CN1686435A - Grosvenor's momordica fruit drip pill an dits preparation method - Google Patents
Grosvenor's momordica fruit drip pill an dits preparation method Download PDFInfo
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Abstract
A Chinese medicine in the form of dripping pill for treating cold, cough and bronchitis is prepared from 7 Chinese-medicinal materials including Grosvenor momordica fruit, loquat leaf, mulberry bark, mint oil, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of expelling phlegm for arresting cough effect that has, the pharmaceutical composition that is usually used in disease treatments such as cold cough and bronchitis is a kind of drug composition oral preparation that feedstock production forms to contain Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs extracts particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound recipe Fructus Momordicae oral liquid that the preparation method that provides among-the B-3882-98 is prepared from, it is a kind of expelling phlegm for arresting cough effect that has, the syrups oral formulations that is usually used in disease treatments such as cold cough and bronchitis, 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-3882-98 the drug standard and technology and brief description:
Prescription: Fructus Momordicae 46g, Folium Eriobotryae 176g, Cortex Mori 12g, Rhizoma Cynanchi Stauntonii 18g, Radix Stemonae 30g, Radix Platycodonis 12g, Oleum menthae 0.2g
Method for making: above seven flavors, except that Mentholum, six of all the other Fructus Momordicaes etc. decoct with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge to decoct, filter, filtrate is concentrated into about 200ml, put cold, the ethanol of 4 times of amounts of adding, stir, leave standstill, filter, filtrate recycling ethanol also is concentrated into an amount of.Other gets sucrose 400g, adds water boil and makes dissolving, filters, and solution mixes with above-mentioned concentrated solution, adds to arrest rafter acid 1g and an amount of Oleum menthae alcoholic solution, antiseptic and essence, adds water to 1000ml again, stirs evenly, promptly.
Function cures mainly: expelling phlegm for arresting cough; Be used for cold cough and bronchitis.
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 the existing deficiency that is used for the oral drug preparation of disease treatments such as cold cough and bronchitis, a kind of bioavailability height is provided, and has a quick release, quick produce effects, the medicament contg height is taken accurate measurement, cheap, and portable grosvenor's momordica fruit drip pill.
Grosvenor's momordica fruit drip pill involved in the present invention is a raw material with the extract that contains Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain grosvenor's momordica fruit drip pill involved in the present invention:
[preparation method]
1. raw material: the extract thick paste or the dry powder that contain Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, 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.
[appendix: a kind of preparation method of extract that contains 7 flavor active ingredient of Chinese herbs such as Fructus Momordicae]
Get Fructus Momordicae 46g, Folium Eriobotryae 176g, Cortex Mori 12g, Rhizoma Cynanchi Stauntonii 18g, Radix Stemonae 30g, Radix Platycodonis 12g, Oleum menthae 0.2g, more than 7 the flavor, except that Oleum menthae, six of all the other Fructus Momordicaes etc. decoct with water 2 times, the 1st time 1.5 hours, the 2nd time 1 hour, merge decoction, filter, it is 1.3～1.35 thick paste that filtrate is concentrated into relative density, shelve to below 60 ℃, the adding Oleum menthae also stirs, and promptly gets the drug extract thick paste; Or continue to make drying after being condensed into thick paste, and be ground into dry powder, spray into Oleum menthae and stir, remember drug extract dry powder.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method;
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound recipe Fructus Momordicae oral liquid that the preparation method that provides among-the B-3882-98 is prepared from, it is a kind of expelling phlegm for arresting cough effect that has, the syrups oral formulations that is usually used in disease treatments such as cold cough and bronchitis, 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.
Grosvenor's momordica fruit drip pill involved in the present invention is compared with its oral liquid has following beneficial effect:
1. grosvenor's momordica fruit drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs; 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. grosvenor's momordica fruit drip 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. grosvenor's momordica fruit drip 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 grosvenor's momordica fruit drip pill of the present invention.
[first group: the test of single-matrix]
1. the preparation of drug extract: it is standby to make the extract dry powder that contains Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs earlier according to [preparation method 1];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the grosvenor's momordica fruit drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared grosvenor's momordica fruit drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared grosvenor's momordica fruit drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared grosvenor's momordica fruit drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug 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 extract dry powder that contains Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs earlier according to [preparation method 1];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the grosvenor's momordica fruit drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared grosvenor's momordica fruit drip 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: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ??50.0 | ??69 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??87 | ??＜30 | ??＜10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??+ |
| Polyethylene Glycol 10000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??87 | ??＜30 | ??＜10 | ??++ |
| Span 40 | ??50.0 | ??66 | ??＜30 | ??＞10 | ??+ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??85 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Sodium lauryl sulphate | ??50.0 | ??76 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??64 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??62 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??58 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??57 | ??＞30 | ??＞10 | ??+ |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ??25.0 | ??74 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??72 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer | ??25.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Sodium lauryl sulphate | ??25.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??75 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??68 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??68 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ??10.0 | ??79 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??89 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??72 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Lauryl sulphate acid | ??10.0 | ??85 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??80 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??80 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??76 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??85 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??79 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??76 | ??＜30 | ??＞10 | ??+ |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??25 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??85 | ??＜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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??86 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??83 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??50 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??91 | ??＜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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??86 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??10 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??10 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??86 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??86 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??25 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??25 | ??86 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed base 1 matter=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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??86 | ??＜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 (6)
1. grosvenor's momordica fruit drip pill that is used for disease treatments such as cold cough and bronchitis, with the extract that contains Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 substrate: 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, above-mentioned carrier one or more mixture wherein;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. grosvenor's momordica fruit drip pill as claimed in claim 1, it is characterized in that the described Fructus Momordicae that contains, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, the extract thick paste or the dry powder of Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs are obtained by following method: get Fructus Momordicae 46g, Folium Eriobotryae 176g, Cortex Mori 12g, Rhizoma Cynanchi Stauntonii 18g, Radix Stemonae 30g, Radix Platycodonis 12g, Oleum menthae 0.2g, more than 7 the flavor, except that Oleum menthae, six of all the other Fructus Momordicaes etc. decoct with water 2 times, the 1st time 1.5 hours, the 2nd time 1 hour, merge and decoct, filter, it is 1.3～1.35 thick paste that filtrate is concentrated into relative density, shelve to below 60 ℃, the adding Oleum menthae also stirs, and promptly gets the drug extract thick paste; Or continue to make drying after being condensed into thick paste, and be ground into dry powder, spray into Oleum menthae and stir, remember drug extract dry powder.
3. grosvenor's momordica fruit drip pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
4. as claim 1 or 3 described any grosvenor's momordica fruit drip pills, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
5. the preparation method of a grosvenor's momordica fruit drip pill is made of following process:
5.1 raw material: the extract thick paste or the dry powder that contain Fructus Momordicae, Folium Eriobotryae, Cortex Mori, Rhizoma Cynanchi Stauntonii, the Radix Stemonae, Radix Platycodonis, Herba Menthae wet goods 7 flavor active ingredient of Chinese herbs;
5.2 substrate: 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, above-mentioned carrier one or more mixture wherein;
5.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
5.4, accurately take by weighing drug extract and substrate according to the given ratio of prescription, 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;
5.5 adjust the temperature control system of 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 ℃;
5.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, 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 and shrink molding promptly.
6. as the preparation method of grosvenor's momordica fruit drip pill as described in the claim 5, it 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 |
|---|---|---|---|
| CNB200510068268XA CN1316961C (en) | 2005-05-08 | 2005-05-08 | Grosvenor's momordica fruit drip pill an dits preparation method |
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|---|---|---|---|
| CNB200510068268XA CN1316961C (en) | 2005-05-08 | 2005-05-08 | Grosvenor's momordica fruit drip pill an dits preparation method |
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| Publication Number | Publication Date |
|---|---|
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| CN1316961C CN1316961C (en) | 2007-05-23 |
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|---|---|---|---|
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101385848B (en) * | 2008-10-20 | 2010-10-13 | 吴伶 | Medicine for treating bronchitis |
| CN103598390A (en) * | 2013-11-12 | 2014-02-26 | 诸辉 | Sugar containing loquat leaf extract and preparation method of sugar |
| CN110777005A (en) * | 2019-11-08 | 2020-02-11 | 湖北中烟工业有限责任公司 | Preparation method of citrus essential oil dropping pill |
-
2005
- 2005-05-08 CN CNB200510068268XA patent/CN1316961C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101385848B (en) * | 2008-10-20 | 2010-10-13 | 吴伶 | Medicine for treating bronchitis |
| CN103598390A (en) * | 2013-11-12 | 2014-02-26 | 诸辉 | Sugar containing loquat leaf extract and preparation method of sugar |
| CN110777005A (en) * | 2019-11-08 | 2020-02-11 | 湖北中烟工业有限责任公司 | Preparation method of citrus essential oil dropping pill |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1316961C (en) | 2007-05-23 |
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