CN1640428A - One-time-clearing soft capsule and its preparing process - Google Patents
One-time-clearing soft capsule and its preparing process Download PDFInfo
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- CN1640428A CN1640428A CN 200410000656 CN200410000656A CN1640428A CN 1640428 A CN1640428 A CN 1640428A CN 200410000656 CN200410000656 CN 200410000656 CN 200410000656 A CN200410000656 A CN 200410000656A CN 1640428 A CN1640428 A CN 1640428A
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Abstract
The present invention relates to a Yiqing capsule or granules new dosage form soft capsule and its preparation process. Said invented Yiqing soft capsule overcomes the defects of existent other dosage forms, not only can depress special abnormal smell of medicinal material extract, but also can raise bioavailability of medicinal material, and its sealed property is good and its appearance is beautiful.
Description
Technical field
The present invention relates to a clearing capsule and granule novel form one clear soft capsule and preparation method thereof.
Background technology
The YIQING KELI prescription is derived from the SANHUANG XIEXIN TANG of Chinese Han generation famous doctor family Zhang Zhongjing " Medical Treasures of the Golden Chamber ", mainly form by Chinese medicines such as Rhizoma Coptidis, Radix Scutellariae, Radix Et Rhizoma Rhei, the fire of Rhizoma Coptidis, the clear eliminating the pathogens from the lung stomach of Radix Scutellariae in the side, the Radix Et Rhizoma Rhei making the adverse-rising QI downwards, its discharge function more bring into play draw heat descending, the effect of purging FU-organs detoxifcation, full side share and integrates pathogenic fire purging, toxin expelling, the clear stasis of blood, plays the effect of eliminating fire and detoxication, eliminating stasis and resolving masses, removing dampness heat clearing away altogether.
YIQING KELI is recorded in " one one of Chinese pharmacopoeia version in 2000, it adopts Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae three flavor medical materials difference decocting effective component extractings, make particulate method, its function is the clearing away heat-fire detoxifcation, the blood stasis dispelling cooling blood for hemostasis, be used for the fever of the body agitation due to the fire-toxin heat in blood, the conjunctival congestion aphtha, throat, gingival swelling and pain, constipation, spit blood diseases such as spitting of blood.
Rhizoma Coptidis has very wide antibacterial range, dysentery bacterium, Bacillus typhi, bacillus pyocyaneus, escherichia coli, diphtheria corynebacterium, bordetella pertussis, tubercule bacillus, staphylococcus, meningococcus, Hemolytic streptococcus, Diplococcus pneumoniae etc. all there is significant inhibitory effect, to leptospira, ameba, infusorian, influenza virus and multiple pathogenic dermatophytes, inhibitory action is arranged also.Wherein the inhibitory action to dysentery bacterium is the strongest.And can strengthen leukocytic phagocytic activity, effects such as blood pressure lowering, function of gallbladder promoting, analgesic, calm, analgesia, diuresis, local paralysis are arranged again.In addition, vascular smooth muscle there is relexation, uterus, bladder intestines and stomach smooth muscle all are excitation.Berberine and some derivants thereof have antitumaous effect.
The Radix Scutellariae decoct has a wider antimicrobial spectrum external, to Bacillus typhi, dysentery bacterium, bacillus pyocyaneus bordetella pertussis, staphylococcus, streptococcus, Diplococcus pneumoniae, meningococcus, etc. inhibitory action all arranged.Influenza virus, leptospira and multiple pathomycete also there is inhibitory action.In addition, analgesic in addition, blood pressure lowering, diuresis, calmness, function of gallbladder promoting, protect the liver, reduce capillary permeability, and suppress function such as intestinal tube wriggling.Baicalin, noroxylin shrink and the whole animal allergic asthma guinea pig in vitro organ anaphylaxis, and mitigation is all arranged, and with ephedrine collaborative effect are arranged again.
Effective ingredient was an anthra-glucoside under Radix Et Rhizoma Rhei rushed down, and mainly was sennoside, and site of action can increase enterokinesia and suppress the enteral moisture absorption mainly at large intestine, promotes defecation; Radix Et Rhizoma Rhei is anti-infectious function again, and multiple Gram-positive and negative bacteria are all had inhibitory action, and wherein the most responsive is glucose coccus and streptococcus, is diphtheria corynebacterium, typhoid fever and Salmonella paratyphi, Diplococcus pneumoniae, dysentery bacterium etc. secondly; Influenza virus also there is inhibitory action; Because due to the tannin, so the constipation phenomenon is arranged again after rushing down; Have be good for the stomach and function of gallbladder promoting do; In addition, stop blooding in addition, protect the liver, effect such as blood pressure lowering, reduction serum cholesterol.
The YIQING KELI prescription is simple, and Fang Zhongsan flavor medical material is the product of bitter cold, and active component immediate access in the granule hides flavor dressing even add, and also is difficult to hide its bitterness; And after hard capsule wraps up its medicinal ingredient with softgel shell, solved the bitterness of immediate access, improve mouthfeel, but bioavailability is unsatisfactory again.
Summary of the invention
Lacking compliance for improving an existing dosage form YIQING KELI and a clearing capsule when the patient takes, particularly is that its mouthfeel and bioavailability are undesirable, the invention provides an a kind of clearing capsule novel form soft capsule and preparation technology thereof.
Because the water extract of three flavor medical materials is insoluble in water in the clear prescription,, need it is prepared into the homogeneous suspension for keeping the steady quality of soft capsule content.Normal oil-soluble substrate (as vegetable oil) and the water-soluble base (as PEG400 etc.) of adopting is as disperse medium in the preparation process of soft capsule suspension, but rely on medicinal component and disperse medium suspendible merely, be difficult to reach ideal effect, suspending agent, the cosolvent that also must select to adapt with disperse medium just can obtain suspendible content satisfactory for result, and selecting good content prescription is key point of the present invention.Evaluation indexes such as the physical stability by investigating suspended matter, flowability, moisture, screening have at last been determined the oil-soluble substrate that is fit to and the prescription of two kinds of contents of water-soluble base.
According to " 33 parts of Rhizoma Coptidis, 50 parts of Radix Scutellariaes, 100 parts of weight ratios of Radix Et Rhizoma Rhei in YIQING KELI of Chinese pharmacopoeia version in 2000, three flavor medical materials are carried out water respectively to be carried, Rhizoma Coptidis, Radix Scutellariae add 10 times of water gagings respectively, Radix Et Rhizoma Rhei adds 12 times of water gagings and decocts respectively twice, 1.5 hours for the first time, 1.0 hours for the second time, collecting decoction, filter, filtrate decompression is concentrated into the extractum that relative density is 1.25 (70 ℃); The Radix Scutellariae extractum spray drying gets extract powder, merges Radix Et Rhizoma Rhei, Rhizoma Coptidis extractum, and spray drying gets extract powder.
The preparation of soft capsule shell is very crucial, and it not only is related to capsular molding and attractive in appearance, but also directly relevant with the quality stability of soft capsule.Softgel shell generally is made up of four class materials such as sizing material, plasticizer, water, additives.The proportioning of various materials is to determine according to the character and the requirement of medicine in the capsule material prescription.Chinese medicine content ingredient complexity particularly, it is more strict to softgel shell constituent and proportion requirement.According to the chemical characteristic of this product content composition, by investigating evaluation indexes such as softgel shell disintegration, hardness, suitable softgel shell prescription has been determined in screening.
Active component in the present invention's one clear soft capsule is made up of the water extract of Rhizoma Coptidis, Radix Scutellariae, Radix Et Rhizoma Rhei three flavor medical materials.
A clear soft capsule is made up of capsule material and content among the present invention, when content adopts water-soluble base, content is made up of compound active composition and dispersant, suspending agent substantially, and their weight ratio is 1: 0.7～1.3: 0.001～0.08, is called the water solublity content in the present invention.
Dispersant is Polyethylene Glycol-200 (PEG-200), Polyethylene Glycol-300 (PEG-300), Polyethylene Glycol-400 (PEG-400) or Polyethylene Glycol-600 (PEG-600) in the content.The compound active composition that found through experiments in the content is pressed powder and is insoluble in oil or other solvents, it should be made into suspension and incapsulate.In the suspension of soft capsule if medicine is suspended in the oleaginous base, though its also can disperse under one's belt, because of each granule is surrounded the stripping that influences medicine by oleaginous base; If with medicine be suspended in the miscible substrate of water in, then disperse rapidly under one's belt, form very big absorbing surface.Active component is slightly soluble in PEG400 or Polyethylene Glycol-600, as the dispersant of content, is characterized in that it has good bioavailability, can obtain good blood drug level by its soft capsule of making, and medicine is absorbed better.Also because Polyethylene Glycol or Polyethylene Glycol-600 should not oxidation under common environment, become sour, being easy to the intestines and stomach liquid mixes, dissolving medicine wherein more effectively is released and absorbs, particularly low-molecular-weight as PEG400 or Polyethylene Glycol-600 is most of after gastrointestinal absorption is discharged by original shape in the urine.Though can mixing with water, PEG400 or Polyethylene Glycol-600 concerning softgel shell, there is no dissolution.
Suspending agent is ethylene glycol-10000, Polyethylene Glycol-8000, Polyethylene Glycol-4000 (PEG-4000) or Polyethylene Glycol-6000 (PEG-6000) in the content.Because the compound active composition in the content is slightly soluble in dispersant, for guaranteeing the bioavailability of a clear soft capsule, by a large amount of experimental selection a kind of toxicity less, can either be dissolved in the dispersant, can well a clear medicated powder be suspended in the dispersant again, and can for a long time stable material, Polyethylene Glycol-4000 or polyethylene glycol 6000 become ideal suspending agent.
In the soft capsule content except that necessary medicine active component and dispersant, suspending agent, can also add stabilizing agent is propylene glycol or glycerol, the weight ratio of compound active composition and stabilizing agent is 1: 0.1～0.4, make the softgel shell sclerosis in order to prevent PEG400 from absorbing the moisture in the softgel shell, in content, add propylene glycol or glycerol, be that moisture between scalable content and the softgel shell is bidirectional balanced, and have certain antisepsis.
When content adopted oil-soluble substrate, content can be made up of compound active composition and diluent, suspending agent, wetting agent, and their weight ratio is 1: 0.7～1.5: 0.1～0.5: 0.001～0.012, is called the oil-soluble content in the present invention.
Diluent can be all kinds of vegetable oil, and vegetable oil can be one or more the mixture in Oleum Sesami, Semen Maydis oil, Oleum Arachidis hypogaeae semen, Oleum Glycines, almond oil, peach kernel oil, Oleum Gossypii semen, Oleum Helianthi, olive oil, rapeseed oil, Petiolus Trachycarpi oil, the Oleum Cocois.
For diluent is the vegetable oil of oily substrate, normally used suspending agent can be selected the solid matter that can increase dispersion medium viscosity for use, is respectively in Carboxymethyl cellulose sodium, hydroxyethyl-cellulose, hyprolose, hydroxypropyl emthylcellulose, methylcellulose, ethyl cellulose, hydroxyethylmethyl-cellulose, carbomer, polyvinyl alcohol, sodium alginate, chitin, chitose, agar, Cera Flava, oily wax mixture, xanthan gum, arabic gum, the casein one or more.They can effectively solve the lamination of content, make the content good fluidity.
Wetting agent can be surfactant-based material, be respectively Tweens (polysorbas20,40,60,65,80,85), spans (span 20,80,85), poloxamer 188, they can increase the absorption and raising bioavailability of effective ingredient, also can increase the flowability of content, the DL better effects if of more single use suspending agent.
No matter be the water solublity content, or oil-soluble content, their capsule material is made up of gelatin, plasticizer and water substantially, three's weight ratio is 1: 0.3～0.4: 0.7～1.4, plasticizer is selected from glycerol, sorbitol, hexanetriol, propylene carbonate, hexanediol, anhydro sorbitol oxolane alcohol ether, diethylene glycol monoethyl ether, 1,3-dimethyl-2-imidazolone or the different sorbate of dimethyl.Effect for preventing that softgel shell from going mouldy is beneficial to long-term storage, also can add antiseptic, and the weight ratio of gelatin and antiseptic is 1: 0.003, and antiseptic can be benzoic acid, sodium benzoate, Methyl p-hydroxybenzoate, ethyl hydroxybenzoate, propylparaben.
A clear soft capsule can adopt conventional soft capsule preparation technology to make among the present invention, as manual die pressing, rotating mould platen press or dropping preparation method.Usually select the rotation pressing for use, use rotation rolling capsule machine automatically, temperature is controlled at 25～30 ℃, rolling soft capsule.
The present invention's one clear soft capsule is compared with other dosage form, have characteristics such as to cover Chinese medicine abnormal flavour, bioavailability height, good looking appearance, because three flavor medical materials are the product of bitter cold in the clear prescription, can keep the effective ingredient in early stage again for covering its bitterness, soft capsule preparation has very rational effect as far as possible.Overcome the defective that existing other dosage form exists as novel form, reduced patient's dose, guaranteed making full use of of effective ingredient, disintegration is short, and the interior absorption of body is fast, and meets the detection requirement under the relevant soft capsule item of Chinese Pharmacopoeia.When more what deserves to be explained is in the water solublity content with PEG-400 or PEG-600 as dispersant, because of they have water absorption, the water that softgel shell itself is contained often can shift to content rapidly, even can reach more than 20% of total amount, thereby the elasticity of softgel shell is reduced, influence the disintegrate, stability of soft capsule etc., if still select the plant oil diluent for use, then overcome the effect of softgel shell to content, the cost of raw material also can reduce significantly.
Compare with capsule with granule, soft capsule content is a suspension, after the medicine disintegrate, can obviously be improved bioavailability of medicament by the very fast absorption of human body.In addition, it is more accurate that soft capsule has a sample-loading amount, and better tightness is aesthetic in appearance, product qualified rate advantages of higher in the production.
One clear soft capsule is the disintegration in simulated gastric fluid (9ml hydrochloric acid adds water to 1000ml, 37 ℃): 0 day is 10 minutes; Be 38 minutes after room temperature kept sample 12 months, meet the Chinese Pharmacopoeia requirement.
The specific embodiment
A clear soft capsule is made up of content and capsule material among the present invention, and the water solublity content preferably is made up of compound active composition and PEG400, Polyethylene Glycol-6000, propylene glycol, preferred 1: 0.9: 0.03～0.06: 0.2 of their weight ratio.
The oil-soluble content preferably is made up of compound active composition and diluent, suspending agent, wetting agent, the preferred Oleum Arachidis hypogaeae semen of vegetable oil in the diluent preferably vegetable oil, Oleum Glycines, Semen Maydis oil, Oleum Sesami, suspending agent preferred oil wax mixture, the preferred sorbester p17 of wetting agent, preferred 1: 0.9: 0.14 of their weight ratio: 0.003～0.005.The oil wax mixture is made up of hydrogenated vegetable oil, Cera Flava, Oleum Cocois, and three's ratio is 1: 1: 3.
The capsule material is made up of gelatin, plasticizer and water substantially among the present invention, the plasticizer preferably glycerine, and gelatin, glycerol, water preferred weight ratio are 1: 0.33～0.35: 0.9, the preferred methyl hydroxybenzoate of antiseptic.
The starch of the two flavor medical material Poria that desire is pulverized in the compound active composition is many, and mealiness is well easily pulverized, and the fibroid of Ramulus Cinnamomi medical material is strong, but with general mechanical activation comminution fineness is reached more than 120 orders, to guarantee the stability of suspension, is beneficial to absorption of human body.Because the complexity of active component, content is the suspension state, from the sedimentation formula V=2r of suspension
2(d
1-d
2)/9n, V are the microgranule sedimentation velocity, and r is a particle radius, d
1Be density of particle, d
2Be disperse medium density, n is the viscosity of disperse medium, can know minimizing granularity increase dispersion medium viscosity by inference and can reduce sedimentation velocity effectively, guarantees the stability of suspension, so the thin more easy more mixing of the granularity of dried cream powder.
The following examples will be described the present invention in more detail.
Embodiment one, one clear preparation of soft capsule
1, preparation compound active composition: take by weighing Rhizoma Coptidis 3300g Radix Et Rhizoma Rhei 10000g Radix Scutellariae 5000g three flavor medical materials, according to a Chinese Pharmacopoeia version YIQING KELI in 2000 or a clearing capsule (WS
3The active component of-794 (Z-145)-2002Z) carries out water to be carried, and obtains extract powder.
2, preparation content: PEG-400 2250 grams, PEG-6000 75 grams and propylene glycol 750 grams are heated to 65 ℃ and make fusing, stir evenly, as water-soluble base; Mix with medicated powder again, stir evenly.
3, preparation capsule material: get gelatin 5000 grams, water 4500 grams, be heated to 70 ℃, get glycerol 1750 grams, methyl hydroxybenzoate 15 grams, stir, evacuation 1 hour mixes with above-mentioned gelatin, 70 ℃ of insulation standing over night.
4, compacting soft capsule: with the capsule dish liquid that makes and the content rotation rolling capsule machine automatically of packing into, temperature is controlled at 25～30 ℃ and suppresses the soft capsule that contains active component 250mg.
Embodiment two, one clear preparation of soft capsule
1, preparation compound active composition: take by weighing Rhizoma Coptidis 3300g Radix Et Rhizoma Rhei 10000g Radix Scutellariae 5000g three flavor medical materials, according to a Chinese Pharmacopoeia version YIQING KELI in 2000 or a clearing capsule (WS
3The active component of-794 (Z-145)-2002Z) carries out water to be carried, and obtains extract powder.
2, preparation content: PEG-400 1750 grams, PEG-6000 25 grams and propylene glycol 250 grams, method is with embodiment one.
3, preparation capsule material: get gelatin 5000 grams, water 3500 grams, be heated to 70 ℃, get glycerol 1500 grams, stir, evacuation 1 hour mixes with above-mentioned gelatin, 70 ℃ of insulation standing over night.
4, compacting soft capsule: with embodiment one.
Three: one clear preparation of soft capsule of embodiment
1, preparation compound active composition: with embodiment one.
2, preparation content: PEG-400 3250 grams, PEG-6000 200 grams and propylene glycol 1000 grams, method is with embodiment one.
3, preparation capsule material: get gelatin 5000 grams, water 7000 grams, be heated to 70 ℃, get glycerol 2000 grams, stir, evacuation 1 hour mixes with above-mentioned gelatin, 70 ℃ of insulation standing over night.
4, compacting soft capsule: with embodiment one.
Embodiment four, one clear preparation of soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: PEG-400 2250 grams, PEG-6000 75 grams are heated to 65 ℃ and make fusing, stir evenly, as water-soluble base; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
Embodiment five, one clear preparation of soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: get Cera Flava 200 grams, Oleum Cocois 600 grams, hydrogenated vegetable oil 200 grams, be heated to 80 ℃ and make fusing, stirring evenly and putting cold-working is suspending agent.
Oleum Glycines 2250 grams, suspending agent 350 grams, sorbester p17 10 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
Embodiment six, one clear preparation of soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: Semen Maydis oil 1750 grams, Cera Flava 250 grams, sorbester p17 2.5 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
Embodiment seven, one clear preparation of soft capsule
1, preparation compound active composition: with embodiment one.
2, preparation content: Oleum Arachidis hypogaeae semen 3750 grams, Cera Flava 750 grams, sorbester p17 30 grams are heated to 60 ℃ and make fusing, stir evenly, as oil-soluble substrate; Mix with medicated powder again, stir evenly.
3, preparation capsule material: with embodiment one.
4, compacting soft capsule: with embodiment one.
Claims (8)
1, a kind of one clear soft capsule is characterized in that it is made up of content and capsule material, and wherein content is made up of compound active composition and dispersant, suspending agent substantially, and their weight ratio is 1: 0.7～1.3: 0.01～0.08.
2, according to claim 1 described one clear soft capsule, it is characterized in that the weight ratio of compound active composition and dispersant, suspending agent, stabilizing agent is preferably 1: 0.9: 0.03～0.06: 0.2～0.3.
3, according to claim 1 described one clear soft capsule, it is characterized in that the capsule material is made up of glue, plasticizer and water substantially, three's weight ratio is 1: 0.3～0.4: 0.7～1.4.
4, according to claim 3 described one clear soft capsule, it is characterized in that the preferred gelatin of capsule material, glycerol, water, three's preferred weight ratio is 1: 0.33～0.35: 0.9.
5, a kind of one clear soft capsule, it is characterized in that it is made up of content and capsule material, wherein content is made up of compound active composition and diluent, suspending agent, wetting agent substantially, and their weight ratio is 1: 0.7～1.5: 0.1～0.5: 0.001～0.012.
6, according to claim 5 described one clear soft capsule, the preferred weight ratio that it is characterized in that compound active composition and diluent, suspending agent, wetting agent is 1: 0.9: 0.14: 0.003～0.005.
7, according to claim 5 described one clear soft capsule, it is characterized in that the capsule material is made up of glue, plasticizer and water substantially, three's weight ratio is 1: 0.3～0.4: 0.7～1.4.
8, according to claim 5 described one clear soft capsule, it is characterized in that the preferred gelatin of capsule material, glycerol, water, three's preferred weight ratio is 1: 0.33～0.35: 0.9.
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| CN 200410000656 CN1640428A (en) | 2004-01-15 | 2004-01-15 | One-time-clearing soft capsule and its preparing process |
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| CN 200410000656 CN1640428A (en) | 2004-01-15 | 2004-01-15 | One-time-clearing soft capsule and its preparing process |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711808B (en) * | 2009-09-11 | 2011-08-24 | 海南海神同洲制药有限公司 | Soft capsule used for clearing away heat and toxic materials and preparation method thereof |
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2004
- 2004-01-15 CN CN 200410000656 patent/CN1640428A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101711808B (en) * | 2009-09-11 | 2011-08-24 | 海南海神同洲制药有限公司 | Soft capsule used for clearing away heat and toxic materials and preparation method thereof |
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Effective date of registration: 20060825 Address after: Dongxing Road, hi tech Development Zone, Jiangxi, Xinyu Applicant after: Jiangxi Our's Medicine Co., Ltd. Address before: Beiqijia Industrial Park, Changping District, Beijing Applicant before: Beijing Shengpuhua Medical Technology Development Co., Ltd. |
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