CN1682819A - Sihuang intense heat purging dripping pill and its preparing method - Google Patents
Sihuang intense heat purging dripping pill and its preparing method Download PDFInfo
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- CN1682819A CN1682819A CNA2005100086215A CN200510008621A CN1682819A CN 1682819 A CN1682819 A CN 1682819A CN A2005100086215 A CNA2005100086215 A CN A2005100086215A CN 200510008621 A CN200510008621 A CN 200510008621A CN 1682819 A CN1682819 A CN 1682819A
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Abstract
The internal heat purging Sihuang dripping pill is a kind of oral medicine composition preparation with the functions of clearing away heat and toxic matter and drying, for treating toxsic materials produced by fire-evil, red and swelling eyes, toothache, aphtha, etc. It has high bioavailability, fast medicine release, fast acting, high effective component content, low cost and less toxic side effect, and the production process has no pollution. The internal heat purging Sihuang dripping pill is prepared with the active components of skullcap root, bezoar, rhubarb, berberine hydrochloride and matrix carrier.
Description
Technical field
The present invention relates to a kind of heat clearing and damp drying that has; the eliminating fire and detoxication effect; be used for containing in the fire-toxin; conjunctival congestion and swelling pain, acute toothache, aphtha of the mouth and tongue; oliguria with reddish urine; the pharmaceutical composition of treatment for diseases such as constipation with dry stool and boil are raw material with extract and the berberine hydrochloride that contains Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei etc. 3 flavor Chinese medicine active pharmaceutical ingredients particularly, the drug composition oral preparation that is prepared from the pharmaceutically suitable carrier as substrate.
Background technology
According to the Sihuang intense heat purging sheet that the prescription that provides among the national drug standards WS-10940 (ZD-0904)-2002 and extraction process are prepared from, be a kind of heat clearing and damp drying that has, the eliminating fire and detoxication effect, be used for containing in the fire-toxin, conjunctival congestion and swelling pain, acute toothache, aphtha of the mouth and tongue; oliguria with reddish urine; the tablet class preparation of treatment for diseases such as constipation with dry stool and boil through clinical verification for many years, steady quality; determined curative effect, are the common drug preparations that clinical and family is used for the treatment of above disease.
Below be the prescription and the preparation method of the Sihuang intense heat purging sheet that provides among the drug standard WS-10940 (ZD-0904)-2002:
Prescription: berberine hydrochloride 7g, Radix Scutellariae extractum (being equivalent to baicalin 7.35g) 10.5g, artificial Calculus Bovis 5g, Radix Et Rhizoma Rhei 200g, magnesium stearate 3g, carboxymethyl starch sodium 10g, starch 77g.
Method for making: above four Chinese medicine material, get Radix Et Rhizoma Rhei 100g, be ground into coarse powder, add 30% alcohol heating reflux and extract three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge extractive liquid, filters, and filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.40 (70～75 ℃); Residue Radix Et Rhizoma Rhei, berberine hydrochloride, Radix Scutellariae extractum, artificial Calculus Bovis's pulverize separately become fine powder, add starch, carboxymethyl starch sodium, and mixing adds in the above-mentioned clear paste, and mixing is granulated, and drying adds magnesium stearate, tabletting, and sugar coating or film-coat, promptly
Annotate: the method for making of Radix Scutellariae extractum:
Get Radix Scutellariae, decoct with water three times, 1.5 hours for the first time, 1 hour for the second time, the 3rd these 40 minutes, collecting decoction, filter, filtrate adds hydrochloric acid and regulates pH value 1～2, leaves standstill 24 hours, abandoning supernatant is got precipitation, is washed with water to pH value to 5～7, to precipitate oven dry, be ground into fine powder, measure content, promptly.
Be explained as follows for this tablet in the appended Sihuang intense heat purging sheet description:
Nomenclature of drug: Sihuang intense heat purging sheet;
Main component: berberine hydrochloride, Radix Scutellariae extractum (being equivalent to baicalin), artificial Calculus Bovis, Radix Et Rhizoma Rhei;
Character: this product is coated tablet or Film coated tablets, removes coating and shows yellowish-brown to brown; Bitter in the mouth, little puckery.
Function cures mainly: heat clearing and damp drying, eliminating fire and detoxication.Be used for containing conjunctival congestion and swelling pain, acute toothache, aphtha of the mouth and tongue, oliguria with reddish urine, diseases such as constipation with dry stool and boil in the fire-toxin.
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 is to replenish existing Sheng in the fire-toxin, the conjunctival congestion and swelling pain of being used for, acute toothache, aphtha of the mouth and tongue, oliguria with reddish urine, the deficiency of the oral drug preparation of treatment for diseases such as constipation with dry stool and boil, provide a kind of bioavailability height, release fast, produce effects fast, toxic and side effects is little, and the medicament contg height, cheap, and free of contamination aborning drug composition oral preparation Sihuang intense heat purging dripping pill.
Sihuang intense heat purging dripping pill involved in the present invention is a raw material with extract and the berberine hydrochloride that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain Sihuang intense heat purging dripping pill involved in the present invention:
[preparation method]
1. raw material---contain the pharmaceutical composition of 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride, below be called drug extract;
2. substrate---Polyethylene Glycol
(1000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, will contain fused solution and/or the emulsion and/or the suspension of 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 or the two or more mixture in liquid paraffin, methyl-silicone oil, vegetable oil, the water;
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 of pharmaceutical compositions method (also being called drug extract) that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride
1. the method for making of Radix Scutellariae extractum: get Radix Scutellariae, decoct with water three times, 1.5 hours for the first time, 1 hour for the second time, the 3rd these 40 minutes, collecting decoction, filter, filtrate adds hydrochloric acid and regulates pH value to 1～2, leaves standstill 24 hours, abandoning supernatant, get precipitation, be washed with water to pH value to 5～7, will precipitate oven dry, be ground into fine powder, standby;
2. contain 3 flavor Chinese medicine active pharmaceutical ingredient preparation method of extract such as Radix Et Rhizoma Rhei, artificial Calculus Bovis: get Radix Et Rhizoma Rhei 200g, artificial Calculus Bovis 5g, be ground into coarse powder, adding 30% alcohol heating reflux extracts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge extractive liquid,, filter, filtrate recycling ethanol and to be concentrated into relative density in 70 ℃～75 ℃ be 1.40 clear paste, standby;
3. calculate with content of baicalin, get Radix Scutellariae extract 7.35g, get berberine hydrochloride 7g; pulverize separately becomes fine powder, adds in the clear paste of above-mentioned Calculus Bovis, Radix Et Rhizoma Rhei, and mix homogeneously promptly gets the drug extract thick paste; or, be ground into dry powder, promptly continuing to make drying below 80 ℃.
What provide above is a kind of method comparatively commonly used, 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 the Sihuang intense heat purging sheet that the prescription that provides among the national drug standards WS-10940 (ZD-0904)-2002 and extraction process are prepared from, be a kind of heat clearing and damp drying that has, the eliminating fire and detoxication effect, be used for containing in the fire-toxin, conjunctival congestion and swelling pain, acute toothache, aphtha of the mouth and tongue; oliguria with reddish urine; the tablet class preparation of treatment for diseases such as constipation with dry stool and boil through clinical verification for many years, steady quality; determined curative effect, are the common drug preparations that clinical and family is used for the treatment of above 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.
Sihuang intense heat purging dripping pill involved in the present invention is compared with the Sihuang intense heat purging sheet, has following beneficial effect:
1. Sihuang intense heat purging dripping pill involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with containing 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. Sihuang intense heat purging dripping pill involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.This one side has not only kept the advantage of sheet, has more than sheet again to be easy to containing, the bioavailability height.Can not produce any residual harmful substance yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously at gastric.
3. Sihuang intense heat purging dripping pill involved in the present invention mixes the drug extract that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride 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 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 Sihuang intense heat purging dripping pill of the present invention.
First group: the test of single-matrix
1. the method that provides according to appendix makes the drug extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride in advance, and is standby;
2. substrate: Polyethylene Glycol
(1000～20000), pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, drug extract: substrate=1: 1～1: 9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the Sihuang intense heat purging dripping pill of all size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the method that provides according to appendix makes the drug extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride in advance, and is standby;
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate, molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether, molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. (with g or kg is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
3.2 hybrid medicine extract: mixed-matrix weight and=1: 1～1: 9.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared Sihuang intense heat purging dripping pill in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 Sihuang intense heat purging dripping pill that drug extract and mixed-matrix make when 1: 1 the proportioning in qualitative difference, 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 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 10.
Test 11: in order to observe Sihuang intense heat purging dripping pill that drug extract and mixed-matrix make when 1: 3 the proportioning in qualitative difference, 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 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 11.
Test 12: in order to observe Sihuang intense heat purging dripping pill that drug extract and mixed-matrix make when 1: 9 the proportioning in qualitative difference, 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 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 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 | ????70 | ???＜30 | ???＞10 | + |
| Polyethylene Glycol 2000 | ?????50.0 | ????63 | ???＜30 | ???＞10 | + |
| Polyethylene Glycol 4000 | ?????50.0 | ????76 | ???＜30 | ???＞10 | ++ |
| Polyethylene Glycol 6000 | ?????50.0 | ????79 | ???＜30 | ???＞10 | ++ |
| Polyethylene Glycol 8000 | ?????50.0 | ????79 | ???＜30 | ???＞10 | ++ |
| Polyethylene Glycol 10000 | ?????50.0 | ????80 | ???＜30 | ???＞10 | ++ |
| Polyethylene Glycol 20000 | ?????50.0 | ????80 | ???＜30 | ???＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ?????50.0 | ????78 | ???＜30 | ???＞10 | ++ |
| Betacyclodextrin | ?????50.0 | ????72 | ???＜30 | ???＞10 | + |
| Poloxamer | ?????50.0 | ????79 | ???＜30 | ???＞10 | ++ |
| Carboxymethyl starch sodium | ?????50.0 | ????73 | ???＜30 | ???＞10 | + |
| Sodium lauryl sulphate | ?????50.0 | ????68 | ???＞30 | ???＞10 | ++ |
| Stearic acid | ?????50.0 | ????55 | ???＞30 | ???＞10 | +++ |
| Sodium stearate | ?????50.0 | ????54 | ???＞30 | ???＞10 | +++ |
| Glycerin gelatine | ?????50.0 | ????55 | ???＞30 | ???＞10 | +++ |
| Lac | ?????50.0 | ????52 | ???＞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 | ????63 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????86 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????91 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????72 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ????10.0 | ????77 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 2000 | ????10.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????94 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????83 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????77 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????73 | ????＞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 | ????85 | ????＜30 | ????＜10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????86 | ????＜30 | ????＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????78 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????94 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????83 | ????＜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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????95 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜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 | ????95 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????94 | ????＜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 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????82 | ????＜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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜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 | ????94 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜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, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is 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. one kind is used for containing in the fire-toxin; conjunctival congestion and swelling pain; acute toothache; aphtha of the mouth and tongue; oliguria with reddish urine, the pharmaceutical composition Sihuang intense heat purging dripping pill of treatment for diseases such as constipation with dry stool and boil is a raw material with extract and the berberine hydrochloride that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei; be prepared from the pharmaceutically suitable carrier as substrate, wherein:
1.1 contain the drug extract of 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride;
1.2 substrate---Polyethylene Glycol
(1000～20000), 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, drug extract: substrate=1: 1～1: 9.
2. Sihuang intense heat purging dripping pill as claimed in claim 1 is characterized in that the described drug extract that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride is made by following method:
2.1 the method for making of Radix Scutellariae extractum: get Radix Scutellariae, decoct with water three times, 1.5 hours for the first time, 1 hour for the second time, the 3rd these 40 minutes, collecting decoction, filter, filtrate adds hydrochloric acid and regulates pH value to 1～2, leaves standstill 24 hours, abandoning supernatant, get precipitation, be washed with water to pH value to 5～7, will precipitate oven dry, be ground into fine powder, standby;
2.2 contain 3 flavor Chinese medicine active pharmaceutical ingredient preparation method of extract such as Radix Et Rhizoma Rhei, artificial Calculus Bovis: get Radix Et Rhizoma Rhei 200g, artificial Calculus Bovis 5g, be ground into coarse powder, adding 30% alcohol heating reflux extracts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, merge extractive liquid,, filter, filtrate recycling ethanol and to be concentrated into relative density in 70 ℃～75 ℃ be 1.40 clear paste, standby;
2.3 calculate with content of baicalin, get Radix Scutellariae extract 7.35g, get berberine hydrochloride 7g; pulverize separately becomes fine powder, adds in the clear paste of above-mentioned Calculus Bovis, Radix Et Rhizoma Rhei, and mix homogeneously promptly gets the drug extract thick paste; or, be ground into dry powder, promptly continuing to make drying below 80 ℃.
3. Sihuang intense heat purging dripping 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. any Sihuang intense heat purging dripping 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.
5. the preparation method of a Sihuang intense heat purging dripping pill is characterized in that being made of following process:
5.1 contain the drug extract of 3 flavor Chinese medicine active pharmaceutical ingredients such as Radix Scutellariae, Calculus Bovis, Radix Et Rhizoma Rhei and berberine hydrochloride;
5.2 substrate---Polyethylene Glycol
(1000～20000), 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;
5.3 proportioning---with g or kg is unit, 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-5 ℃～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, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, and splash into to shrink in the condensing agent and be shaped promptly.
6. as the preparation method of Sihuang intense heat purging dripping 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 |
|---|---|---|---|
| CNB2005100086215A CN100367938C (en) | 2005-02-28 | 2005-02-28 | Sihuang intense heat purging dripping pill and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100086215A CN100367938C (en) | 2005-02-28 | 2005-02-28 | Sihuang intense heat purging dripping pill and its preparing method |
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| Publication Number | Publication Date |
|---|---|
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| CN100367938C CN100367938C (en) | 2008-02-13 |
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|---|---|---|---|
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101045091B (en) * | 2007-03-23 | 2010-09-08 | 田岷山 | Traditional Chinese medicine decoction for treating acute toothache |
| CN101274024B (en) * | 2008-05-20 | 2010-10-13 | 马占国 | Pharmaceutical compositions for curing toothache |
| CN109674755A (en) * | 2019-01-18 | 2019-04-26 | 武汉太福制药有限公司 | A kind of purging intense heat piece of toxin-expelling and face nourishing and preparation method thereof |
-
2005
- 2005-02-28 CN CNB2005100086215A patent/CN100367938C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101045091B (en) * | 2007-03-23 | 2010-09-08 | 田岷山 | Traditional Chinese medicine decoction for treating acute toothache |
| CN101274024B (en) * | 2008-05-20 | 2010-10-13 | 马占国 | Pharmaceutical compositions for curing toothache |
| CN109674755A (en) * | 2019-01-18 | 2019-04-26 | 武汉太福制药有限公司 | A kind of purging intense heat piece of toxin-expelling and face nourishing and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100367938C (en) | 2008-02-13 |
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