CN1698831A - Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root for treating hepatitis and its preparation method - Google Patents
Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root for treating hepatitis and its preparation method Download PDFInfo
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Abstract
Disclosed is a dripping pill for treating humid heat, sallow complexion, distending pain in hypochondriac region, nausea and emesis, dark urine caused by acute, delayed and chronic hepatitis. The objective of the invention is to provide a medicinal composition having the advantages of high biological availability, quick-speed medicine release, quick-speed effect, higher medicinal content, accurate administration dosage, low price, no acute allergic reaction or adverse effect, and facilitated carrying. The glycyrrhizin drop pill is prepared from the extract of oriental wormwood, cape jasmine, baikal skullcap root, honeysuckle flower as raw material, and medicinal carrying agent as the base material.
Description
Technical field
The present invention relates to a kind of heat clearing away that has, detoxifcation, dampness removing, the jaundice eliminating effect is used for dampness-heat in the liver and gallbladder, and appearance is known Huang, distending pain in the chest and hypochondrium, nausea and vomiting, yellowish or reddish urines etc. are acute, the pharmaceutical composition of delay property, chronic hepatitis symptom treatment, and the extract of pharmaceutically active ingredient composition is a kind of oral formulations that feedstock production forms in particularly containing with 4 kinds of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, Flos Lonicerae extracts etc.
Background technology
According to the drug standard WS promulgated by the ministries or commissions of the Central Government of country
3The Yinzhihuang Injection that the preparation method that provides among-the B-2736-97 is prepared from is a kind of heat clearing away that has, detoxifcation, dampness removing, jaundice eliminating effect, be used for dampness-heat in the liver and gallbladder, appearance is known Huang, distending pain in the chest and hypochondrium, nausea and vomiting; yellowish or reddish urine etc. are acute, the pure Chinese medicine injection of delay property, chronic hepatitis treatment; through clinical verification, determined curative effect is the common drug that is used for the treatment of above-mentioned disease.
Below be drug standard WS
3Prescription that provides among-the B-2736-97 and technology and brief description:
Prescription: Herba Artemisiae Scopariae extract 6g, Fructus Gardeniae extract 3.2g, baicalin 20g, Flos Lonicerae extract (in chlorogenic acid) 4g
Method for making: above four flavors, get baicalin and add an amount of moistening of water, dissolve with sodium hydroxide solution; Three flavors such as all the other Herba Artemisiae Scopariae extract are dissolved in water respectively, and other gets glucose 20g, and meglumine 5g is dissolved in water, and mixing is regulated pH value, is diluted to 1000ml with water for injection, filter, and embedding, sterilization, promptly.
Function cures mainly: heat clearing away, detoxifcation, dampness removing, jaundice eliminating.Be used for dampness-heat in the liver and gallbladder, appearance is known Huang, distending pain in the chest and hypochondrium, nausea and vomiting, yellowish or reddish urine.Acute, delay property, chronic hepatitis.Belong to above-mentioned time person.
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 is that additional having now is used for dampness-heat in the liver and gallbladder, and appearance is known Huang, distending pain in the chest and hypochondrium, nausea and vomiting, yellowish or reddish urines etc. are acute, the deficiency of the oral drug preparation of delay property, chronic hepatitis treatment, 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 dripping pills with capillary artemisia, cape jasmine and baikal skullcap root that transports and carry.Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root involved in the present invention is a raw material with 4 kinds of extracts that contain active ingredient of Chinese herbs such as Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, Flos Lonicerae extracts, is prepared from pharmaceutically acceptable substrate.Be prepared by the following technical solutions, can obtain dripping pills with capillary artemisia, cape jasmine and baikal skullcap root involved in the present invention:
[preparation method]
1. raw material: get Herba Artemisiae Scopariae extract 60g, Fructus Gardeniae extract 32g, baicalin 200g, Flos Lonicerae extract (in chlorogenic acid) 40g, more than four flavors, mix homogeneously, the hybrid medicine raw material, standby;
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 hybrid medicine raw material: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing hybrid medicine raw material and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing hybrid medicine raw material 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, to contain the fused solution of hybrid medicine raw material and substrate and/or emulsion and/or suspension places 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 the drug standard WS promulgated by the ministries or commissions of the Central Government of country
3The Yinzhihuang Injection that the preparation method that provides among-the B-2736-97 is prepared from is a kind of heat clearing away that has, detoxifcation, dampness removing, jaundice eliminating effect, be used for dampness-heat in the liver and gallbladder, appearance is known Huang, distending pain in the chest and hypochondrium, nausea and vomiting; yellowish or reddish urine etc. are acute, the pure Chinese medicine injection of delay property, chronic hepatitis treatment; through clinical verification, determined curative effect is the common drug that 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.
Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root involved in the present invention is compared the following beneficial effect of tool with Yinzhihuang Injection:
1. dripping pills with capillary artemisia, cape jasmine and baikal skullcap root involved in the present invention; utilize surfactant to be substrate; with Herba Artemisiae Scopariae extract; Fructus Gardeniae extract; baicalin; 4 kinds of hybrid medicine raw materials that contain active ingredient of Chinese herbs such as Flos Lonicerae extract are 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. dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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. dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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. dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 dripping pills with capillary artemisia, cape jasmine and baikal skullcap root of the present invention.
[first group: the test of single-matrix]
1. hybrid medicine raw material: get Herba Artemisiae Scopariae extract 60g, Fructus Gardeniae extract 32g, baicalin 200g, Flos Lonicerae extract (in chlorogenic acid) 40g, more than four flavors, mix homogeneously, the hybrid medicine raw material, 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 hybrid medicine raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the dripping pills with capillary artemisia, cape jasmine and baikal skullcap root of different size.
[result of the test]
Test 1: for observe hybrid medicine raw material and different substrates when 1: 1 the proportioning prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe hybrid medicine raw material and different substrates when 1: 3 the proportioning prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe hybrid medicine raw material and different substrates when 1: 9 the proportioning prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root in qualitative difference, according to 1: 1 ratio, with the hybrid medicine raw material 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 hybrid medicine raw material and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. hybrid medicine raw material: get Herba Artemisiae Scopariae extract 60g, Fructus Gardeniae extract 32g, baicalin 200g, Flos Lonicerae extract (in chlorogenic acid) 40g, more than four flavors, mix homogeneously, the hybrid medicine raw material, 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 hybrid medicine raw material: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the dripping pills with capillary artemisia, cape jasmine and baikal skullcap root of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are 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 hybrid medicine raw material and mixed-matrix prepared dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 different with the 4 kinds respectively mixing matrix phases of hybrid medicine raw material are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment that 4 hybrid medicines raw material and mixed-matrixes are constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: 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 | ????64 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????83 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????84 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 10000 | ????50.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Span 40 | ????50.0 | ????63 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????50.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????50.0 | ????74 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????62 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ????50.0 | ????62 | ????＞30 | ????＞10 | ++ |
| Glycerin gelatine | ????50.0 | ????61 | ????＞30 | ????＞10 | + |
| Lac | ????50.0 | ????60 | ????＞30 | ????＞10 | + |
The group practices of table 2 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: 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 | ????72 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????25.0 | ????75 | ????＜30 | ????＞10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: 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 | ????89 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????10.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????10.0 | ????73 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????86 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????78 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????77 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????73 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????50 | ????84 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????85 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????84 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????77 | ????＜30 | ????＞10 | + |
The group practices of table 5 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜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 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????86 | ????＜30 | ????＜10 | ++ |
The group practices of table 8 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????88 | ????＜30 | ????＜10 | +++ |
The group practices of table 9 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????86 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 hybrid medicine raw material and single-matrix
(hybrid medicine raw material: substrate=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 hybrid medicine raw material 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 hybrid medicine raw material 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 hybrid medicine raw material 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. pharmaceutical composition dripping pills with capillary artemisia, cape jasmine and baikal skullcap root that is used for acute and chronic treating hepatitis, the extract that contains middle pharmaceutically active ingredient composition with 4 kinds of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, Flos Lonicerae extracts etc. is a raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 hybrid medicine raw material: get Herba Artemisiae Scopariae extract 60g, Fructus Gardeniae extract 32g, baicalin 200g, calculate with chlorogenic acid, Flos Lonicerae extract 40g, more than four flavors, mix homogeneously, the hybrid medicine raw material, standby;
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, above-mentioned carrier one or more mixture wherein;
1.3 proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9.
2. dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 dripping pills with capillary artemisia, cape jasmine and baikal skullcap root 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 dripping pills with capillary artemisia, cape jasmine and baikal skullcap root is characterized in that being made of following process:
4.1 hybrid medicine raw material: get Herba Artemisiae Scopariae extract 60g, Fructus Gardeniae extract 32g, baicalin 200g, calculate with chlorogenic acid, Flos Lonicerae extract 40g, more than four flavors, mix homogeneously, the hybrid medicine raw material, standby;
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, above-mentioned carrier one or more mixture wherein;
4.3 proportioning: with g or kg is unit, by weight, and hybrid medicine raw material: substrate=1: 1～1: 9;
4.4, accurately take by weighing hybrid medicine raw material 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 hybrid medicine raw material and substrate and/or emulsion and/or suspension;
4.5 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 ℃;
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, fused solution and/or the emulsion and/or the suspension that will contain hybrid medicine raw material and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
5. as the preparation method of dripping pills with capillary artemisia, cape jasmine and baikal skullcap root as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510076627 CN1698831A (en) | 2005-06-13 | 2005-06-13 | Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root for treating hepatitis and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510076627 CN1698831A (en) | 2005-06-13 | 2005-06-13 | Dripping pills with capillary artemisia, cape jasmine and baikal skullcap root for treating hepatitis and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1698831A true CN1698831A (en) | 2005-11-23 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1330294C (en) * | 2005-07-06 | 2007-08-08 | 鲁南制药集团股份有限公司 | Yinzhihuang dropping pill oriental wormwood cape jasmine and baicalin, and its preparing ad detecting method |
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2005
- 2005-06-13 CN CN 200510076627 patent/CN1698831A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1330294C (en) * | 2005-07-06 | 2007-08-08 | 鲁南制药集团股份有限公司 | Yinzhihuang dropping pill oriental wormwood cape jasmine and baicalin, and its preparing ad detecting method |
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