CN1718233A - Capsule for treating diabetes, and its prepn. process - Google Patents
Capsule for treating diabetes, and its prepn. process Download PDFInfo
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- CN1718233A CN1718233A CNA2004100624548A CN200410062454A CN1718233A CN 1718233 A CN1718233 A CN 1718233A CN A2004100624548 A CNA2004100624548 A CN A2004100624548A CN 200410062454 A CN200410062454 A CN 200410062454A CN 1718233 A CN1718233 A CN 1718233A
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Abstract
A Tangniaole capsule for treating diabetes is composed of the shell prepared from gelatin, plasticizer and water in Wt ratio of 1:(0.1-1):(0.5-2) and the core prepared from active component, water-soluble disperser and suspending aid in wt ratio of 1:(0.5-2):(0.005-0.1) or from active component, oil-soluble disperser, suspending aid and wetting agent in wt ratio of 1:(0.5-2):(0.05-0.6):(0.001-0.1).
Description
Technical field
The present invention relates to a kind of novel form-soft capsule and preparation technology thereof of TANGNIAOLE hard capsule.
Background technology
TANGNIAOLE hard capsule prescription comes from good wine soup among the Zhang Xichun " Records of Tradition Chinese and Western Medicine in Combination ", is made up of 13 flavor medical materials such as Radix Trichosanthis, Rhizoma Dioscoreae, the Radix Astragali, Radix Rehmanniae, Radix Ginseng Rubra, Fructus Lycii, the Rhizoma Anemarrhenae, Radix Asparagi, Poria, Fructus Corni, Fructus Schisandrae Chinensis, Radix Puerariae, Endothelium Corneum Gigeriae Galli.Clinical practice has thousands of years history, and our prescription is rigorous, and compatibility is ingenious, and nourishing YIN and clearing away heat promotes the production of body fluid and develop simultaneously in tonifying Qi and lifting yang cloth Tianjin, in full side's the moon sun is arranged, and have in giving birth to and fall, so the energy regulating yin and yang makes the body fluid lifting orderly, be the efficacious prescriptions that have for the treatment diabetes.
The domestic dosage form of having developed listing is a hard capsule, records in 13 WS of health ministry standard Chinese medicine
3-B-2644-97, prescription: Radix Trichosanthis 208.6g Rhizoma Dioscoreae 208.6g Radix Astragali 52g Radix Ginseng Rubra 31.3g Radix Rehmanniae 52g Fructus Lycii 31.3g Rhizoma Anemarrhenae 31.3g Radix Asparagi 15.6g Poria 21g Fructus Corni 21g Fructus Schisandrae Chinensis 15.6g Radix Puerariae 21 Endothelium Corneum Gigeriae Galli (stir-fry) 21g, method for making: above 13 flavors, get Rhizoma Dioscoreae 104.3g, Radix Trichosanthis 104.3g, Endothelium Corneum Gigeriae Galli, be ground into coarse powder; All the other Rhizoma Dioscoreae 104.3g, Radix Trichosanthis 104.3g, the Radix Rehmanniae, Fructus Corni, Fructus Lycii, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Radix Puerariae, Radix Asparagi, Poria decoct with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into thick paste; Add Rhizoma Dioscoreae, Radix Trichosanthis, the Endothelium Corneum Gigeriae Galli coarse powder, drying together is ground into fine powder with Radix Ginseng Rubra, and mixing incapsulates, and makes 1000, promptly.
Compound Chinese medicinal preparation for the such determined curative effect of TANGNIAOLE, the dosage form of now having developed has only hard capsule, very far away with the gap of clinical needs, develop multiple dosage form, improve the application status of Chinese medicine in clinical, utilization modern pharmacy theory and the definite curative effect of Chinese medicine combine, and are one of directions of Chinese medicine development from now on.
Summary of the invention
The purpose of this invention is to provide a kind of TANGNIAOLE hard capsule novel form-soft capsule and preparation technology thereof.
That soft capsule preparation is used for more is water-insoluble, to photaesthesia, run into damp and hot instability, the volatile medicine of oxidation easily, to strengthen stability of drug, the effect of cover the adverse drug taste in addition in addition, being convenient to take experimental results show that the bioavailability of soft capsule is higher than hard capsule and conventional tablet.Because these characteristics of soft capsule have determined that medicine is hedged off from the outer world in the shell, its face shaping, disintegration time and stability etc., none is the influence of receptaculum material and content component not.
In the TANGNIAOLE hard capsule prescription, contain 13 kinds of medical materials, the Rhizoma Dioscoreae of half recipe quantity, Radix Trichosanthis and full dose Endothelium Corneum Gigeriae Galli powder are broken into coarse powder, all the other Rhizoma Dioscoreaes, Radix Trichosanthis, the Radix Rehmanniae, Fructus Corni, Fructus Lycii, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Radix Puerariae, Radix Asparagi, Poria decoct with water secondary, each 2 hours, collecting decoction filters, and filtrate is condensed into thick paste; Add Rhizoma Dioscoreae, Radix Trichosanthis, the Endothelium Corneum Gigeriae Galli coarse powder, drying together is ground into fine powder with Radix Ginseng Rubra, mixing, the hard capsule of packing into.Because the active component complexity uses single solvent to be difficult to make the content component to form stabilising system, and soft capsule molding and quality are all had severe bad influence, also is difficult for determining to be suitable for the capsule material of content.Therefore realize that the key of the object of the invention is stability, the homogeneity problem that solves soft capsule content, Chinese crude drug extract for the active component complexity, often consider to make content form stable suspension, find by a large amount of experiments, when using water-soluble base or oil-soluble substrate as dispersant, the content prescription has significant difference, but two kinds of prescriptions can both satisfy the soft capsule quality requirement, is described in detail with regard to two kinds of different prescriptions of content below.
The content active component is with 13 WS of health ministry standard Chinese medicine
3-B-2644-97 TANGNIAOLE JIAONANG.
Capsule for treating diabetes is made up of capsule material and content among the present invention, and content is made up of active component and water soluble dispersing agent, suspending agent substantially, and their weight ratio is 1: 0.5～2.0: 0.005～0.1.
Water soluble dispersing agent in the content is for being selected from Polyethylene Glycol-200 (PEG-200), Polyethylene Glycol-300 (PEG-300), Polyethylene Glycol-400 (PEG-400) or Polyethylene Glycol-600 (PEG-600).
Because the active component in the content is the mixture of pressed powder and thick paste, can not be dissolved in oil or other solvents, it can be made into suspension and incapsulate.In the suspension of soft capsule if medicine is suspended in the oil-soluble substrate, 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.The TANGNIAOLE 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 PEG400 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 selected from Polyethylene Glycol-10000, Polyethylene Glycol-8000, Polyethylene Glycol-4000 (PEG-4000) or Polyethylene Glycol-6000 (PEG-6000) in the content.
Because the active component in the content is slightly soluble in dispersant, for guaranteeing the bioavailability of capsule for treating diabetes, by a large amount of experimental selection a kind of toxicity less, can either be dissolved in the dispersant, can well TANGNIAOLE 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 such as propylene glycol or glycerol, so that content is more stable, the weight ratio of active component and stabilizing agent is 1: 0.005～1, make the softgel shell sclerosis in order to prevent PEG400 from absorbing the moisture in the softgel shell, add propylene glycol or glycerol in content, promptly the moisture between scalable content and the softgel shell is bidirectional balanced, and has certain antisepsis.
In soft capsule content, except that using water soluble dispersing agent, also often use oil-soluble dispersant, so content of the present invention is made up of active component and oil-soluble dispersant, suspending agent, wetting agent, their weight ratio is 1: 0.5～2.0: 0.05～0.6: 0.001～0.1.
Oil-soluble dispersant is selected from all kinds of vegetable oil, as 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 or the Oleum Cocois.
When using vegetable oil, usually suspending agent is the solid matter that can increase dispersant viscosity, is selected from 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 or the casein one or more.They can effectively solve the lamination of content, improve the content flowability, are easy to suppress soft capsule.
Wetting agent can be surfactant-based material, be selected from Tweens (polysorbas20,40,60,65,80,85), spans (span 20,80,85) or 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 dispersant is water miscible or oil-soluble, no matter content component also involved in the present invention how, but their capsule material is made up of gelatin, plasticizer and water substantially, three's weight ratio is 1: 0.1～1: 0.5～2, 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.
Capsule for treating diabetes 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 25～35 ℃, rolling soft capsule.In order to make the content suspension more stable, before the compacting soft capsule, content is crossed colloid mill, to guaranteeing that product quality is more favourable.
The capsule for treating diabetes of the present invention significant advantage of having compared with other dosage forms, overcome the defective that existing dosage form exists, can suppress scattering and disappearing of volatile ingredient in some medical material, guaranteed making full use of of effective ingredient, the abnormal flavour that can also completely cut off medical material and extract, disintegration is short, absorbs fast in the body, the bioavailability height, and meet detection requirement under the relevant soft capsule item of Chinese Pharmacopoeia.More what deserves to be explained is when using PEG-400 or PEG-600 in the water soluble dispersing agent, 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, thus the elasticity of softgel shell is reduced, influence the disintegrate, stability of soft capsule etc., therefore content quality requires high, if but select oil-soluble dispersant such as plant oil for use, then overcome the effect of softgel shell to content, the cost of raw material also can reduce significantly.
Capsule for treating diabetes is the disintegration in simulated gastric fluid (9ml hydrochloric acid adds water to 1000ml, 37 ℃): 0 day is 7 minutes; Be 30 minutes after room temperature kept sample 12 months, meet the Chinese Pharmacopoeia requirement, illustrate that its content component is reasonable, capsule for treating diabetes is in technology and be feasible dosage form qualitatively.
The specific embodiment
When using water soluble dispersing agent, capsule for treating diabetes preferred contents component of the present invention is active component, PEG400, Polyethylene Glycol-6000, propylene glycol, preferred 1: 0.8: 0.02～0.03: 0.1 of weight ratio.
When using oil-soluble dispersant, capsule for treating diabetes preferred contents component of the present invention is active component, vegetable oil, oily wax mixture, sorbester p17, preferred 1: 0.75: 0.15 of weight ratio: 0.008～0.012, 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 following examples will be described the present invention in more detail.
The preparation of embodiment one, capsule for treating diabetes
1, preparation active component: according to 13 WS of health ministry standard Chinese medicine
3-B-2644-97, prescription: Radix Trichosanthis 208.6g Rhizoma Dioscoreae 208.6g Radix Astragali 52g Radix Ginseng Rubra 31.3g Radix Rehmanniae 52g Fructus Lycii 31.3g Rhizoma Anemarrhenae 31.3g Radix Asparagi 15.6g Poria 21g Fructus Corni 21g 15.6g Radix Puerariae 21 Endothelium Corneum Gigeriae Galli (stir-fry) 21g that distinguishes the flavor of, method for making: above 13 flavors, get Rhizoma Dioscoreae 104.3g, Radix Trichosanthis 104.3g, Endothelium Corneum Gigeriae Galli, be ground into coarse powder; All the other Rhizoma Dioscoreae 104.3g, Radix Trichosanthis 104.3g, the Radix Rehmanniae, Fructus Corni, Fructus Lycii, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Radix Puerariae, Radix Asparagi, Poria decoct with water secondary, and each 2 hours, collecting decoction filtered, and filtrate is condensed into thick paste; Add Rhizoma Dioscoreae, Radix Trichosanthis, the Endothelium Corneum Gigeriae Galli coarse powder, drying together is ground into fine powder with Radix Ginseng Rubra, and mixing obtains about 300 grams of active component.
2, preparation content: PEG-400 256 grams, PEG-4000 9.6 grams and propylene glycol 32 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 25～35 ℃ and suppresses 1000 of soft capsules that contain active component 300mg.
The preparation of embodiment two, capsule for treating diabetes
1, preparation compound active composition: with embodiment one.
2, preparation content: PEG-400 160 grams, PEG-6000 1.6 grams and propylene glycol 1.6 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.
Embodiment three: the preparation of capsule for treating diabetes
1, preparation compound active composition: with embodiment one.
2, preparation content: PEG-400 640 grams, PEG-6000 32 grams and propylene glycol 320 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.
The preparation of embodiment four, capsule for treating diabetes
1, preparation compound active composition: with embodiment one.
2, preparation content: PEG-400 256 grams, PEG-6000 6.4 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.
The preparation of embodiment five, capsule for treating diabetes
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 240 grams, suspending agent 48 grams, sorbester p17 3.2 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.
The preparation of embodiment six, capsule for treating diabetes
1, preparation compound active composition: with embodiment one.
2, preparation content: Semen Maydis oil 160 grams, Cera Flava 16 grams, sorbester p17 0.32 gram is heated to 60 ℃ and makes fusing, stirs 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.
The preparation of embodiment seven, capsule for treating diabetes
1, preparation compound active composition: with embodiment one.
2, preparation content: Oleum Arachidis hypogaeae semen 640 grams, Cera Flava 192 grams, sorbester p17 32 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 (11)
1, a kind of capsule for treating diabetes, it is made up of capsule material and content, it is characterized in that content is made up of active component and water soluble dispersing agent, suspending agent substantially, and their weight ratio is 1: 0.5～2.0: 0.005～0.1.
2, described according to claim 1, it is characterized in that containing in the content stabilizing agent, the weight ratio of active component and stabilizing agent is 1: 0.005～1.
3, described according to claim 1 or 2, it is characterized in that water soluble dispersing agent is for being selected from Polyethylene Glycol-200, Polyethylene Glycol-300, Polyethylene Glycol-400 or Polyethylene Glycol-600.
4, described according to claim 1 or 2, it is characterized in that suspending agent is selected from Polyethylene Glycol-10000, Polyethylene Glycol-8000, Polyethylene Glycol-4000 or Polyethylene Glycol-6000.
5, described according to claim 2, it is characterized in that stabilizing agent is selected from propylene glycol or glycerol.
6, a kind of capsule for treating diabetes, it is made up of capsule material and content, it is characterized in that content is made up of active component and oil-soluble dispersant, suspending agent, wetting agent, and their weight ratio is 1: 0.5～2.0: 0.05～0.6: 0.001～0.1.
7, described according to claim 6, it is characterized in that oil-soluble dispersant is selected from all kinds of vegetable oil, as 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.
8, described according to claim 6, it is characterized in that suspending agent is selected from one or more 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.
9, described according to claim 6, it is characterized in that wetting agent is selected from Tweens 20, polysorbate40, polysorbate60, polysorbate65, Tween 80, polysorbate85, span 20, sorbester p17, sorbester p37, poloxamer 188.
10, according to claim 1,2 or 6 described, it is characterized in that their capsule material is made up of gelatin, plasticizer and water substantially, three's weight ratio is 1: 0.1～1: 0.5～2.
11, described according to claim 10, it is characterized in that 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.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2004100624548A CN1718233A (en) | 2004-07-09 | 2004-07-09 | Capsule for treating diabetes, and its prepn. process |
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| CNA2004100624548A CN1718233A (en) | 2004-07-09 | 2004-07-09 | Capsule for treating diabetes, and its prepn. process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008153502A1 (en) * | 2007-06-08 | 2008-12-18 | Eu Yan Sang International Ltd | Compositions for prevention and/or treatment of diabetes |
| WO2019047141A1 (en) * | 2017-09-08 | 2019-03-14 | 北京慧宝源生物技术股份有限公司 | Pharmaceutical composition for controlling blood sugar |
| CN115282264A (en) * | 2022-08-31 | 2022-11-04 | 北京志宣生物科技有限公司 | Compound preparation for reducing blood sugar and improving immunity and preparation method thereof |
-
2004
- 2004-07-09 CN CNA2004100624548A patent/CN1718233A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008153502A1 (en) * | 2007-06-08 | 2008-12-18 | Eu Yan Sang International Ltd | Compositions for prevention and/or treatment of diabetes |
| WO2019047141A1 (en) * | 2017-09-08 | 2019-03-14 | 北京慧宝源生物技术股份有限公司 | Pharmaceutical composition for controlling blood sugar |
| CN110300594A (en) * | 2017-09-08 | 2019-10-01 | 北京慧宝源生物技术股份有限公司 | Control the pharmaceutical composition of blood glucose |
| US11957726B2 (en) | 2017-09-08 | 2024-04-16 | Beijing Hebabiz Biotechnology Co., Inc. | Pharmaceutical composition for controlling blood sugar |
| CN115282264A (en) * | 2022-08-31 | 2022-11-04 | 北京志宣生物科技有限公司 | Compound preparation for reducing blood sugar and improving immunity and preparation method thereof |
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