CN1686434A - Compound mactra clam drip pill and its preparation method - Google Patents
Compound mactra clam drip pill and its preparation method Download PDFInfo
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- CN1686434A CN1686434A CN 200510068267 CN200510068267A CN1686434A CN 1686434 A CN1686434 A CN 1686434A CN 200510068267 CN200510068267 CN 200510068267 CN 200510068267 A CN200510068267 A CN 200510068267A CN 1686434 A CN1686434 A CN 1686434A
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Abstract
A Chinese medicine in the form of dripping pill for treating cough, asthma, chronic senile tracheitis, pneumonectasis, and asthmatic bronchitis is prepared from 9 Chinese-medicinal materials including toad venom, astragalus root, gingko seed, black pepper, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind ofly have QI invigorating and astringe the lung, relieving cough and asthma, the temperature drink effect of reducing phlegm, be used for the cough due to deficiency of the lung, the asthma abundant expectoration, the pharmaceutical composition of disease treatments such as senile chronic tracheitis, emphysema, asthmatic bronchitis is a kind of drug composition oral preparation that feedstock production forms to contain 9 flavor Chinese medicine active pharmaceutical ingredient extracts such as Bufo siccus, the Radix Astragali, Semen Ginkgo, Semen Armeniacae Amarum, Radix Asteris, Radix Peucedani, Fructus Schisandrae Chinensis, Radix Aconiti Lateralis Preparata, black pepper particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The compound clam white injection that the preparation method that provides among-the B-3914-98 is prepared from is a kind ofly to have QI invigorating and astringe the lung, relieving cough and asthma, the temperature drink effect of reducing phlegm, be used for the cough due to deficiency of the lung, the asthma abundant expectoration, the pure Chinese medicine injection of disease treatments such as senile chronic tracheitis, emphysema, asthmatic bronchitis is through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be drug standard WS
3The prescription that provides among-the B-3914-98, technology and brief description:
Prescription: Bufo siccus 40g, Radix Astragali 50g, Semen Ginkgo 20g, Semen Armeniacae Amarum 25g, Radix Asteris 25g, Radix Peucedani 15g, Fructus Schisandrae Chinensis 15g, Radix Aconiti Lateralis Preparata 5g, black pepper 5g
Method for making: above nine flavors decoct 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 reach 60% respectively, 70%, 80%, co-precipitation 3 times is left standstill, and filters, reclaim ethanol, residue adds an amount of water dissolution, boils 10 minutes, it is an amount of to add activated carbon, filters, and adds the injection water to 900ml, add sodium chloride and transfer to etc. and to ooze, transfer pH value to 7.5, left standstill 48 hours with 4% sodium hydroxide solution, filter, filtrate adds the 3ml polyoxyethylene sorbitan monoleate, boils, filter, filtrate adds the injection water to 1000ml, embedding, sterilization, promptly.
Function cures mainly: QI invigorating is astringed the lung, relieving cough and asthma, the temperature drink that reduces phlegm; Be used for the cough due to deficiency of the lung, asthma abundant expectoration, senile chronic tracheitis, emphysema.Asthmatic bronchitis is more suitable.The person has preventive effect to repeated cold.
Owing to reasons such as technologies of preparing, the research of the compatibility of Chinese medicine injection can not show a candle to Western medicine, and causes allergy easily.Existing FUFANG BANBIANLIAN ZHUSHEYE does not still have similar other dosage form listings at present.This kind Chinese medicine is an effective component extracting from Chinese crude drug, the intravital concentrated solution of Gong the injection of making.Because the extensive use of modern biotechnology in the natural drug exploitation, the domestic herbal species that is used to inject is more and more, and application is more and more wider clinically, and adverse reaction rate also increases.According to data: the dosage form of Chinese patent medicine adverse reaction rate is that injection accounts for 31% successively, tablet accounts for 24%, pill accounts for 10%.Chinese medicine untoward reaction consequence is serious, and Chinese medicine and preparation thereof cause anaphylactic shock and rank first place, and the trend that increases is arranged year by year, this with use clinically more relevant.Chinese medicine composition more complicated is injected human body with this mixture from blood vessel, forces human body to go metabolism, and itself has just had potential danger, if again with the other medicines compatibility, contingent reaction often is difficult to prediction.The compatibility difficulty of Chinese medicine is bigger, and incompatibility is studied the compatibility of Chinese medicine without ready patterns to follow, and it is perfect also to can not show a candle to Western medicine.Chinese medicine injection causes allergy easily, and reason is to contain albumen, polysaccharide, polypeptide etc. in its composition; The purity of extracting is not enough; Plurality of Chinese is extracted, and each composition interacts; Contain cosolvent, solubilizing agent etc.
In addition, the oral formulations of the oral formulations of most drug, especially Chinese medicine exists 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, be to replenish the existing cough due to deficiency of the lung that is used for, asthma abundant expectoration, the deficiency of disease treatment oral drug preparations such as senile chronic tracheitis, emphysema, asthmatic bronchitis, a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, take accurate measurement, cheap, no acute allergic reaction or untoward reaction, and be convenient to the compound mactra clam drip pill that transports and carry.
Compound mactra clam drip pill involved in the present invention, to contain 9 flavor Chinese medicine active pharmaceutical ingredient extracts such as Bufo siccus, the Radix Astragali, Semen Ginkgo, Semen Armeniacae Amarum, Radix Asteris, Radix Peucedani, Fructus Schisandrae Chinensis, Radix Aconiti Lateralis Preparata, black pepper is raw material, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain compound mactra clam drip pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: get Bufo siccus 40g, Radix Astragali 50g, Semen Ginkgo 20g, Semen Armeniacae Amarum 25g, Radix Asteris 25g, Radix Peucedani 15g, Fructus Schisandrae Chinensis 15g, Radix Aconiti Lateralis Preparata 5g, black pepper 5g, more than nine the flavor, decoct with water 2 times, the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, it is 1.3～1.35 thick paste that filtrate is concentrated into relative density, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating 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, 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 compound clam white injection that the preparation method that provides among-the B-3914-98 is prepared from is a kind ofly to have QI invigorating and astringe the lung, relieving cough and asthma, the temperature drink effect of reducing phlegm, be used for the cough due to deficiency of the lung, the asthma abundant expectoration, the pure Chinese medicine injection of disease treatments such as senile chronic tracheitis, emphysema, asthmatic bronchitis is through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.Owing to reasons such as technologies of preparing, the research of the compatibility of Chinese medicine injection can not show a candle to Western medicine, and causes allergy easily.Existing FUFANG BANBIANLIAN ZHUSHEYE does not still have similar other dosage form listings at present.This kind Chinese medicine is an effective component extracting from Chinese crude drug, the intravital concentrated solution of Gong the injection of making.Because the extensive use of modern biotechnology in the natural drug exploitation, the domestic herbal species that is used to inject is more and more, and application is more and more wider clinically, and adverse reaction rate also increases.According to data: the dosage form of Chinese patent medicine adverse reaction rate is that injection accounts for 31% successively, tablet accounts for 24%, pill accounts for 10%.Chinese medicine untoward reaction consequence is serious, and Chinese medicine and preparation thereof cause anaphylactic shock and rank first place, and the trend that increases is arranged year by year, this with use clinically more relevant.Chinese medicine composition more complicated is injected human body with this mixture from blood vessel, forces human body to go metabolism, and itself has just had potential danger, if again with the other medicines compatibility, contingent reaction often is difficult to prediction.The compatibility difficulty of Chinese medicine is bigger, and incompatibility is studied the compatibility of Chinese medicine without ready patterns to follow, and it is perfect also to can not show a candle to Western medicine.Chinese medicine injection causes allergy easily, and reason is to contain albumen, polysaccharide, polypeptide etc. in its composition; The purity of extracting is not enough; Plurality of Chinese is extracted, and each composition interacts; Contain cosolvent, solubilizing agent etc.
In addition, the oral formulations of the oral formulations of most drug, especially Chinese medicine exists 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.
Compound mactra clam drip pill involved in the present invention is compared the following beneficial effect of tool with compound clam white injection or its oral formulations:
1. compound mactra clam drip pill involved in the present invention; utilize surfactant to be substrate; with contain Bufo siccus; the Radix Astragali; Semen Ginkgo; Semen Armeniacae Amarum; Radix Asteris; Radix Peucedani; Fructus Schisandrae Chinensis; Radix Aconiti Lateralis Preparata; the extract of 9 flavor Chinese medicine active pharmaceutical ingredients such as black pepper is made solid dispersion together; make medicine be molecule; colloid or microcrystalline state are 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, performance is efficient; quick-acting effects etc.
2. compound mactra clam 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. compound mactra clam 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. compound mactra clam drip pill involved in the present invention, stable in properties than injection, has the anaphylaxis of not being prone to, and side effect is little, also has advantages such as high bioavailability simultaneously.
5. 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.
6. 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 compound mactra clam drip pill of the present invention.
[first group: the test of single-matrix]
1. the preparation of drug extract: make in advance according to [preparation method 1] that to contain Bufo siccus, the Radix Astragali, Semen Ginkgo, Semen Armeniacae Amarum, Radix Asteris, Radix Peucedani, Fructus Schisandrae Chinensis, Radix Aconiti Lateralis Preparata, black pepper etc. 9 flavor Chinese medicine active pharmaceutical ingredient extract dry powder standby;
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 compound mactra clam drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared compound mactra clam 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 compound mactra clam 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 composition experiments that contain drug extract and different substrates, and obtain 13 groups of different experiments
The results are shown in Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared compound mactra clam 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: make in advance according to [preparation method 1] that to contain Bufo siccus, the Radix Astragali, Semen Ginkgo, Semen Armeniacae Amarum, Radix Asteris, Radix Peucedani, Fructus Schisandrae Chinensis, Radix Aconiti Lateralis Preparata, black pepper etc. 9 flavor Chinese medicine active pharmaceutical ingredient extract dry powder 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 compound mactra clam drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 compound mactra clam drip 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, 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 | ??68 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | 50.0 | ??81 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 6000 | 50.0 | ??80 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 10000 | 50.0 | ??80 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 20000 | 50.0 | ??81 | ??＜30 | ??＞10 | ??++ |
| Span 40 | 50.0 | ??62 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | 50.0 | ??81 | ??＜30 | ??＞10 | ??+ |
| Poloxamer | 50.0 | ??83 | ??＜30 | ??＞10 | ??+ |
| Sodium lauryl sulphate | 50.0 | ??60 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | 50.0 | ??60 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | 50.0 | ??62 | ??＞30 | ??＞10 | ??+ |
| Glycerin gelatine | 50.0 | ??58 | ??＞30 | ??＞10 | ??+ |
| Lac | 50.0 | ??59 | ??＞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 | ??77 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??25.0 | ??87 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 6000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??65 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??85 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Stearic acid | ??25.0 | ??71 | ??＞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 1000 | ??10.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??88 | ??＜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 | ??67 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??82 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??72 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??71 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??71 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??81 | ??＜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 | ??89 | ??＜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 | ??83 | ??＜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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??85 | ??＜30 | ??＞10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??84 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??88 | ??＜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) | Different (the % of the ball method of double differences | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ??25 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??25 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??89 | ??＜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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??90 | ??＜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 | ??92 | ??＜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 | ??88 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??10 | ??89 | ??＜30 | ??＜10 | ??+++ |
1. can be seen by the result in the table: when the ratio of 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 (5)
1. one kind is used for the cough due to deficiency of the lung, the asthma abundant expectoration, the pharmaceutical composition of disease treatments such as senile chronic tracheitis, emphysema, asthmatic bronchitis is composed compound mactra clam drip pill, to contain 9 flavor Chinese medicine active pharmaceutical ingredient extracts such as Bufo siccus, the Radix Astragali, Semen Ginkgo, Semen Armeniacae Amarum, Radix Asteris, Radix Peucedani, Fructus Schisandrae Chinensis, Radix Aconiti Lateralis Preparata, black pepper is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of drug extract: get Bufo siccus 40g, Radix Astragali 50g, Semen Ginkgo 20g, Semen Armeniacae Amarum 25g, Radix Asteris 25g, Radix Peucedani 15g, Fructus Schisandrae Chinensis 15g, Radix Aconiti Lateralis Preparata 5g, black pepper 5g, more than nine the flavor, decoct with water 2 times, the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, it is 1.3～1.35 thick paste that filtrate is concentrated into relative density, promptly;
1.2 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, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. compound mactra clam 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.
3. any compound mactra clam drip pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of a compound mactra clam drip pill is characterized in that being made of following process:
4.1 the preparation of drug extract: get Bufo siccus 40g, Radix Astragali 50g, Semen Ginkgo 20g, Semen Armeniacae Amarum 25g, Radix Asteris 25g, Radix Peucedani 15g, Fructus Schisandrae Chinensis 15g, Radix Aconiti Lateralis Preparata 5g, black pepper 5g, more than nine the flavor, decoct with water 2 times, the 1st time 2 hours, the 2nd time 1 hour, collecting decoction filtered, it is 1.3～1.35 thick paste that filtrate is concentrated into relative density, promptly;
4.2 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, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
4.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4.4, 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;
4.5 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) ℃;
4.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
5. as the preparation method of compound mactra clam drip pill as described in the claim 4, it is characterized in that: method 4.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
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| CNB2005100682675A CN1316960C (en) | 2005-05-08 | 2005-05-08 | Compound mactra clam drip pill and its preparation method |
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|---|---|---|---|
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| CN104971136A (en) * | 2014-04-10 | 2015-10-14 | 耿福能 | Preparation technology of traditional Chinese medicine compound Haqing extract and application thereof |
| CN104971134A (en) * | 2014-04-08 | 2015-10-14 | 耿福能 | Preparation method for traditional Chinese medicine compound Haqing injection |
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| CN104971134A (en) * | 2014-04-08 | 2015-10-14 | 耿福能 | Preparation method for traditional Chinese medicine compound Haqing injection |
| CN104971134B (en) * | 2014-04-08 | 2019-05-10 | 耿福能 | A kind of preparation method of Chinese medicine compound prescription clam white injection |
| CN104971136A (en) * | 2014-04-10 | 2015-10-14 | 耿福能 | Preparation technology of traditional Chinese medicine compound Haqing extract and application thereof |
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