CN1294903C - Loquat drip pill for treating cough and its preparation method - Google Patents
Loquat drip pill for treating cough and its preparation method Download PDFInfo
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- CN1294903C CN1294903C CNB2005100711127A CN200510071112A CN1294903C CN 1294903 C CN1294903 C CN 1294903C CN B2005100711127 A CNB2005100711127 A CN B2005100711127A CN 200510071112 A CN200510071112 A CN 200510071112A CN 1294903 C CN1294903 C CN 1294903C
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- polyethylene glycol
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- Medicinal Preparation (AREA)
Abstract
The present invention discloses a medicinal composition. The present invention has the functions of clearing lung heat, relieving cough and eliminating phlegm, and is used for treating dry mouth and thirst, cough and counterflow and copious phlegm, which are caused by wind-heat attack for the lung, bronchitic cough and other diseases. The present invention aims to supplement the shortage of the existing oral medicinal preparation for treating the diseases and to provide a loquat dripping pill for treating cough, which has high bioavailability, high drug releasing speed, high effectual rate, high drug content, accurate admitting dosage, low price and convenient carrying. The loquat dripping pill for treating cough of the present invention is prepared from the active extracts of loquat leaf, stemona root, peucedanum root, platycodon root, white mulberry root-bark and other traditional Chinese medicines, menthol and a medicine carrier which is used as a substrate.
Description
Technical field
The present invention relates to a kind of clearing away lung-heat that has, cough-relieving, phlegm-dispelling functions, being used for wind heat invades the xerostomia that lung causes and does thirsty, the pharmaceutical composition of disease treatments such as cough with dyspnea abundant expectoration and bronchitic cough is a kind of drug composition oral preparation that feedstock production forms to contain 5 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori and Mentholum particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3Distillate Folium Eriobotryae is coughed in controlling that the preparation method that provides among-the B-3877-98 is prepared from, it is a kind of clearing away lung-heat that has, cough-relieving, phlegm-dispelling functions, be used for wind heat and invade xerostomia that lung causes and do yearningly, the syrups oral formulations of disease treatments such as cough with dyspnea abundant expectoration and bronchitic cough is 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 WS
3Prescription that provides in-B-3877-98 the drug standard and technology and brief description:
Prescription: Folium Eriobotryae 131g, Radix Stemonae 23g, Radix Peucedani 14g, Radix Platycodonis 9g, Cortex Mori 9g, Mentholum 0.16g
Method for making: above Six-element, except that Mentholum, the five tastes such as all the other Folium Eriobotryaes decoct with water twice, each 2 hours, collecting decoction filtered, and filtrate is concentrated in right amount, add sucrose 300g and benzoic acid 3g, boil and make dissolving, filter, filtrate adds Mentholum, citric acid 0.5g, almond essence 1.6g, and Fructus Myricae rubrae essence 1.2g is with adding with stirring, leave standstill, get supernatant and add water adjustment total amount, stir evenly, promptly to 1000ml.
Function cures mainly: clearing away lung-heat, cough-relieving is eliminated the phlegm.Be used for wind heat invade xerostomia that lung causes do thirsty, cough with dyspnea abundant expectoration and bronchitic cough, the double child of the controlling singultus of catching cold, cough with profuse sputum.
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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
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, being to replenish the existing wind heat that is used for invades the xerostomia that lung causes and does thirsty, the deficiency of the oral drug preparation of disease treatments such as cough with dyspnea abundant expectoration and bronchitic cough, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, take accurate measurement, cheap, and portable loquat drip pill for treating cough.
Loquat drip pill for treating cough involved in the present invention is a raw material to contain 5 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori and Mentholum, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain loquat drip pill for treating cough involved in the present invention:
[preparation method]
1. the preparation of hybrid medicine extract: get Folium Eriobotryae 131g, Radix Stemonae 23g, Radix Peucedani 14g, Radix Platycodonis 9g, Cortex Mori 9g, Mentholum 0.16g, above Six-element, except that Mentholum, the five tastes such as all the other Folium Eriobotryaes decoct with water 2 times, each 2 hours, collecting decoction filters, it is below 1.2 that filtrate is concentrated into relative density, stop to heat when treating that temperature drops to below 60 ℃, add Mentholum, be 1.3～1.35 thick paste being decompressed to 0.1MPa, being concentrated into relative density below 60 ℃ while stirring, or make drying under the same conditions, 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 hybrid medicine extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing hybrid medicine extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing hybrid medicine 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, fused solution and/or the emulsion and/or the suspension that will contain hybrid medicine extract and substrate, place 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]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3Distillate Folium Eriobotryae is coughed in controlling that the preparation method that provides among-the B-3877-98 is prepared from, it is a kind of clearing away lung-heat that has, cough-relieving, phlegm-dispelling functions, be used for wind heat and invade xerostomia that lung causes and do yearningly, the syrups oral formulations of disease treatments such as cough with dyspnea abundant expectoration and bronchitic cough is 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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
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.
Loquat drip pill for treating cough involved in the present invention is coughed Distillate Folium Eriobotryae and is compared and have following beneficial effect with controlling:
1. loquat drip pill for treating cough involved in the present invention; utilize surfactant to be substrate; make solid dispersion with containing 5 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori and Mentholum; 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. loquat drip pill for treating cough 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. loquat drip pill for treating cough involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, 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 loquat drip pill for treating cough of the present invention.
[first group: the test of single-matrix]
1. the preparation of drug extract: it is standby to make the hybrid medicine extract dry powder that contains 5 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori and Mentholum 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 hybrid medicine extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the loquat drip pill for treating cough of different size.
[result of the test]
Test 1: for observe hybrid medicine extract and different substrates when 1: 1 the proportioning prepared loquat drip pill for treating cough in qualitative difference, according to 1: 1 ratio, with the hybrid medicine 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 13 pharmaceutical compositions experiments that contain hybrid medicine extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe hybrid medicine extract and different substrates when 1: 3 the proportioning prepared loquat drip pill for treating cough in qualitative difference, according to 1: 3 ratio, with the hybrid medicine 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 13 pharmaceutical compositions experiments that contain hybrid medicine extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe hybrid medicine extract and different substrates when 1: 9 the proportioning prepared loquat drip pill for treating cough in qualitative difference, according to 1: 9 ratio, with the hybrid medicine 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 13 pharmaceutical compositions experiments that contain hybrid medicine extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: it is standby to make the hybrid medicine extract dry powder that contains 5 flavor active ingredient of Chinese herbs extracts such as Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori and Mentholum 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 hybrid medicine extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the loquat drip pill for treating cough of different size.
Test 4: in order to observe the mass discrepancy of hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 hybrid medicine extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are 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 hybrid medicine extract and mixed-matrix prepared loquat drip pill for treating cough 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 the hybrid medicine 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 pharmaceutical composition experiment that 4 hybrid medicines extract and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 hybrid medicine extract and single-matrix
(hybrid medicine 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 | 66 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 83 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 83 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 66 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 74 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 65 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 64 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 62 | ＞30 | ＞10 | + |
| Lac | 50.0 | 62 | ＞30 | ＞10 | + |
The group practices of table 2 hybrid medicine extract and single-matrix
(hybrid medicine 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 | 72 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 76 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 75 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 75 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 hybrid medicine extract and single-matrix
(hybrid medicine 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 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 79 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 76 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 74 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 72 | ＞30 | ＞10 | +++ |
The group practices of table 4 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 78 | ＜30 | ＞10 | + |
The group practices of table 5 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 83 | ＜30 | ＞10 | ++ |
The group practices of table 6 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 90 | ＜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 | 85 | ＜30 | ＞10 | +++ |
The group practices of table 7 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
The group practices of table 8 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 10 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 89 | ＜30 | ＞10 | +++ |
The group practices of table 11 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 hybrid medicine extract and mixed-matrix
(hybrid medicine 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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 89 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of hybrid medicine 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 hybrid medicine 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 hybrid medicine 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. a loquat drip pill for treating cough is a raw material with Folium Eriobotryae, the Radix Stemonae, Radix Peucedani, Radix Platycodonis, Cortex Mori, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) gets Folium Eriobotryae 131g, Radix Stemonae 23g, Radix Peucedani 14g, Radix Platycodonis 9g, Cortex Mori 9g, Mentholum 0.16g, above Six-element, except that Mentholum, the five tastes such as all the other Folium Eriobotryaes decoct with water 2 times, each 2 hours, collecting decoction filters, it is below 1.2 that filtrate is concentrated into relative density, stop to heat when treating that temperature drops to below 60 ℃, add Mentholum, be decompressed to 0.1MPa while stirring, be concentrated into relative density below 60 ℃ and be 1.3～1.35 thick paste, or make drying under the same conditions, be ground into dry powder, promptly get the extract that contains above-mentioned 6 kinds of effective ingredients, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; The ratio of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10; Describedly contain the extract of 6 kinds of effective ingredients and the ratio of described substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described drug extract and substrate, be placed on heating while stirring in the heating container, until the fused solution that obtains containing described drug extract and substrate, or emulsion, or suspension, standby;
(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 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state of temperature respectively, will contain the fused solution of described drug extract and substrate, or emulsion, or suspension, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
2. loquat drip pill for treating cough according to claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/vegetable oil.
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