CN1709461A - Calculus bovis detoxifying dropping pill, and its preparing method - Google Patents
Calculus bovis detoxifying dropping pill, and its preparing method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine composition Neuhuang Jiedu dripping pill preparation with effects of clearing away heat and removing toxic material for curing the diseases of sore swollen throat, gingivitis, mouth and tongue sores and sore and swollen eyes due to pathogenic interior fire with obvious therapeutic effect. Said Chinese medicine dripping pill preparation is made up by using 8 Chinese medicinal materials of bovine bezoar, realgar, gypsum, rhubarb, scutellaria root and others and adopting a certain preparation process.
Description
Technical field
The present invention relates to a kind of antipyretic and antidote functions that has; be used for burning hot interior the Sheng; laryngopharynx swelling and pain; gingival swelling and pain; aphtha of the mouth and tongue; the pharmaceutical composition of treatment for diseases such as conjunctival congestion and swelling pain is a kind of drug composition oral preparation that feedstock production forms to contain 8 flavor active ingredient of Chinese herbs extracts such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae particularly.
Background technology
The cow-bezoar anti-toxic bolus that is prepared from according to the preparation method that provides under 2005 editions 386 pages of cow-bezoar anti-toxic bolus items of Chinese Pharmacopoeia; it is a kind of antipyretic and antidote functions that has; be used for burning hot interior the Sheng; laryngopharynx swelling and pain, gingival swelling and pain, aphtha of the mouth and tongue; the oral formulations of treatment for diseases such as conjunctival congestion and swelling pain; 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 prescription and technology and the brief description that provides in this drug standard:
Prescription: artificial Calculus Bovis 5g, Realgar 50g, Gypsum Fibrosum 200g, Radix Et Rhizoma Rhei 200g, Radix Scutellariae 150g, Radix Platycodonis 100g, Borneolum Syntheticum 25g, Radix Glycyrrhizae 50g
Method for making: above eight flavors, except that artificial Calculus Bovis, Borneolum Syntheticum, Realgar water flies into impalpable powder, and ground spices such as all the other Gypsum Fibrosum are broken into fine powder; with Borneolum Syntheticum, artificial Calculus Bovis's porphyrize,, sieve mixing with above-mentioned powder facing-up; every 100g powder adds refined honey 100～110g, makes big honeyed pills, gets final product.
Function cures mainly: heat-clearing and toxic substances removing.Be used for burning hot interior Sheng, laryngopharynx swelling and pain, gingival swelling and pain, aphtha of the mouth and tongue, conjunctival congestion and swelling pain.
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.
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 existing burning hot interior Sheng, laryngopharynx swelling and pain, the gingival swelling and pain of being used for; aphtha of the mouth and tongue; the deficiency of the oral drug preparation of treatment for diseases such as conjunctival congestion and swelling pain provides a kind of bioavailability height, and has quick release; quick produce effects; the medicament contg height, cheap, and portable calculus bovis detoxifying dropping pill.Calculus bovis detoxifying dropping pill involved in the present invention is a raw material with the extract that contains 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain calculus bovis detoxifying dropping pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae;
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;
More preferred proportioning is: drug extract: substrate=1: 1～1: 5;
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: two kinds contain 8 flavor active ingredient of Chinese herbs preparation method of extract such as Calculus Bovis, Realgar]
Water extraction: Calculus Bovis or artificial Calculus Bovis 5g, Realgar 50g, Gypsum Fibrosum 200g, Radix Et Rhizoma Rhei 200g, Radix Scutellariae 150g, Radix Platycodonis 100g, Borneolum Syntheticum 25g, Radix Glycyrrhizae 50g, method for making: above 8 flavors, Calculus Bovis or artificial Calculus Bovis, Borneolum Syntheticum, the back of pulverizing, sieve is standby; Realgar water flies into impalpable powder; The five tastes such as all the other Gypsum Fibrosum, Radix Glycyrrhizae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Platycodonis, water decoct 3 times, and each 1-3 hour, filter, filtrate decompression is to 0.06MPa, is condensed into relative density under 70 ℃～80 ℃ conditions and is 1.00～1.05 thick paste; Or continue to make drying under the same conditions, be ground into dry powder, promptly.
Decoction and alcohol sedimentation technique: Calculus Bovis or artificial Calculus Bovis 5g, Realgar 50g, Gypsum Fibrosum 200g, Radix Et Rhizoma Rhei 200g, Radix Scutellariae 150g, Radix Platycodonis 100g, Borneolum Syntheticum 25g, Radix Glycyrrhizae 50g; More than 8 the flavor, Calculus Bovis or artificial Calculus Bovis, Borneolum Syntheticum, pulverize, sieve the back standby; Realgar water flies into impalpable powder; All the other Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis and the Radix Glycyrrhizae five tastes boil 3 times with the decocting of 10 times of amounts, and each 2 hours, collecting decoction filtered, and filtrate is condensed into every ml and contains the 1g crude drug; Concentrated solution adds ethanol to be made and contains alcohol amount and reach 70%, leaves standstill cold preservation 24 hours, filters and removes precipitation, and filtrate is condensed into the thick paste shape, or dry, is ground into dry powder, promptly.
What provide above is the preparation method of two kinds of typical drug extracts, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
[beneficial effect]
The cow-bezoar anti-toxic bolus that is prepared from according to the preparation method that provides under 2005 editions 386 pages of cow-bezoar anti-toxic bolus items of Chinese Pharmacopoeia; it is a kind of antipyretic and antidote functions that has; be used for burning hot interior the Sheng; laryngopharynx swelling and pain, gingival swelling and pain, aphtha of the mouth and tongue; the oral formulations of treatment for diseases such as conjunctival congestion and swelling pain; 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.
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.
Calculus bovis detoxifying dropping pill involved in the present invention is compared with the antiphlogistic bezoar oral liquid has following beneficial effect:
1. calculus bovis detoxifying dropping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae; 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. calculus bovis detoxifying dropping 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. calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae earlier according to [appendix];
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 calculus bovis detoxifying dropping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae earlier according to [appendix];
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 calculus bovis detoxifying dropping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 calculus bovis detoxifying dropping 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 | ??66 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??83 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??83 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 10000 | ??50.0 | ??82 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??82 | ??＜30 | ??＞10 | ??++ |
| Span 40 | ??50.0 | ??64 | ??＜30 | ??＞10 | ??+ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??82 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Sodium lauryl sulphate | ??50.0 | ??76 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??61 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??59 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??57 | ??＞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 | ??75 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??25.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??70 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Sodium lauryl sulphate | ??25.0 | ??83 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??75 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??75 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??68 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??67 | ??＞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 | ??77 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??74 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??83 | ??＜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 | ??76 | ??＞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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??78 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??75 | ??＜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 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??84 | ??＜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 | ??86 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??85 | ??＜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 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??87 | ??＜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 | ??88 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??10 | ??87 | ??＜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 | ??90 | ??＜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 | ??84 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??25 | ??87 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??10 | ??88 | ??＜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 (7)
1. one kind is used for burning hot interior the Sheng; laryngopharynx swelling and pain; gingival swelling and pain; aphtha of the mouth and tongue; the pharmaceutical composition calculus bovis detoxifying dropping pill of treatment for diseases such as conjunctival congestion and swelling pain; with the extract that contains Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae etc. 8 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. calculus bovis detoxifying dropping pill as claimed in claim 1, it is characterized in that the described 8 flavor active ingredient of Chinese herbs extracts such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae that contain are made by following preparation method: Calculus Bovis or artificial Calculus Bovis 5g, Realgar 50g, Gypsum Fibrosum 200g, Radix Et Rhizoma Rhei 200g, Radix Scutellariae 150g, Radix Platycodonis 100g, Borneolum Syntheticum 25g, Radix Glycyrrhizae 50g, method for making: above 8 flavors, Calculus Bovis or artificial Calculus Bovis, Borneolum Syntheticum, the back of pulverizing, sieve is standby; Realgar water flies into impalpable powder; The five tastes such as all the other Gypsum Fibrosum, Radix Glycyrrhizae, Radix Scutellariae, Radix Et Rhizoma Rhei, Radix Platycodonis, water decoct 3 times, and each 1-3 hour, filter, filtrate decompression is to 0.06MPa, is condensed into relative density under 70 ℃～80 ℃ conditions and is 1.00～1.05 thick paste; Or continue to make drying under the same conditions, be ground into dry powder, promptly.
3. calculus bovis detoxifying dropping pill as claimed in claim 1 is characterized in that the described 8 flavor active ingredient of Chinese herbs extracts such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae that contain are made by following preparation method: decoction and alcohol sedimentation technique: Calculus Bovis or artificial Calculus Bovis 5g, Realgar 50g, Gypsum Fibrosum 200g, Radix Et Rhizoma Rhei 200g, Radix Scutellariae 150g, Radix Platycodonis 100g, Borneolum Syntheticum 25g, Radix Glycyrrhizae 50g; More than 8 the flavor, Calculus Bovis or artificial Calculus Bovis, Borneolum Syntheticum, pulverize, sieve the back standby; Realgar water flies into impalpable powder; All the other Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis and the Radix Glycyrrhizae five tastes boil 3 times with the decocting of 10 times of amounts, and each 2 hours, collecting decoction filtered, and filtrate is condensed into every ml and contains the 1g crude drug; Concentrated solution adds ethanol to be made and contains alcohol amount and reach 70%, leaves standstill cold preservation 24 hours, filters and removes precipitation, and filtrate is condensed into the thick paste shape, or dry, is ground into dry powder, promptly.
4. calculus bovis detoxifying dropping 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.
5. as claim 1 or 3 or 4 described any calculus bovis detoxifying dropping pills, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
6. the preparation method of a calculus bovis detoxifying dropping pill is made of following process:
6.1 raw material: the extract that contains 8 flavor active ingredient of Chinese herbs such as Calculus Bovis, Realgar, Gypsum Fibrosum, Radix Et Rhizoma Rhei, Radix Scutellariae, Radix Platycodonis, Borneolum Syntheticum, Radix Glycyrrhizae;
6.2 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;
6.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
6.4, 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;
6.5 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 ℃;
6.6 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.
7. as the preparation method of calculus bovis detoxifying dropping pill as described in the claim 6, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943706B (en) * | 2006-10-25 | 2011-03-09 | 北京天力正元医药技术开发有限公司 | A Chinese traditional medicine for clearing away heat and expelling toxin |
| CN106138254A (en) * | 2015-03-27 | 2016-11-23 | 索绪斌 | A kind of preparation method and applications of antiphlogistic bezoar buccal tablet |
-
2005
- 2005-07-12 CN CNB2005100827617A patent/CN100542517C/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1943706B (en) * | 2006-10-25 | 2011-03-09 | 北京天力正元医药技术开发有限公司 | A Chinese traditional medicine for clearing away heat and expelling toxin |
| CN106138254A (en) * | 2015-03-27 | 2016-11-23 | 索绪斌 | A kind of preparation method and applications of antiphlogistic bezoar buccal tablet |
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| CN100542517C (en) | 2009-09-23 |
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