CN100348173C - Drop pills of honeysuckle flower in use for clearing away heat and toxic materials and preparing method - Google Patents
Drop pills of honeysuckle flower in use for clearing away heat and toxic materials and preparing method Download PDFInfo
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- CN100348173C CN100348173C CNB2005100049517A CN200510004951A CN100348173C CN 100348173 C CN100348173 C CN 100348173C CN B2005100049517 A CNB2005100049517 A CN B2005100049517A CN 200510004951 A CN200510004951 A CN 200510004951A CN 100348173 C CN100348173 C CN 100348173C
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Abstract
The present invention relates to a medicine composition which has the function of clearing heat and toxin and is used for the treatment of fever, hydrodipsia, asthma, heat bump, pyogenic infection of skin, pediatric pyretic toxicity and other diseases, particularly an oral medicine composition preparation prepared from the raw materials of honeysuckle, caulis lonicerae and other Chinese medicines. The present invention has the purpose of complementing the deficiency of the existing oral medicine preparations used for the treatment of fever, hydrodipsia, asthma, heat bump, pyogenic infection of skin, pediatric pyretic toxicity and other diseases, and provides honeysuckle dripping pills which are oral medicine composition preparations having the advantages of high bioavailability, quick medicine release, rapid effect, high medicine content, accurate administration measurement, low price and convenient carrying. The honeysuckle dripping pills of the present invention are prepared by taking honeysuckle, caulis lonicerae and other Chinese medicines as raw materials and preparing the raw materials with a medicinal carrier serving as a matrix.
Description
Technical field
The present invention relates to a kind of antipyretic and antidote functions that has, it is thirsty to be used for the treatment of heating, laryngopharynx swelling and pain, furuncle skin infection, the pharmaceutical composition of diseases such as children's's pyretic toxicity is a kind of drug composition oral preparation that feedstock production forms with two flavor Chinese medicines such as Flos Lonicerae, Caulis Lonicerae particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Flos Lonicerae syrup that the preparation method that provides among-the B-2781-97 is prepared from, it is a kind of antipyretic and antidote functions that has, it is thirsty to be used for the treatment of heating, laryngopharynx swelling and pain, the furuncle skin infection, the syrups oral formulations of diseases such as children's's pyretic toxicity is through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be drug standard WS
3Prescription that provides among-the B-2781-97 and technology and brief description:
Prescription: Flos Lonicerae 75g, Caulis Lonicerae 175g
Method for making: above two flavors, Flos Lonicerae is distilled with the way of distillation, collects distillate 100ml, adds antiseptic, and is standby; Medicinal residues and Caulis Lonicerae add water at 80 ℃ of dipping secondaries, and each 1 hour, filter, merging filtrate is concentrated into about 250ml, leaves standstill, and inclines and gets supernatant, filters.Other gets sucrose 650g, adds water boil, filters, and merges with above-mentioned filtrate, is concentrated into about 900ml, and the adding antiseptic is put coldly, adds above-mentioned distillate, and mixing adds water to 1000ml, promptly.
Function cures mainly: heat-clearing and toxic substances removing; It is thirsty to be used to generate heat, laryngopharynx swelling and pain, furuncle skin infection, children's's pyretic toxicity.
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, be to replenish that existing to be used for the treatment of heating thirsty, laryngopharynx swelling and pain, furuncle skin infection, the deficiency of the oral drug preparation of diseases such as children's's pyretic toxicity, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, take accurate measurement, cheap, and portable drug composition oral preparation Flos Lonicerae drop pill.
Flos Lonicerae drop pill involved in the present invention is a raw material with two flavor Chinese medicines such as Flos Lonicerae, Caulis Lonicerae, after extraction obtains containing the extract of pharmaceutically active ingredient in above two flavors, is prepared from the pharmaceutically suitable carrier as substrate again.Be prepared by the following technical solutions, can obtain Flos Lonicerae drop pill involved in the present invention:
[preparation method]
1. the system Shandong of drug extract: with g or kg is unit, by weight, gets 3 parts Flos Lonicerae and 7 parts Caulis Lonicerae, more than two flavors, Flos Lonicerae is distilled with the way of distillation, collects distillate, and is standby; Medicinal residues and Caulis Lonicerae add water at 80 ℃ of dipping secondaries, and each 1 hour, filter, merging filtrate, and add above-mentioned distillate is condensed into relative density and is 1.3～1.35 thick paste promptly under decompression (0.1MPa), low temperature (60 ℃) condition; Or continue dry in the above conditions, be ground into dry powder, promptly;
2. substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
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, fused solution and/or the emulsion and/or the suspension that will contain drug 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
3The Flos Lonicerae syrup that the preparation method that provides among-the B-2781-97 is prepared from, it is a kind of antipyretic and antidote functions that has, it is thirsty to be used for the treatment of heating, laryngopharynx swelling and pain, the furuncle skin infection, the syrups oral formulations of diseases such as children's's pyretic toxicity is through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of 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.
Flos Lonicerae drop pill involved in the present invention is compared with the Flos Lonicerae syrup has following beneficial effect:
1. Flos Lonicerae drop pill involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing two flavors such as Flos Lonicerae, Caulis Lonicerae; 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. Flos Lonicerae drop pill 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. Flos Lonicerae drop pill 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 Flos Lonicerae drop pill of the present invention.
First group: the test of single-matrix
1. the preparation of drug extract: be prepared according to preparation method 1, the extract dry powder that obtains containing pharmaceutically active ingredient in two flavors such as Flos Lonicerae, Caulis Lonicerae is standby;
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
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 Flos Lonicerae drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared Flos Lonicerae drop pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared Flos Lonicerae drop pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared Flos Lonicerae drop pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: be prepared according to preparation method 1, the extract dry powder that obtains containing pharmaceutically active ingredient in two flavors such as Flos Lonicerae, Caulis Lonicerae is 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. 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 Flos Lonicerae drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared Flos Lonicerae drop pill 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained Flos Lonicerae drop pill when 1: 1 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained Flos Lonicerae drop pill when 1: 3 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained Flos Lonicerae drop pill when 1: 9 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, 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see 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 2000 | 50.0 | 64 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 76 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 86 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 74 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 72 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 71 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 69 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 58 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 54 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 56 | ＞30 | ＞10 | + |
| Lac | 50.0 | 53 | ＞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 2000 | 25.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 70 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 70 | ＞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 2000 | 10.0 | 84 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Sodium lauryl sulphate | 10.0 | 81 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 79 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 78 | ＞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 | 82 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 72 | ＜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 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 86 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 82 | ＜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 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 80 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 86 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 91 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 84 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 91 | ＜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. a Flos Lonicerae drop pill is a raw material with Chinese medicine Flos Lonicerae, Caulis Lonicerae, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) by weight, get 3 parts Flos Lonicerae and 7 parts Caulis Lonicerae, more than two flavors, Flos Lonicerae is distilled with the way of distillation, collects distillate, and is standby; Medicinal residues and Caulis Lonicerae add water at 80 ℃ of dipping secondaries, each 1 hour, filter, merging filtrate, and add above-mentioned distillate, being decompressed to and being condensed into relative density under 0.1MPa, 60 ℃ of conditions of low temperature is 1.3～1.35 thick paste, or continue dry in the above conditions, be ground into dry powder, promptly get the extract that contains pharmaceutically active ingredient in above-mentioned 2 flavors, standby;
(2) described substrate is the mixture of Macrogol 2000 or Macrogol 4000 or polyethylene glycol 6000 or Polyethylene Glycol 8000 or cetomacrogol 1000 0 or Macrogol 2000 0 and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; By weight, the ratio of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and described Polyethylene Glycol is 1: 1～1: 10, describedly contains that the extract of pharmaceutically active ingredient and the ratio of substrate are 1: 1～1: 3 in above-mentioned 2 flavors;
(3) take by weighing described extract and substrate according to aforementioned proportion, be placed on heating while stirring in the heating container, until the fused solution or emulsion or the suspension that obtain containing described extract and substrate, standby;
(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) treating that dropping-pill machine head and condensing agent reach described state of temperature respectively, will contain fused solution or the emulsion or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
2. Flos Lonicerae drop pill according to 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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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100049517A CN100348173C (en) | 2005-01-31 | 2005-01-31 | Drop pills of honeysuckle flower in use for clearing away heat and toxic materials and preparing method |
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|---|---|---|---|
| CNB2005100049517A CN100348173C (en) | 2005-01-31 | 2005-01-31 | Drop pills of honeysuckle flower in use for clearing away heat and toxic materials and preparing method |
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| CN100348173C true CN100348173C (en) | 2007-11-14 |
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| CN102441022A (en) * | 2011-11-30 | 2012-05-09 | 中山市中智药业集团有限公司 | Honeysuckle oral liquid |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1544042A (en) * | 2003-11-12 | 2004-11-10 | 北京正大绿洲医药科技有限公司 | Liuwei Dihuang dripping pills and its preparation |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1544042A (en) * | 2003-11-12 | 2004-11-10 | 北京正大绿洲医药科技有限公司 | Liuwei Dihuang dripping pills and its preparation |
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14册 154，中华人民共和国药典委员会 1997 * |
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