CN100427070C - Dripping pills for treating all kinds of rhinitis and its preparation method - Google Patents
Dripping pills for treating all kinds of rhinitis and its preparation method Download PDFInfo
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- CN100427070C CN100427070C CNB200510072174XA CN200510072174A CN100427070C CN 100427070 C CN100427070 C CN 100427070C CN B200510072174X A CNB200510072174X A CN B200510072174XA CN 200510072174 A CN200510072174 A CN 200510072174A CN 100427070 C CN100427070 C CN 100427070C
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Abstract
The present invention discloses a medical composition having the functions of dispelling wind, relieving exterior syndromes, reducing fever and dredging channels and used for treating various kinds of rhinitis. The present invention aims to overcome the defects in the existing medicinal preparations used for treating various kinds of rhinitis, and provides a nose-recovering dripping pill which has the advantages of high biologic utilization rate, fast medicine release, instant effect, high medicine content, convenient administration and low price and has the functions of treating both manifestation and root cause of disease. The nose-recovering dripping pill is prepared from an extract containing active ingredients of two meshes of traditional Chinese medicines of small centipeda herb, solidago, etc., and a medicinal carrier used as a base material.
Description
Technical field
The present invention relates to a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, the pharmaceutical composition that is used for the treatment of various rhinitis is a kind of drug composition oral preparation that feedstock production forms to contain 2 flavor active ingredient of Chinese herbs extracts such as Herba Centipedae, Herba Solidaginis particularly.
Background technology
The peaceful spray of nose that is prepared from according to the preparation method among the national drug standards WS-10548 (ZD-0548)-2002, it is a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, the spray that is used for the treatment of various rhinitis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be prescription and technology and the brief description that provides among the drug standard WS-10548 (ZD-0548)-2002:
Prescription: Herba Centipedae 60g, Herba Solidaginis 250g, sorbic acid 2g, sodium chloride 9g, polyoxyethylene sorbitan monoleate g
Method for making: above two flavor medical materials, added water infiltration 12 hours, vapor distillation is collected 3 times of amounts that Aromatic water is about medical material; Medicinal residues decoct with water three times, and 2 hours for the first time, second and third time respectively was 1.5 hours, collecting decoction filters, and it is 1.15 clear paste that filtrate is concentrated into relative density, adding ethanol makes and contains alcohol amount and reach 70%, stir evenly, cold preservation was left standstill 24 hours, getting that supernatant reclaims ethanol and be concentrated into relative density is 1.20 clear paste, Aromatic water adds polyoxyethylene sorbitan monoleate, adds clear paste, stirs evenly, adding sodium chloride accent etc. oozes, add sorbic acid, regulate pH value to 4.0～6.0, add water to ormal weight with sodium hydrogen phosphate, stir evenly, leave standstill, get supernatant, promptly.
Function cures mainly:
The Seedling doctor: lead to and rob the pile mark, the triumphant mark of rising sun loud, high-pitched sound how, and steep, post is said thick stick heat, and illiteracy is bought (or sell) on credit triumphant several;
The traditional Chinese medical science: dispelling wind to relieve the exterior syndrome, heat clearing away is sensible.Be used for acute rhinitis (cold nasal obstruction), chronic simple rhinitis, allergic rhinitis.
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.The spray manufacturing cost is higher, uses also not easily, simultaneously also can only can not play the effect for the treatment of both the principal and secondary aspects of a disease as topical administration.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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 the existing deficiency that is used for the treatment of the pharmaceutical preparation of various rhinitis, and a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, taking convenience, cheap, and can play the nose drip pills for the treatment of both the principal and secondary aspects of a disease effect.Nose drip pills involved in the present invention is a raw material with the extract that contains 2 flavor active ingredient of Chinese herbs such as Herba Centipedae, Herba Solidaginis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain nose drip pills involved in the present invention:
[preparation method]
1. the preparation of drug extract: get Herba Centipedae 60g, Herba Solidaginis 250g, more than two flavor medical materials, added water infiltration 12 hours, vapor distillation is collected 3 times of amounts that Aromatic water is about medical material; Medicinal residues decoct with water three times, and 2 hours for the first time, second and third time respectively was 1.5 hours, collecting decoction filters, and it is 1.15 clear paste that filtrate is concentrated into relative density, adding ethanol makes and contains alcohol amount and reach 70%, stir evenly, cold preservation was left standstill 24 hours, getting that supernatant reclaims ethanol and be concentrated into relative density is 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, 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 drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract 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. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the 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]
The peaceful spray of nose that is prepared from according to the preparation method among the national drug standards WS-10548 (ZD-0548)-2002, it is a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, the spray that is used for the treatment of various rhinitis, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned 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.The spray manufacturing cost is higher, uses also not easily, simultaneously also can only can not play the effect for the treatment of both the principal and secondary aspects of a disease as topical administration.
In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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.
Nose drip pills involved in the present invention is compared with the peaceful spray of nose has following beneficial effect:
1. nose drip pills involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 2 flavor Chinese medicine active pharmaceutical ingredients such as Herba Centipedae, Herba Solidaginis; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. nose drip pills involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. nose drip pills involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splash in the not miscible condensed fluid and make. therefore, the stability of drug height, not facile hydrolysis, oxidation, and operation is to carry out under liquid state, and no dust pollution is not subject to the influence of crystal formation, thereby guaranteed the quality of medicine, 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. and 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, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of nose drip pills of the present invention.
[first group: the test of single-matrix]
1. raw material: it is standby to make the extract dry powder that contains 2 flavor Chinese medicine active pharmaceutical ingredients such as Herba Centipedae, Herba Solidaginis earlier according to [preparation method 1];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the nose drip pills of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared nose drip pills in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared nose drip pills in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared nose drip pills in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: it is standby to make the extract dry powder that contains 2 flavor Chinese medicine active pharmaceutical ingredients such as Herba Centipedae, Herba Solidaginis 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. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the nose drip pills of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared nose drip pills 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: 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 | 69 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 64 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 73 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 66 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 65 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 65 | ＞30 | ＞10 | + |
| Lac | 50.0 | 63 | ＞30 | ＞10 | + |
The group practices of table 2 drug extract and single-matrix
(drug extract: 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 | 76 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 89 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 73 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 77 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: 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 | 84 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 76 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 73 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 74 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 71 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 70 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: 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 | 85 | ＜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 drug extract and mixed-matrix
(drug extract: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: 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 | 89 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 88 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: 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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: 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 | 88 | ＜30 | ＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 86 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: 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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 88 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract 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 drug extract 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 drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves 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 nose drip pills of the various rhinitis of treatment is a raw material with Herba Centipedae, Herba Solidaginis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) get Herba Centipedae 60g, Herba Solidaginis 250g, more than two flavor medical materials, added water infiltration 12 hours, vapor distillation is collected 3 times of amounts that Aromatic water is about medical material; Medicinal residues decoct with water three times, and 2 hours for the first time, second and third time respectively was 1.5 hours, collecting decoction filters, and it is 1.15 clear paste that filtrate is concentrated into relative density, add ethanol and make and contain alcohol amount and reach 70%, stir evenly cold preservation, left standstill 24 hours, getting that supernatant reclaims ethanol and be concentrated into relative density is 1.3～1.35 thick paste, or continues to make drying, is ground into dry powder, promptly get the extract that contains pharmaceutically active ingredient in above-mentioned two kinds, standby;
(2) 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: 5, describedly contains the extract of pharmaceutically active ingredient in two kinds and the ratio of substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. nose drip pills as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CNB200510072174XA CN100427070C (en) | 2005-05-26 | 2005-05-26 | Dripping pills for treating all kinds of rhinitis and its preparation method |
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| CN102657689A (en) * | 2012-05-03 | 2012-09-12 | 贵州百花医药股份有限公司 | Method for preparing nose spray |
| CN104523794A (en) * | 2014-12-12 | 2015-04-22 | 百花医药集团股份有限公司 | Method for preparing nose disease relieving preparation |
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Non-Patent Citations (4)
| Title |
|---|
| 中药药剂学. 范碧亭，380 381 383，上海科学技术出版社. 1997 * |
| 中药药剂学. 范碧亭，380 381，上海科学技术出版社. 1997 * |
| 国家中成药标准汇编（耳鼻喉分册）. 国家药品监督管理局，173，国家药品监督管理局. 2002 中药药剂学. 范碧亭，380 381，上海科学技术出版社. 1997 中药药剂学. 范碧亭，380 381 383，上海科学技术出版社. 1997 |
| 国家中成药标准汇编（耳鼻喉分册）. 国家药品监督管理局，173，国家药品监督管理局. 2002 * |
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Assignee: Shanghai General Pharmaceutical Co., ltd. Assignor: Beijing Zhengda Oasis Medicine Technology Co., Ltd. Contract record no.: 2011310000166 Denomination of invention: Dripping pills for treating all kinds of rhinitis and its preparation method Granted publication date: 20081022 License type: Exclusive License Open date: 20051123 Record date: 20110831 |
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