CN100462083C - Method for relieving bitter taste in compound Chinese medicine - Google Patents
Method for relieving bitter taste in compound Chinese medicine Download PDFInfo
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- CN100462083C CN100462083C CNB2006100264749A CN200610026474A CN100462083C CN 100462083 C CN100462083 C CN 100462083C CN B2006100264749 A CNB2006100264749 A CN B2006100264749A CN 200610026474 A CN200610026474 A CN 200610026474A CN 100462083 C CN100462083 C CN 100462083C
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Abstract
The invention relates to a method for solving the bitter of Chinese traditional medicine, wherein it adds taste corrector into the extractive of traditional medicine. Said method has high load, stable quality and wide application.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of method of improving the Chinese medicine compound bitterness.
Background technology
The taste of medicine is to influence the take medicine key factor of compliance of patient.Any preparation prescription, if good mouthfeel all can be better than similar competing product, especially department of pediatrics medication, taste is easy to children's and accepts, and can improve the medication compliance greatly.For Chinese medicine, the composition of Chinese medicine compound mostly is natural product, effect is gentle, little, the treating both the principal and secondary aspects of a disease of side effect, is suitable for children, the medication of old conditioning property, and chronic disease long-term control medication, but Chinese medicine compound has the shortcoming that is difficult to overcome aspect clinical practice, as complicated component, dose is big, majority has intensive bad smell and taste, has a strong impact on patient and takes compliance.In view of Chinese medicine compound is suitable for crowd's particularity and the intrinsic weakness of itself, the bitterness of improvement Chinese medicine compound has practical significance widely.
Taste masking generally changes taste bud to the sensitivity of bitterness with by reducing dose or the two kinds of methods of drug level that contact with taste bud.Is the simplest method commonly used in the existing pharmaceutical preparation by changing taste bud to the sensitivity taste masking method of bitterness, promptly adds sweeting agent, aromatic or effervescent.By reducing dose or the drug level taste masking method contact with taste bud, suitable development has also been arranged, studying more is the film coating method.The microencapsulation method also has certain research, and relevant patent has US6, and 139,865 prepare flavor hidden microcapsule by the coacervation that is separated; CN03116387 adopts the fluidized bed powder coating to make flavor hidden microcapsule; IN867/DEL/99 carries out the microencapsulation taste masking to Macrocyclolactone lactone kind medicine.Spray drying is a preparation microcapsule common method, and CN90105089 utilizes spray drying method that medicines such as pipemidic acid, nitrofurantoin are carried out the microencapsulation taste masking, makes no herbal medicine.Because the variation of Chinese medicine compound flavour of a drug, dose is big, so microcapsule technology is difficult to use the report that does not also have microencapsulation taste masking technology to use at present in Chinese medicine compound in Chinese medicine compound.
Relevant patent to the Chinese medicine compound taste masking has CN92108278.9, CN93111897.2, and CN95102974.6, CN03108972.0 etc. all are to carry out taste masking by adding various correctivess merely.Even but most Chinese medicine compound is added a large amount of correctivess and can not be reached desirable taste masking effect.
Utilize correctivess such as sweeting agent to be difficult to satisfy the taste masking requirement of Chinese medicine compound merely, adopt physical isolation methods such as microencapsulation also low merely, have the not strong problem of feasibility because of drug loading.If microencapsulation is combined with adding the correctives method, the advantage of two kinds of methods of performance, complementary shortcoming, it is big then can to obtain drug loading, the compound preparation of features good taste.Comprehensive literature is retrieved, and does not still have both at home and abroad at present by microencapsulation to prepare pertinent literature or the patent report that Chinese medicine compound does not have the bitterness preparation with the method that the interpolation correctives combines.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of drug loading to be fit to improve the method for Chinese medicine compound bitterness greatly by adopting microencapsulation physics isolation junction to close the interpolation correctives.
The method of improving the Chinese medicine compound bitterness disclosed by the invention comprises the following steps:
1) macromolecular material is dissolved in the solvent preparation encystation material solution;
2), be made into compound extract solution or suspension with Chinese medicine compound extract dissolving or be suspended in the solvent identical with step 1);
3) with the weight ratio of extract and capsule material ratio greater than 1:0.6, extract solution slowly is added in the capsule material solution, mixing, the percent weight in volume concentration that makes capsule material in the mixed solution is 0.5%～10%, spray drying obtains particle diameter at 1～100 μ m microcapsule or microsphere;
4) above-mentioned microcapsule or microsphere are added preparation total amount 0.001%～10% correctives, other do not have in the drug component and pharmaceutic adjuvant of abnormal flavour, make various oral formulations according to a conventional method.
The solvent of pocket material and Chinese medicine extract is selected from the ethanol water of water, dehydrated alcohol and various concentration in the inventive method.
The concentration of the capsule material solution that is made into is that 1%～10% (w/v) preferred concentration is 2～5%.
Chinese medicine compound extract solution that is made into or suspension concentration are that 0.25%～10% (w/v) preferred concentration is 2～6%.When extract solution was suspension, its solid grain size should be below 100 μ m.
After extract solution and the mixing of capsule material solution, the concentration of capsule material is preferably 1～4% in the mixed solution that makes (promptly treating hydrojet); Extract and capsule material weight ratio are preferably 1:0.6-2.
The macromolecular material that the present invention is used to prepare the capsule material is selected from the pharmaceutic adjuvant that is not dissolved in the human saliva and can be applicable to oral formulations, comprises methacrylic acid-dimethylamino ethyl ester (Eudragit E), methacrylic acid-methyl methacrylate 1:1 copolymer (Eudragit L), methacrylic acid-methyl methacrylate 1:2 copolymer (Eudragit S), ethyl cellulose (EC), hydroxypropylmethyl cellulose phthalate (HPMCP), zein, gelatin, hydroxypropyl cellulose (HPC), cellulose acetate (CA), carbopol (Carbopol) and their mixture.
Correctives of the present invention is sweeting agent, aromatic or bitter tasting retarding agent commonly used in the preparation oral formulations, and consumption is 0.001%～10% of a preparation total amount, and preferable amount is 0.01～1%.Wherein sweeting agent comprises sucrose, saccharin sodium, cyclamate, stevioside, aspartame and has the monellin such as the thaumati of flavored action, Semen Capparis albumen, Rhizoma Curculiginis sweet protein etc.; Aromatic comprises the natural volatile oil spice that menthol, apple essence, Cortex cinnamomi japonici (Ramulus Cinnamomi) essence, flavoring banana essence, cinnamic aldehyde, ethyl acetate etc. are edible and the essence and flavoring agent of synthetic; Bitter tasting retarding agent comprises monosodium glutamate, adenylic acid etc.
Spray drying process is adopted in the preparation of microcapsule of the present invention or microsphere usually, can adjust suitable spray drying condition according to the spray dryer different model, to obtain particle diameter at following microcapsule of 100 μ m or microsphere.
The taste masking difficulty of sheltering than Western medicine for the bitterness of Chinese medicine compound is greater, and key issue is that the Chinese medicine extract amount is big, and the bitterness source is complicated, and taste masking requires high.The present invention finds that through a large amount of experiments the ratio of capsule material and Chinese medicine extract, the concentration for the treatment of hydrojet and spray drying condition all directly have influence on the taste masking effect and the drug loading of Chinese medicine compound.See Table 1 and the experimental data of table 2
The ratio of table 1 Chinese medicine extract and capsule material is to the influence of taste masking effect
Table 2 is treated the concentration of hydrojet and the spray drying condition influence (medicine: capsule material 1:0.8) to the taste masking effect
(annotate: table 1, related " the bitterness score " 0 of table 2 be not for there being bitterness; 1 for feeling bitterness; 2 grades: obvious bitterness is arranged; 3 grades: bitterness significantly is difficult to swallow; 4 grades: bitterness is strong, spues 5 grades: extremely bitter, it is extremely bitter to cause vomiting) at once.
Above-mentioned result of the test shows that the ratio of extract and capsule material all has remarkable influence to taste masking effect and drug loading, and from taste masking effect and preparation cost consideration, preferred extract and capsule material ratio are 1:0.6-2.Concentration and the spray drying condition for the treatment of capsule material in the hydrojet also have certain influence to the taste masking effect.According to the bitterness of different extracts and to the requirement of taste masking, can do further optimization.
The present invention compared with prior art has following advantage by the method that adopts microencapsulation physics isolation junction to close to add correctives to improve the Chinese medicine compound bitterness:
1, the Chinese medicine compound extract is made microcapsule or microsphere, reduce the dose that contacts with taste bud, further add less correctives again, can fundamentally reach the purpose of taste masking.
2, the complementation of microencapsulation and correctives has reduced the consumption of capsule material and correctives respectively; Adopt method of the present invention, capsule material drug loading improves greatly, reaches as high as about 70%; The consumption of correctives also is significantly less than normal use amount; Therefore make recipe quantity reduce obviously to have improved patient's compliance.
3, microcapsule/microsphere of making has taste masking simultaneously, improve shortcoming such as the strong and mobile poor compressibility of Chinese medicine extract powder hygroscopicity, makes things convenient for the preparation of preparation and improves the quality of preparation.
Adopt good, the steady quality of compound Chinese medicinal preparation mouthfeel of the inventive method preparation, be easy to old man and children taking especially.This method is fit to suitability for industrialized production; be particularly suitable for containing the preparation of the taste masking preparation of following one or more Chinese medicine extract: Rhizoma Coptidis; Fructus Forsythiae; Radix Et Rhizoma Rhei; Radix Gentianae Macrophyllae; Radix Gentianae, Radix Isatidis; the Rhizoma Anemarrhenae; Plumula Nelumbinis; Fel Ursi; Herba Commelinae; Fructus Gardeniae; Spica Prunellae; Radix Scutellariae; Cortex Phellodendri; Radix Sophorae Flavescentis; Cortex Dictamni; Cortex Ailanthi; Folium Isatidis; Rhizoma Osmundae; Herba Taraxaci; Herba Violae; Flos Chrysanthemi Indici; Herba Senecionis Scandentis; Ilex purpurea Hassk.[I.chinensis Sims; Herba Andrographis; Herba Scutellariae Barbatae; Radix Rhapontici; Caulis Sargentodoxae; Herba Patriniae; the Radix Pulsatillae; Cortex Fraxini; Herba Schizonepetae; Rhizoma Belamcandae; Radix Sophorae Tonkinensis; Cortex Moutan; Radix Paeoniae Rubra; Herba Artemisiae Annuae; Rhizoma Picrorhizae; Semen Pharbitidis; Radix Stephaniae Tetrandrae; Radix Tripterygii Wilfordii; Cortex Acanthopancis; Caulis Akebiae; Herba Agrimoniae; the Pseudobulbus Bletillae (Rhizoma Bletillae); Rhizoma Corydalis; Radix Curcumae; Radix Salviae Miltiorrhizae; Herba Leonuri; Semen Vaccariae; catechu; Rhizoma Arisaematis; Radix Peucedani; Bulbus Fritillariae Cirrhosae; Calculus Bovis and Fructus Cnidii.
The invention will be further described below in conjunction with embodiment.
The specific embodiment
Embodiment 1, SHUANGHUANLIAN taste masked particle
Prescription is formed: Fructus Forsythiae Radix Scutellariae Flos Lonicerae
Get Eudragit E50g in beaker, the ethanol water 1000ml dissolving of adding 75%, get SHUANGHUANLIAN extract dried powder 50g and in another beaker, add 75% ethanol water 1000ml dissolving, extract solution is slowly joined in the Eudragit E solution, mixing, extract and Eudragit E ratio are 1:1 in the mixed solution that obtains, and Eudragit E concentration is 2.5%, spray drying.The dry gas inlet temperature is 75 ℃, and dry gas air intake air quantity is 35m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 10ml/min, the coolant circulation pump temperature is 5 ℃.Add aspartame 0.1g again in the microsphere that obtains, menthol 0.5g is evenly mixed, granulates, and obtains the SHUANGHUANLIAN taste masked particle.
Above-mentioned granule does not have bitterness substantially in mouth, refrigerant mouthfeel is arranged.
Embodiment 2, liyan jiedu granule
Prescription is formed: Radix Isatidis Fructus Forsythiae Flos Lonicerae Fructus Arctii Folium Isatidis Herba Menthae Radix Platycodonis etc.
Get ethyl cellulose (EC) 50g in beaker, add dehydrated alcohol aqueous solution 1000ml dissolving, get prescription water extract dried powder 40g (particle diameter is less than 100 μ m) and in another beaker, add dehydrated alcohol aqueous solution 1000ml dissolving, the extract mixture suspension is slowly joined in the EC solution, mixing, extract and EC ratio are 1:1.25 in the mixed solution that obtains, and EC concentration is 2.5%, spray drying.The dry gas inlet temperature is 70 ℃, and dry gas air intake air quantity is 40m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 10ml/min, the coolant circulation pump temperature is 5 ℃.Add Rhizoma Curculiginis sweet protein 0.01g again in the microsphere that obtains, add the volatile oil component of prescription extract, 3% PVP aqueous solution is an amount of granulates promptly.
Above-mentioned granule is contained in does not have bitterness substantially in the mouth, the salubrious abnormal smells from the patient of Herba Menthae is arranged.
Embodiment 3, xiao'er ganmao granules
Prescription is formed: Herba Pogostemonis Fructus Forsythiae Flos Chrysanthemi Folium Isatidis Radix Isatidis Radix Rehmanniae etc.
Get Eudragit E 50g in beaker, add dehydrated alcohol aqueous solution 800ml dissolving, get xiao'er ganmao granules prescription water extract dried powder 58g (particle diameter is less than 100 μ m) and in another beaker, add dehydrated alcohol aqueous solution 1000ml dissolving, the extract mixture suspension is slowly joined in the Eudragit E solution, mixing, extract and Eudragit E ratio are 1:0.86 in the mixed solution that obtains, and Eudragit E concentration is 2.8%, spray drying.The dry gas inlet temperature is 70 ℃, and dry gas air intake air quantity is 40m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 10ml/min, the coolant circulation pump temperature is 5 ℃.In the microsphere that obtains, add stevioside 0.1g again, dextrin 10g, 1.5% PVP aqueous solution is an amount of, and the granulation of Radix Isatidis medicinal powder, drying, the volatile oil component mixing of adding prescription extract, promptly.
Above-mentioned granule is contained in does not have bitterness substantially in the mouth.
Embodiment 4, drench granule clearly
Prescription is formed: Herba Dianthi Herba Polygoni Avicularis Caulis Akebiae Semen Plantaginis gardenia-rhubarb etc.
Get gelatin 50g in beaker, add hot water (70 ℃) 1800ml dissolving, get and drench granule prescription water extract dried powder (particle diameter is less than 100 μ m) 58g clearly and in another beaker, adds hot water 1000ml and dissolve, slowly join the extract mixture suspension in the gelatin solution, mixing, extract and gelatin ratio are 1:0.86 in the mixed solution that obtains, and gelatin concentration is 1.8%, spray drying.The dry gas inlet temperature is 150 ℃, and dry gas air intake air quantity is 40m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 10ml/min.In the microsphere that obtains, add saccharin sodium 0.01g again, monosodium glutamate 0.01g, 1% PVP aqueous solution is an amount of granulates promptly
Above-mentioned granule is contained in does not have bitterness substantially in the mouth, do not have bad abnormal smells from the patient.
Embodiment 5: the flu relaxation grain
Prescription is formed: Folium Isatidis Fructus Forsythiae Herba Schizonepetae etc.
Get Eudragit L 45g in beaker, add 75% ethanol 500ml dissolving, (1g crude drug/ml) add 50% ethanol 500ml dissolving in another beaker slowly adds dehydrated alcohol again to get flu relaxation grain prescription water extract-alcohol precipitation extractum 30g, make and contain alcohol amount and reach 75%, mixing.The extract mixture suspension is slowly joined in the Eudragit L solution, mixing, extract and Eudragit L ratio are 1:1.5 in the mixed solution that obtains, Eudragit L concentration is 3.0%, spray drying.The dry gas inlet temperature is 100 ℃, and dry gas air intake air quantity is 40m
3/ h, spray gas pressure are 0.35m
3/ h, sample introduction speed is 12ml/min.Add cyclamate 0.01g again in the microsphere that obtains, add the volatile oil component of prescription extract, 1% PVP aqueous solution is an amount of granulates promptly
Above-mentioned granule is contained in does not have bitterness substantially in the mouth, the volatile oil abnormal smells from the patient is arranged.
Embodiment 6: the precious granule of woman
Prescription is formed: Radix Rehmanniae Caulis Lonicerae Radix Dipsaci Fructus Toosendan Radix Paeoniae Alba Rhizoma Corydalis Caulis Sargentodoxae etc.
Get ethyl cellulose (EC) 50g in beaker, add dehydrated alcohol aqueous solution 800ml dissolving, get the precious granule prescription water extract dried powder 55g of woman (particle diameter is less than 100 μ m) and in another beaker, add dehydrated alcohol aqueous solution 1000ml dissolving, the extract mixture suspension is slowly joined in the EC solution, mixing, extract and EC ratio are 1:0.9 in the mixed solution that obtains, and EC concentration is 2.8%, spray drying.The dry gas inlet temperature is 70 ℃, and dry gas air intake air quantity is 40m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 10ml/min, the coolant circulation pump temperature is 5 ℃.Add aspartame 0.01g again in the microsphere that obtains, 3% PVP aqueous solution is an amount of granulates promptly.
Above-mentioned granule is contained in does not have bitterness substantially in the mouth, do not have bad abnormal smells from the patient.
Embodiment 7: GANMAO TUIRE KELI
Prescription is formed: Folium Isatidis Radix Isatidis Fructus Forsythiae etc.
Get gelatin 35g, carbomer 14g is in same beaker, add hot water (70 ℃) 1000ml dissolving, get GANMAO TUIRE KELI prescription water extract-alcohol precipitation supernatant gained clear paste 300ml (being equivalent to dry extract 38.5g) and in another beaker, add hot water, the extract mixture suspension is slowly joined in the mictocystis material solution mixing to 1000ml, extract and EC ratio are 1:0.9 in the mixed solution that obtains, mictocystis material concentration is 2.5%, is incubated at 60 ℃ spray drying.The dry gas inlet temperature is 150 ℃, and dry gas air intake air quantity is 45m
3/ h, spray gas pressure are 0.40m
3/ h, sample introduction speed is 8ml/min.Add cyclamate 0.02g again in the microsphere that obtains, pure water is an amount of granulates promptly.
Above-mentioned granule is contained in does not have bitterness substantially in the mouth, do not have bad abnormal smells from the patient.
Claims (9)
1. a method of improving the Chinese medicine compound bitterness is characterized in that this method comprises the following steps:
1) methacrylic acid-dimethylamino ethyl ester is dissolved in the solvent preparation encystation material solution;
2), be made into compound extract solution or suspension with Chinese medicine compound extract dissolving or be suspended in the solvent identical with step 1);
3) with the ratio of the weight ratio 1:0.6-2 of extract and capsule material, extract solution slowly is added in the capsule material solution, mixing, the percent weight in volume concentration that makes capsule material in the mixed solution is 0.5%～10%, spray drying obtains particle diameter at 1～100 μ m microcapsule or microsphere;
4) above-mentioned microcapsule or microsphere are added preparation total amount 0.001%～10% correctives, other do not have in the drug component and pharmaceutic adjuvant of abnormal flavour, make various oral formulations according to a conventional method.
2. the method for improving the Chinese medicine compound bitterness according to claim 1 is characterized in that the solvent of pocket material and Chinese medicine extract in this method is selected from the ethanol water of water, dehydrated alcohol and various concentration.
3. the method for improving the Chinese medicine compound bitterness according to claim 1, the bulking value concentration of the capsule material solution that it is characterized in that wherein being made into is 1%～10%.
4. the method for improving the Chinese medicine compound bitterness according to claim 3, the bulking value concentration of the capsule material solution that it is characterized in that wherein being made into is 4～10%.
5. the method for improving the Chinese medicine compound bitterness according to claim 1, the Chinese medicine compound extract solution that it is characterized in that wherein being made into or the bulking value concentration of suspension are 0.25%～10%.
6. the method for improving the Chinese medicine compound bitterness according to claim 5, the Chinese medicine compound extract solution that it is characterized in that wherein being made into or the bulking value concentration of suspension are 2～6%.
7. the method for improving the Chinese medicine compound bitterness according to claim 1 is characterized in that the bulking value concentration of capsule material in the mixed solution that step 3) makes is 1～4%.
8. the method for improving the Chinese medicine compound bitterness according to claim 1 is characterized in that wherein the consumption of correctives is 0.01～1% of a preparation total amount.
9. the method for improving the Chinese medicine compound bitterness according to claim 1 is characterized in that wherein said correctives is sweeting agent, aromatic or bitter tasting retarding agent.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006100264749A CN100462083C (en) | 2006-05-12 | 2006-05-12 | Method for relieving bitter taste in compound Chinese medicine |
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| CNB2006100264749A CN100462083C (en) | 2006-05-12 | 2006-05-12 | Method for relieving bitter taste in compound Chinese medicine |
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| CN1965866A CN1965866A (en) | 2007-05-23 |
| CN100462083C true CN100462083C (en) | 2009-02-18 |
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| CNB2006100264749A Expired - Fee Related CN100462083C (en) | 2006-05-12 | 2006-05-12 | Method for relieving bitter taste in compound Chinese medicine |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104840967A (en) * | 2015-05-13 | 2015-08-19 | 上海中医药大学 | Taste correction method for oral liquid preparation of traditional Chinese medicine containing ethyl alcohol |
| CN108940147B (en) * | 2018-08-22 | 2021-01-01 | 南京林业大学 | Polyethylene glycol/cellulose triacetate phase change microcapsule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1055484A (en) * | 1990-04-09 | 1991-10-23 | 沈阳药学院 | The drying process with atomizing of preparation tasteless micro capsule for medicine |
| CN1695689A (en) * | 2005-05-13 | 2005-11-16 | 天津大学 | New type quick oral disintegration tablet of Subing and preparation method |
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2006
- 2006-05-12 CN CNB2006100264749A patent/CN100462083C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1055484A (en) * | 1990-04-09 | 1991-10-23 | 沈阳药学院 | The drying process with atomizing of preparation tasteless micro capsule for medicine |
| CN1695689A (en) * | 2005-05-13 | 2005-11-16 | 天津大学 | New type quick oral disintegration tablet of Subing and preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 《银杏提取物掩味方法筛选及口腔崩解片制备》. 冯丽莉，胡杰，黄华，崔福德.沈阳药科大学学报，第22卷第6期. 2005 |
| 《银杏提取物掩味方法筛选及口腔崩解片制备》. 冯丽莉，胡杰，黄华，崔福德.沈阳药科大学学报，第22卷第6期. 2005 * |
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