CN102302672B - Honeysuckle flower buccal tablets and preparation method thereof - Google Patents
Honeysuckle flower buccal tablets and preparation method thereof Download PDFInfo
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- CN102302672B CN102302672B CN 201110288117 CN201110288117A CN102302672B CN 102302672 B CN102302672 B CN 102302672B CN 201110288117 CN201110288117 CN 201110288117 CN 201110288117 A CN201110288117 A CN 201110288117A CN 102302672 B CN102302672 B CN 102302672B
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Abstract
The invention discloses honeysuckle flower buccal tablets and a preparation method thereof. The honeysuckle flower tablets comprise the following raw materials (based on 1000 tablets): honeysuckle flower, lilyturf root or fragrant solomonseal rhizome, dark plum, mannitol, crystal sugar, lactose, aspartame, citric acid, menthol, sodium carboxymethylcellulose and magnesium stearate. The honeysuckle flower buccal tablets can obviously improve throat discomfort caused by a plurality of causes; and meanwhile the buccal tablets can be taken by patients suffering from chronic pharyngitis for a long time due to high safety so as to achieve the treatment effect. The preparation method of the honeysuckle flower buccal tablets comprises the following procedures: extracting; pre-treating; mixing and granulating; drying and pelletizing; and blending and tabletting. The preparation method has the advantages of simple and feasible process and good repeatability; and the obtained product has the advantages of moderate and refreshing taste and extremely good treatment effect on throat discomfort, and is convenient for large-scale industrial production and popularization.
Description
Technical field
The present invention relates to the guttural tablets technology, particularly relate to a kind of honeysuckle lozenge and preparation method thereof.
Background technology
Along with the quickening of people's rhythm of life, bring bad life style (as: smoking, happiness food pungent etc.) to cause easily throat discomfort and chronic pharyngitis; In addition, some people also can cause the illness such as throat discomfort because work is excessive through throat commonly used such as teacher, salesman etc.Although this is not the large problem in the life, is often perplexing people's life, even cause other more serious disease.
Above-mentioned situation, people seek help from medicine usually, hardly realize to have in these medicines much to be not suitable for eating.For example: the product that has contains iodine, the watermelon crystal that contains contraindication in pregnancy and the Borneolum Syntheticum that have, and long-term taking can cause the throat dysbacteriosis, can't cure.
Therefore, for addressing the above problem, provide the technology of a kind of honeysuckle lozenge and preparation method thereof to seem particularly important.
Summary of the invention
One of purpose of the present invention is to avoid weak point of the prior art and a kind of safe, good effect and the good honeysuckle lozenge of mouthfeel is provided.
Two of purpose of the present invention be to avoid weak point of the prior art and provide that a kind of technique is simple, good reproducibility and be convenient to the preparation method of the honeysuckle lozenge that industrialization uses.
Purpose of the present invention is achieved through the following technical solutions:
The invention provides a kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 400g~3000g
Radix Ophiopogonis 400g~2400g
Fructus Mume 100g~1000g
Mannitol 100g~500g
Crystal sugar 50g~500g
Lactose 50g~500g
Aspartame 1g~15g
Citric acid 1g~15g
Mentholum 1g~16g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 600g~2500g
Radix Ophiopogonis 400g~1000g
Fructus Mume 100g~500g
Mannitol 100g~250g
Crystal sugar 150g~450g
Lactose 100g~300g
Aspartame 5g~10g
Citric acid 5g~10g
Mentholum 1g~10g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 1000g~1500g
Radix Ophiopogonis 400g~800g
Fructus Mume 100g~250g
Mannitol 150g~250g
Crystal sugar 200g~400g
Lactose 150g~250g
Aspartame 5g~10g
Citric acid 5g~10g
Mentholum 1g~10g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g.
The present invention also provides a kind of preparation method of honeysuckle lozenge, may further comprise the steps:
Step 1, abstraction process: be 40 ﹪~85 ﹪ alcohol reflux 1~4 time by feed liquid mass ratio 1:6~20 usefulness concentration with Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80~120 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract; Will Radix Ophiopogonis by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, extracted 0.5~2 hour, filter, merging filtrate Radix Ophiopogonis, should Radix Ophiopogonis filtrate when being concentrated into relative density and being 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Radix Ophiopogonis extract; Fructus Mume by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract;
Step 2, pretreatment procedure: take by weighing mannitol and Mentholum mix homogeneously with Mentholum equivalent, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get crystal sugar, lactose, citric acid, remaining mannitol and pulverized 80 orders~120 mesh sieves, for subsequent use; Get sodium carboxymethyl cellulose, add purified water, be configured in mass ratio concentration and be the aqueous solution of the sodium carboxymethyl cellulose of 0.2 ﹪~2 ﹪, for subsequent use;
Step 3, mixing granulation operation: extracting honeysuckle extract, Radix Ophiopogonis extract, Fructus Mume extract, aspartame, and residue mannitol, crystal sugar, lactose, citric acid behind crushing screening, mix homogeneously, take the aqueous solution of sodium carboxymethyl cellulose as binding agent, cross 20 mesh sieves and granulate and obtain granule;
Step 4, dry, granulate operation: the granule that makes is dry in 45 ℃~65 ℃ baking ovens, and the control pellet moisture is at 3 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves;
Step 5, total mixed, sheeting process: in the good granule of granulate, add magnesium stearate and process the Mentholum mixture that obtains through step 2, mixing, compression molding namely gets 1000 honeysuckle lozenge.
The present invention also provides a kind of honeysuckle lozenge, and in 1000, it contains following composition of raw materials:
Flos Lonicerae 400g~3000g
Rhizoma Polygonati Odorati 500g~2000g
Fructus Mume 100g~1000g
Mannitol 100g~400g
Crystal sugar 50g~600g
Lactose 50g~450g
Aspartame 5g~12g
Citric acid 5g~12g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 400g~1600g
Rhizoma Polygonati Odorati 500g~1000g
Fructus Mume 100g~550g
Mannitol 100g~250g
Crystal sugar 50g~300g
Lactose 50g~250g
Aspartame 5g~8g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 700g~1000g
Rhizoma Polygonati Odorati 600g~800g
Fructus Mume 200g~400g
Mannitol 200g~250g
Crystal sugar 150g~300g
Lactose 150g~250g
Aspartame 5g~8g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 1600g~3000g
Rhizoma Polygonati Odorati 1000g~2000g
Fructus Mume 550g~1000g
Mannitol 250g~400g
Crystal sugar 300g~600g
Lactose 250g~450g
Aspartame 8g~12g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials:
Flos Lonicerae 2000g~3000g
Rhizoma Polygonati Odorati 1500g~2000g
Fructus Mume 800g~1000g
Mannitol 300g~400g
Crystal sugar 450g~600g
Lactose 300g~450g
Aspartame 8g~12g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
The present invention also provides a kind of preparation method of honeysuckle lozenge, may further comprise the steps:
Step 1, abstraction process: be 45 ﹪~85 ﹪ alcohol reflux 1~4 time by feed liquid mass ratio 1:6~20 usefulness concentration with Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80~120 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract; Rhizoma Polygonati Odorati by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Rhizoma Polygonati Odorati filtrate, when this Rhizoma Polygonati Odorati filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Rhizoma Polygonati Odorati extract; Fructus Mume by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract;
Step 2, pretreatment procedure: take by weighing mannitol and Mentholum mix homogeneously with Mentholum equivalent, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get crystal sugar, lactose, citric acid, remaining mannitol and pulverized 80 orders~120 mesh sieves, for subsequent use; Get sodium carboxymethyl cellulose, add purified water, be configured in mass ratio concentration and be the aqueous solution of the sodium carboxymethyl cellulose of 0.2 ﹪~2 ﹪, for subsequent use;
Step 3, mixing granulation operation: extracting honeysuckle extract, Rhizoma Polygonati Odorati extract, Fructus Mume extract, aspartame, and remaining mannitol, crystal sugar, lactose, citric acid behind crushing screening, mix homogeneously, take the aqueous solution of sodium carboxymethyl cellulose as binding agent, cross 20 mesh sieves and granulate and obtain granule;
Step 4, dry, granulate operation: the granule that makes is dry in 50 ℃~65 ℃ baking ovens, and the control pellet moisture is at 3 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves;
Step 5, total mixed, sheeting process: in the good granule of granulate, add magnesium stearate and through step 2 process obtain the Mentholum mixture, mixing, compression molding namely gets 1000 honeysuckle lozenge.
Beneficial effect of the present invention:
A kind of honeysuckle lozenge, in 1000, it contains following composition of raw materials: Flos Lonicerae 400g~3000g, Radix Ophiopogonis 400g~2400g, Fructus Mume 100g~1000g, mannitol 100g~500g, crystal sugar 50g~500g, lactose 50g~500g, aspartame 1g~15g, citric acid 1g~15g, Mentholum 1g~16g, sodium carboxymethyl cellulose 0.5g~16g, magnesium stearate 4g~16g.Perhaps can also be Flos Lonicerae 2000g~3000g, Rhizoma Polygonati Odorati 1500g~2000g, Fructus Mume 800g~1000g, mannitol 300g~400g, crystal sugar 450g~600g, lactose 300g~450g, aspartame 8g~12g, citric acid 5g~8g, Mentholum 4g~15g, sodium carboxymethyl cellulose 0.5g~5g, magnesium stearate 5g~20g.
The three flavor medical materials that the present invention uses, Flos Lonicerae, Radix Ophiopogonis or Rhizoma Polygonati Odorati, Fructus Mume all are China's tradition conventional crude drugs, and are among the people also as edible.Ministry of Public Health is all included it in integration of edible and medicinal herbs medical material list, and as seen its safety is reliable.Flos Lonicerae has good heat-clearing and toxic substances removing, the effects such as wind-heat dissipating; The modern pharmacological research data shows that Flos Lonicerae contains abundant chlorogenic acid, has widely bacteriostasis, and common Respirovirus is had stronger inhibitory action, and chlorogenic acid and coffee mesitoyl quinine acid composition are the main active substances of preventing respiratory viruses effect.Rhizoma Polygonati Odorati or Radix Ophiopogonis, " book on Chinese herbal medicine justice " carries " control lung dryness of the stomach heat, body fluid dries up, the diseases such as thirsty dry sensation in the pharynx, and excessiveness of stomach-fire, dry thirsty rapid digestion of food, polyorexia person, You Youjie effect "; Be mainly used in nourishing the stomach to promote the production of body fluid, control cough caused by dryness, chronic cough; The dry throat and mouth of the cloudy liquid consumption of calentura wound; Interior-heat is quenched one's thirst; Deficiency of YIN diseases caused by exogenous pathogenic factor; Dizzy dizzy; Muscle arteries and veins spasm and pain.Fructus Mume has astringes the lung, astringing intestine to stop diarrhea, and the effect of promoting the production of body fluid, modern pharmacological research shows that Fructus Mume has the effect of resisting pathogenic microbes.The present invention carries out prescription further according to China's traditional Chinese medicine theory according to the monarch principle.Take heat-clearing and toxic substances removing medical material Flos Lonicerae as monarch drug, nourishing the stomach to promote the production of body fluid medical material Radix Ophiopogonis or Rhizoma Polygonati Odorati are ministerial drug, strengthen the Flos Lonicerae antipyretic and antidote functions.Fructus Mume is astringed the lung, is promoted the production of body fluid, and resisting pathogenic microbes had both been helped and helped the Flos Lonicerae antibiosis and antiviral functions, can promote the production of body fluid again simultaneously, can alleviate the disease of holding concurrently of xerostomia discomfort, is adjuvant drug.In addition, be equipped with the freshener n-ethyl-p-menthane-3 brain, it is pungent in flavor and cool in property, and fragrant wind dispelling both can be helped sore-throat relievings such as helping Flos Lonicerae, but the through throat of priming produces refrigerant sense to alleviate discomfort and pain again, is adjuvant drug.On this basis, selecting crystal sugar is sweeting agent, and this has never seen in document in the past, and other component is in addition made the honeysuckle lozenge of the moistening and cleaning throat of direct onset again.Honeysuckle lozenge of the present invention, the throat discomfort that many reasons is caused all has obvious improvement, and because safe, for patients with chronic pharyngitis, can long-term taking, can reach the effect for the treatment of.
A kind of preparation method of honeysuckle lozenge comprises abstraction process: with Flos Lonicerae, Radix Ophiopogonis or Rhizoma Polygonati Odorati, and Fructus Mume extracts; Pretreatment procedure: take by weighing mannitol and Mentholum mix homogeneously with Mentholum equivalent, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get crystal sugar, lactose, citric acid, remaining mannitol and pulverized 80 orders~120 mesh sieves, for subsequent use; Get sodium carboxymethyl cellulose, add purified water, be configured in mass ratio concentration and be the aqueous solution of the sodium carboxymethyl cellulose of 0.2 ﹪~2 ﹪, for subsequent use; Mixing granulation operation: extracting honeysuckle extract, Radix Ophiopogonis extract, Fructus Mume extract, aspartame, and remaining mannitol, crystal sugar, lactose, citric acid, mix homogeneously is crossed the granulation of 20 mesh sieves take the aqueous solution of sodium carboxymethyl cellulose as binding agent and is obtained granule; Dry, granulate operation: the granule that makes is dry in 50 ℃~65 ℃ baking ovens, and the control pellet moisture is at 3 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves; Total mixed, sheeting process: the Mentholum mixture that in the good granule of granulate, adds magnesium stearate and process through above-mentioned steps, mixing, compression molding namely gets 1000 honeysuckle lozenge.
Adopt preparation method of the present invention to prepare honeysuckle lozenge, its technique simple possible, good reproducibility, and the product taste of preparation is moderate, and mouthfeel is pure and fresh, gladdens the heart and refresh the mind, and is extremely effective to throat discomfort, and is convenient to the production of industrialization large tracts of land and promotes.
The specific embodiment
The invention will be further described with the following Examples.
Embodiment 1.
A kind of honeysuckle lozenge, each raw material use amount is as follows:
Flos Lonicerae 40kg
Radix Ophiopogonis 24kg
Fructus Mume 8kg
Mannitol 9.08kg
Crystal sugar 9.32kg
Lactose 6.8kg
Aspartame 0.28kg
Citric acid 0.28kg
Mentholum 0.48kg
Sodium carboxymethyl cellulose 0.08kg
Magnesium stearate 0.48kg.
The above-mentioned raw materials use amount can make 40000 honeysuckle lozenge, the heavy 0.8g/ sheet of sheet.
Embodiment 2.
The preparation method of a kind of honeysuckle lozenge in a kind of Preparation Example 1 may further comprise the steps:
Step 1, abstraction process: be that 1:10 concentration is 55 ﹪ alcohol reflux 3 times by solid-liquid ratio with the 40kg Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract 2kg; Be 1:10 extracting in water 3 times with 24kg Radix Ophiopogonis by solid-liquid ratio, extracted 2 hours, filter, merge filtrate Radix Ophiopogonis, should Radix Ophiopogonis filtrate when being concentrated into relative density and being 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Radix Ophiopogonis extract 2.4kg; Be 1:10 extracting in water 3 times with the 8kg Fructus Mume by solid-liquid ratio, extracted 2 hours, filter, merge Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract 0.8kg.
Step 2, pretreatment procedure: take by weighing the mannitol of 0.48kg and the Mentholum mix homogeneously of 0.48kg, pulverize, cross 120 mesh sieves, the Mentholum mixture after obtaining processing is for subsequent use; Get the lactose of crystal sugar, the 6.8kg of 9.32kg, the citric acid of 0.28kg, the mannitol of residue 8.6kg and pulverized 80 orders~120 mesh sieves, for subsequent use; Get the sodium carboxymethyl cellulose of 0.08kg, add purified water, be configured in mass ratio the aqueous solution that concentration is the sodium carboxymethyl cellulose of 1.5 ﹪, for subsequent use.Because the viscosity of Mentholum is large, is not easy to sieve, mix so before the mixing granulation operation, take by weighing first with the mannitol of Mentholum equivalent, because mannitol is powdery, after Mentholum mixes, so that the viscosity of Mentholum reduces the processing of being convenient to sieve.Concrete, producing of the aqueous solution of sodium carboxymethyl cellulose takes by weighing sodium carboxymethyl cellulose 0.08kg, first with a small amount of purified water swelling, progressively adds the water agitation and dilution, until add the aqueous solution that the 8kg water that weighs up namely gets sodium carboxymethyl cellulose again.
Step 2, mixing granulation operation: with above-mentioned Flos Lonicerae extract 2kg, Radix Ophiopogonis extract 2.4kg, Fructus Mume extract 0.8kg, aspartame 0.28kg, and behind crushing screening remaining mannitol, crystal sugar, lactose, citric acid, mix homogeneously, take the aqueous solution of sodium carboxymethyl cellulose as binding agent, cross 20 mesh sieves and granulate and obtain granule.Wherein, above-mentioned Flos Lonicerae extract 2kg, Radix Ophiopogonis extract 2.4kg, Fructus Mume extract 0.8kg, aspartame 0.28kg; and the mixing of remaining mannitol, crystal sugar, lactose, citric acid behind crushing screening, can be in one-step-granulating method under 45 ℃ of preheating condition abundant mix homogeneously.
Step 3, dry, granulate operation: the granule that makes is dry in 60 ℃ of baking ovens, so that pellet moisture is controlled at 3 ﹪~5 ﹪; Dried granule carries out granulate with 20 mesh sieves.
Step 4, total mixed, sheeting process: in the good granule of granulate, add through step 2 and process Mentholum mixture, the magnesium stearate 0.48kg that obtains, mixing, compression molding namely gets 40000 honeysuckle lozenge.Can adopt 3 D multi-directional mixer mixing 15min, again with 24 stamping machine compression moldings, sheet weighs the 0.8g/ sheet after the taking-up.
Embodiment 3.
A kind of honeysuckle lozenge, each raw material use amount is as follows:
Flos Lonicerae 70kg
Rhizoma Polygonati Odorati 42kg
Fructus Mume 14kg
Mannitol 15.89kg
Crystal sugar 16.31kg
Lactose 11.9kg
Aspartame 0.49kg
Citric acid 0.49kg
Mentholum 0.84kg
Sodium carboxymethyl cellulose 0.14kg
Magnesium stearate 0.84kg.
The above-mentioned raw materials use amount can make 70000 honeysuckle lozenge, the heavy 0.8g/ sheet of sheet.
Embodiment 4.
The preparation method of a kind of honeysuckle lozenge in a kind of Preparation Example 3 may further comprise the steps:
Step 1, abstraction process: be that 1:15 concentration is 70 ﹪ alcohol reflux 3 times by solid-liquid ratio with the 70kg Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract 3.5kg; Be 1:15 extracting in water 3 times with the 42kg Rhizoma Polygonati Odorati by solid-liquid ratio, extracted 2 hours, filter, merge Rhizoma Polygonati Odorati filtrate, when this Rhizoma Polygonati Odorati filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Rhizoma Polygonati Odorati extract 4.2kg; Be 1:15 extracting in water 4 times with the 14kg Fructus Mume by solid-liquid ratio, extracted 2 hours, filter, merge Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract 1.4kg.
Step 2, pretreatment procedure: take by weighing the mannitol of 0.84kg and the Mentholum mix homogeneously of 0.84kg, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get the lactose of crystal sugar, the 11.9kg of 16.31kg, the citric acid of 0.49kg, the mannitol of residue 15.05kg and pulverized 120 mesh sieves, for subsequent use; Get the sodium carboxymethyl cellulose of 0.14kg, add purified water, be configured in mass ratio the aqueous solution that concentration is the sodium carboxymethyl cellulose of 2 ﹪, for subsequent use.Because the viscosity of Mentholum is large, is not easy to sieve, mix so before the mixing granulation operation, take by weighing first with the mannitol of Mentholum equivalent, because mannitol is powdery, after Mentholum mixes, so that the viscosity of Mentholum reduces the processing of being convenient to sieve.Concrete, producing of the aqueous solution of sodium carboxymethyl cellulose takes by weighing sodium carboxymethyl cellulose 0.14kg, first with a small amount of purified water swelling, progressively adds the water agitation and dilution, until add the aqueous solution that the 14kg water that weighs up namely gets sodium carboxymethyl cellulose again.
Step 2, mixing granulation operation: extracting honeysuckle extract 3.5kg, Rhizoma Polygonati Odorati extract 4.2kg, Fructus Mume extract 1.4kg, aspartame 0.49kg, and behind crushing screening remaining mannitol, crystal sugar, lactose, citric acid, mix homogeneously is crossed the granulation of 20 mesh sieves take the aqueous solution of sodium carboxymethyl cellulose as binding agent and is obtained granule.Wherein, above-mentioned Flos Lonicerae extract 3.5kg, Rhizoma Polygonati Odorati extract 4.2kg, Fructus Mume extract 1.4kg, aspartame 0.49kg; and the mixing of remaining mannitol, crystal sugar, lactose, citric acid behind crushing screening, can be in one-step-granulating method under 45 ℃ of preheating condition abundant mix homogeneously.
Step 3, dry, granulate operation: the granule that makes is dry in 50 ℃ of baking ovens, so that pellet moisture is controlled at 5 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves.
Step 4, total mixed, sheeting process: in the good granule of granulate, add Mentholum mixture, magnesium stearate 0.84kg after processing, mixing, compression molding namely gets 70000 honeysuckle lozenge.Can adopt 3 D multi-directional mixer mixing 15min, again with 24 stamping machine compression moldings, sheet weighs the 0.8g/ sheet after the taking-up.
Embodiment 5.
A kind of honeysuckle lozenge, each raw material use amount is as follows:
Flos Lonicerae 112kg
Radix Ophiopogonis 72kg
Fructus Mume 36kg
Mannitol 18kg
Crystal sugar 14.8kg
Lactose 4kg
Aspartame 0.56kg
Citric acid 0.52kg
Mentholum 0.48kg
Sodium carboxymethyl cellulose 0.06kg
Magnesium stearate 0.48kg.
The above-mentioned raw materials use amount can make 40000 honeysuckle lozenge, the heavy 0.8g/ sheet of sheet.
Embodiment 6.
A kind of honeysuckle lozenge, each raw material use amount is as follows:
Flos Lonicerae 25kg
Rhizoma Polygonati Odorati 20kg
Fructus Mume 5kg
Mannitol 12.5kg
Crystal sugar 17.5kg
Lactose 12kg
Aspartame 0.15kg
Citric acid 0.2kg
Mentholum 0.15kg
Sodium carboxymethyl cellulose 0.3kg
Magnesium stearate 0.5kg
The above-mentioned raw materials use amount can make 50000 honeysuckle lozenge, the heavy 0.8g/ sheet of sheet.
Embodiment 1,3,5,6 prepared honeysuckle lozenges are carried out the functional evaluation experiment, and this experiment purpose is in order to check the function of the prepared honeysuckle lozenge of present patent application, this evaluation experimental to be divided into zoopery and human experiment experiment two parts.
Zoopery.
Experiment material: honeysuckle lozenge places cool place, dry place to preserve.
Laboratory animal: cleaning level SD female rats, 150-220g.
Cotton balls preparation: take by weighing the absorbent cotton that weight is 35 ± 2mg, be prepared into the cotton balls of diameter 0.55cm.Behind autoclaving, each cotton balls adds 1mg/0.1mL ampicillin 0.1ml, and is after 50 ℃ of oven for drying, for subsequent use.
Sample treatment: establish the low middle Senior Three dosage group of honeysuckle lozenge, be equivalent to respectively 1 times, 5 times, 10 times of human body recommended amounts, dosage is 0.45g/kgbw, 2.25 g/kgbw, 4.5 g/kgbw respectively.Take by weighing respectively honeysuckle lozenge 7.2g, 36g, 72g, be dissolved in water, be diluted to 100ml, shake up, for subsequent use.
Experimental technique: adopt the rat cotton balls to implant experimental technique.
Rat is at ether light anaesthesia aseptic condition lower cut, and it is subcutaneous that the cotton balls for preparing is implanted rat both sides axillary fossa.Postoperative is divided into blank group and 3 given the test agent dosage groups at random.Given the test agent dosage group gives the given the test agent solution by the various dose of rat body weight calculating, and the blank group gives solvent.Experiment finishes the same day again to a given the test agent, after 1 hour the disconnected neck of rat is put to death, and peels off and take out granulation tissue, weighs after 1 hour in 60-90 ℃ of baking oven inner drying, deducts the raw cotton ball weight, is the granuloma net weight.With granulation quality and rat body weight mass ratio, use the mg(granuloma)/the 100g(rat body weight) expression, relatively each dosage group and blank group granuloma weight the results are shown in Table 1.
Table 1 granulation body ratio
Annotate: ◆ with negative control group remarkable reduction (P<0.05) is arranged relatively
The result: each test dose group granulation body is than with negative control group statistical significance (P<0.05) being arranged relatively.
Human experimentation.
Experiment material: honeysuckle lozenge, blank, the latter is placebo, processes with blank adjuvant.
Experimental technique: adopt two kinds of control design between self and group.Pharyngeal symptom, sign by the experimenter are divided into test-meal group and matched group at random, consider as far as possible affect result's principal element such as the course of disease, age, sex etc., carry out harmony to check, with the comparability between the assurance group.Every group of wounded body is no less than 50 examples.
Dosage and take method: the test-meal group is subjected to trial product by taking five of every days, and matched group is taken placebo.Given the test agent gives 15 days.
Efficiency index: each measures once indices when experiment begins and finish, and checks pharyngeal inquiry symptom, the record situation of change.
Observation of symptoms: detailed medical history-taking, main pharyngeal symptom: pharyngalgia, itching throat, dry pharynx, dry cough, foreign body sensation polylogia increase the weight of etc., calculate integration by symptom weight (1 degree, 1 minute, 2 degree, 2 minutes, 3 degree, 3 minutes), and the statistics integration changes, the doing well,improving rate.The results are shown in Table 2.
Table 2 clinical symptoms is improved situation
Annotate: ◆ test-meal group and matched group relatively have significantly effectively (P<0.05)
After the test-meal, always improvement rate of test-meal group is 61.29%, and always improvement rate of matched group is 20%.The two has significant difference (P<0.05).
Sign is observed.
Pharyngeal inspection: the signs such as pharyngeal mucosa hyperemia, myxedema, retropharyneal folliculosis, secretions.
Light by check result, in, heavily be divided into I, II, III level, record respectively test-meal before and after sign change, calculate somatic feature score and improvement rate.
The observation index effect is judged:
Effectively: sx↓ 1 degree, pharyngeal sign check result alleviates the I level
Invalid: symptom, sign are all without obviously changing
The results are shown in Table 3.
The pharyngeal sign of table 3 is improved the result
Annotate: ◆ test-meal group and matched group relatively have significantly effectively (P<0.05)
After the test-meal, always improvement rate of test-meal group is 46.00%, and always improvement rate of matched group is 12.00%.The two has significant difference (P<0.05).
After the test-meal between test-meal group self comparison and matched group relatively, pharyngeal clinical symptoms, somatic feature score obviously reduce, and symptom, sign improvement rate be significantly increased than matched group, difference has significance, judges that honeysuckle lozenge has function of clearing throat.
Should be noted that at last; above embodiment is only in order to illustrate technical scheme of the present invention; but not limiting the scope of the invention; although with reference to preferred embodiment the present invention has been done to explain; those of ordinary skill in the art is to be understood that; can make amendment or be equal to replacement technical scheme of the present invention, and not break away from essence and the scope of technical solution of the present invention.
Claims (10)
1. a honeysuckle lozenge is characterized in that, in 1000, raw material contains:
Flos Lonicerae 400g~3000g
Radix Ophiopogonis 400g~2400g
Fructus Mume 100g~1000g
Mannitol 100g~500g
Crystal sugar 50g~500g
Lactose 50g~500g
Aspartame 1g~15g
Citric acid 1g~15g
Mentholum 1g~16g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g;
Wherein, pharmacodynamic raw materials is Flos Lonicerae, Radix Ophiopogonis, Fructus Mume and Mentholum.
2. a kind of honeysuckle lozenge according to claim 1 is characterized in that: in 1000:
Flos Lonicerae 600g~2500g
Radix Ophiopogonis 400g~1000g
Fructus Mume 100g~500g
Mannitol 100g~250g
Crystal sugar 150g~450g
Lactose 100g~300g
Aspartame 5g~10g
Citric acid 5g~10g
Mentholum 1g~10g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g.
3. a kind of honeysuckle lozenge according to claim 2 is characterized in that: in 1000:
Flos Lonicerae 1000g~1500g
Radix Ophiopogonis 400g~800g
Fructus Mume 100g~250g
Mannitol 150g~250g
Crystal sugar 200g~400g
Lactose 150g~250g
Aspartame 5g~10g
Citric acid 5g~10g
Mentholum 1g~10g
Sodium carboxymethyl cellulose 0.5g~16g
Magnesium stearate 4g~16g.
4. the preparation method of each described a kind of honeysuckle lozenge in the claims 1 to 3 is characterized in that, may further comprise the steps:
Step 1, abstraction process: be 40 ﹪~85 ﹪ alcohol reflux 1~4 time by feed liquid mass ratio 1:6~20 usefulness concentration with Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80~120 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract; Will Radix Ophiopogonis by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, extracted 0.5~2 hour, filter, merging filtrate Radix Ophiopogonis, should Radix Ophiopogonis filtrate when being concentrated into relative density and being 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Radix Ophiopogonis extract; Fructus Mume by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract;
Step 2, pretreatment procedure: take by weighing mannitol and Mentholum mix homogeneously with Mentholum equivalent, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get crystal sugar, lactose, citric acid, remaining mannitol and pulverized 80 orders~120 mesh sieves, for subsequent use; Get sodium carboxymethyl cellulose, add purified water, be configured in mass ratio concentration and be the aqueous solution of the sodium carboxymethyl cellulose of 0.2 ﹪~2 ﹪, for subsequent use;
Step 3, mixing granulation operation: extracting honeysuckle extract, Radix Ophiopogonis extract, Fructus Mume extract, aspartame, and residue mannitol, crystal sugar, lactose, citric acid behind crushing screening, mix homogeneously, take the aqueous solution of sodium carboxymethyl cellulose as binding agent, cross 20 mesh sieves and granulate and obtain granule;
Step 4, dry, granulate operation: the granule that makes is dry in 45 ℃~65 ℃ baking ovens, and the control pellet moisture is at 3 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves;
Step 5, total mixed, sheeting process: in the good granule of granulate, add magnesium stearate and process the Mentholum mixture that obtains through step 2, mixing, compression molding namely gets 1000 honeysuckle lozenge.
5. a honeysuckle lozenge is characterized in that, in 1000, raw material contains:
Flos Lonicerae 400g~3000g
Rhizoma Polygonati Odorati 500g~2000g
Fructus Mume 100g~1000g
Mannitol 100g~400g
Crystal sugar 50g~600g
Lactose 50g~450g
Aspartame 5g~12g
Citric acid 5g~12g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g;
Wherein, pharmacodynamic raw materials is Flos Lonicerae, Rhizoma Polygonati Odorati, Fructus Mume and Mentholum.
6. a kind of honeysuckle lozenge according to claim 5 is characterized in that: in 1000:
Flos Lonicerae 400g~1600g
Rhizoma Polygonati Odorati 500g~1000g
Fructus Mume 100g~550g
Mannitol 100g~250g
Crystal sugar 50g~300g
Lactose 50g~250g
Aspartame 5g~8g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
7. a kind of honeysuckle lozenge according to claim 6 is characterized in that: in 1000:
Flos Lonicerae 700g~1000g
Rhizoma Polygonati Odorati 600g~800g
Fructus Mume 200g~400g
Mannitol 200g~250g
Crystal sugar 150g~300g
Lactose 150g~250g
Aspartame 5g~8g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
8. a kind of honeysuckle lozenge according to claim 5 is characterized in that: in 1000:
Flos Lonicerae 1600g~3000g
Rhizoma Polygonati Odorati 1000g~2000g
Fructus Mume 550g~1000g
Mannitol 250g~400g
Crystal sugar 300g~600g
Lactose 250g~450g
Aspartame 8g~12g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
9. a kind of honeysuckle lozenge according to claim 8 is characterized in that: in 1000:
Flos Lonicerae 2000g~3000g
Rhizoma Polygonati Odorati 1500g~2000g
Fructus Mume 800g~1000g
Mannitol 300g~400g
Crystal sugar 450g~600g
Lactose 300g~450g
Aspartame 8g~12g
Citric acid 5g~8g
Mentholum 4g~15g
Sodium carboxymethyl cellulose 0.5g~5g
Magnesium stearate 5g~20g.
10. the preparation method of each described a kind of honeysuckle lozenge in the claim 5 to 9 is characterized in that, may further comprise the steps:
Step 1, abstraction process: be 45 ﹪~85 ﹪ alcohol reflux 1~4 time by feed liquid mass ratio 1:6~20 usefulness concentration with Flos Lonicerae, merge Flos Lonicerae extractive solution, this Flos Lonicerae extractive solution concentrating under reduced pressure Recycled ethanol is obtained the Flos Lonicerae concentrated solution, this Flos Lonicerae concentrated solution is dry, pulverize, cross 80~120 mesh sieves, it is for subsequent use to obtain Flos Lonicerae extract; Rhizoma Polygonati Odorati by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Rhizoma Polygonati Odorati filtrate, when this Rhizoma Polygonati Odorati filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Rhizoma Polygonati Odorati extract; Fructus Mume by feed liquid mass ratio 1:6~20 extracting in waters 1~5 time, was extracted 0.5~2 hour, filter, merging Fructus Mume filtrate, when this Fructus Mume filtrate is concentrated into relative density and is 80 ℃ 1.02~1.10, spray drying, it is for subsequent use to obtain Fructus Mume extract;
Step 2, pretreatment procedure: take by weighing mannitol and Mentholum mix homogeneously with Mentholum equivalent, pulverize, cross 120 mesh sieves, it is for subsequent use to obtain the Mentholum mixture; Get crystal sugar, lactose, citric acid, remaining mannitol and pulverized 80 orders~120 mesh sieves, for subsequent use; Get sodium carboxymethyl cellulose, add purified water, be configured in mass ratio concentration and be the aqueous solution of the sodium carboxymethyl cellulose of 0.2 ﹪~2 ﹪, for subsequent use;
Step 3, mixing granulation operation: extracting honeysuckle extract, Rhizoma Polygonati Odorati extract, Fructus Mume extract, aspartame, and remaining mannitol, crystal sugar, lactose, citric acid behind crushing screening, mix homogeneously, take the aqueous solution of sodium carboxymethyl cellulose as binding agent, cross 20 mesh sieves and granulate and obtain granule;
Step 4, dry, granulate operation: the granule that makes is dry in 50 ℃~65 ℃ baking ovens, and the control pellet moisture is at 3 ﹪~8 ﹪; Dried granule carries out granulate with 20 mesh sieves;
Step 5, total mixed, sheeting process: in the good granule of granulate, add magnesium stearate and through step 2 process obtain the Mentholum mixture, mixing, compression molding namely gets 1000 honeysuckle lozenge.
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