CN1322852C - Dripping pills for treating rhinitis and its preparing process - Google Patents
Dripping pills for treating rhinitis and its preparing process Download PDFInfo
- Publication number
- CN1322852C CN1322852C CNB2004100971666A CN200410097166A CN1322852C CN 1322852 C CN1322852 C CN 1322852C CN B2004100971666 A CNB2004100971666 A CN B2004100971666A CN 200410097166 A CN200410097166 A CN 200410097166A CN 1322852 C CN1322852 C CN 1322852C
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- mixed
- rhinitis
- principal agent
- substrate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention discloses an oral drop pill preparation which has the functions of clearing wind heat and relieving a stuffy nose and is used for treating chronic rhinitis, chronic accessory nasosinusitis and allergic rhinitis, namely a Huodan rhinitis drop pill medicine composition. The purpose of the present invention is to replenish the insufficiency of the existing oral medicine preparation which has the functions of clearing wind heat and relieving a stuffy nose and is used for treating chronic rhinitis, chronic accessory nasosinusitis and allergic rhinitis, the present invention provides a Huodan rhinitis drop pill of a medicine composition oral preparation, which has the advantages of high biological utilization rate, rapid medicine release, rapid positive effect, little toxic side effect, high medicine content, low administration dosage, accurate administration dosage, convenient administration, low cost and convenient carrying under the condition of an outing.
Description
Technical field
The present invention relates to a kind of fresh breeze heat that has, the effect of clearing the nasal passage is used for the treatment of chronic rhinitis, the pharmaceutical composition of symptoms such as chronic paranasal rhinitis and allergic rhinitis, be particularly related to based on the Chinese traditional patent formulation HUODAN BIYAN JIAONANG, change a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology
According to the HUODAN BIYAN JIAONANG that the prescription that provides among the ministry standard WS3-B-2822-97 and extraction process are prepared from, be a kind of have fresh breeze heat, clearing the nasal passage; Be used for chronic rhinitis, the shape tablet class preparation of diseases such as chronic paranasal rhinitis and allergic rhinitis treatments, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation of above disease.
Below be the prescription and the extraction process of the HUODAN BIYAN JIAONANG that provides among the ministry standard WS3-B-2822-97:
Prescription: Fructus Xanthii extract 76g, patchouli oil 26.7ml, refining Fel Sus domestica dry paste 65g;
Method for making: above three flavors, get oil of Herba Pogostemonis, make microcapsule, with Fructus Xanthii extract, refining Fel Sus domestica dry paste and appropriate amount of starch mix homogeneously, be distributed into 1000, promptly.
Be explained as follows for this tablet in the appended HUODAN BIYAN JIAONANG description:
Nomenclature of drug: HUODAN BIYAN JIAONANG;
Main component: Fructus Xanthii extract, patchouli oil, refining Fel Sus domestica dry paste;
Character: this product is a capsule, and content is green powder or granule; The fragrance that the tool Herba Pogostemonis is special, bitter in the mouth;
Function cures mainly: fresh breeze heat, clearing the nasal passage; Be used for chronic rhinitis, chronic paranasal rhinitis and allergic rhinitis;
Usage and dosage: oral, one time 2,3 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.Existing HUODAN BIYAN JIAONANG does not still have similar other dosage form listings at present.
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 be used for the treatment of chronic rhinitis, the deficiency of the oral drug preparation of chronic paranasal rhinitis and allergic rhinitis, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and medicament contg height, taking dose is little, and taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation dripping pills for treating rhinitis of going out to carry.
Dripping pills for treating rhinitis involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation HUODAN BIYAN JIAONANG, 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 dripping pills for treating rhinitis involved in the present invention:
[preparation method]
1. Fructus Xanthii extract 76g, patchouli oil 26.7ml, refining Fel Sus domestica dry paste 65g; Merge above three flavors for principal agent, standby;
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 principal agent and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing principal agent 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, is incubated under the temperature conditions close with the water dropper temperature, 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.
[appendix 1: a kind of preparation method of Fructus Xanthii extract]
Take by weighing the Fructus Xanthii that cleans 880 grams, add the alcohol reflux three times of 6 times of amounts, 2 hours for the first time, for the second time, each 1 hour for the third time, filter merging filtrate, filtrate recycling ethanol; The water washing secondary that adds 10 times of amounts of extractum behind the branch water-yielding stratum, is put and is flung to remaining moisture in the evaporation boiler, promptly gets Fructus Xanthii extract 76g.
[appendix 2: a kind of preparation method of refining Fel Sus domestica dry paste]
Get Fel Sus domestica peeling extracting juice, filter, filtrate is condensed into dried cream, uses the ethanol heating extraction, filters, and reclaims ethanol, drying, promptly.
Given here is to change according to a kind of preparation method of extract among the ministry standard WS3-B-2822-97 to form, and similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
HUODAN BIYAN JIAONANG according to the prescription that provides among the ministry standard WS3-B-2822-97 and extraction process are prepared from has fresh breeze heat, clearing the nasal passage; Be used for chronic rhinitis, the capsule class preparation of chronic paranasal rhinitis and allergic rhinitis treatment, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation 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 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.
Dripping pills for treating rhinitis involved in the present invention is compared with HUODAN BIYAN JIAONANG, has following beneficial effect:
1. dripping pills for treating rhinitis involved in the present invention; 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. dripping pills for treating rhinitis 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. dripping pills for treating rhinitis 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.
In sum, make dripping pills for treating rhinitis 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 dripping pills for treating rhinitis of the present invention.
First group: the test of single-matrix
1. the ratio that provides according to [preparation method] 1 takes by weighing the principal agent of some, and principal agent makes according to [appendix 1: a kind of preparation method of Fructus Xanthii extract] and [appendix 2: a kind of preparation method of refining Fel Sus domestica dry paste].Standby;
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 dripping pills for treating rhinitis of various different sizes.
[result of the test]
Test 1: for observe principal agent and different substrates when 1: 1 the proportioning prepared dripping pills for treating rhinitis in qualitative difference, 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: for observe principal agent and different substrates when 1: 3 the proportioning prepared dripping pills for treating rhinitis in qualitative difference, 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: for observe principal agent and different substrates when 1: 9 the proportioning prepared dripping pills for treating rhinitis in qualitative difference, 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. the ratio that provides according to [preparation method] 1 takes by weighing the principal agent of some, and principal agent makes according to [appendix 1: a kind of preparation method of Fructus Xanthii extract] and [appendix 2: a kind of preparation method of refining Fel Sus domestica dry paste].Standby;
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 dripping pills for treating rhinitis of various different sizes.
[result of the test]
Test 4: for observe principal agent and mixed-matrix when 1: 1 the proportioning prepared dripping pills for treating rhinitis 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 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: for observe principal agent and mixed-matrix when 1: 3 the proportioning prepared dripping pills for treating rhinitis 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 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: for observe principal agent and mixed-matrix when 1: 9 the proportioning prepared dripping pills for treating rhinitis 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 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: for observe principal agent and mixed-matrix when 1: 1 the proportioning prepared dripping pills for treating rhinitis 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 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: for observe principal agent and mixed-matrix when 1: 3 the proportioning prepared dripping pills for treating rhinitis 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 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: for observe principal agent and mixed-matrix when 1: 9 the proportioning prepared dripping pills for treating rhinitis 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 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: in order to observe dripping pills for treating rhinitis that principal agent 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 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: in order to observe dripping pills for treating rhinitis that principal agent 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 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: in order to observe dripping pills for treating rhinitis that principal agent 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 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 | 75 | ＜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 | 91 | ＜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 2000 | 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 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 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 | 77 | ＜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 | 84 | ＜30 | ＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 87 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 79 | ＜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 | 94 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜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 | 94 | ＜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 | 95 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 93 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 85 | ＜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 | 96 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 93 | ＜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 | 97 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 85 | ＜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 | 93 | ＜30 | ＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 94 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 89 | ＜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 | 95 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 89 | ＜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 undesirable, 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 (2)
1. a dripping pills for treating rhinitis is a raw material with Fructus Xanthii extract, patchouli oil, refining Fel Sus domestica dry paste, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) preparation of Fructus Xanthii extract: take by weighing the Fructus Xanthii that cleans 880 grams, add the alcohol reflux three times of 6 times of amounts, 2 hours for the first time, for the second time, three times each 1 hour, filter merging filtrate, filtrate recycling ethanol; The water washing secondary that adds 10 times of amounts of extractum behind the branch water-yielding stratum, is put and is flung to remaining moisture in the evaporation boiler, promptly gets Fructus Xanthii extract 76g;
(2) preparation of refining Fel Sus domestica dry paste: get Fel Sus domestica peeling extracting juice, filter, filtrate is condensed into dried cream, uses the ethanol heating extraction, filters, and reclaims ethanol, drying, promptly;
(3) patchouli oil is the commercially available prod;
(4) get Fructus Xanthii extract 76g, patchouli oil 26.7ml, refining Fel Sus domestica dry paste 65g merges above-mentioned three kinds of raw material for standby;
(5) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; By weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and described Fructus Xanthii extract, patchouli oil, the mixture of refining Fel Sus domestica dry paste and the ratio of substrate are 1: 3;
(6) according to aforementioned proportion, accurately take by weighing described mixed material and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described mixed material and substrate and/or emulsion and/or suspension;
(7) 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 ℃;
(8) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively when reaching described state of temperature, will contain the fused solution of described mixed material and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splashes into to shrink in the condensing agent to be shaped promptly.
2. dripping pills for treating rhinitis as claimed in 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 |
|---|---|---|---|
| CNB2004100971666A CN1322852C (en) | 2004-12-13 | 2004-12-13 | Dripping pills for treating rhinitis and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100971666A CN1322852C (en) | 2004-12-13 | 2004-12-13 | Dripping pills for treating rhinitis and its preparing process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634144A CN1634144A (en) | 2005-07-06 |
| CN1322852C true CN1322852C (en) | 2007-06-27 |
Family
ID=34847925
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100971666A Expired - Fee Related CN1322852C (en) | 2004-12-13 | 2004-12-13 | Dripping pills for treating rhinitis and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1322852C (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1368349A (en) * | 2001-02-05 | 2002-09-11 | 杨孟君 | Nano medicine 'Huodan Biyan' and its preparing process |
-
2004
- 2004-12-13 CN CNB2004100971666A patent/CN1322852C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1368349A (en) * | 2001-02-05 | 2002-09-11 | 杨孟君 | Nano medicine 'Huodan Biyan' and its preparing process |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药品标准中药成方制剂第十四册 中华人民共和国卫生部药典委员会，202-203 1997 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1634144A (en) | 2005-07-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1322855C (en) | Oral drop pill in use for clearing away heat and toxic material and preparation method | |
| CN100382785C (en) | Cough suppressing phlegm transforming drip pill and its preparation method | |
| CN1315471C (en) | Basis-reinforcing eyesight-improving dropping pill for treating eye disease and its preparing method | |
| CN100382786C (en) | Bastard feverfew throat clearing drip pill and its preparation method | |
| CN100382784C (en) | Danhong drip pill prepared from salvia root and carthamus and its preparation method | |
| CN100364513C (en) | 'Gansu' dripping pills for treating hepatitis and its preparation method | |
| CN100367936C (en) | Oral drop pill in use for clearing sway heat and toxic material, relieving inflammation and dysentery, and preparation method | |
| CN100358562C (en) | Tendril-leaved fritillary bulb loquat drop pills and preparation method thereof | |
| CN100367934C (en) | Yin-nourishing lung-heat clearing drop pills | |
| CN100542515C (en) | Milkwort root pill and preparation method thereof | |
| CN100453072C (en) | Isatis root drops and preparation thereof | |
| CN100348169C (en) | Saussurea involucrata drop pill and its preparation method | |
| CN1322852C (en) | Dripping pills for treating rhinitis and its preparing process | |
| CN100358504C (en) | Gastrodia brain arousing drip pill for nourishing liver and kidney and its preparation method | |
| CN100367937C (en) | Throat dripping pill for clearing away heat and toxic material and its preparing method | |
| CN1315463C (en) | Guanxinning drip pill for treating heart disease and its preparation method | |
| CN100348177C (en) | Two kinds of oral drip pills for treating tracheitis and its preparation method | |
| CN100427070C (en) | Dripping pills for treating all kinds of rhinitis and its preparation method | |
| CN100427068C (en) | Kangai drip pill for treating tumour, hepatitis B and its preparation method | |
| CN100367935C (en) | Oral drop pills in use for treating diseases of bacterial infection and preparation method | |
| CN100364505C (en) | Fengshining drop pill for treating rheumatism and its preparation method | |
| CN100358496C (en) | 'Xingnaojing' dripping pills for treating cephalitis and hepatic coma and preparation process thereof | |
| CN100375609C (en) | Dripping pills of emblic leafflower fruit and its preparation process | |
| CN1325044C (en) | Drop pills for treating apoplexy diseases and preparation method thereof | |
| CN100358500C (en) | Fleabane and earthworm dripping pill and its preparing method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20070627 Termination date: 20100113 |