CN1301094C - Throat pain relieving anti-inflammation drop pills for treating oral disease and preparation method thereof - Google Patents
Throat pain relieving anti-inflammation drop pills for treating oral disease and preparation method thereof Download PDFInfo
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Abstract
The present invention discloses a sore throat inflammation relieving drop pill of a drop pill preparation of oral administration for curing swelling and sore in a throat, furuncle, moth throat, boil and poison of carbuncle and mouth and tongue sores, which aims to overcome the deficiencies of the existing medicine preparation of oral administration for curing throat diseases and to provide a sore throat inflammation relieving drop pill of an oral administration preparation of a medicine preparation, and the sore throat inflammation relieving drop pill has the advantages of high biologic utilization degree, rapid medicine release, rapid effect, small toxic and side effect, high medicine content, low administration dosage, accurate administration dosage, convenient administration, low cost and portability for going out. The sore throat inflammation relieving drop pill is formed by the reform in dosage forms on the basis of the extraction process of a sore throat inflammation relieving pill (water pill) in a Chinese traditional patent formula.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, anti-inflammatory analgetic; Be used for the treatment of laryngopharynx swelling and pain, furuncle moth larynx, carbuncle furuncle and phyma poison, the pharmaceutical composition of symptoms such as aphtha of the mouth and tongue treatment particularly based on Chinese traditional patent formulation Laryngalgia anti-inflammation ball, is changed a social system a kind of drug composition oral preparation that forms through dosage form.
Background technology
According to the Laryngalgia anti-inflammation watered pill that the prescription that provides among the national drug standards WS-10065 (ZD-0065)-2002 and extraction process are prepared from, be heat-clearing and toxic substances removing, anti-inflammatory analgetic; Be used for laryngopharynx swelling and pain, furuncle moth larynx, carbuncle furuncle and phyma poison, symptom watered pill class preparations such as aphtha of the mouth and tongue treatment, 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.Still there are not other similar oral formulations at present.
Below be the prescription and the method for making of the Laryngalgia anti-inflammation ball (watered pill) that provides among the drug standard WS-10065 (ZD-0065)-2002:
Prescription: artificial Calculus Bovis 0.53g, Indigo Naturalis 0.35g, Margarita 0.53g, Venenum Bufonis 0.35g, Borneolum Syntheticum 0.35g, Pulvis Fumi Carbonisatus 0.53g, Realgar 0.35g; Make 1000 balls.
Method for making: above seven flavors, except that Pulvis Fumi Carbonisatus, Margarita, Realgar water fly into impalpable powder; Artificial Calculus Bovis, Borneolum Syntheticum, Venenum Bufonis, Indigo Naturalis be porphyrize respectively, with above-mentioned fine powder facing-up, sieves, and mixing is used water pill, and drying is used the Pulvis Fumi Carbonisatus coating, polishing, promptly.
Be explained as follows for this tablet in the appended Laryngalgia anti-inflammation ball description:
Nomenclature of drug: Laryngalgia anti-inflammation ball;
Main component: artificial Calculus Bovis, Indigo Naturalis, Margarita, Venenum Bufonis, Borneolum Syntheticum, Pulvis Fumi Carbonisatus, Realgar;
Character: this product is the black watered pill; Gas perfume (or spice), bitter in the mouth, numb feeling in the tongue is arranged;
Function cures mainly: heat-clearing and toxic substances removing, anti-inflammatory analgetic; Be used for laryngopharynx swelling and pain, furuncle moth larynx, carbuncle furuncle and phyma poison, aphtha of the mouth and tongue;
Usage and dosage: buccal, one time 5～10 ball.
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.Watered pill Chinese medicine active constituent content, the single taking dose is big, therefore takes inconvenience, carries inconvenience.Secondly, the storage inconvenience of the watered pill, the difficult problem that very difficult solution is gone mouldy, the shelf-life is shorter.
In addition, conventional peroral dosage form as tablet, 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 is to replenish existing heat-clearing and toxic substances removing, anti-inflammatory analgetic; Be used for laryngopharynx swelling and pain, furuncle moth larynx, carbuncle furuncle and phyma poison, the deficiency of the oral drug preparation of symptoms such as aphtha of the mouth and tongue treatment provides a kind of bioavailability height, release fast, quick produce effects, toxic and side effects is littler, and the medicament contg height, and taking dose is little, and taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation throat pain relieving anti-inflammation drop pills of going out to carry.
Throat pain relieving anti-inflammation drop pills involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation Laryngalgia anti-inflammation ball (watered pill), process is adjusted extracting section technology, and cooperates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain throat pain relieving anti-inflammation drop pills involved in the present invention:
[preparation method]
1. be unit with g or kg, according to the weight portion meter, respectively 3 parts of artificial Calculus Bovis, Margarita, Pulvis Fumi Carbonisatuss, respectively 2 parts of Indigo Naturalis, Venenum Bufonis, Borneolum Syntheticum, Realgars, more than each the flavor, Margarita, Realgar water fly into impalpable powder, and artificial Calculus Bovis, Borneolum Syntheticum, Venenum Bufonis, Indigo Naturalis be porphyrize respectively, with above-mentioned fine powder and with the Pulvis Fumi Carbonisatus facing-up, sieve, mixing, drying, standby;
Given here is to change according to the preparation method of a kind of fine powder among the drug standard WS-10065 (ZD-0065)-2002 to form, and similarly method is a lot, is not limited to this a kind of method during actual enforcement.
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as betacyclodextrin, poloxamer, polyoxyethylene stearate 40 esters, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and fine drug powder: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing fine drug powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing fine drug powder 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 during desired state of temperature, and insulation places in the water dropper jar of drop pill machine, splashes 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.
Beneficial effect
According to the Laryngalgia anti-inflammation ball (watered pill) that the prescription that provides among the national drug standards WS-10065 (ZD-0065)-2002 and extraction process are prepared from, be heat-clearing and toxic substances removing, anti-inflammatory analgetic; Be used for laryngopharynx swelling and pain, furuncle moth larynx, carbuncle furuncle and phyma poison, the watered pill class preparation of symptoms such as aphtha of the mouth and tongue treatment, 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.Watered pill preparation also exists stores inconvenient (easily going mouldy), and taking dose is big, the low deficiency that waits of active constituent content.
In addition, conventional peroral dosage form as tablet, 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.
Throat pain relieving anti-inflammation drop pills involved in the present invention is compared with Laryngalgia anti-inflammation ball (watered pill), has following beneficial effect:
1. throat pain relieving anti-inflammation drop pills involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with containing the active constituents of medicine fine powder; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate has wetting action to medicine, can make that medicine is rapidly molten to loose into microgranule or solution, thereby makes 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. throat pain relieving anti-inflammation drop pills involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.
3. throat pain relieving anti-inflammation drop pills involved in the present invention mixes the fine powder 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.Storage period is long than the watered pill.
In sum, make throat pain relieving anti-inflammation drop pills involved in the present invention have the advantage of 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).
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of throat pain relieving anti-inflammation drop pills of the present invention.
First group: the test of single-matrix
1. it is standby to make the fine drug powder of being made up of seven flavor Chinese medicines such as Margarita, Realgar, artificial Calculus Bovis, Borneolum Syntheticum, Venenum Bufonis, Indigo Naturalis, Pulvis Fumi Carbonisatus earlier according to [preparation method] 1;
2. substrate: Polyethylene Glycol
(1000,2000,4000,6000,8000,9300,10000,20000), 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 fine drug powder: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the throat pain relieving anti-inflammation drop pills of various different sizes.
[result of the test]
Test 1: for observe fine drug powder and different substrates when 1: 1 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, according to 1: 1 ratio, with fine drug powder respectively with 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 fine drug powder and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe fine drug powder and different substrates when 1: 3 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, according to 1: 3 ratio, with fine drug powder respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
9300, Polyethylene Glycol
8000, 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 fine drug powder and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe fine drug powder and different substrates when 1: 9 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, according to 1: 9 ratio, with fine drug powder respectively with 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 fine drug powder and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. it is standby to make the fine drug powder of being made up of seven flavor Chinese medicines such as Margarita, Realgar, artificial Calculus Bovis, Borneolum Syntheticum, Venenum Bufonis, Indigo Naturalis, Pulvis Fumi Carbonisatus earlier according to [preparation method] 1;
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 hybrid medicine fine powder: 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 throat pain relieving anti-inflammation drop pills of various different sizes.
[result of the test]
Test 4: for observe fine drug powder and mixed-matrix when 1: 1 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe fine drug powder and mixed-matrix when 1: 3 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe fine drug powder and mixed-matrix when 1: 9 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe fine drug powder and mixed-matrix when 1: 1 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe fine drug powder and mixed-matrix when 1: 3 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe fine drug powder and mixed-matrix when 1: 9 the proportioning prepared throat pain relieving anti-inflammation drop pills in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe throat pain relieving anti-inflammation drop pills that fine drug powder and mixed-matrix make when 1: 1 the proportioning in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe throat pain relieving anti-inflammation drop pills that fine drug powder and mixed-matrix make when 1: 3 the proportioning in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe throat pain relieving anti-inflammation drop pills that fine drug powder and mixed-matrix make when 1: 9 the proportioning in qualitative difference, 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 fine drug powder 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 fine drug powder and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 fine drug powder and single-matrix
(fine drug powder: 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 2000 | 50.0 | 63 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 77 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 9300 | 50.0 | 82 | ＜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 | 80 | ＜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 fine drug powder and single-matrix
(fine drug powder: 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 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 | 82 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 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 fine drug powder and single-matrix
(fine drug powder: 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 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 | 82 | ＜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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and mixed-matrix
(fine drug powder: 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 fine drug powder and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of fine drug powder 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 fine drug powder 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 (2)
1. the throat pain relieving anti-inflammation drop pills with anti-inflammatory analgetic effect is a raw material with artificial Calculus Bovis, Indigo Naturalis, Margarita, Venenum Bufonis, Borneolum Syntheticum, Realgar, Pulvis Fumi Carbonisatus, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that described preparation process is as follows:
(1) according to the weight portion meter, get respectively 3 parts of artificial Calculus Bovis, Margarita, Pulvis Fumi Carbonisatuss, each 2 parts of Indigo Naturaliss, Venenum Bufonis, Borneolum Syntheticum, Realgar, more than each flavor, Margarita, Realgar water fly into impalpable powder, artificial Calculus Bovis, Borneolum Syntheticum, Venenum Bufonis, Indigo Naturalis be porphyrize respectively, with above-mentioned fine powder and with the Pulvis Fumi Carbonisatus facing-up, sieve mixing, drying, promptly;
(2) mixture with Polyethylene Glycol and polyoxyethylene stearate 40 esters or poloxamer is a substrate, and by weight, its mixed proportion is 1: 5; The ratio of fine drug powder and substrate is 1: 3;
(3) according to the given ratio of prescription, accurately take by weighing fine drug powder and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing fine drug powder and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50 ℃～90 ℃, and the temperature cooling of condensing agent also remains on-5 ℃～40 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, the above-mentioned fused solution that contains fine drug powder and substrate and/or emulsion and/or suspension are placed in the water dropper jar of drop pill machine, splash into to shrink in the condensing agent and be shaped promptly.
2. the preparation method of throat pain relieving anti-inflammation drop pills according to claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100967105A CN1301094C (en) | 2004-12-02 | 2004-12-02 | Throat pain relieving anti-inflammation drop pills for treating oral disease and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100967105A CN1301094C (en) | 2004-12-02 | 2004-12-02 | Throat pain relieving anti-inflammation drop pills for treating oral disease and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634491A CN1634491A (en) | 2005-07-06 |
| CN1301094C true CN1301094C (en) | 2007-02-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100967105A Expired - Fee Related CN1301094C (en) | 2004-12-02 | 2004-12-02 | Throat pain relieving anti-inflammation drop pills for treating oral disease and preparation method thereof |
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| Country | Link |
|---|---|
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1088784A (en) * | 1993-01-01 | 1994-07-06 | 绍兴中药厂 | Civet " Liushenwan " pills |
-
2004
- 2004-12-02 CN CNB2004100967105A patent/CN1301094C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1088784A (en) * | 1993-01-01 | 1994-07-06 | 绍兴中药厂 | Civet " Liushenwan " pills |
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| Publication number | Publication date |
|---|---|
| CN1634491A (en) | 2005-07-06 |
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