CN100345534C - Yinzhi huang capsule, its preparation method and use - Google Patents
Yinzhi huang capsule, its preparation method and use Download PDFInfo
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- CN100345534C CN100345534C CNB2004101008030A CN200410100803A CN100345534C CN 100345534 C CN100345534 C CN 100345534C CN B2004101008030 A CNB2004101008030 A CN B2004101008030A CN 200410100803 A CN200410100803 A CN 200410100803A CN 100345534 C CN100345534 C CN 100345534C
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Abstract
The present invention provides a sort of anti-hepatitis-jaundice soft capsule and the making method, this also provides the application of this capsule for treating the icteric hepatitis, oxyhepatitis or chronic hepatitis, persisting hepatitis, ABO hemolytic jaundice of newborn and severe hepatitis. The soft capsule of the invention do not contain corrective and antiseptic, it tastes good and the content of this soft capsule is stable and uniform.
Description
Technical field
The present invention relates to a kind of icterohepatitis that cures mainly, acute, chronic hepatitis, chronic persistent hepatitis, soft capsule of neonate ABO hemolytic jaundice and hepatitis gravis and preparation method thereof relates to Yinzhi huang capsule and preparation method thereof particularly.
Background technology
Yinzhihuang oral liquid is made up of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, Flos Lonicerae extract, it is the medicine of clinical treatment liver and gall diseases, effect with heat-clearing and toxic substances removing, dampness removing jaundice eliminating, the effect of jaundice eliminating subcutaneous ulcer and reduction glutamate pyruvate transaminase is arranged, acute due to being used for accumulateing in the damp and hot malicious heresy, delay property, chronic hepatitis and hepatitis gravis, the Comprehensive Treatment that also can be used for its alloytype hepatitis gravis, determined curative effect.But it contains a large amount of sucrose and Mel, is unfavorable for that the diabetes patient uses; Also contain the sodium benzoate antiseptic in the oral liquid, and bitter in the mouth, it is poor to take mouthfeel, and patient's compliance is poor, has limited the application of medicine; It is unstable that this oral liquid is placed the back in addition, is prone to precipitation, and dosage was wayward when patient took, and had influenced the use curative effect, had also influenced patient's compliance.Therefore develop a kind of correctives that do not contain, mouthfeel is easy to take well and the content stable uniform, and the controlled soft capsule of using dosage has far-reaching clinical meaning.
For Chinese medicinal ingredients, preparation soft capsule diluent commonly used is a vegetable oil, and mattress Cape jasmine Huang is the medicine that is used for hepatitis, do the burden of liver that diluent can increase the weight of hepatitis if adopt vegetable oil (oil substances), influence drug effect, therefore how to select diluent for use, how to improve the difficult problem that drug effect becomes the preparation Yinzhi huang capsule.
Summary of the invention
The invention provides a kind of Yinzhi huang capsule.
The invention provides the preparation method of Yinzhi huang capsule.
The invention provides Yinzhi huang capsule in preparation treatment icterohepatitis, acute, chronic hepatitis, chronic persistent hepatitis, the application in the medicine of neonate ABO hemolytic jaundice and hepatitis gravis.
Yinzhi huang capsule provided by the invention is made up of capsule material and medicinal liquid, and medicinal liquid is made up of mattress Cape jasmine Huang and diluent, and its weight ratio is 1: 1.4～2, be preferably 1: 1.6～and 2, more preferably 1: 1.8.
The capsule material is made up of sizing material, plasticizer, water and additives.Sizing material can be in gelatin, the arabic gum or its combination, is preferably gelatin, and the gel strength of gelatin generally should be at 150-250 Bo Lumuke, range of viscosities 25-45mPa.s.Plasticizer can be glycerol, sorbitol or its combination, is preferably glycerol.Additives are selected from opacifier, and opacifier can be Fe
2O
3, TiO
2Or in the pigment one or more, be preferably Fe
2O
3
When sizing material was selected gelatin for use, the dry product weight ratio of gelatin and plasticizer was generally 1: 0.4～0.6, and the weight ratio of water and dry gelatin is generally 1: 0.7～1.4, and the consumption of additives is the 0.0075-0.75mg/kg gelatin.
Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Flos Lonicerae extract are water solublity, and baicalin transfers pH neutrality to make the baicalin sodium salt through sodium hydroxide, also is water solublity.The present invention is from alleviating the burden of liver of hepatitis, improve the angle of drug effect and set out, by a large amount of experimentatioies, having selected water miscible Polyethylene Glycol is diluent, it can be Macrogol 600 (PEG600) or PEG400 (PEG400), is preferably PEG400 (PEG400).
Soft capsule of the present invention can adopt conventional soft capsule preparation technology to make, as manual die pressing, rotating mould platen press or dropping preparation method.Generally select die pressing such as rotating mould platen press for use, use rotation rolling capsule machine automatically, temperature is controlled between 40-50 ℃, makes each capsule contain the active drug of ormal weight.
Yellow each extract of mattress Cape jasmine can be by the preparation of the extracting method in the oral liquid all by the known method preparation, and concrete preparation method is:
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decoct with water three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into every 1ml and contains crude drug 2g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol contains crude drug 5g to every ml, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 10g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into the thick paste shape, vacuum drying, promptly.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water three times, first and second time each 1 hour, 0.5 hour for the third time, collecting decoction, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 5g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into thick paste, vacuum drying, promptly.
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decoct with water three times, each 1 hour, collecting decoction filters, and filtrate is heated to 80 ℃, adds hydrochloric acid and regulates pH value 1-2, leave standstill, filter, precipitate adds water and stirs into pasty state, adds 40% sodium hydroxide and regulates PH to 6.5-7, filter, filtrate adds equivalent ethanol, is heated to 80 ℃, add hydrochloric acid and regulate PH to 1-2, baicalin is separated out, filter, use washing with alcohol, drying, promptly.Baicalin is added water stir into pasty state in right amount, regulate pH to 6.5～7.0 with 10% sodium hydroxide solution, drying under reduced pressure was pulverized 100 mesh sieves, promptly got the baicalin sodium salt.
The preparation of Flos Lonicerae extract: extracting honeysuckle decocts with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated into every ml and contains crude drug 2g, be chilled to 45-60 ℃, add the 20-40% aqua calcis and regulate pH value to 12, filter, precipitate adds ethanol, leaves standstill, and regulates pH value to 3.0-4.0 with 50% sulphuric acid, filter, filtrate is regulated pH value to 6.5-7.0 with 40% sodium hydroxide solution, reclaims ethanol, be concentrated into dried, promptly.
Each extract is mixed by 1: 1.4～2 with diluent, and colloid mill grinds well, and is prepared into medicinal liquid.
Soft capsule can make the 400mg/ grain,, 500mg/ grain, 650mg/ grain.
Soft capsule provided by the invention does not contain sucrose and Mel, is fit to the diabetes patient and uses; Do not contain antiseptic, features good taste, patient's compliance is good; The content stable uniform, taking dose is controlled, determined curative effect; Adopting water solublity PEG is diluent, has alleviated the burden of hepatitis patient.
The specific embodiment:
Embodiment 1: the preparation soft capsule
A. extract preparation:
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decoct with water three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into every 1ml and contains crude drug 2g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol contains crude drug 5g to every ml, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 10g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into the thick paste shape, vacuum drying, promptly.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water three times, first and second time each 1 hour, 0.5 hour for the third time, collecting decoction, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 5g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into thick paste, vacuum drying, promptly.
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decoct with water three times, each 1 hour, collecting decoction filters, and filtrate is heated to 80 ℃, adds hydrochloric acid and regulates pH value 1-2, leave standstill, filter, precipitate adds water and stirs into pasty state, adds 40% sodium hydroxide and regulates PH to 6.5-7, filter, filtrate adds equivalent ethanol, is heated to 80 ℃, add hydrochloric acid and regulate PH to 1-2, baicalin is separated out, filter, use washing with alcohol, drying, promptly.Baicalin is added water stir into pasty state in right amount, regulate pH to 6.5～7.0 with 10% sodium hydroxide solution, drying under reduced pressure was pulverized 100 mesh sieves, promptly got the baicalin sodium salt.
The preparation of Flos Lonicerae extract: extracting honeysuckle decocts with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated into every ml and contains crude drug 2g, be chilled to 45-60 ℃, add the 20-40% aqua calcis and regulate pH value to 12, filter, precipitate adds ethanol, leaves standstill, and regulates pH value to 3.0-4.0 with 50% sulphuric acid, filter, filtrate is regulated pH value to 6.5-7.0 with 40% sodium hydroxide solution, reclaims ethanol, be concentrated into dried, promptly.
B. prescription is formed (400mg/ grain):
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 24.4
Fructus Gardeniae extract 13.0
Baicalin sodium salt 85.3
Flos Lonicerae extract 16.2
PEG400 256.8
C. prepare soft capsule: take by weighing gelatin and add 100L gelatin retort, add suitable quantity of water at stirring, airtight, treat that gelatin dissolves fully after, after adding glycerol, stirring, vacuumize degassing 2 hours is put into the gelatin heat-preserving container, the insulation standing over night is stand-by; Take by weighing Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin sodium salt, Flos Lonicerae extract, mix with PEG400, behind the mixing, colloid mill grinds well, and room temperature leaves standstill.The medicinal liquid for preparing is put in the drug bucket, pressed soft capsule with mould.Adjust the soft capsule loading amount to scope of design, drying at room temperature two days, reject the soft gelatin capsule of presentation quality difference, with soft gelatin capsule washing (removing the lubricating oil in the pelleting process), again in 24 ℃ of dryings two days, get the Yinzhi huang capsule semi-finished product, the qualified back packing of quality testing, labeling, packing promptly get the Yinzhi huang capsule finished product.
Embodiment 2: preparation soft capsule (400mg/ grain)
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 30.2
Fructus Gardeniae extract 16.1
Baicalin sodium salt 105.6
Flos Lonicerae extracts 20.2
PEG600 233 prescriptions are formed as above, and other is with embodiment 1.
Embodiment 3: preparation soft capsule (650mg/ grain)
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 40
Fructus Gardeniae extract 21.3
Baicalin sodium salt 139.8
Flos Lonicerae extract 26.7
PEG400 421.8
Prescription is formed as above, and other is with embodiment 1.
Embodiment 4: preparation soft capsule (650mg/ grain)
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 45
Fructus Gardeniae extract 24.1
Baicalin sodium salt 158.1
Flos Lonicerae extract 30.2
Macrogol 600 400
Prescription is formed as above, and other is with embodiment 1.
Embodiment 5: preparation soft capsule (650mg/ grain)
Group component (gram/grain)
Herba Artemisiae Scopariae extract 39.2
Fructus Gardeniae extract 20.9
Baicalin sodium salt 137.1
Flos Lonicerae extracts 26.2
PEG400 433.3
Prescription is formed as above, and other is with embodiment 1.
Embodiment 6: preparation soft capsule (500mg/ grain)
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 37.6
Fructus Gardeniae extract 20.0
Baicalin sodium salt 131.4
Flos Lonicerae extract 25.0
PEG400 291.7
Prescription is formed as above, and other is with embodiment 1.
Embodiment 7: preparation soft capsule (500mg/ grain)
Group component (restraining/1000)
Herba Artemisiae Scopariae extract 30.2
Fructus Gardeniae extract 16.1
Baicalin sodium salt 105.7
Flos Lonicerae extracts 20.2
PEG600 333
Prescription is formed as above, and other is with embodiment 1.
Test example 1: adopt the soft capsule of different diluent, enzyme falls in oral liquid to mice hepatitis effect
1.1: material:
Bifendate drop pill: Dezhou, Shandong Province pharmaceutical factory, lot number: 030205, be suspended in 0.5% sodium carboxymethyl cellulose after the grinding.
Yinzhihuang oral liquid: Shuanghe High-Tech. Natural Medicine Co., Ltd., Beijing, lot number: 272053, face with preceding with 0.5% distilled water diluting administration.
Yinzhi huang capsule (Oleum Glycines): by the preparation of preparation example 1 method, diluent is an Oleum Glycines.
Yinzhi huang capsule (PEG): by the preparation of preparation example 1 method.
Aspartate amino transferase (GOT) test kit: Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd., lot number: 010191.Glutamate pyruvate transaminase (GPT) is measured test kit: Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd. produces, lot number: 010012.
Kunming mouse: Shandong Province's natural natural drug Engineering Technical Research Centre animal center, credit number: SYXK20030020.
1.2 method:
60 of female Kunming mouses are divided into 5 groups at random by body weight, press rank shown in the table 1 and dosed administration, and model group gives equal-volume 0.5% sodium carboxymethyl cellulose, once a day, and successive administration 3 days.After the last administration 1 hour, each organized the equal lumbar injection 0.1% carbon tetrachloride injection soybean oil solution 10ml/kg of mice.Water is can't help in mice fasting 16 hours, and eye socket is got blood, and separation of serum is pressed the test kit description and measured GOT and GPT activity.The results are shown in Table 1.
Table 1 Yinzhi huang capsule and oral liquid are to the effect of reducing enzyme levels of mouse carbon tetrachloride hepatitis
| Group | Dosage | GPT | GOT |
| Model group bifendate Yinzhihuang oral liquid Yinzhi huang capsule (Oleum Glycines) Yinzhi huang capsule (PEG) | —— 150mg/kg 5ml/kg 90mg/kg 90mg/kg | 289.8±80.7 21.3±9.5 ** 45.4±12.3 ** 164.2±51.4 ** 45.2±14.4 **## | 226.3±55.8 15.8±9.8 ** 37.4±13.9 ** 112.5±42.9 ** 38.4±18.1 **## |
Annotate: compare with model group:
*, P＜0.01.Compare with Oleum Glycines dilution soft capsule:
##, P＜0.01.
The result shows, molten Yinzhi huang capsule of oil and the molten Yinzhi huang capsule of PEG all have certain function for protecting liver and reducing enzyme activity, remarkable with the poor heteropole of model group, but oily insoluble capsule effect is far away from PEG insoluble capsule effect, two groups of poor heteropoles are remarkable, and PEG insoluble capsule effect is suitable with the Yinzhihuang oral liquid effect.
Claims (9)
1. Yinzhi huang capsule, form by capsule material and medicinal liquid, medicinal liquid is made up of yellow extract of mattress Cape jasmine and diluent, wherein the weight ratio of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin sodium salt, Flos Lonicerae extract is 1.5: 0.8: 5 in the yellow extract of mattress Cape jasmine: 1, diluent is PEG400 or Macrogol 600, the weight ratio of yellow extract of mattress Cape jasmine and diluent is 1: 1.4～2
The preparation of Herba Artemisiae Scopariae extract: get Herba Artemisiae Scopariae, decoct with water three times, 1.5 hours for the first time, second and third time each 1 hour, collecting decoction filters, and filtrate is concentrated into every 1ml and contains crude drug 2g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol contains crude drug 5g to every ml, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 10g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into the thick paste shape, vacuum drying, promptly;
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae, be ground into coarse powder, decoct with water three times, first and second time each 1 hour, 0.5 hour for the third time, collecting decoction, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, adds ethanol and makes and contain the alcohol amount and reach 70%, cold preservation 24 hours filters, and filtrate recycling ethanol extremely every ml contains crude drug 5g, add the about 5 times of amounts of water, cold preservation 48 hours filters, filtrate is condensed into thick paste, vacuum drying, promptly;
The preparation of baicalin: get Radix Scutellariae, be ground into coarse powder, decoct with water three times, each 1 hour, collecting decoction filters, and filtrate is heated to 80 ℃, adds hydrochloric acid and regulates pH value 1-2, leave standstill, filter, precipitate adds water and stirs into pasty state, adds 40% sodium hydroxide and regulates PH to 6.5-7, filter, filtrate adds equivalent ethanol, is heated to 80 ℃, add hydrochloric acid and regulate PH to 1-2, baicalin is separated out, filter, use washing with alcohol, drying, promptly.Baicalin is added water stir into pasty state in right amount, regulate pH to 6.5～7.0 with 10% sodium hydroxide solution, drying under reduced pressure was pulverized 100 mesh sieves, promptly got the baicalin sodium salt;
The preparation of Flos Lonicerae extract: extracting honeysuckle decocts with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated into every ml and contains crude drug 2g, be chilled to 45-60 ℃, add the 20-40% aqua calcis and regulate pH value to 12, filter, precipitate adds ethanol, leaves standstill, and regulates pH value to 3.0-4.0 with 50% sulphuric acid, filter, filtrate is regulated pH value to 6.5-7.0 with 40% sodium hydroxide solution, reclaims ethanol, be concentrated into dried, promptly.
2. soft capsule according to claim 1, the weight ratio of yellow extract of mattress Cape jasmine and diluent is 1: 1.6-2.
3. soft capsule according to claim 2, the weight ratio of yellow extract of mattress Cape jasmine and diluent is 1: 1.8.
4. according to the arbitrary described soft capsule of claim 1-3, diluent is a PEG400.
5. according to the arbitrary described soft capsule of claim 1-3, the capsule material is made up of sizing material, plasticizer, water and additives.
6. soft capsule according to claim 5, sizing material are selected from gelatin, arabic gum or its combination; Plasticizer is selected from glycerol, sorbitol or its combination; Additives are selected from opacifier, and opacifier is Fe
2O
3, TiO
2Or in the pigment one or more.
7. soft capsule according to claim 6, sizing material are gelatin, and its intensity is at 150-250 Bo Lumu, and range of viscosities is at 25-45mPa.s; Plasticizer is a glycerol; Additives are Fe
2O
3
8. according to claim 6 or 7 described soft capsules, the dry product weight ratio of gelatin and plasticizer is 1: 0.4-0.6, the weight ratio of water and gelatin is 1: 0.7-1.4, the consumption of additives are the 0.0075-0.75mg/kg gelatin.
9. the arbitrary described soft capsule of claim 1-8 is in preparation treatment icterohepatitis, acute, chronic hepatitis, chronic persistent hepatitis, the application in the medicine of neonate ABO hemolytic jaundice and hepatitis gravis.
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|---|---|---|---|
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|---|---|---|---|
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204445B (en) * | 2007-12-19 | 2012-09-12 | 姚俊华 | Soft capsule for hepatitis and preparation method thereof |
| CN101204446B (en) * | 2007-12-19 | 2011-08-24 | 姚俊华 | Soft capsule containing medicine for acute and chronic hepatitis |
| CN101204447B (en) * | 2007-12-19 | 2011-08-24 | 姚俊华 | Anti-hepatitis-jaundice soft capsule and preparation method thereof |
| CN107095921A (en) * | 2017-03-30 | 2017-08-29 | 浙江大学 | A kind of Chinese medicine composition and application for being used to prevent icterus neonatorum |
| CN111419923A (en) * | 2020-03-20 | 2020-07-17 | 鲁南制药集团股份有限公司 | Yinzhihuang micro capsule preparation and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528392A (en) * | 2003-10-13 | 2004-09-15 | 张文芳 | Capillary artemisia -cape jasmine-rhubarb lyophilized powder injection with therapeutic hepatitis activity and preparing method thereof |
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| CN1528392A (en) * | 2003-10-13 | 2004-09-15 | 张文芳 | Capillary artemisia -cape jasmine-rhubarb lyophilized powder injection with therapeutic hepatitis activity and preparing method thereof |
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