CN100512841C - Medication for treating bronchitis - Google Patents
Medication for treating bronchitis Download PDFInfo
- Publication number
- CN100512841C CN100512841C CNB2003101072969A CN200310107296A CN100512841C CN 100512841 C CN100512841 C CN 100512841C CN B2003101072969 A CNB2003101072969 A CN B2003101072969A CN 200310107296 A CN200310107296 A CN 200310107296A CN 100512841 C CN100512841 C CN 100512841C
- Authority
- CN
- China
- Prior art keywords
- adjuvant
- drop pill
- xylitol
- medicine
- starch
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A medicine for treating bronchitis is disclosed. Its advantages are high safety and lower toxic by-effect.
Description
Technical field
The present invention relates to field of medicaments, particularly, relating to Chinese medicine is the bronchitic pharmaceutical preparation of treatment that raw material is made.
Background technology
Bronchitis is a common clinical, frequently-occurring disease, and clinical serves as main performance with cough, expectoration, dyspnea with rapid and short breath, can be divided into two kinds of acute bronchitis, chronic bronchitiss according to its course of disease length, is the commonly encountered diseases of respiratory system.And chronic bronchitis is called for short chronic bronchitis, be meant the chronic non-specially property inflammation of trachea, bronchial mucosa and surrounding tissue, clinically with cough, expectoration or with panting and the chronic process of outbreak repeatedly is a feature, heal because of the chronic bronchitis delay is difficult, easily cause emphysema, pulmonary heart disease, so chronic bronchitis is bigger than the hazardness of acute bronchitis, it is more difficult to treat.
At present mostly the Western medicine medicine that is used for the treatment of the chronic bronchial pharynx is symptomatic treatment, and side effect is bigger, as Fa Site: can occur one after taking medicine and cross property mouth, pharyngeal numb sensation, untoward reaction such as weak, dizzy, epigastric discomfort and erythra are still arranged in addition; Terbutaline: small number of patients can have the side effect such as tremble of drowsiness, cardiopalmus, headache, xerostomia, finger, the careful usefulness of hypertension, coronary heart disease, hyperthyroidism, diabetes and anemia of pregnant woman; Yi Tanning: hypertension, coronary heart disease, hyperthyroidism, the careful usefulness of diabetes, share with sympathomimetic and can increase the weight of side effect; As seen Slow-release Theopylline feels sick or slight gastrointestinal upset, and theophylline class allergy sufferers is forbidden; Maxivent, Meptin, diprophylline, clorprenaline hydrochloride, bricasol, breathe heavily happy peaceful, Meptin, Maxivent, terbutaline atomized soln etc. in various degree side effect is also all arranged.
The treatment by Chinese herbs chronic bronchitis mostly is decoction, syrup, pill etc., and onset is slow, and uncertain therapeutic efficacy is fixed, and it is bigger that curative effect is influenced by extraneous factor.The synthetic chemical substance that modern medicine is commonly used has spreaded all over each corner of human lives, chemical synthetic drug becomes the main flow of medicine, yet, appearance along with multiple difficult serious symptom miscellaneous diseases, western medical treatment presents imperfect, the human lives and the healthy reality and the up-to-date successes achieved in research have all proposed query to this situation, particularly along with the continuous appearance of chemical drugs toxic and side effects, the change of spectrum of disease and conversion of medical, make modern medicine be subjected to unprecedented challenge, and people also place hope in the application and development of traditional medicine on gradually.Advocate back to nature, pay attention to plant amedica use, hanker after traditional remedies, the trend of advocating natural drug forms, making full use of natural materials is human best selections.
At present, in the world, natural drug all has certain market, along with people increasing and the aging of population to the health requirements level of understanding, sub-health stateization, people thirst for back to nature more, the problem of utilize the high Drug therapy of pure natural degree, preventing some chemical synthetic drugs cann't be solved, so the background that exceeds its original traditional national culture has been expanded in the application of natural plant.From natural drug, seek the little and inexpensive medicine of side effect and become the target that countries in the world pharmaceutical manufacturer is chased.The European Community has carried out unified legislation to medical herbs, state medical herbs status such as Canada and Australia have legalized, U.S. government has also drafted the plant amedica management method, the compound recipe mix preparation that begins to accept natural drug is as curative, and these provide good international environment for Chinese medicine enters international medical market as curative.On the other hand, along with the quickening of global economic integration progress, particularly China becomes a full member of WTO, and Chinese Medicine market incorporates the breadth and depth of international medical big market and will further aggravate.Face the enormous impact of Asian countries's traditional medicine product such as the keen competition of powerful transnational medical group and Japan, Korea S, India, Thailand and European countries' plant amedica such as Germany, France, numerous products that China's Chinese medicine produces are owing to still can not meet the standard of international medical market and requirement and being kept outside of the door.
Expansion and human back to nature requirement along with the market global range, use the low medicine of toxic and side effects, especially pure natural medical more and more becomes people's first-selection, dropping pill formulation be a kind of have efficient, quick-acting new medicine preparations, it has overcome the shortcoming and deficiency of Chinese medicine preparation in the past, but present dropping pill formulation generally faces following problem: 1, drop pill adjuvant pure natural degree is not high: at present, drop pill substrate adjuvant mostly is synthetic, natural degree is lower, the searching of new alternative substrate adjuvant, the searching of the alternative substrate adjuvant that particularly natural degree is high and preparation technology thereof determine, it is again very difficult thing, because the required preparation condition of at present common possible natural substrates adjuvant succedaneum is very harsh, it all is to influence the key that drop pill prepares molding that adjuvant temperature and drop pill thereof drip the system condition.The too high then viscosity of adjuvant melt temperature is low, and poor plasticity is though the adjuvant melt temperature is crossed lowplastcity by force, but drop pill has shortcomings such as easily sticking ball, distortion, therefore, seek pure natural degree height, and the adjuvant that is suitable for substituting existing drop pill substrate is a very job of hardships.2, the drop pill outlet encounters problems: along with expanding economy, more and more internationalize in market, China is also just making great efforts to adapt to this trend, present Chinese medicine dripping pills preparation as health food, successful export to many countries, but also face many problems at present, because different countries is different to the approval of the selected adjuvant of Chinese medicine dropping pill formulation, especially industrial flourishing Europe, more strict to food adjuvant and medical auxiliary materials, and as the selected chemosynthesis adjuvant (as Polyethylene Glycol) of the dropping pill formulation of health food outlet not in the catalogue of some national food additive, it is very unfavorable that this moves towards the international market to the Chinese medicine dropping pill formulation, becomes the stumbling-block that Chinese medicine enters the international market, therefore, seek the new of one or more, can be particularly important, also very urgent for the substrate adjuvant that the international market is accepted.3, the shortcoming of mouthfeel and onset speed: the mouthfeel of Chinese medicine and preparation thereof is relatively poor to be the big characteristics of one, people when taking some drugs to the frightened of disagreeable taste that medicine had even be better than fear far away to disease, What is more, some patients are because can not overcome the poor taste of Chinese medicine or its preparation or abnormal smells from the patient and abandon the treatment of Chinese medicine, though can improve mouthfeel as medicine being made capsule or sugar coated tablet, reducing stimulates, but disintegration rate prolongs, be unfavorable for the rapid onset of medicine, to some disease, particularly need the disease of the rapid onset of medicine inapplicable.4, the preparation process difficulty of drop pill suitability for industrialized production: in the replacement process of dropping pill formulation adjuvant, determining of the preparation process of its suitability for industrialized production is very difficult something, as the ratio of the melt temperature of substrate adjuvant, the proportioning of dripping system temperature, adjuvant and medicine, dropper bore, condensing agent etc. all are the factors that influence drop pill, therefore, the replacement of substrate and to be suitable for suitability for industrialized production be a job consuming time, as to expend substantial contribution.
In order to change drop pill substrate adjuvant for a long time based on the situation of chemosynthesis adjuvant, it is low to solve the pure natural degree that present drop pill substrate faced, and can not satisfy more and more that people require back to nature, take low toxicity, the problem of the pure natural medical that has no side effect; Also can solve some problems that Chinese medicine preparation, particularly dropping pill formulation are run in exit procedure, strengthen the competitiveness of international market; The present invention has invented the pure Chinese medicine dripping pills preparation that a kind of toxic and side effects is low, evident in efficacy, moderate, adapt to industrialized great production by a large amount of tests and the research of preparation process.
Summary of the invention
The purpose of this invention is to provide a kind of bronchitic medicine of treatment with the preparation of new type natural substrate adjuvant.
Another object of the present invention provides a kind of preparation method for the treatment of bronchitis pharmaceutical preparation.
The selected substrate adjuvant of the present invention is resulting by a large amount of tests, it is little to have molecular weight, soluble in water, and molten diffusing speed is faster, pure natural degree height, toxic and side effects is lower, and can reduce the medicine irritation abnormal smells from the patient, has the oral cavity of improvement acid-base value during the buccal of oral cavity, improve the characteristics of oral cavity smell, the used substrate adjuvant of the present invention is the agent of food sedan-chair flavor, takes that mouthfeel is good, the acceptant characteristics of patient, is the direction of following substrate adjuvant development.
The consumption of drug component of the present invention and the selection of adjuvant thereof also grope to sum up to draw through the inventor in a large number, each component raw material survival dose all has curative effect preferably in following ranges: Radix Physochlainae paste: adjuvant is the preparation that 0.01:1～1:1 makes, wherein adjuvant comprises filler and plasticity substrate, said filler is selected from the natural adjuvant of following one or more plant origins: erythritol, sorbitol, fructose, D-ribonic acid-gamma lactone, arabitol, trehalose, D-ribose, low melting-point agarose, Lac, xylitol, Raffinose, glucose, malic acid, citric acid, isomalt, lactose, maltose etc., and they contain the water of crystallization chemical compound; Said plasticity substrate is selected from the natural adjuvant of following one or more plant origins: starch and derivant thereof, cellulose and derivant thereof, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, dextrin, cyclodextrin, agar, lactose; Described starch and derivant thereof such as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch, described cellulose and derivant thereof such as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose; The consumption and the adjuvant thereof of preferred drug component of the present invention are Radix Physochlainae paste: adjuvant is the preparation that 0.1:1 :～0.6:1 makes, filler adjuvant wherein is selected from following one or more the natural adjuvant of plant origin: sorbitol, xylitol, lactose, maltose, and they contain the water of crystallization chemical compound; Plasticity substrate wherein is selected from following one or more the natural adjuvant of plant origin: pregelatinized Starch, carboxymethyl starch, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, arabic gum, alginic acid, dextrin, cyclodextrin, agar, lactose; The consumption and the adjuvant thereof of best drug component of the present invention are Radix Physochlainae paste: adjuvant is the preparation that 0.2:1～0.4:1 makes, and filler adjuvant wherein is selected from following one or more the natural adjuvant of plant origin: xylitol, lactose; Plasticity substrate wherein is selected from following one or more the natural adjuvant of plant origin: starch, arabic gum.
Can also contain chemosynthesis adjuvant and animal origin adjuvant in the above-mentioned dressing, wherein filler comprises phenylglycol, hexadecanol, octadecanol, sodium stearate, tristerin, tripalmitin, carbamide, polyoxyethylene monostearate, polyoxyethylene alkyl ether; Wherein plasticity substrate comprises polyvinylpyrrolidone, crospolyvinylpyrrolidone, carbomer, polyvinyl alcohol, acrylic resin, poloxamer, gelatin.
In screening to above adjuvant, we find: plant colloid such as carrageenan, the tragakanta, pectin, agar, arabic gum, Ficus elastica, tamarind gum, locust bean gum, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, guar gum, Konjac glucomannan, it is big that plant colloids such as POLY-karaya have viscosity, mobile poor, characteristics such as do not solidify after the condensation, and arabic gum has high dense low sticking character, can be mixed with the aqueous solution of 50% concentration and still have flowability, this is one of not available characteristics of other hydrophilic colloid, arabic gum has at high temperature, under the low concentration, can ooze, but not condensation, at low temperature, under the high concentration, be difficult for oozing, but characteristics such as energy condensation.Polysaccharide such as polysaccharide such as starch and derivant thereof (as gelling starch, carboxymethyl starch etc.), cellulose derivative (as methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose etc.), alginic acid, dextrin, cyclodextrin, lactose, in screening, find alginic acid have viscosity big, be the fruit jelly sample, dextrin has the colloid sample, characteristics such as lactose coagulability difference; And starch and derivant thereof are materials commonly used in the medical science adjuvant, thus in polysaccharide preferred starch and derivant thereof.Polyhydric alcohol such as sorbitol (88～102 ℃), xylitol (88～94.5 ℃), lactose (70～80 ℃), mannitol (166～169 ℃), maltose alcohol (135～140 ℃), isomalt polyhydric alcohol such as (98～103 ℃) screen, and find that it has following characteristics as drop pill substrate: sorbitol, lactose, isomalt are mobile poor; Mannitol, maltose alcohol fusing point are too high; The xylitol coagulability is poor slightly.After Preliminary screening, preferred xylitol, lactose, sorbitol in the selection of polyhydric alcohol, the best is an xylitol.Xylitol has following characteristics as drop pill substrate: in the time of 91 ℃, molten condition has appearred in xylitol, but not fusion fully, cooling rapidly, it separates out crystallization very soon, xylitol mixes the back good fluidity with extractum at certain proportion, can drip and can condensation, but be condensed into Powdered thing, loosely organized, the toughness extreme difference, that pinches is promptly broken.Organic acid and salt, alkali such as citric acid (100 ℃), sorbic acid (133 ℃), succinic acid (181～189 ℃), sodium acetate organic acid such as (58 ℃) and salt, alkali, its as drop pill substrate have fusing point too high, with Chinese medical concrete can't mixing etc. shortcoming.
Because of above single adjuvant existing shortcoming in as the drop pill preparation process, particularly we by above-mentioned Preliminary screening after, determine two kinds of adjuvants are used and screen: mainly be that above various adjuvants are carried out combined sorting, final determine following several: the plant colloid cooperates with the plant colloid, the cooperating of polyhydric alcohol and polyhydric alcohol, polyhydric alcohol and plant colloidally cooperate, the cooperating of the cooperating of xylitol and arabic gum, lactose and arabic gum, based on the composite auxiliary material of xylitol.Find preferred the cooperation to be xylitol, lactose and the compound use of other adjuvant, this kind combination has following characteristics: make up with mannitol: can drip not condensation; Make up with sorbic acid: both do not dissolve each other; Make up with lactose: can drip the energy condensation, but frangible; Make up with pomelo-pectin, tragakanta, sodium alginate: viscosity is big, can't drip; Make up with arabic gum: can drip, coagulability is poor slightly; Make up with dextrin: can drip, coagulability is poor slightly; Make up with starch: can drip, coagulability is also better.Determine that at last best of breed is that xylitol cooperates with arabic gum with starch, xylitol with starch, lactose.
At xylitol and starch, lactose and starch, in the research of xylitol and arabic gum combination, xylitol and starch Application of composite being prepared some required in the process of drop pill factors investigated, mainly is to the xylitol type, condensed fluid, condensate temperature influences the drop pill mouldability, xylitol and starch proportion influence mouldability, temperature is to the influence of drop pill mouldability, the extractum amount influences the drop pill mouldability, mixing time influences the drop pill mouldability, the dropper bore is to the influence of drop pill particle diameter, the formulation optimization of drop pill, the Preliminary Determination of drop pill, dissolve scattered time limit is investigated.Find that the solid xylitol has three types of powder, granular and crystallinity, and the easiest fusion of powder xylitol, again can fine dissolving be dispersed in the mixed liquor that starch, extractum forms, good fluidity, drippage is easy, and granular and crystalline xyhose alcohol is difficult for fusion, solubility property is also slightly poor, the mix flow that they and starch, extractum form is relatively poor, viscosity is very big, almost cannot drip, and therefore drips first-selected powder xylitol in the system process at drop pill.
At ratio of adjuvant molding is found in the sex research, in the combination of xylitol and starch, lactose and starch, xylitol and arabic gum, low melting point substrate adjuvant is 1:0～1:1.5 with the ratio of the weight of plasticity substrate adjuvant, be preferably 1:0.1～1:0.9, the best is 1:0.1～1:0.5.Low melting point substrate adjuvant of being formed within this scope and plasticity substrate adjuvant, the drug matrices fused solution all can ooze, and can condensation.Specific to each combination, xylitol is preferably 1:0.2～1:0.3 with the ratio of the weight of starch, and lactose is preferably 1:0.2～1:0.3 with the ratio of the weight of starch, and the ratio of the weight of xylitol and arabic gum is preferably 1:0.2～1:0.4.Find that in the research of temperature temperature is big especially to the influence of drop pill mouldability to the influence of drop pill mouldability, when temperature is too low, owing to the too big effect that oozes that influences drop pill of viscosity of substrate, when temperature is too high, not condensation of drop pill.Find that mixing time can have influence on the mouldability of drop pill in mixing time in to the sex research of drop pill molding, mixing time is too short, and mobile poor, influence oozes, and mixing time is oversize, influences the condensation of drop pill.Dripping under the system temperature, mixing time in 1～120 minute all can, suitable mixing time was at 10～30 minutes.Consider that mixing time can not be too short in the suitability for industrialized production, adopt the method that low temperature stirs for a long time, high temperature drips system.Find that in the research of dropper bore to the influence of drop pill particle diameter the dropper bore influences the size of drop pill and the flowability of fusion substrate, the system effect is dripped in influence.Drop pill diminishes and diminishes along with bore, but after 1.4 millimeters, along with the bore change of size that diminishes is not obvious, but the matrix flow reduction, system is dripped in influence.
So in the preparation method of preparation, medicine mixes mixing time with the substrate adjuvant be 10～30 minutes; The mixed heating and melting temperature of medicine and substrate adjuvant is 45～115 ℃, dripping the system temperature is 45～95 ℃, and liquid coolant is liquid paraffin, methyl-silicone oil or vegetable oil (Oleum Glycines, Semen Ricini wet goods), and the temperature of liquid coolant is-20～25 ℃, dropper mouth internal diameter is 1.0～4.0 millimeters; Preferred heating and melting temperature is 60～85 ℃, and dripping a system temperature is 60～85 ℃, and condensing agent is liquid paraffin, methyl-silicone oil, and the condensing agent temperature is 0～18 ℃, and the dropper bore is 1.1～3.5 millimeters, and the difference of dropper mouth external diameter and internal diameter is less for well; Best heating and melting temperature is that to make temperature be that 64 ℃, dropper bore are that 1.2～2.5 millimeters, condensing agent are 0 ℃ methyl-silicone oil to 64 ℃, droplet.
The substrate adjuvant of the best of the present invention is xylitol and starch, and xylitol is 1:0.2～1:0.3 with the ratio of the weight of starch; Or be lactose and starch, lactose is 1:0.2～1:0.3 with the ratio of the weight of starch; Or be xylitol and arabic gum, the ratio of the weight of xylitol and arabic gum is 1:0.2～1:0.4.
Xylitol is a kind of natural plant sweetening agent, approve through World Health Organization (WHO), xylitol is a kind of safest sweeting agent, countries in the world are extensive use of in fields such as food and oral-cavity articles, xylitol enters the help that need not insulin in the cell, when sugar utilizes obstacle, can not cause blood sugar increasing yet, can improve diabetics symptom, have the ketoplastic effect of powerful inhibition, can promote the generation of liver glycogen, directly infiltrate the Developmental and Metabolic Disorder that tissue is participated in metabolism, can be corrected protein, fat and steroid; Xylose is the internal metabolism intermediate product, and body has higher toleration to it.Clinical practice proves: the highest oral dosis tolerata can reach 220g every day, and intravenous drip every day can reach 100g.The oral 25700mg/Kg of median lethal dose(LD 50) (LD50) mice, quiet notes 6400mg/Kg, the quiet notes of rat 6200mg/Kg.
Medicine mesostroma adjuvant of the present invention and amount of drug are than can being the scope that allows on the galenic pharmacy, medicine described here can be that crude drug also can be the effective ingredient extract, in order to adapt to industrialized great production, the ratio range of mesostroma adjuvant of the present invention and medicine refers to the weight proportion of adjuvant and extract drugs extractum, and the substrate adjuvant is 1:0.1～1:1 with the ratio of the weight of drug extract; Preferred substrate adjuvant is 1:0.1～1:0.6 with the ratio of the weight of extract drugs extractum; Best substrate adjuvant is 1:0.2～1:0.4 with the ratio of the extraction extractum weight of medicine.
Medicine of the present invention can adopt the preparation of Chinese medicine preparation conventional method.The preparation of effective ingredient of the present invention can be adopted following method: water extraction, decoction and alcohol sedimentation technique, extraction, infusion process, percolation, reflux extraction, continuous backflow extraction method, macroreticular resin absorbing method preparation.For example, these crude drug pulverize mix homogeneously can be made powder takes after mixing it with water; Also can be with these medicines decocting together, the condensed water decocting liquid is made oral liquid then; But, preferably adopt following technology to extract, but this can not limit protection scope of the present invention to raw material in order to make each crude drug of this medicine better bring into play drug effect.
The preparation method of medicine of the present invention is as follows:
(a): get Radix Physochlainae paste: adjuvant is that 0.01:1～1:1 is standby;
(b): in appropriate amount of auxiliary materials, add Radix Physochlainae extractum, fully mix, mixture is at 45～115 ℃ of heating and meltings, stir, mixing time is 1～120 minute, and insulation is 1.0～4.0 millimeters at 45～95 ℃ of temperature following system, dropper bore and splashes in-20～25 ℃ liquid paraffin, methyl-silicone oil or the vegetable oil, make drop pill, promptly.
Preferred manufacturing procedure comprises the following steps:
(a): get Radix Physochlainae paste: adjuvant is 0.1:1 :～0.6:1 is standby;
(b): in appropriate amount of auxiliary materials, add above-mentioned Radix Physochlainae extractum, fully mix, mixture stirs at 60～85 ℃ of heating and meltings, and mixing time is 10～30 minutes, insulation, be 1.1～3.5 millimeters at 60～85 ℃ of temperature following system, dropper bore and splash in 0～18 ℃ the liquid paraffin, methyl-silicone oil, to the greatest extent and wipe liquid coolant, back packing to be dried the drop pill drop that forms, make drop pill, promptly.
Best preparation method comprises the following steps:
(a): get Radix Physochlainae paste: adjuvant is that 0.2:1～0.4:1 is standby;
(b): in appropriate amount of auxiliary materials, add above-mentioned Radix Physochlainae extractum and fully mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, to the greatest extent and wipe liquid coolant, back packing to be dried the drop pill drop that forms, make drop pill, promptly.
The best preparation method of medicine of the present invention is:
(a): get Radix Physochlainae paste: adjuvant is that 0.2:1～0.4:1 is standby;
(b): the ratio to an amount of weight is xylitol and the starch mixture of 1:0.2～1:0.3; Or be lactose and the starch mixture of 1:0.2～1:0.3 for the ratio of weight; Or for the ratio of weight be to add above-mentioned Radix Physochlainae extractum in the xylitol of 1:0.2～1:0.4 and the arabic gum mixture fully to mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, to the greatest extent and wipe liquid coolant, back packing to be dried the drop pill drop that forms, make drop pill, promptly.
More than form when producing and to increase or to reduce according to corresponding ratio, as large-scale production can be unit with kilogram or with the ton, small-scale production can be unit with the gram also, and weight can increase or reduce, but the crude drug material weight proportion constant rate between each composition.
Medicine of the present invention can be determined usage and dosage according to patient's situation in use, but every day 1-3 times, and every day, each crude drug consumption was as the criterion with the state-promulgated pharmacopoeia dosage, was no more than the pharmacopeia ormal weight.
The drop pill that the present invention is prepared, conventional drop pill advantage is simple as preparing except having, steady quality, can make liquid medicine solidification, convenient drug administration, efficient, quick-acting, its biggest advantage is:
1, the selected adjuvant pure natural of the present invention degree height: the substrate adjuvant that employed substrate adjuvant derives from natural plants or originates based on natural plants among the present invention, selected substrate adjuvant is xylitol and starch or lactose and starch or xylitol and arabic gum, this substrate adjuvant has pure natural degree height, toxic and side effects is low, mouthfeel is good, dissolve scattered time limit is short, rapid-action, it is a kind of new medium adjuvant, can be used for substituting present chemosynthesis adjuvant, the drop pill made from this kind adjuvant, it is low to solve the pure natural degree that present drop pill substrate faced, and more and more can not satisfy people and require back to nature, take low toxicity, the problem of the pure natural medical that has no side effect.
2, some problems in the outlet of solution Chinese medicine: medicine of the present invention also can solve Chinese medicine preparation, some problems of in exit procedure, being run into of dropping pill formulation particularly, solve because different countries, especially the European countries of industry prosperity are to the difference identification of the selected adjuvant of Chinese medicine dropping pill formulation, overcome as the selected adjuvant Polyethylene Glycol of the dropping pill formulation of the health food outlet defective in some national food additive catalogue not, improve the Chinese medicine dripping pills preparation and move towards the international market, strengthen the competitiveness of international market.
3, solve the relatively poor problem of drop pill taste and further improve drug effect speed (dissolve scattered time limit): the medicinal dropping ball made from this kind substrate adjuvant of the present invention, can improve Chinese medicine preparation, the particularly present not good shortcoming of dropping pill formulation taste, improve mouthfeel, more easy for patients to accept, and the drop pill that adopts the selected adjuvant of medicine of the present invention to make has shorter dissolve scattered time limit, making drug effect faster, is that bronchitic medicine is treated in a kind of onset faster.
4, higher safety and solve some problems in the drop pill storage process: the selected substrate of the present invention is not only additive, nutrient commonly used in the food industry, and can do medicinal, but do not see that it uses as the drug matrices adjuvant, therefore, with regard to substrate, be perfectly safe, have no side effect, a large amount of evidences, the drop pill made from this adjuvant can reduce effective ingredient separating out in storage process, the sticking ball of drop pill, easy shortcomings such as moisture absorption deliquescing, but the big production of suitability for industrialized.
The present invention is under instruction of Chinese Medicine theory, preparation technology's test that process is a large amount of and pharmacology, the resulting preparation of pharmacodynamics test.The present invention is evident in efficacy, and the effect of have Dingchuan, cough-relieving, eliminating the phlegm is used for the treatment of chronic bronchitis, asthmatic bronchitis clinically.Poisonous side effect of medicine of the present invention is low, it is bigger to have overcome western medicine chronic bronchitis toxic and side effects, the Chinese medicine curative effect is low, flavour of a drug are many, the shortcoming of incompatibility large-scale production, in addition, the food adjuvant that this substrate adjuvant is a kind of excellent taste, can reduce the penetrating odor of medicine, improve the medicine mouthfeel, be the medicine of the treatment chronic bronchitis determined of a kind of economy, material benefit, curative effect.
In order to understand the present invention better, drip test explanation advantages of the present invention such as, drop pill soft durometer different, the sticking ball of drop pill below with new substrate Radix Physochlainae with dissolve scattered time limit, the ball method of double differences of the Radix Physochlainae drop pill made for the substrate adjuvant with the Polyethylene Glycol.
Test example 1: dissolve scattered time limit, the different contrast experiment's example of the ball method of double differences
In vitro tests
The present invention be that the Radix Physochlainae drop pill that adjuvant is made compares with the Polyethylene Glycol, by measuring dissolve scattered time limit, investigate its good releasing effect; By measuring indexs such as the ball method of double differences is different, investigate whether it ripe in preparation technology, whether be fit to suitability for industrialized production.
1. test medication: the new substrate Radix Physochlainae of the present invention drop pill (newly) is the Radix Physochlainae drop pill (old) that adjuvant is made with the Polyethylene Glycol.
2. method and result:
Dissolve scattered time limit: by " method is measured under this item of Chinese pharmacopoeia; The ball method of double differences is different: by " method is measured under this item of Chinese pharmacopoeia.Result of the test sees Table 1.
The Radix Physochlainae drop pill (newly) that three batches in table 1 is made with the new medium adjuvant with the polyethylene glycol 6000 be Radix Physochlainae drop pill (old) dissolve scattered time limit made of adjuvant, weight differential relatively
Result of the test shows, the dissolve scattered time limit of new substrate Radix Physochlainae drop pill is lacking of the Radix Physochlainae drop pill made of adjuvant with the Polyethylene Glycol, and the ball method of double differences of the Radix Physochlainae drop pill that new and old substrate is made is different all to be controlled in the pharmacopeia prescribed limit.Presentation of results, the molten diffusing speed of the Radix Physochlainae drop pill made from novel adjuvant is faster, is more conducive to medicine and plays a role in the shortest time; The ball method of double differences is different all to be controlled in the pharmacopeia prescribed limit, and the alternative present chemosynthesis adjuvant of this natural substrates adjuvant is described, but suitability for industrialized production.
Test example 2: the present invention with the polyethylene glycol 6000 be the sticking ball comparative observation of Radix Physochlainae drop pill soft durometer, drop pill that adjuvant is made
The present invention be that the Radix Physochlainae drop pill that adjuvant is made compares with the Polyethylene Glycol, by measuring indexs such as above-mentioned, investigate its effect.
1. test medication: the new substrate Radix Physochlainae of the present invention drop pill (newly) is provided by the Jinshili Medicine Research ﹠. Development Co., Ltd., Tianjin; With the Polyethylene Glycol is the Radix Physochlainae drop pill (old) that adjuvant is made, commercially available.
2. method and result:
Get three batches of new, old substrate Radix Physochlainae drop pill, be loaded in the porcelain vase respectively, and use the bottle stopper good seal.Putting it into the bottom has in the exsiccator of saturated Nacl (humidity 75%) solution, exsiccator is put into 40 ℃ of drying baker of constant temperature again, and timing sampling is observed situations such as drop pill soft durometer, the sticking ball of drop pill, the results are shown in Table 2.1, table 2.2.
Three batches in table 2.1 is that the Radix Physochlainae drop pill reserved sample observing that adjuvant is made compares with the polyethylene glycol 6000
Table 2.2: the three batches of Radix Physochlainae drop pill made from the new medium adjuvant (newly) with the polyethylene glycol 6000 be Radix Physochlainae drop pill (old) character observation made of adjuvant relatively
Test data shows, the drop pill soft durometer of new substrate Radix Physochlainae drop pill changes and be that the Radix Physochlainae drop pill made of adjuvant is similar, strong slightly with the Polyethylene Glycol; The sticking ball variation of the drop pill of new substrate Radix Physochlainae drop pill, firmness change and be that the Radix Physochlainae drop pill made of adjuvant is similar with the Polyethylene Glycol.Presentation of results, the sticking ball of the Radix Physochlainae drop pill that new and old substrate adjuvant is made changes, firmness change is similar, and the alternative present chemosynthesis adjuvant of this natural substrates adjuvant is described, but suitability for industrialized production.
The specific embodiment
Embodiment 1:
(a): get Radix Physochlainae 25g, xylitol 5.2g, starch 1.3g is standby;
(b):. get Radix Physochlainae and decoct with water 3 times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate concentrates, and adds 2 times of amount 90% ethanol, left standstill 10 hours, filter, reclaim ethanol, filtrate is concentrated under 50 ℃ of conditions, relative density is 1.15～1.25 thick paste (1);
(c): 5.2g xylitol and 1.3g starch is fully mixed, stir, add thick paste (1), heating and melting, be incubated 80～95 ℃, select the dropper of suitable bore for use, drip system with the speed of 30～45 of per minutes, splash in the methyl-silicone oil, make 1000, after the shaping, ball is taken out, wipe away dried drop pill surface with absorbent paper, promptly.
Embodiment 2:
(a): get Radix Physochlainae 15g, xylitol 6g, arabic gum 1.8g is standby;
(b):. get Radix Physochlainae and decoct with water 2 times, collecting decoction filters, and filtrate concentrates, and adds 5 times of amount 85～95% ethanol, leaves standstill 5 hours, filter, recovery ethanol, filtrate is concentrated under 70～80 ℃ of conditions, relative density is 1.10～1.25 clear paste (1);
(c): get 6g xylitol and 1.8g starch, the two is fully mixed, adds thick paste (1), stir evenly, heating and melting is incubated 60～70 ℃, select the dropper of suitable bore for use, speed with 60～80 of per minutes is dripped system, splashes in the liquid paraffin, makes 1000 drop pill, after the shaping, ball is taken out, wipe away dried drop pill surface with absorbent paper, promptly.
Embodiment 3:
(a): get Radix Physochlainae 10g, lactose 15g, starch 2g is standby;
(b): get Radix Physochlainae and decoct with water 4 times, 4 hours for the first time, 3 hours, 2.5 hours for the third time, the 4th time 1.5 hours for the second time, collecting decoction, filter, filtrate concentrates, and adds 5 times of amount 85～90% ethanol, left standstill 12 hours, filter, reclaim ethanol, filtrate is concentrated under 40～50 ℃ of conditions, relative density is 1.05～1.15 thick paste (1);
(c): get the 15g lactose and 2g starch is fully mixed, add thick paste (1), stir, heating and melting, system is dripped in insulation, splashes in the methyl-silicone oil, makes 1000 drop pill, after the shaping, ball is taken out, and wipes away dried drop pill surface with absorbent paper, promptly.
Embodiment 4
(a): get Radix Physochlainae 35g, xylitol 14g, erythritol 1.3g, Furcellaran 2.5g are standby;
(b): get Radix Physochlainae and decoct with water 3 times, collecting decoction filters, and filtrate concentrates, and adds 3 times of amount 95% ethanol, leaves standstill 20 hours, filter, and recovery ethanol, filtrate is concentrated under 50～75 ℃ of conditions, relative density is 1.20～1.30 thick paste (1);
(c): get xylitol 14g, erythritol 1.3g, Furcellaran 2.5g fully mixes, add thick paste (1) and stir evenly, heating and melting is 80～85 ℃ of insulations, select the dropper of suitable bore for use, speed with 30～50 of per minutes is dripped system, splashes into in the refrigerative liquid paraffin of ice bath, makes 1000 drop pill, after the shaping, ball is taken out, inhale the liquid Paraffin that goes to the ball surface with absorbent paper, promptly.
Embodiment 5
(a): get Radix Physochlainae 18g, lactose 20g, xanthan gum 2.0g, chitin 6g are standby;
(b):. get the Radix Physochlainae decocting and boil 2 times, collecting decoction filters, and filtrate concentrates, and adds 2.5 times of amount 90～97% ethanol, leaves standstill 7 hours, filter, recovery ethanol, filtrate is concentrated under 50～75 ℃ of conditions, relative density is 1.20～1.40 thick paste (1);
(c): get lactose 20g, xanthan gum 2.0g, chitin 6g is fully mixed, add thick paste (1), stir evenly heating and melting, system is dripped in insulation, splashes into in the refrigerative liquid paraffin of ice bath, after the shaping, ball is taken out, inhale the liquid Paraffin that goes to the ball surface with absorbent paper, promptly.
Embodiment 6
(a): get Radix Physochlainae extractum 4.5g, xylitol 4.5g, Ficus elastica 1g, starch 1g are standby;
(b):. above-mentioned substance is fully mixed, heating and melting, stir, be incubated 68～72 ℃, select the dropper of suitable bore for use, speed with 60～80 of per minutes is dripped system, splash into in the refrigerative liquid paraffin of ice bath, after the shaping, ball is taken out, inhale the liquid Paraffin that goes to the ball surface with absorbent paper, promptly.
Embodiment 7
(a): get Radix Physochlainae paste 6.7g, xylitol 27.5g, starch 5.55g is standby;
(b): in xylitol, starch mixture, add Radix Physochlainae extractum, fully mix, mixture is at 55～95 ℃ of heating and meltings, stir, mixing time is 10～20 minutes, and insulation is 1.30～4.0 millimeters at 55～75 ℃ of temperature following system, dropper bore and splashes in-20～25 ℃ the methyl-silicone oil, make 1000 drop pill, promptly.
Embodiment 8
(a): get Radix Physochlainae paste 11.5g, xylitol 20.5g, arabic gum 8g is standby;
(b): in xylitol, arabic gum mixture, add Radix Physochlainae extractum, fully mix, mixture is at 85～115 ℃ of heating and meltings, stir, mixing time is 5～12 minutes, insulation, at 45～75 ℃ of temperature following system, dropper bore is 1.20～3.0 millimeters, splash in 0～10 ℃ the liquid paraffin, make 1000 drop pill, promptly.
Embodiment 9
(a): get Radix Physochlainae paste 15g, lactose 19.2g, starch 5.8g is standby;
(b): in lactose, starch mixture, add Radix Physochlainae extractum, fully mix, mixture is at 45～75 ℃ of heating and meltings, stir, mixing time is 30～60 minutes, and insulation is 1.20～3.5 millimeters at 55～65 ℃ of temperature following system, dropper bore and splashes in 5～15 ℃ the liquid paraffin, make 1000 drop pill, promptly.
Embodiment 10
(a): get Radix Physochlainae paste 3.7g, xylitol 29.2g, starch 7.1g is standby;
(b): add above-mentioned Radix Physochlainae extractum in xylitol and starch mixture, fully mix, mixture is at 60～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, and insulation is 1.1～3.5 millimeters at 60～85 ℃ of temperature following system, dropper bore, splash in 0～18 ℃ the liquid methyl-silicone oil, make 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried, make drop pill, promptly.
Embodiment 11
(a): it is standby to get Radix Physochlainae paste 13.4g, xylitol 13.3, starch 13.3g;
(b): add above-mentioned Radix Physochlainae extractum in xylitol and starch mixture, fully mix, mixture is at 60～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, and insulation is 1.21～3.0 millimeters at 60～85 ℃ of temperature following system, dropper bore, splash in-10～18 ℃ the methyl-silicone oil, make 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried, make drop pill, promptly.
Embodiment 12
(a): it is standby to get Radix Physochlainae paste 1.5g, lactose 28.5, starch 8.5.3g, chitin 1.5g;
(b): add above-mentioned Radix Physochlainae extractum in lactose, starch and chitin mixture, fully mix, mixture is at 70～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, and insulation is 1.5～3.0 millimeters at 60～65 ℃ of temperature following system, dropper bore, splash in 0～18 ℃ the liquid paraffin, make 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried, make drop pill, promptly.
Embodiment 13
(a): it is standby to get Radix Physochlainae paste 5.8g, xylitol 23.6, starch 5.6g;
(b): add above-mentioned Radix Physochlainae extractum in lactose and starch mixture, fully mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, in following system of 64 ℃ of temperature, the dropper bore is 1.2～2.5 millimeters, splashes in 0 ℃ the methyl-silicone oil, makes 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
Embodiment 14
(a): it is standby to get Radix Physochlainae paste 12g, lactose 16.4, starch 6.6g;
(b): add above-mentioned Radix Physochlainae extractum in lactose and starch mixture, fully mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, in following system of 64 ℃ of temperature, the dropper bore is 1.2～2.5 millimeters, splashes in 0 ℃ the vegetable oil, makes 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
Embodiment 15
(a): get Radix Physochlainae paste 5g, xylitol 19.2g, arabic gum 5.8g is standby;
(b): add above-mentioned Radix Physochlainae extractum in xylitol and arabic gum mixture, fully mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～20 minutes, insulation, in following system of 64 ℃ of temperature, the dropper bore is 1.21～2.5 millimeters, splashes in-10～10 ℃ the methyl-silicone oil oil, makes 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
Embodiment 16
(a): get Radix Physochlainae paste 7.5g, xylitol 13.5g, starch 4g is standby;
(b): add above-mentioned Radix Physochlainae extractum in xylitol and starch mixture, fully mix, mixture is at 65 ℃ of heating and meltings, stir, mixing time is 10～20 minutes, insulation, in following system of 64 ℃ of temperature, the dropper bore is 1.21～2.5 millimeters, splashes in 0～10 ℃ the methyl-silicone oil oil, makes 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
Embodiment 17
(a): get Radix Physochlainae paste 7.5g, xylitol 13.5g, tragakanta 4g is standby;
(b): add above-mentioned Radix Physochlainae extractum in xylitol and tragakanta mixture, fully mix, mixture is at 55～75 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, in following system of 60～70 ℃ of temperature, the dropper bore is 1.21～2.5 millimeters, splashes in 0～10 ℃ the methyl-silicone oil oil, makes 1000 drop pill, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
Claims (9)
1, the bronchitic medicine of a kind of treatment, it is characterized in that it is by Radix Physochlainae paste: adjuvant is the preparation that 0.01:1～1:1 makes, wherein adjuvant comprises filler and plasticity substrate, and said filler is selected from the natural adjuvant of following one or more plant origins: erythritol, sorbitol, fructose, trehalose, D-ribose, low melting-point agarose, xylitol, Raffinose, isomalt, lactose, said plasticity substrate is selected from the natural adjuvant of following one or more plant origins: starch and derivant thereof, arabic gum, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, the tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, agar; The weight ratio of described filler and plasticizer is: 1:0.1～1:0.9.
2, medicine as claimed in claim 1, it is characterized in that it is by Radix Physochlainae paste: adjuvant is the preparation that 0.1:1 :～0.6:1 makes, and filler adjuvant wherein is selected from following one or more the natural adjuvant of plant origin: erythritol, xylitol, lactose; Plasticity substrate wherein is selected from following one or more the natural adjuvant of plant origin: pregelatinized Starch, arabic gum, alginic acid and salt thereof, chitin, Ficus elastica, Furcellaran, tragakanta, xanthan gum; The weight ratio of described filler and plasticizer is 1:0.1～1:05.
3, medicine as claimed in claim 2, it is characterized in that it is by Radix Physochlainae paste: adjuvant is the preparation that 0.2:1～0.4:1 makes, filler adjuvant wherein is selected from following one or more the natural adjuvant of plant origin: xylitol, lactose; Plasticity substrate wherein is selected from following one or more the natural adjuvant of plant origin: starch, arabic gum; The weight ratio of described filler and plasticizer is 1:0.1～1:0.5.
4, medicine as claimed in claim 3 is characterized in that described adjuvant is xylitol and starch, and xylitol is 1:0.2～1:0.3 with the ratio of the weight of starch.
5, medicine as claimed in claim 3 is characterized in that described adjuvant is lactose and starch, and lactose is 1:0.2～1:0.3 with the ratio of the weight of starch.
6, medicine as claimed in claim 3 is characterized in that described adjuvant is xylitol and arabic gum, and the ratio of the weight of xylitol and arabic gum is 1:0.2～1:0.4.
7, the preparation method of claim 1,2 or 3 described medicines is characterized in that this method comprises the steps:
(a): get Radix Physochlainae paste: adjuvant is that 0.01:1～1:1 is standby;
(b): in appropriate amount of auxiliary materials, add Radix Physochlainae extractum, fully mix, mixture is at 45～115 ℃ of heating and meltings, stir, mixing time is 1～120 minute, insulation, at 45～95 ℃ of temperature following system, dropper bore is 1.0～4.0 millimeters, splash in-20～25 ℃ liquid paraffin, methyl-silicone oil or the vegetable oil, make drop pill, promptly.
8, the preparation method of medicine as claimed in claim 8 is characterized in that this method comprises the steps:
(a): get Radix Physochlainae paste: adjuvant is 0.1:1 :～0.6:1 is standby;
(b): in appropriate amount of auxiliary materials, add above-mentioned Radix Physochlainae extractum, fully mix, mixture stirs at 60～85 ℃ of heating and meltings, mixing time is 10～30 minutes, insulation is 1.1～3.5 millimeters at 60～85 ℃ of temperature following system, dropper bore, splashes in 0～18 ℃ the liquid paraffin, methyl-silicone oil, liquid coolant is use up and wiped to the drop pill drop that forms, back packing to be dried is made drop pill, promptly.
9, as the preparation method of medicine as described in the claim 8, it is characterized in that this method comprises the steps:
(a): get Radix Physochlainae paste: adjuvant is that 0.2:1～0.4:1 is standby;
(b): in appropriate amount of auxiliary materials, add above-mentioned Radix Physochlainae extractum and fully mix, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, to the greatest extent and wipe liquid coolant, back packing to be dried the drop pill drop that forms, make drop pill, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101072969A CN100512841C (en) | 2003-12-11 | 2003-12-11 | Medication for treating bronchitis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2003101072969A CN100512841C (en) | 2003-12-11 | 2003-12-11 | Medication for treating bronchitis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1626137A CN1626137A (en) | 2005-06-15 |
| CN100512841C true CN100512841C (en) | 2009-07-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2003101072969A Expired - Fee Related CN100512841C (en) | 2003-12-11 | 2003-12-11 | Medication for treating bronchitis |
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| Country | Link |
|---|---|
| CN (1) | CN100512841C (en) |
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2003
- 2003-12-11 CN CNB2003101072969A patent/CN100512841C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| 中华人民共和国药典一部. 国家药典委员会，451，化学工业出版社. 2000 中华人民共和国药典一部2000. 国家药典委员会，451，化学工业出版社. 2000 |
| 中华人民共和国药典一部. 国家药典委员会，451，化学工业出版社. 2000 * |
| 中华人民共和国药典一部2000. 国家药典委员会，451，化学工业出版社. 2000 * |
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| CN1626137A (en) | 2005-06-15 |
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Granted publication date: 20090715 Termination date: 20191211 |