10 parts of xanthans, 4 parts of sodium citrate With 10 parts of sodium bicarbonate.
Preparation method:
S1 cleans fresh trollflower, is put into the ethyl alcohol that concentration of volume percent is 80%, the addition of the ethyl alcohol Amount is 10 times of the trollflower weight, and refluxing extraction 50min, the Extracting temperature is 80 DEG C of filterings, obtains extracting solution, will extract Ethyl alcohol and concentrated extracting solution is recovered under reduced pressure in liquid, dry, and the drying temperature is 50 DEG C, obtains lily feet pollen;
The lily feet pollen that step S1 is obtained is sufficiently stirred by S2 with Coixol and syringic acid, obtains mixture;
Step S2 is obtained mixture and is uniformly mixed with sorbierite, xanthans, sodium citrate and sodium bicarbonate by S3, opposite Humidity be 25% environment in carry out tabletting to get.
Embodiment 3, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
60 parts of lily feet pollen, 30 parts of Coixol, 22 parts of syringic acid, 30 parts of sorbierite, 12 parts of xanthans, 6 parts of sodium citrate With 12 parts of sodium bicarbonate.
Preparation method:
S1 cleans fresh trollflower, is put into the ethyl alcohol that concentration of volume percent is 85%, the addition of the ethyl alcohol Amount is 12 times of the trollflower weight, and refluxing extraction 60min, the Extracting temperature is 85 DEG C of filterings, obtains extracting solution, will extract Ethyl alcohol and concentrated extracting solution is recovered under reduced pressure in liquid, dry, and the drying temperature is 55 DEG C, obtains lily feet pollen;
The lily feet pollen that step S1 is obtained is sufficiently stirred by S2 with Coixol and syringic acid, obtains mixture;
Step S2 is obtained mixture and is uniformly mixed with sorbierite, xanthans, sodium citrate and sodium bicarbonate by S3, opposite Humidity be 30% environment in carry out tabletting to get.
Comparative example 1, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
61 parts of lily feet pollen, 35 parts of Coixol, 22 parts of sorbierite, 10 parts of xanthans, 4 parts of sodium citrate and sodium bicarbonate 10 Part.
Preparation method is similar to Example 2.
The difference from example 2 is that not adding syringic acid, increase the parts by weight of lily feet pollen and Coixol.
Comparative example 2, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of gallic acid, 22 parts of sorbierite, 10 parts of xanthans, sodium citrate 4 10 parts of part and sodium bicarbonate.
Preparation method is similar to Example 2.
The difference from example 2 is that syringic acid is replaced with gallic acid.
Comparative example 3, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 22 parts of sucrose, 10 parts of xanthans, 4 parts of sodium citrate and 10 parts of sodium bicarbonate.
Preparation method is similar to Example 2.
The difference from example 2 is that sorbierite is replaced with sucrose.
Comparative example 4, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 27 parts of sorbierite, 9 parts of sodium citrate and sodium bicarbonate 10 Part.
Preparation method is similar to Example 2.
The difference from example 2 is that not adding xanthans, increase the parts by weight of sorbierite and sodium citrate.
Comparative example 5, a kind of trollflower effervescent tablet
The trollflower effervescent tablet is made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 24 parts of sorbierite, 12 parts of xanthans and sodium bicarbonate 10 Part.
Preparation method is similar to Example 2.
The difference from example 2 is that not adding sodium citrate, increase the parts by weight of sorbierite and xanthans.
The influence experiment of test example one, trollflower effervescent tablet to idiopathic pulmonary fibrosis
1, subjects:Healthy male SD rat 70, weight 260-280g is chosen, by Zhongshan University experimental animal The heart provides.
2, test material:Trollflower effervesce prepared by embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2 Piece, pirfenidone capsule are purchased from Beijing Kangdini Pharmaceutical Co., Ltd., Chinese medicines quasi-word H20133376.
3, idiopathic pulmonary fibrosis Animal Model:
It selects 10 at random from 70 rats and is only used as control rats, remaining rats by intraperitoneal injection 3% is a concentration of The yellow Jackets of 30mg/kg, fixed mouse platform of lying on the back after anesthesia, routine disinfection drape after neck preserved skin are cut after skin successively Blunt separation exposes tracheae, tracheal strips is pierced into the syringe diagonal of 1mL, to intrapulmonary fast injection bleomycin solution 0.2- 0.3ml holds up mouse plate immediately, after the 2min that rolls, sterilizes skin closure wound again.
3, test method:
Successful 60 rats will be modeled and be randomly divided into model group, pirfenidone group, 1 group of embodiment, 2 groups of embodiment, reality 2 groups of 3 groups of example, 1 group of comparative example and comparative example are applied, each group dosage is as follows:
Control group:The isometric physiological saline of gavage;
Model group:The isometric physiological saline of gavage;
Pirfenidone group:The pirfenidone of gavage 10mg/kg;
1 group of embodiment:Trollflower effervescent tablet prepared by the embodiment 1 of gavage 10mg/kg;
2 groups of embodiment:Trollflower effervescent tablet prepared by the embodiment 2 of gavage 10mg/kg;
3 groups of embodiment:Trollflower effervescent tablet prepared by the embodiment 3 of gavage 1mg/kg;
1 group of comparative example:Trollflower effervescent tablet prepared by the comparative example 1 of gavage 1mg/kg;
2 groups of comparative example:Trollflower effervescent tablet prepared by the comparative example 2 of gavage 1mg/kg;
Rat free water during experiment is fed (standard diet).It is primary that rat body weight is measured weekly.It is given in on-test Put to death rat within the 4th week after medicine.Rat is put to death using femoral artery depletion method after yellow Jackets anesthesia rat lies on the back fixation It on mouse platform, opens chest and appears cardiopulmonary, cleaned with physiological saline after removing lungs, weighed in and lung weight with electronic balance repeatedly, Paragonimus cyst (lung weight/weight × 100%) is calculated, Serum Laminin (LN) content of rat is detected using kit. Then, right upper lung, lower-left lung are fixed using 4% formaldehyde, 5 μ m-thick paraffin sections are made, in case HE is dyed in conventional dehydration embedding.
The judgment criteria of the pathology semi-quantitative analysis of idiopathic pulmonary fibrosis, pulmonary alveolitis and pulmonary fibrosis degree is as follows:
(1) pulmonary alveolitis is classified:
0 grade:Without pulmonary alveolitis;
1 grade:Slight pulmonary alveolitis, extent of disease are confined to 20% or less full lung;
2 grades:Moderate pulmonary alveolitis, extent of disease account for full lung 20%-50%;
3 grades:Diffuse alveolar is scorching, and extent of disease is more than 50%.
(2) pulmonary interstitial fibrosis is classified:
0 grade:Without pulmonary interstitial fibrosis;
1 grade:Slight pulmonary interstitial fibrosis, extent of disease are confined to 20% or less full lung;
2 grades:Moderate pulmonary interstitial fibrosis, extent of disease account for full lung 20%-50%;
3 grades:Severe pulmonary interstitial fibrosis, extent of disease is more than 50%, fusion of pulmonary alveoli, pulmonary parenchyma structure disturbance.
Using microimage analysing system, pulmonary alveolitis and fibrosis automatic measurement are carried out to pathological section, by lung group It knits HE coloring pathological sections and is divided into following three regions and analyzed:
Without dye area:For alveolar space occupied area;
The areas Shen Ran:For nucleus occupied area;
Understain area:For interstitial lung fibrous connective tissue occupied area.
Pulmonary alveolitis and the degree of pulmonary fibrosis can be determined by the difference of three above region occupied area.When pulmonary alveolitis Interstitial lung inflammatory cell infiltration increases, and shows as the areas Shen Ran area and increases, and when pulmonary interstitial fibrosis, alveolar collapses or disappears mostly It loses, a large amount of collagenous fibres occurs in interstitial, shows as reducing without dye area's area, understain area area increases.Cell is represented with the areas Shen Ran Core occupied area, i.e. alveolar inflammation area, understain area represent fibrous connective tissue and collagenous fibres occupied area, and no dye area represents Alveolar cavity area.Pathological section is placed under image analyzer microscope, under the visuals field 10x, every slice is by left-to-right, by upper It chooses 10 visuals field successively under and carries out image analysis.
5, test result:
5.1, influence of the trollflower effervescent tablet to idiopathic pulmonary fibrosis rat model paragonimus cyst and LN contents such as 1 institute of table Show.
Influence of the 1 trollflower effervescent tablet of table to idiopathic pulmonary fibrosis rat model paragonimus cyst and LN contents
Group Paragonimus cyst LN contents (pg/mL)
Control group 0.40±0.02 73.85±9.38
Model group 0.60±0.06 135.66±18.23
Pirfenidone group 0.47±0.04* 90.78±15.18**
1 group of embodiment 0.44±0.05* 88.45±14.30**
2 groups of embodiment 0.42±0.04* 85.64±14.22**
3 groups of embodiment 0.45±0.03* 89.32±14.35**
1 group of comparative example 0.56±0.05 109.36±16.40
2 groups of comparative example 0.54±0.04 114.36±16.98
Compared with model group,*P<0.05,**P<0.01。
As shown in Table 1, compared with model group, 3 groups of pirfenidone group, 1 group of embodiment, 2 groups of embodiment and embodiment Significantly to reduce the paragonimus cyst of idiopathic pulmonary fibrosis model, and the drop of 1 group of embodiment, 3 groups of 2 groups of embodiment and embodiment The effect of low paragonimus cyst and the effect of pirfenidone capsule are good, meanwhile, 3 groups of 1 group of embodiment, 2 groups of embodiment and embodiment may be used also To significantly reduce the LN contents of idiopathic pulmonary fibrosis model, illustrate that trollflower effervescent tablet provided by the invention is fine to idiopathic lung Dimensionization has significant improvement result.
5.2, influence of the trollflower effervescent tablet to pathologic:
Compared with the control group, severe pulmonary alveolitis is presented in model group rats, locally there is more hemorrhagic focus, and alveolar septa is broadening, scorching Property cellular infiltration, macrophage activation are apparent:Volume increases, and contains a large amount of particles into the cell, and most of macrophage is in foam Sample changes;The fibroblast of sheet aggregation activation is closely adjacent, and alveolar septa and areas of inflammation are shown in the collagenous fibres of sheet hyperplasia, Fibrosis obviously increases.Compared with model group, 3 groups of pirfenidone group, 1 group of embodiment, 2 groups of embodiment and embodiment The significant pulmonary alveolitis for improving idiopathic pulmonary fibrosis model, macrophage foam cell formation sample change, fibrocyte activation and collagen are fine The symptoms such as dimension hyperplasia, and the improvement unobvious of 2 groups of 1 group of comparative example and comparative example, illustrate trollflower bubble provided by the invention Rise piece has significant improvement result to idiopathic pulmonary fibrosis.
The stability test of test example two, trollflower effervescent tablet
1, test material:Lily feet prepared by embodiment 1, embodiment 2, embodiment 3, comparative example 3, comparative example 4 and comparative example 5 Flower effervescent tablet.
2, test method:With reference to《Chinese Pharmacopoeia》The method of the second annex IA tablet of version in 2010, investigation embodiment 1, The character of trollflower effervescent tablet prepared by embodiment 2, embodiment 3, comparative example 3, comparative example 4 and comparative example 5, disintegration time, again Measure difference and average gas release.3 parts of sample is taken, in (25 ± 2) DEG C, 18 are placed under conditions of relative humidity (60 ± 10) % Month, it was measured by sampling in 0,3,6,12,18 month.
3, test result:
Test result is as shown in table 2.
The stability test of 2 trollflower effervescent tablet of table
As shown in Table 2, the trollflower effervescent tablet that prepared by 1-3 of the embodiment of the present invention in (25 ± 2) DEG C, relative humidity (60 ± 10) it is placed 18 months under conditions of %, character is bright and clean, and weight differential meets regulation, and disintegration time and average gas release are basic It is unchanged, there is higher stability, and trollflower effervescent tablet prepared by comparative example 3-4 is in (25 ± 2) DEG C, relative humidity (60 ± 10) it is placed 6 months under conditions of %, character starts loss of gloss, uneven, and weight differential is unqualified, disintegration time peace Equal gas release continuously decreases, and illustrates that pears alcohol, xanthans and the sodium citrate in trollflower effervescent tablet provided by the invention are mutually assisted The stability action for having adjusted enhancing trollflower effervescent tablet can greatly improve the stability of trollflower effervescent tablet, improve lily feet The presentation quality of flower effervescent tablet.

Claims (9)

1. a kind of trollflower effervescent tablet, which is characterized in that be made of following component and its parts by weight:
40-60 parts of lily feet pollen, 20-30 parts of Coixol, 10-22 parts of syringic acid, 15-30 parts of sorbierite, 8-12 parts of xanthans, lemon 8-12 parts of 2-6 parts of lemon acid sodium and sodium bicarbonate.
2. trollflower effervescent tablet as described in claim 1, which is characterized in that be made of following component and its parts by weight:
52 parts of lily feet pollen, 26 parts of Coixol, 18 parts of syringic acid, 22 parts of sorbierite, 10 parts of xanthans, 4 parts of sodium citrate and carbon 10 parts of sour hydrogen sodium.
3. trollflower effervescent tablet as claimed in claim 1 or 2, which is characterized in that the preparation method of the lily feet pollen is:
Fresh trollflower is cleaned, is put into the ethyl alcohol that concentration of volume percent is 75-85%, the additive amount of the ethyl alcohol is 8-12 times of the trollflower weight, refluxing extraction 45-60min, filtering obtain extracting solution, ethyl alcohol are recovered under reduced pressure simultaneously in extracting solution Concentrated extracting solution, it is dry to get.
4. trollflower effervescent tablet as claimed in claim 3, which is characterized in that the Extracting temperature is 75-85 DEG C.
5. trollflower effervescent tablet as claimed in claim 3, which is characterized in that the drying temperature is 45-55 DEG C.
6. a kind of preparation method of trollflower effervescent tablet according to any one of claims 1 to 5, which is characterized in that including following step Suddenly:
S1 cleans fresh trollflower, is put into the ethyl alcohol that concentration of volume percent is 75-85%, the additive amount of the ethyl alcohol It is 8-12 times of the trollflower weight, refluxing extraction 45-60min is filtered, obtained extracting solution, ethyl alcohol is recovered under reduced pressure in extracting solution And concentrated extracting solution, it is dry, obtain lily feet pollen;
The lily feet pollen that step S1 is obtained is sufficiently stirred by S2 with Coixol and syringic acid, obtains mixture;
Step S2 is obtained mixture and is uniformly mixed with sorbierite, xanthans, sodium citrate and sodium bicarbonate by S3, in relative humidity For in the environment of 20-30% carry out tabletting to get.
7. the preparation method of trollflower effervescent tablet as claimed in claim 6, which is characterized in that Extracting temperature in the step S1 It is 75-85 DEG C.
8. the preparation method of trollflower effervescent tablet as claimed in claim 6, which is characterized in that drying temperature in the step S1 It is 45-55 DEG C.
9. trollflower effervescent tablet as claimed in claim 1 or 2 answering in preparing auxiliary treatment idiopathic pulmonary fibrosis drug With.
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CN106420656B (en) * 2016-11-25 2018-10-02 广东大鹏医药科技有限公司 A kind of trollflower effervescent tablet and preparation method thereof
CN109699979A (en) * 2019-01-04 2019-05-03 广东大鹏医药科技有限公司 The honey and preparation method and purposes of a kind of ingredient containing trollflower in trollflower flower source
CN109673896A (en) * 2019-01-04 2019-04-26 广东大鹏医药科技有限公司 A kind of trollflower dew beverage and its preparation method and application

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CN1281207C (en) * 2004-07-23 2006-10-25 张晴龙 Globeflower oral disintegration tablet and its preparing method
CN100342848C (en) * 2005-09-07 2007-10-17 北京因科瑞斯生物制品研究所 Effervescence tablet for reducing fever comprising tropaeolum and process for preparing the same
CN1315500C (en) * 2005-09-07 2007-05-16 北京因科瑞斯生物制品研究所 Effervescence tablet of Chinese globeflower and its preparation process
CN104547469A (en) * 2013-10-09 2015-04-29 天津中盛海天制药有限公司 Dry granulation method of Trollius chinensis Bunge heat-clearing effervescent tablet
CN106420656B (en) * 2016-11-25 2018-10-02 广东大鹏医药科技有限公司 A kind of trollflower effervescent tablet and preparation method thereof

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