CN1322854C - Cold drop pills of mulberry and ginger in use for eliminating draft, clearing away heat, and preparing method - Google Patents
Cold drop pills of mulberry and ginger in use for eliminating draft, clearing away heat, and preparing method Download PDFInfo
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- CN1322854C CN1322854C CNB2005100049428A CN200510004942A CN1322854C CN 1322854 C CN1322854 C CN 1322854C CN B2005100049428 A CNB2005100049428 A CN B2005100049428A CN 200510004942 A CN200510004942 A CN 200510004942A CN 1322854 C CN1322854 C CN 1322854C
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- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 8
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- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medical composition which has the functions of eliminating draft, clearing away heat, expelling phlegm and stopping cough and is used for treating diseases such as cold, cough, headache, swelling pain of a throat, etc., particularly an oral preparation of the medical composition; the oral preparation of the medical composition is formed by preparing six tastes of Chinese medicine, such as mulberry leaves, chrysanthemum, perilla, forsythia, bitter apricot seeds, dry ginger, etc., as raw materials. The goal of the present invention is to supplement the defects of the existing oral medical preparation used for treating the diseases for providing a cold drop pill of mulberry and ginger; the cold drop pill of mulberry and ginger has the advantages of high biologic utilization degree, rapid medicine release, rapid effect display, high medicine content, correct administration measurement, low price, no pollution in production processes, and convenient transportation and carrying. The cold drop pill of mulberry and ginger of the present invention uses the six tastes of Chinese medicine such as the mulberry leaves, the chrysanthemum, the perilla, the forsythia, the bitter apricot seeds, the dry ginger, etc., as the materials, and is prepared together with a medicinal carrier as a substrate.
Description
Technical field
The present invention relates to a kind of diffusing wind heat clearing away that has, the expelling phlegm for arresting cough effect, be used for the treatment of flu, cough, headache, the pharmaceutical composition of diseases such as laryngopharynx swelling and pain is a kind of drug composition oral preparation that feedstock production forms with 6 flavor Chinese medicines such as Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, Semen Armeniacae Amarum, Rhizoma Zingiberis particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The mulberry leaf-ginger common cold injection that the preparation method that provides among-the B-3954-98 is prepared from, it is a kind of diffusing wind heat clearing away that has, the expelling phlegm for arresting cough effect, be used for the treatment of flu, cough, headache, the pure Chinese medicine injection of diseases such as laryngopharynx swelling and pain, 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-3954-98 and technology and brief description:
Prescription: Folium Mori 150g, Flos Chrysanthemi 20g, Folium Perillae 80g, Fructus Forsythiae 80g, Semen Armeniacae Amarum 80g, Rhizoma Zingiberis 50g;
Method for making: above Six-element decocts with water secondary, 2 hours for the first time, 1 hour for the second time, merge decoction, filter, filtrate is concentrated into 100ml, adds ethanol, makes to contain alcohol amount and be respectively 60%, 70%, 80%, leave standstill, filter, reclaim ethanol, residue is dissolved in water and boiled 10 minutes, and it is an amount of to add active carbon, filters, add water to 900ml, add benzyl alcohol 10ml, transfer pH value to 7.5 with 4% sodium hydroxide solution, transfer to etc. with sodium chloride and to ooze, left standstill 48 hours, filter, add the 3ml polyoxyethylene sorbitan monoleate, boil, filter, filtrate adds the injection water to 1000ml, embedding, sterilization, promptly.
Function cures mainly: the wind heat clearing away of loosing, expelling phlegm for arresting cough.Be used for flu, cough, headache, laryngopharynx swelling and pain.
Owing to be subjected to the influence of existing injection technology of preparing restriction and Chinese medicinal ingredients complexity, Chinese medicine injection often is easy to generate acute allergic reaction or untoward reaction, it is big also to exist operation easier simultaneously, the patient suffering is big, make and the medical treatment cost height, transportation stores inconvenience, and patient economy burden is heavy, shortcomings such as unsuitable family use.
In addition, 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.Simultaneously, conventional peroral dosage form, regular meeting produces 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.The production technology of conventional oral formulations is more complicated also, and 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 flu that is used for the treatment of, cough, headache, the deficiency of the oral drug preparation of diseases such as laryngopharynx swelling and pain provides a kind of bioavailability height, and has quick release, quick produce effects, the medicament contg height is taken accurate measurement, and is cheap, and pollution-free aborning, and be convenient to the mulberry leaf-ginger common cold drop pill that transports and carry.
Mulberry leaf-ginger common cold drop pill involved in the present invention, with 6 flavor Chinese medicines such as Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, bitter Fructus Pruni two, Rhizoma Zingiberis is raw material, after extraction obtains containing the extract of pharmaceutically active ingredient in above 6 flavors, be prepared from pharmaceutically suitable carrier again as substrate.Be prepared by the following technical solutions, can obtain mulberry leaf-ginger common cold drop pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: accurately take by weighing Folium Mori 150g, Flos Chrysanthemi 20g, Folium Perillae 80g, Fructus Forsythiae 80g, Semen Armeniacae Amarum 80g, Rhizoma Zingiberis 50g, above Six-element, decoct with water secondary, 2 hours for the first time, 1 hour for the second time, merge decoction, filter, filtrate is concentrated into 100ml, add ethanol, make to contain alcohol amount and be respectively 60%, 70%, 80%, leave standstill, filter, reclaim ethanol, be condensed into relative density under decompression (0.1MPa), low temperature (60 ℃) condition and be 1.3～1.35 thick paste, or continue to make drying again, 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 mulberry leaf-ginger common cold injection that the preparation method that provides among-the B3954-98 is prepared from, it is a kind of diffusing wind heat clearing away that has, the expelling phlegm for arresting cough effect, be used for the treatment of flu, cough, headache, the pure Chinese medicine injection of diseases such as laryngopharynx swelling and pain, 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 be subjected to the influence of existing injection technology of preparing restriction and Chinese medicinal ingredients complexity, Chinese medicine injection often is easy to generate acute allergic reaction or untoward reaction, it is big also to exist operation easier simultaneously, the patient suffering is big, make and the medical treatment cost height, transportation stores inconvenience, and patient economy burden is heavy, shortcomings such as unsuitable family use.
In addition, 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.Simultaneously, conventional peroral dosage form, regular meeting produces 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.The production technology of conventional oral formulations is more complicated also, and 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.
Mulberry leaf-ginger common cold drop pill involved in the present invention is compared with the mulberry leaf-ginger common cold injection has following beneficial effect:
1. mulberry leaf-ginger common cold drop pill involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing 6 flavors such as Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, Semen Armeniacae Amarum, Rhizoma Zingiberis; 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. mulberry leaf-ginger common cold 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. mulberry leaf-ginger common cold 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 mulberry leaf-ginger common cold 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, it is standby to make the extract dry powder that contains pharmaceutically active ingredient in 6 flavors such as Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, Semen Armeniacae Amarum, Rhizoma Zingiberis;
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 mulberry leaf-ginger common cold drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared mulberry leaf-ginger common cold 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 mulberry leaf-ginger common cold 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 mulberry leaf-ginger common cold 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, it is standby to make the extract dry powder that contains pharmaceutically active ingredient in 6 flavors such as Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, Semen Armeniacae Amarum, Rhizoma Zingiberis;
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 mulberry leaf-ginger common cold drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained mulberry leaf-ginger common cold 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: 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 obtained mulberry leaf-ginger common cold 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: 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 obtained mulberry leaf-ginger common cold 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: 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 obtained mulberry leaf-ginger common cold 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: 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 obtained mulberry leaf-ginger common cold 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: 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 obtained mulberry leaf-ginger common cold 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: 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 mulberry leaf-ginger common cold 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 experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained mulberry leaf-ginger common cold 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 experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained mulberry leaf-ginger common cold 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 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 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 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 88 | ＜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 | 91 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 84 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 75 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 72 | ＞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 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 80 | 0 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 74 | ＜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 | 89 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 88 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 84 | ＜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 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 87 | ＜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 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 91 | ＜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 | 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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 87 | ＜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. one kind is used for the treatment of flu, cough, and headache, the mulberry leaf-ginger common cold drop pill of laryngopharynx swelling and pain is a raw material with Folium Mori, Flos Chrysanthemi, Folium Perillae, Fructus Forsythiae, Semen Armeniacae Amarum, Rhizoma Zingiberis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that preparation process such as following:
(1) accurately take by weighing Folium Mori 150g, Flos Chrysanthemi 20g, Folium Perillae 80g, Fructus Forsythiae 80g, Semen Armeniacae Amarum 80g, Rhizoma Zingiberis 50g, above Six-element decocts with water secondary, 2 hours for the first time, 1 hour for the second time, merge decoction, filter, filtrate is concentrated into 100ml, adds ethanol, make to contain alcohol amount and be respectively 60%, 70%, 80%, leave standstill, filter, reclaim ethanol, being decompressed to and being condensed into relative density under 0.1MPa, the 60 ℃ of conditions is 1.3～1.35 thick paste, or continues to make drying again, be ground into dry powder, standby;
(2) described substrate is the mixture of Macrogol 2000～Macrogol 2000 0 and polyoxyethylene stearate 40 esters or poloxamer, and by weight, the ratio of polyoxyethylene stearate 40 esters or poloxamer and described Polyethylene Glycol is 1: 1～1: 10; Described drug extract is 1: 3 with the ratio of described substrate;
(3) according to aforementioned proportion, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, until the fused solution that obtains containing 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 the said temperature state respectively, the fused solution that will contain drug extract and substrate, or emulsion, or suspension, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
2. mulberry leaf-ginger common cold 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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