CN1679675A - Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof - Google Patents
Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof Download PDFInfo
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Abstract
A Chuanhuang Xiaoyan dripping pill based on the Chuanhuang xiaoyan tablet for treating acute upper respiratory tract infection, acute tonsillitis, and pharyngolaryngitis is disclosed. Its advantages are high release speed and quickly taking its high curative effect.
Description
Technical field
The present invention relates to a kind of antipyretic and antidote functions that has, the pharmaceutical composition that is used for disease treatments such as hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis, be particularly related to based on Chinese traditional patent formulation and wear yellow Pianomide, change a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
Wear yellow Pianomide according to what the prescription that provides among the national drug standards WS-11053 (ZD-1053)-2002 and extraction process were prepared from, it is a kind of antipyretic and antidote functions that has, the tablet that is used for disease treatments such as hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Below be the prescription of wearing yellow Pianomide and the extraction process that provides among the drug standard WS-11053 (ZD-1053)-2002:
Prescription: Herba Andrographis 375g, Herba Solidaginis 625g, starch 58g;
Method for making: above two flavor medical materials, Herba Andrographis 100g is ground into fine powder; All the other Herba Andrographis and Herba Solidaginis decoct with water secondary, and 2 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), puts cold, adding ethanol is 60% to containing the alcohol amount, stirs, and leaves standstill 48 hours, filter, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃), adds above-mentioned Herba Andrographis fine powder and starch, mixing is granulated drying, tabletting, sugar coating or film-coat promptly get 1000.
Appended wearing in the yellow Pianomide description is explained as follows for this sheet:
Nomenclature of drug: wear yellow Pianomide;
Main component: Herba Andrographis, Herba Solidaginis;
Character: this product is a coated tablet, removes coating and shows sepia; Bitter in the mouth.
Function cures mainly: heat-clearing and toxic substances removing; Be used for hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis.
Usage and consumption: oral, one time 6～8,3 times on the one.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form as sheet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish the existing deficiency that is used for the oral drug preparation of disease treatments such as hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis, a kind of bioavailability height is provided, release fast, quick produce effects, pollution-free in the production, and cheap drug composition oral preparation is worn yellow anti-inflammatory dripping pills.
Involved in the present invention wear yellow anti-inflammatory dripping pills, determine through a large amount of experiment sievings, the extraction process of wearing yellow Pianomide based on Chinese traditional patent formulation, through extracting section technology is adjusted, and cooperation drop pill preparation technology is prepared from.Be prepared by the following technical solutions, can obtain the yellow anti-inflammatory dripping pills of wearing involved in the present invention:
[preparation method]
1. Herba Andrographis, Herba Solidaginis extract thick paste or dry powder, and the fine powder made of a part of Herba Andrographis;
2. substrate---one or more the mixture in pharmaceutically suitable carrier such as Polyethylene Glycol (1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning---with g or kg is unit, by weight, and principal agent: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and Herba Andrographis fine powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step and is incubated during desired state of temperature, mix homogeneously, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, condensing agent can be any one of liquid paraffin, methyl-silicone oil, vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of preparation method of Chinese medicine extract]
Herba Andrographis 375g, Herba Solidaginis 625g gets Herba Andrographis 100g earlier, it is standby to be ground into fine powder, and all the other Herba Andrographis and Herba Solidaginis decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), puts cold, adding ethanol is 60% to containing the alcohol amount, stirs, and leaves standstill 48 hours, filter, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃); Through the low-temperature reduced-pressure drying, pulverize again, promptly get dry powder.
Given here is to change according to a kind of preparation method of extract among the drug standard WS-11053 (ZD-1053)-2002 to form, and similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
Wearing yellow Pianomide according to what the prescription that provides among the national drug standards WS-11053 (ZD-1053)-2002 and extraction process were prepared from, is a kind of heat-clearing and toxic substances removing; The sheet class preparation that is used for symptom treatments such as hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form as sheet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
The yellow anti-inflammatory dripping pills of wearing involved in the present invention is compared with wearing yellow Pianomide, has following beneficial effect:
1. involved in the present invention wear yellow anti-inflammatory dripping pills; utilize surfactant etc. to be substrate; make solid dispersion with extractum that contains active constituents of medicine or dry powder; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases, and substrate is hydrophilic, and medicine is had wetting action; can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the administering mode of traditional oral formulations, exist essential distinction.With the drop pill of solid dispersion technology preparation, can adopt oral, can also sublingual administration, effective ingredient is fully contacted with mucomembranous surface, by the mucomembranous epithelial cell absorption, directly enter blood circulation.Owing to directly enter blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. involved in the present invention wear yellow anti-inflammatory dripping pills, contact promptly with saliva and dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and also the influence of not taken food, promptly all can containing take after meal ante cibum, local application's onset is faster.
3. the yellow anti-inflammatory dripping pills of wearing involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind.
In sum, make the advantage that yellow anti-inflammatory dripping pills has triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use) of wearing involved in the present invention.
The specific embodiment
Now, be described further with regard to preparation method of wearing yellow anti-inflammatory dripping pills of the present invention with several groups of specific embodiments.
First group: the test of single-matrix
1. according to [appendix: a kind of preparation method of Chinese medicine extract], get Herba Andrographis 375g, Herba Solidaginis 625g, get Herba Andrographis 100g earlier, it is standby to be ground into fine powder, and all the other Herba Andrographis and Herba Solidaginis decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), put coldly, adding ethanol to the alcohol amount of containing is 60%, stirs, left standstill 48 hours, filter, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃), again through the low-temperature reduced-pressure drying, pulverize, it is standby promptly to get principal agent dry powder;
2. substrate: Polyethylene Glycol
(1000～20000), pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and principal agent: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the yellow anti-inflammatory dripping pills of wearing of various different sizes.
[result of the test]
Test 1: principal agent and different substrates are prepared when 1: 1 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, according to 1: 1 ratio, with principal agent respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain principal agent and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: principal agent and different substrates are prepared when 1: 3 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, according to 1: 3 ratio, with principal agent respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain principal agent and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: principal agent and different substrates are prepared when 1: 9 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, according to 1: 9 ratio, with principal agent respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain principal agent and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. according to [appendix: a kind of preparation method of Chinese medicine extract], get Herba Andrographis 375g, Herba Solidaginis 625g, get Herba Andrographis 100g earlier, it is standby to be ground into fine powder, and all the other Herba Andrographis and Herba Solidaginis decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), put coldly, adding ethanol to the alcohol amount of containing is 60%, stirs, left standstill 48 hours, filter, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃), again through the low-temperature reduced-pressure drying, pulverize, it is standby promptly to get principal agent dry powder;
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. (with g or kg is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
3.2 mixing principal agent: mixed-matrix weight and=1: 1～1: 9.
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the yellow anti-inflammatory dripping pills of wearing of various different sizes.
[result of the test]
Test 4: principal agent and mixed-matrix are prepared when 1: 1 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: principal agent and mixed-matrix are prepared when 1: 3 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: principal agent and mixed-matrix are prepared when 1: 9 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: principal agent and mixed-matrix are prepared when 1: 1 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: principal agent and mixed-matrix are prepared when 1: 3 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: principal agent and mixed-matrix are prepared when 1: 9 the proportioning wears yellow anti-inflammatory dripping pills in qualitative difference in order to observe, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: wear yellow anti-inflammatory dripping pills in qualitative difference for what observe that principal agent and mixed-matrix make when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: wear yellow anti-inflammatory dripping pills in qualitative difference for what observe that principal agent and mixed-matrix make when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: wear yellow anti-inflammatory dripping pills in qualitative difference for what observe that principal agent and mixed-matrix make when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio principal agent is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that principal agent and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 principal agent and single-matrix
(principal agent: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ????50.0 | ????80 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????50.0 | ????70 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 9300 | ????50.0 | ????88 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????72 | ????＜30 | ????＞10 | + |
| Poloxamer | ????50.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????73 | ????＜30 | ????＞10 | + |
| Sodium lauryl sulphate | ????50.0 | ????68 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????55 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????50.0 | ????54 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????50.0 | ????55 | ????＞30 | ????＞10 | +++ |
| Lac | ????50.0 | ????52 | ????＞30 | ????＞10 | +++ |
The group practices of table 2 principal agent and single-matrix
(principal agent: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ????25.0 | ????80 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????86 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 9300 | ????25.0 | ????94 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 1000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 2000 | ????25.0 | ????91 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 principal agent and single-matrix
(principal agent: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ????10.0 | ????80 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????10.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 9300 | ????10.0 | ????89 | ????＜30 | ????＞10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????83 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????77 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????73 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????50 | ????85 | ????＜30 | ????＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????86 | ????＜30 | ????＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????78 | ????＜30 | ????＞10 | + |
The group practices of table 5 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????50 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????83 | ????＜30 | ????＞10 | ++ |
The group practices of table 8 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????25 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????95 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????89 | ????＜30 | ????＜10 | ++ |
The group practices of table 9 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????10 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????82 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????25 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 principal agent and mixed-matrix
(principal agent: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????10 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
1. can be seen by the result in the table: when the ratio of principal agent and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all comparatively desirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of principal agent and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of principal agent and substrate is 1: 9, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (7)
1. a drug composition oral preparation that is used for disease treatments such as hyperactivity of toxic heat such as acute upper respiratory tract infection, acute tonsillitis, pharyngolaryngitis is worn yellow anti-inflammatory dripping pills, with Herba Andrographis, Herba Solidaginis is raw material of Chinese medicine, be prepared from a certain proportion of pharmaceutically suitable carrier, wherein:
1.1 Herba Andrographis, Herba Solidaginis extract thick paste or dry powder, and the fine powder made of a part of Herba Andrographis;
1.2 substrate---Polyethylene Glycol
(1000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
1.3 proportioning---with g or kg is unit, by weight, and principal agent: substrate=1: 1～1: 9.
2. as claimed in claim 1ly wear yellow anti-inflammatory dripping pills, it is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
3. any yellow anti-inflammatory dripping pills of wearing as claimed in claim 1 or 2, it is characterized in that: the mixed proportion of described principal agent and substrate is 1: 1～1: 5.
4. as claimed in claim 1ly wear yellow anti-inflammatory dripping pills, it is characterized in that described drug extract extractum or dry powder obtain by the following method: Herba Andrographis 375g, Herba Solidaginis 625g, get Herba Andrographis 100g earlier, it is standby to be ground into fine powder, all the other Herba Andrographis and Herba Solidaginis, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), puts coldly, and adding ethanol is 60% to containing alcohol amount, stir, left standstill 48 hours, and filtered, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃); Through the low-temperature reduced-pressure drying, pulverize again, promptly get dry powder.
5. preparation method of wearing yellow anti-inflammatory dripping pills is characterized in that being made of following process:
5.1. Herba Andrographis, Herba Solidaginis extract thick paste or dry powder, and the fine powder made of a part of Herba Andrographis;
5.2 substrate---Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
5.3 proportioning---with g or kg is unit, by weight, and principal agent: substrate=1: 1～1: 9;
5.4, accurately take by weighing principal agent and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5.5 adopt homemade or general drop pill machine, and adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on-5 ℃～40 ℃;
5.6 treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, insulation places in the water dropper jar of drop pill machine, splashes into to shrink in the condensing agent by water dropper to be shaped promptly.
6. the preparation method as wearing yellow anti-inflammatory dripping pills as described in the claim 5, it is characterized in that method 5.1 described drug extract extractum or dry powder obtain by the following method: Herba Andrographis 375g, Herba Solidaginis 625g, get Herba Andrographis 100g earlier, it is standby to be ground into fine powder, all the other Herba Andrographis and Herba Solidaginis, decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14～1.16 (85 ℃), puts coldly, and adding ethanol is 60% to containing alcohol amount, stir, left standstill 48 hours, and filtered, filtrate is concentrated into the thick paste that relative density is 1.31～1.35 (60～80 ℃); Through the low-temperature reduced-pressure drying, pulverize again, promptly get dry powder.
7. the preparation method as wearing yellow anti-inflammatory dripping pills as described in the claim 5 is characterized in that: method 5.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002885 CN1679675A (en) | 2005-01-28 | 2005-01-28 | Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510002885 CN1679675A (en) | 2005-01-28 | 2005-01-28 | Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1679675A true CN1679675A (en) | 2005-10-12 |
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ID=35066681
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510002885 Pending CN1679675A (en) | 2005-01-28 | 2005-01-28 | Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103518912A (en) * | 2013-10-22 | 2014-01-22 | 张家界航空工业职业技术学院 | Traditional Chinese medicinal health-protection tea for treating chronic pharyngitis and preparation method of traditional Chinese medicinal health-protection tea |
| CN107961257A (en) * | 2017-12-04 | 2018-04-27 | 安徽金太阳生化药业有限公司 | A kind of preparation method for wearing yellow antipyretic capsule |
-
2005
- 2005-01-28 CN CN 200510002885 patent/CN1679675A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103518912A (en) * | 2013-10-22 | 2014-01-22 | 张家界航空工业职业技术学院 | Traditional Chinese medicinal health-protection tea for treating chronic pharyngitis and preparation method of traditional Chinese medicinal health-protection tea |
| CN107961257A (en) * | 2017-12-04 | 2018-04-27 | 安徽金太阳生化药业有限公司 | A kind of preparation method for wearing yellow antipyretic capsule |
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