CN102657778B - Honeysuckle throat clearing tablets and preparation method thereof - Google Patents
Honeysuckle throat clearing tablets and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of medicinal preparations, and particularly relates to a honeysuckle throat clearing formula and a tablet preparation method thereof. The honeysuckle throat clearing tablets contain medicament extract and pharmaceutically acceptable diluting agent, lubricating agent and disintegrating agent. The honeysuckle throat clearing tablets prepared by the invention have a better treatment effect on acute pharyngitis.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of Flos Lonicerae moistening and cleaning throat side and method for preparing tablet thereof thereof.
Background technology
Modern medicine is thought, chronic inflammation pharynx is many to show effect repeatedly because of acute pharyngitis, because of long-term nasal obstruction mouth breathing, dental caries, habits of smoking and alcohol drinking and other bad life habits, harmful gas stimulates, general disease, as upper respiratory tract infection, digestive system disease, endocrine regulation, diabetes, anemia etc. all can be brought out primary disease.Pathological change is divided into three types: chronic simple pharyngitis, chronic hypertrophic pharyngitis and atrophic pharyngitis.
The traditional Chinese medical science is thought, when swallowing mainly due to acute pharyngitis due to wind-heat, chronic inflammation sends out, and pathogenic heat damaging YIN, deficiency of YIN of both the lung and kidney, void is scorching burns for a long time, and fiery dry Tianjin is withered, and the withered liquid in Tianjin dries up and is difficult to hold, and swallows key mistake and supports, and sarolemma is dry to wither as paraffin paper, and the dry simmer down to crust of liquid invests pharynx key, sends out as primary disease.Chronic simple pharyngitis, belongs to traditional Chinese medical science hypopyretic laryngalgia category, is main mainly with YIN-deficiency of the lung and kidney, hyperactivity of deficient fire, or remaining heresy does not disappear after being ill, deficient vital QI leading to lingering of pathogen, and touching difficulty is more.Control suitable nourishing YIN to lower pathogenic fire, relieving sore-throat by clearing away heat, strengthening vital QI to eliminate pathogenic factors.
The treatment of chronic pharyngitis, doctor trained in Western medicine is mainly applied antibiotics, painting iodine glycerol, benzoin tincture suction and laser therapy, though there is certain curative effect, not ideal enough.Atomization sucks as the conventional effectively outer treating method also more employing clinically of acute pharyngolaryngitis, but because atomization sucks many need carrying out in hospital, patient is subject to the restriction in time and space more during treating, and causes medication compliance poor, has affected therapeutic effect.There are in recent years many Chinese patent medicines, as watermelon crystal buccal tablet, Herba Pileae Scriptae Tabellae, Jinsangliyan ball, Shuanghua Compound sheet etc., all played certain effect for relief of symptoms.
The present invention intends, on the basis of existing clinical experience, using modern preparation technique, and a kind of new Flos Lonicerae moistening and cleaning throat formula and tablet thereof are provided, and said preparation is prepared to the aspects such as technique, quality controllability, pharmacodynamics and studies.
Summary of the invention
A first aspect of the present invention relates to a kind of Chinese medicine composition of Flos Lonicerae moistening and cleaning throat, and it comprises Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae;
Preferably, in this Chinese medicine composition, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae is 2 ~ 4: 2 ~ 4: 1 ~ 3: 1 ~ 3: 1 ~ 3: 1 ~ 3: 0.8 ~ 1.5: 0.5 ~ 1.5, be preferably 3: 3: 2: 2: 2: 2: 1.2: 1;
Preferably, in this Chinese medicine composition, also contain pharmaceutically acceptable adjuvant;
Preferably, described pharmaceutically acceptable adjuvant is diluent, lubricant and/or disintegrating agent;
Preferably, the dosage form of this Chinese medicine composition is granule, tablet or pill, is preferably tablet.
A second aspect of the present invention relates to a kind of Flos Lonicerae moistening and cleaning throat tablet, and it comprises drug extract, and the acceptable diluent of pharmacy, lubricant, disintegrating agent, wherein:
Described drug extract is the mixture of Flos Lonicerae extractum, Fructus Forsythiae extractum, Rhizoma Belamcandae extractum, Radix Isatidis extractum, Radix Scrophulariae extractum, Radix Ophiopogonis extractum, Radix Platycodonis extractum, Radix Glycyrrhizae extractum, or the extractum that Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae are made after mixing, be preferably water extraction extractum, the extractum that when more preferably extracting solution is concentrated into 60 DEG C, density is 1.2 ~ 1.3g/ml.
Preferably, described diluent is the mixture of starch, dextrin, lactose,
Preferably, described disintegrating agent is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose or polyvinylpolypyrrolidone, is preferably carboxymethyl starch sodium,
Preferably, described lubricant is magnesium stearate.
Wherein said drug extract refers to that medical material extracts through appropriate solvent, and extracting solution is through the dope of concentrated gained.
In a specific embodiment, described tablet also has following a) to the one or more feature in c):
A) described drug extract and the weight ratio of diluent are 0.8 ~ 1.2: 1.5 ~ 2.5, are preferably 1: 2;
B) in described drug extract, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae is 2 ~ 4: 2 ~ 4: 1 ~ 3: 1 ~ 3: 1 ~ 3: 1 ~ 3: 0.8 ~ 1.5: 0.5 ~ 1.5, be preferably 3: 3: 2: 2: 2: 2: 1.2: 1;
C) in described diluent, the weight ratio of starch, dextrin, lactose is 2 ~ 4: 1 ~ 3: 1 ~ 3, be preferably 3: 1: 1.
In a specific embodiment, in tablet of the present invention, described drug extract and the weight ratio of diluent are 0.8 ~ 1.2: 1.5 ~ 2.5, are preferably 1: 2; In described drug extract, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae is 3: 3: 2: 2: 2: 2: 1.2: 1; In described diluent, the weight ratio of starch, dextrin, lactose is 3: 1: 1.
Chinese medicine composition of the present invention or Flos Lonicerae moistening and cleaning throat tablet, its route of administration is preferably oral, comprises buccal and swallows.
A third aspect of the present invention relates to a kind of preparation method of Flos Lonicerae moistening and cleaning throat tablet, comprises the following steps:
A) extract: by Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae extracting in water, obtain water extraction liquid, the concentrated rear extractum that obtains;
B) prepare granule: after the extractum heating that step a) is obtained, add diluent, stir, with appropriate suitable wetting agent soft material processed, the granulation of sieving, the dry rear granule that obtains;
C) prepare tablet: in granule b) obtaining in step, add appropriate disintegrating agent, lubricant, mix rear tabletting.
In a specific embodiment, described step a) in:
The amount that adds water is 8 ~ 12 times of medical material weight, is preferably 10 times;
Preferably, extraction time is 1 ~ 4 time, preferably extracts 2 times;
Preferably, extraction time is 1 ~ 4 hour, preferably 2 hours;
Preferably, concentrated mode is concentrating under reduced pressure.
In a specific embodiment, described step b) in:
The temperature of extractum heating is 60 DEG C;
Preferably, described wetting agent is ethanol, is preferably concentration and is 50% alcoholic solution;
Preferably, after soft material processed, crossing 14 mesh sieves granulates;
Preferably, drying condition is 50 ~ 70 DEG C, is preferably 60 DEG C;
Preferably, also comprise the step of granulate after being dried, preferably arranging step is that dry granule is crossed to 18 order granulate.
In a specific embodiment, described step c) in:
The amount of the disintegrating agent adding be the granule that b) obtains of step weight 4 ~ 8%, be preferably 6%; The amount of the lubricant adding be the granule that b) obtains of step weight 0.5 ~ 1.5%, be preferably 1%.
The purposes that a fourth aspect of the present invention relates to, for the preparation of the purposes in the medicine for the treatment of pharyngitis.
The beneficial effect of the invention
Prescription of the present invention is better perfect, technique favorable reproducibility, and active constituent content is stable, and its tablets is convenient, has improved patient's the use of complying with.Because the viscosity of extractum is larger, while adding adjuvant, should not stir, the appropriate to the occasion caking of granulating, so the temperature to extractum and density are investigated; In order to shorten the disintegration time of tablet, the proportioning of diluent to be screened, result shows that the diluent of different proportionings is on disintegration time impact or obvious, concrete outcome is in table 1.
The present invention, by the screening to adjuvant, filters out best diluent components, lubricant composition, disintegrating agent composition, and filters out the best proportioning of active component and above-mentioned adjuvant.Wherein, add the diluent of extractum quality twice in the prescription medical material extractum that density is 1.2～1.3g/ml in the time of 60 DEG C, wherein the mass ratio of starch, dextrin, lactose is 3: 1: 1; Select additional carboxymethyl starch sodium as disintegrating agent, consumption be after granulate granule gross weight 6%; Select magnesium stearate as lubricant, consumption be after granulate granule gross weight 1%; 50% ethanol, as wetting agent, can overcome the phenomenon that soft material viscosity is large, lump, and makes the process of soft material processed convenient and easy.
Tablet of the present invention has good hardness and disintegration time, has improved the outward appearance of preparation, has improved disintegration rate, can reach the object of quick absorption.
Flos Lonicerae moistening and cleaning throat formula of the present invention and tablet thereof can make the improvement of acute pharyngitis rats breathing difficulty, oral secretion reduce, and red swelling of the pharynx transference cure, plays the effect of improving pharyngitis symptom, and acute pharyngitis is had to good therapeutical effect.
Brief description of the drawings:
The blank group of Figure 1A rat pharyngeal pathological section figure;
The pharyngeal body of gland pathological section of Figure 1B blank group rat figure;
Fig. 2 A model group rat pharyngeal pathological section figure;
The pharyngeal body of gland pathological section of Fig. 2 B model group rat figure;
Fig. 3 A positive drug group rat pharyngeal pathological section figure;
The pharyngeal body of gland pathological section of Fig. 3 B positive drug group rat figure;
Fig. 4 A Flos Lonicerae throat moistening and cleaning tablet high dose group rat pharyngeal pathological section figure;
The pharyngeal body of gland pathological section of Fig. 4 B Flos Lonicerae throat moistening and cleaning tablet high dose group rat figure;
The pharyngeal pathological section figure of dosage group rat in Fig. 5 Flos Lonicerae throat moistening and cleaning tablet;
The pharyngeal pathological section figure of Fig. 6 Flos Lonicerae throat moistening and cleaning tablet low dose group rat;
The pharyngeal pathological section figure of Fig. 7 natural recovering group rat.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example is only for the present invention is described, and should not be considered as limiting scope of the present invention.Unreceipted actual conditions person in embodiment, carries out according to the condition of normal condition or manufacturer's suggestion.The unreceipted person of production firm of agents useful for same or instrument, being can be by the conventional products of commercial acquisition.
The preparation of embodiment 1 Flos Lonicerae moistening and cleaning throat tablet
1. material
1.1 instrument DP/30 single punch tablet machinees (Beijing Gylongli Sci.&Tech. Co., Ltd.); ZB-1D Intelligent disintegration tester (Tianda Tianfa Science and Technology Co. Ltd.); Constant Temp. Oven GZX-DH-50 × 55-B5(Shanghai leap medical apparatus and instruments factory); HH/S electric-heated thermostatic water bath (Jiangsu shoal medical apparatus and instruments factory); Standard inspection sieve (manufacture of Sha Shai factory of Shangyu city of Zhejiang Province).
1.2 supplementary product starch (lot number: 10121501, pharmaceutcal corporation, Ltd of Liaoning Dongyuan County), dextrin (lot number: 10112501, pharmaceutcal corporation, Ltd of Liaoning Dongyuan County), lactose (lot number: 8509100312, pharmaceutcal corporation, Ltd of Liaoning Dongyuan County), carboxymethyl starch is received (carboxymethylsrarch sodium, CMS-Na, lot number: 20110309, Huzhou Zhanwang Pharmaceutical Co., Ltd.), crospolyvinylpyrrolidone (crospovidone, PVPP, lot number: 62533109T0, Huzhou Zhanwang Pharmaceutical Co., Ltd.), low-substituted hydroxypropyl cellulose (low-substituted hydroxypropylcellulso, L-HPC, lot number: 20110215, Huzhou Zhanwang Pharmaceutical Co., Ltd.), magnesium stearate (lot number: 20110301, Beijing Feng Lijingqiu commerce and trade Co., Ltd).
2. method
The preparation of 2.1 Flos Lonicerae moistening and cleaning throat tablet extractum
Flos Lonicerae moistening and cleaning throat prescription medical material (Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae) is added to 10 times of water gagings, extract 2 times each 2h, when water extraction liquid is evaporated to 60 DEG C, relative density is for the extractum of (1.2～1.3), for subsequent use.
The preparation of 2.2 tablets
Get the drug extract under " 2.1 " item, be heated to 60 DEG C, stir evenly, under at the uniform velocity stirring, add the diluent of extractum amount twice, with 50% appropriate amount of ethanol soft material processed, crossing 14 mesh sieves granulates, dry under 60 DEG C of conditions, cross the quality that weighs granule after 18 mesh sieve granulate in the balance, the carboxymethyl starch sodium that adds granule gross mass 6% as disintegrating agent, 1% magnesium stearate as lubricant, after mixing, use single punch tablet machine tabletting.
When temperature is low, the viscosity of extractum is larger, while adding adjuvant, should not stir; Excess Temperature destroys to some extent to the effective ingredient in extractum, considers rear final selection extractum is heated to 60 DEG C, then add adjuvant.In the time selecting drying time, be also consider dry rate and do not destroy after these two conditions of effective ingredient, be finally chosen at 60 DEG C medicinal liquid is dried.
Total consumption of 2.3 diluent is investigated
In experiment, get the drug extract under " 2.1 ", add respectively the adjuvant of 1 times, 1.5 times, 2 times amount of drug extract amount to granulate, with the complexity of soft material process processed and after sieving granule be shaped as investigation index, total consumption of diluent is investigated.
In 2.4 diluent, the consumption proportion of starch, dextrin, lactose is investigated
Starch, dextrin, lactose is the most frequently used diluent adjuvant, respectively has its pluses and minuses, normal mixing used.In order to obtain the best proportioning of diluent in this prescription medical material extractum, fixed drug extractum amount and diluent total amount, with nine kinds of different amounts proportionings of starch, dextrin, lactose in diluent, concrete proportioning is in Table 1-1.For investigation factor, carry out single factor experiment, select the best proportioning of starch in diluent, dextrin, lactose.
Concrete operations: get respectively 9 parts of concentrated extracts for subsequent use, 200 grams every part, be heated to 60 DEG C, stir companion, by table 1-1, under at the uniform velocity stirring, add respectively the diluent of the different amounts proportioning of extractum amount twice, with 50% appropriate amount of ethanol soft material processed, crossing 14 mesh sieves granulates, dry under 60 DEG C of conditions, cross the quality that weighs granule after 18 mesh sieve granulate in the balance, the carboxymethyl starch sodium that adds granular mass 6% as disintegrating agent, 1% magnesium stearate as lubricant, after mixing, use single punch tablet machine tabletting.50, the tablet of pressure sheet different time sections, randomly draws 6, measures disintegration time and hardness, calculates comprehensive index value after asking its meansigma methods.
The investigation of 2.5 disintegrating agents
Get the drug extract under " 2.1 " item, add the diluent of 2 times of extractum amounts, wherein the mass ratio of starch, dextrin, lactose is 3: 1: 1, after the preparation method granulate of the lower tablet of " 2.2 " item, add respectively the carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone of same amount as disintegrating agent, select the best disintegrating agent of disintegrate effect.
Concrete operations: get 600 grams of concentrated extracts for subsequent use, be heated to 60 DEG C, stir companion, under at the uniform velocity stirring, add the diluent (wherein starch: dextrin: the mass ratio of lactose is 3: 1: 1) of extractum quality twice, with 50% appropriate amount of ethanol soft material processed, crossing 14 mesh sieves granulates, dry under 60 DEG C of conditions, after crossing 18 mesh sieve granulate, be divided into 3 parts, the carboxymethyl starch sodium of additional same amount respectively, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone is as disintegrating agent, after mixing, use single punch tablet machine tabletting, 50, the tablet of pressure sheet different time sections, randomly draw 6, measure disintegration time and hardness, after asking its meansigma methods, calculate comprehensive index value.
The optimum amount of 2.6 orthogonal test screening disintegrating agents, lubricant, wetting agent
In order further to determine the consumption of disintegrating agent, lubricant, wetting agent, adopt optimization of orthogonal test A(disintegrating agent), B (lubricant), C(wetting agent) optimum amount in tablet.
Concrete operations: get respectively 9 parts of concentrated extracts for subsequent use, 200 grams every part, be heated to 60 DEG C, stir companion, under at the uniform velocity stirring, add the diluent (wherein starch: dextrin: the mass ratio of lactose is 3: 1: 1) of extractum amount twice, adopt the appropriate amount of ethanol soft material processed of variable concentrations (50%, 60%, 75%), crossing 14 mesh sieves granulates, dry under 60 DEG C of conditions, cross the quality that weighs granule after 18 mesh sieve granulate in the balance, add the not commensurability carboxymethyl starch sodium of granular mass and magnesium stearate, after mixing, measure angle of repose, then use single punch tablet machine tabletting.50, the tablet of pressure sheet different time sections, randomly draws 6, measures disintegration time and hardness, asks its meansigma methods.Calculate the comprehensive index value of angle of repose, disintegration time, three indexs of hardness.
2.7 investigate the mensuration of index
In experiment, select the mobility of granule, the disintegration time of tablet, three of the hardness of tablet are carried out overall merit on the larger index of tablet impact to it.Fixation pressure and sheet weight in mensuration process.
2.7.1 the calculating of aggregative indicator
In the optimization Test of many indexs, some index wants to ask its maximum, and some index is the smaller the better.In many situations, may be conflicting between these indexs, so need each index to consider and weigh in optimizing process.Therefore, design an aggregative indicator (overalldesirability, OD), each index has been unified to integrated survey, carried out intuitive analysis and variance analysis with aggregative indicator.Before calculating aggregative indicator, need first each index be standardized.Reach maximized index for wanting, as hardness, its normalization equation is di=(Yi-Ymin)/(Ymax-Ymin).Wherein Ymax and Ymin be respectively each index can received maximum and minima.Peaked selection is according to being: in the time that desired value exceedes maximum, the quality of product can not be significantly improved, and therefore, in the time that the desired value of certain each test equals or exceeds Ymax, is 1 by di.On the contrary, in the time that certain desired value is equal to or less than Ymin, di is 0.For carrying out minimized index, as disintegration time, angle of repose etc., its normalization equation is di=(Ymax-Yi)/(Ymax-Ymin).Now, in the time that actual measurement desired value equals or exceeds the maximum of setting, di is 0.In the time that measured value is equal to or less than Ymin, di is 1.According to test objective and result of the test, select the minimum and maximum value of investigating index.Going out after the normalized value of each index according to normalization Equation for Calculating, calculate aggregative indicator OD=(d1+d2+d3...dk)/k.The maximum that each observation index is set and minima are in Table 1-5.
2.7.2 the mensuration of mobility of particle
Granule is placed in the funnel above the mid point that is fixed on circular culture dish, the radius of culture dish is r, and granule flows out from funnel, until particle packing is overflowing from plate upper limb.Measure the summit of granuloplastic cone to the height h of plate upper limb, angle of repose, α was calculated by following formula: tan α=h/r.
2.7.3 the mensuration of disintegration of tablet time
Get the Flos Lonicerae moistening and cleaning throat tablet of each group of test, get 6 for every group, measure by " Chinese Pharmacopoeia " version annex X II A inspection technique disintegration in 2010, record disintegration time, average.
2.7.4 the mensuration of tablet hardness
Get the test Flos Lonicerae moistening and cleaning throat tablet of each group, get 6 for every group, put tablet hardness instrument and measure, read not the hardness of tablet on the same group, get in every group the meansigma methods of 6 as the hardness of this group tablet, record numerical value.
2.8 demonstration test
Flos Lonicerae moistening and cleaning throat tablet formulation and preparation technology three batches of Flos Lonicerae moistening and cleaning throat tablet samples are prepared by best testing program in order further to verify.
Concrete operations: get the drug extract under " 2.1 " item, add the diluent of 2 times of extractum amounts, wherein the mass ratio of starch, dextrin, lactose is 3: 1: 1, with 50% appropriate amount of ethanol soft material processed, crosses 14 mesh sieves and granulates, dry under 60 DEG C of conditions, cross the quality that weighs granule after 18 mesh sieve granulate in the balance, the carboxymethyl starch sodium of additional granular mass 6% as disintegrating agent, 1% magnesium stearate as lubricant, after mixing, measure angle of repose, then use single punch tablet machine tabletting.50, the tablet of pressure sheet different time sections, randomly draws 6, measures disintegration time and hardness, asks its meansigma methods.Calculate the comprehensive index value of angle of repose, disintegration time, three indexs of hardness.
3. result
3.1 extractum and diluent proportioning result
While adding the adjuvant of 1 times of amount in prescription medical material extractum (60 DEG C of relative densities are 1.2～1.3), the too rare and sticky hands of soft material, granule is shapeless; While adding the adjuvant of 1.5 times of amounts, soft material glues screen cloth, and granule is strip; While adding the adjuvant of 2 times of amounts, soft material can reach gently pinch agglomerating, that locate and loose state and sieving easily, shaping particles is better, so select the adjuvant soft material processed of 2 times of amounts of extractum.
The selection result of 3.2 diluent
By the comparison to disintegration of tablet time, hardness and comprehensive index value in nine groups of single factor experiments, in diluent, the mass ratio of starch, dextrin, lactose is that while testing proportioning 1,2,4, No. 8 in table 1-1, hardness level is undesirable; In diluent, the mass ratio of starch, dextrin, lactose is that while testing proportioning 3,5,6, No. 9 in table 1-1, although tablet hardness meets the requirements, the disintegration time of tablet is long; In diluent, the mass ratio of starch, dextrin, lactose is 3: 1: 1 o'clock, and the hardness of tablet is moderate and disintegration time is the shortest, comprehensive index value maximum.
The selection result of 3.3 disintegrating agents
After disintegrating agent carboxymethyl base Starch Sodium by additional equal in quality, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium is during as disintegrating agent, and disintegration time is the shortest and hardness is moderate, and comprehensive index value maximum, the results are shown in Table 1-2.
The selection result of 3.4 disintegrating agents, lubricant, wetting agent
Disintegrating agent (A), lubricant (B), wetting agent (C) they are A > B > C on the size order that affects of tablet quality, but there are no significant difference.The best testing program of orthogonal test gained is A
2b
2c
3, disintegrating agent carboxymethyl base Starch Sodium be after granulate granular mass 6%, magnesium stearate lubricant be after granulate granular mass 1%, when selecting 50% ethanol, wetting agent can overcome soft material viscosity large, the phenomenon of caking, makes the process of soft material processed convenient and easy, the results are shown in Table 1-3 and table 1-4.
3.5 demonstration test results
Demonstration test result shows three batches of Flos Lonicerae moistening and cleaning throat tablets of preparation, and the angle of repose of granule, the disintegration time of tablet, hardness and comprehensive index value convergence are consistent, and obtained experimental result favorable reproducibility is described, stable preparation process, result is satisfactory, and formulation optimization success is described, the results are shown in Table 1-6.
Table 1-1 diluent the selection result
Table 1-2 disintegrating agent the selection result
Table 1-3 orthogonal experiment plan is taken into account interpretation of result
Note: K1 represents when each factor is got first level, the result of the test sum of each corresponding factor.
K2 represents when each factor is got second level, the result of the test sum of each corresponding factor.
K2 represents when each factor is got the 3rd level, the result of the test sum of each corresponding factor.
R represents the size of each factor on experimental result impact.
Table 1-4 the results of analysis of variance
Maximum and minima that the each observation index of table 1-5 is set
Table 1-6 demonstration test result
Pharmaceutical necessities is the material base that pharmaceutical preparation exists, and selects to be applicable to the required adjuvant of own trituration according to the dosage form of the physicochemical property of medicine and selection.Adjuvant has significant effect for slow, the controlled release of the raising of the improvement of preparation performance, bioavailability and medicine etc.Screen by the prescription to preparation, in experimentation, pass through to change quality and the proportioning of starch, dextrin, lactose in diluent, although learn that the kind of diluent used is identical, but because formability and the disintegration time of ratio difference on preparation has larger impact, that experimental data demonstration disintegration time is the shortest is 15.6min, and that the longest is 23.5min.Accelerate absorption rate in order to shorten disintegration time, in experimentation, add as disintegrating agent.In the time that disintegrating agent consumption is identical, disintegration rate is addition in the inside and outside addition > of outer addition >, but dissolution rate is the outer addition of addition > in inside and outside addition >.In Flos Lonicerae moistening and cleaning throat prescription, active ingredient is water solublity and contains polysaccharide composition, and viscosity is larger, so disintegration rate is the most important condition of its absorption, therefore, selects the method for additional disintegrating agent to shorten disintegration time.
The present invention investigates by the total consumption to adjuvant, finally determines the twice that supplementary product consumption is extractum.The amount ratio of finally determining starch, dextrin, lactose in diluent by nine groups of single factor experiments is 3: 1: 1.Investigate by total class and consumption to disintegrating agent, lubricant, select carboxymethyl starch sodium as disintegrating agent, adopt arrange after additional mode add, consumption be after granulate granule gross weight 6%; Select magnesium stearate as lubricant, consumption be after granulate granule gross weight 1%.
Embodiment 2 Flos Lonicerae moistening and cleaning throat tablet pharmacodynamic studies
1. material
1.1 animal Wistar rats, male and female half and half, body weight 200 ± 20g(PLA General Hospital Experimental Animal Center provides).
1.2 medicines and reagent Herba Pileae Scriptae Tabellae (Jiangzhong Pharmaceutical Factory, Jiangxi Prov is produced. and No. (1996) 07300l, the accurate space of medicine are defended in Jiangxi) lot number: 20100412; Flos Lonicerae throat moistening and cleaning tablet (PLA General Hospital Drug Manufacturing Room provide) lot number: 20100625; Ammonia (Beijing Chemical Plant) lot number: 20090401, concentration 25%～28%; Chloral hydrate (Chinese People's Liberation Army General Hospital produces, always No. (2006) B01043, word processed) lot number: 20100408.
1.3 instrument laryngeal sprays: Taizhou City Hui Chun Medical Devices Co., Ltd. manufactures, No. 1050003rd, the safe food of element medicine prison tool (standard) word 2010, XE-2100 cellanalyzer (Japan manufactures), blood taking tube, self-control spatula.
2. method
The foundation of 2.1 acute pharyngitis animal models
Adopt the method for the pharyngeal spraying of ammonia to set up the acute pharyngitis animal model of Wistar rat.
Concrete operations: grab after steady rat, push down the tongue of rat with spatula, expose pharyngeally, the ammonia that is 15% to its pharyngeal spray concentration with laryngeal spray sprays 3 times at every turn, each spray morning and afternoon every day once, continuous spraying 3 days.
2.2 grouping and administrations
Wistar rat is divided into 7 groups at random, 8 every group, is respectively modeling group, natural recovering group (only spraying not administration of ammonia), blank group, positive drug group (Herba Pileae Scriptae Tabellae), the high, medium and low dosage group of Flos Lonicerae throat moistening and cleaning tablet.Taking 60kg people as standard, calculate rat dosage with reference to body surface area dosage scaling method by clinical application.Positive drug group (Herba Pileae Scriptae Tabellae) 420mg ﹒ kg
-1﹒ d, Flos Lonicerae throat moistening and cleaning tablet high dose group 840mg ﹒ kg
-1﹒ d, dosage group 420mg ﹒ kg in Flos Lonicerae throat moistening and cleaning tablet
-1﹒ d, Flos Lonicerae throat moistening and cleaning tablet low dose group 210mg ﹒ kg
-1﹒ d, Herba Pileae Scriptae Tabellae and Flos Lonicerae throat moistening and cleaning tablet are all used distilled water wiring solution-forming, spray delivery after modeling, morning and afternoon every day respectively once, continuously spray delivery 4 days.
2.3 indexs detect
2.3.1 auxiliary characteristics
Experimental session, the each treated animal apparent condition of observed and recorded every day and drinking-water situation, observe the pharyngeal situation of animal every day 1 time, comprises mucosa form, color and luster etc.
2.3.2 objective indicator
Rat pharyngeal mucosa and undertissue's section thereof are made to PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM, and each treated animal is put to death front eye socket and is got blood survey routine blood test.
Concrete operations: model group animal: the 4th day morning, eye socket was got blood survey routine blood test; Blank group: the 4th day eye socket got blood and surveyed routine blood test; Natural recovering group: the 9th day eye socket got blood and surveyed routine blood test; Positive drug group: the 8th day eye socket got blood and surveyed routine blood test; The high, medium and low dosage group of Flos Lonicerae throat moistening and cleaning tablet, the 8th day eye socket got blood and surveyed routine blood test, and each treated animal eye socket is got after blood, and the chloral hydrate solution 0.7ml of lumbar injection 10%, after Animal Anesthesia, takes off pharyngeal mucosa and undertissue makes sections observation.
2.4 statistical method
Data information all adopts SPSS17.0 statistical software to carry out statistical analysis, and data information adopts two sample t inspections, with
represent.
3. result
3.1 characterize observation
After modeling 1 day, rat engenders that the oral area of scratching, dyspnea are with “ Snore Snore " symptom such as sound, oral secretion increase, amount of drinking water increases, within the 3rd day, symptom is more obvious; There is not above-mentioned situation in blank group; Through the Drug therapy of 4 days, high, the middle dosage group of Flos Lonicerae throat moistening and cleaning tablet and Herba Pileae Scriptae Tabellae group above-mentioned symptom disappeared substantially, and it is normal that sign is recovered substantially; Flos Lonicerae throat moistening and cleaning tablet low dose group above-mentioned symptom alleviates to some extent; Natural recovering group 4 days above-mentioned symptom and signs after modeling still exist.
3.2 routine blood test indexs change
After modeling, model treated animal blood medium-sized lymphocyte quantity increases, and neutrophilic granulocyte quantity reduces, but compares there was no significant difference (P>0.05) with blank group; After the Drug therapy of 4 days, positive drug group, the each treated animal blood of high, the middle dosage of Flos Lonicerae moistening and cleaning throat medium-sized lymphocyte quantity decrease than model group lymphocyte quantity, neutrophilic granulocyte quantity increases to some extent, but with blank group and model group relatively there are no significant difference (P>0.05), concrete outcome is in Table 2-1.
The conventional variation of seven groups of rat serum of table 2-1 (
n=8)
3.3 histopathological findings
Under blank treated animal pharyngeal pathological section mirror, show: throat organizes body of gland in the slight keratinization of epithelium, mucosa loose connective tissue, and blood vessel often has no, and the results are shown in Figure 1A and Figure 1B.
Under model group animal pharyngeal pathological section mirror, show: a large amount of keratinization of pharyngeal epithelium, mucosa, in connective tissue, body of gland tails off, vasodilation, hyperemia, edema, a large amount of cell infiltration, the necrosis of mucous gland epithelial cell, downright bad mucous gland body formation cavity or structureless mucus are netted, the results are shown in Figure 2A and Fig. 2 B.
Under positive drug group and Flos Lonicerae moistening and cleaning throat high dose group animal pharyngeal pathological section mirror, show: throat organizes body of gland in the slight keratinization of epithelium, mucosa loose connective tissue to increase, slightly expansion, blood vessel no abnormality seen, the results are shown in Figure 3A and Fig. 3 B, Fig. 4 A and Fig. 4 B.
In Flos Lonicerae moistening and cleaning throat, under dosage treated animal pharyngeal pathological section mirror, show: body of gland mile abnormality in throat's tissue is slight cornu cutaneum, mucosa loose connective tissue, blood vessel is slightly expanded, and the results are shown in Figure 5.
Under Flos Lonicerae moistening and cleaning throat low dose group animal pharyngeal pathological section mirror, show: throat organizes top layer squamous epithelial cancer keratinization, mucosa, nuclear staining is dark, and body of gland reduces, and little vasodilation, hyperemia, edema, the results are shown in Figure 6.
Under natural recovering group animal pharyngeal pathological section mirror, show: throat organizes a large amount of keratinization of top layer squamous epithelial cancer, mucosa, nuclear staining is dark, and body of gland reduces, visible a large amount of downright bad, little vasodilation, hyperemia, edema, visible inflammatory cell infiltrates, and the results are shown in Figure 7.
Acute pharyngitis is a kind of common clinical, frequently-occurring disease.Zest chemical gas is one of its paathogenic factor.Accordingly, applicant selects Wistar rat, the animal model with ammonia at the method development acute pharyngitis of pharyngeal spraying.This experiment determines that whether model is successful, is to judge from sign performance, routine blood test index and the pharyngeal pathological change three aspects: of animal.
With ammonia modeling after 1 day, rat engenders that the oral area of scratching, dyspnea are with “ Snore Snore " symptom such as sound, oral secretion increase, amount of drinking water increases; within the 3rd day, symptom is more obvious, close with the diagnostic criteria of primary disease in " guideline of clinical investigations of new Chinese medicine treatment acute pharyngitis "; After modeling, pharyngeal tissue pathological slice result shows the outer keratinization of mucous epithelium of pharynx tissue, the obvious hypertrophy of mucous epithelium layer, tela submucosa is very thin, with lamina propria without obvious demarcation line, little vasodilation in lamina propria, hyperemia, edema, the necrosis of part mucous gland epithelial cell, forms cavity or structureless mucus netted, lamina propria region and sticky crossing between gland have a large amount of inflammatory cell infiltrations, basically identical with the pathological manifestations of Clinical Acute pharyngitis.After modeling, blood lymphocyte quantity increases to some extent, and neutrophilic granulocyte quantity decreases, and these results all illustrate the success of acute pharyngitis model manufacturing.
Herba Pileae Scriptae Tabellae is the active drug for the treatment of acute pharyngitis, therefore sets it as positive drug.After modeling, through the recovery of 4 days, the performance of the sign of natural recovering group rat did not have clear improvement, and pharyngeal pathological section result shows consistent with model group, illustrated that pathological changes fails recovery; After modeling, after the Flos Lonicerae moistening and cleaning throat tablets of 4 days and Herba Pileae Scriptae Tabellae treatment, high, the middle dosage group of Flos Lonicerae moistening and cleaning throat tablet and positive drug group rats breathing are normal, oral secretion reduces, pharyngeal pathological changes is corrected substantially, Flos Lonicerae moistening and cleaning throat low dose group symptom is improved not obvious, and these results all illustrate that high, the middle dosage of Flos Lonicerae moistening and cleaning throat tablet of the present invention has good therapeutical effect to acute pharyngitis.
The present invention, by observing the symptom and sign of rat, learns that Flos Lonicerae moistening and cleaning throat tablet of the present invention can make the improvement of acute pharyngitis rats breathing difficulty, oral secretion reduce, and red swelling of the pharynx transference cure, plays the effect of improving pharyngitis symptom; Learn the reaction that can cause inflammation of the method for ammonia spraying by analyzing routine blood test medium-sized lymphocyte, neutrophilic granulocyte number change; By more blank group, model group, positive drug group, the high, medium and low dosage group of Flos Lonicerae moistening and cleaning throat tablet, natural recovering group rat pharyngeal pathological section is learnt Herba Pileae Scriptae Tabellae, and the Flos Lonicerae moistening and cleaning throat tablet of middle and high dosage has good therapeutical effect to acute pharyngitis.
Claims (29)
1. a Flos Lonicerae moistening and cleaning throat tablet, it comprises drug extract, and the acceptable diluent of pharmacy, lubricant and disintegrating agent, wherein:
Described drug extract is the mixture of Flos Lonicerae extractum, Fructus Forsythiae extractum, Rhizoma Belamcandae extractum, Radix Isatidis extractum, Radix Scrophulariae extractum, Radix Ophiopogonis extractum, Radix Platycodonis extractum, Radix Glycyrrhizae extractum, or the extractum that Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae are made after mixing, in described drug extract, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae raw material is 2～4 ﹕ 2～4 ﹕ 1～3 ﹕ 1～3 ﹕ 1～3 ﹕ 1～3 ﹕ 0.8～1.5 ﹕ 0.5～1.5;
Described drug extract and the weight ratio of diluent are 0.8～1.2 ﹕ 1.5～2.5;
In described diluent, the weight ratio of starch, dextrin, lactose is 2～4 ﹕ 1～3 ﹕ 1～3.
2. the tablet of claim 1, wherein said extractum is water extraction extractum.
3. the tablet of claim 2, the extractum that when wherein said the water extracted immersing paste is 60 DEG C, density is 1.2～1.3g/ml.
4. the tablet of claim 1, wherein said diluent is the mixture of starch, dextrin, lactose.
5. the tablet of claim 1, wherein said disintegrating agent is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose or polyvinylpolypyrrolidone.
6. the tablet of claim 1, wherein said lubricant is magnesium stearate.
7. the tablet of claim 1, is characterized in that,
In described drug extract, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae is 3 ﹕ 3 ﹕ 2 ﹕ 2 ﹕ 2 ﹕ 2 ﹕ 1.2 ﹕ 1.
8. the tablet of claim 1, is characterized in that following a) to the one or more feature in b):
A) described drug extract and the weight ratio of diluent are 1 ﹕ 2;
B) in described diluent, the weight ratio of starch, dextrin, lactose is 3 ﹕ 1 ﹕ 1.
9. the tablet of claim 1, wherein said drug extract and the weight ratio of diluent are 0.8～1.2 ﹕ 1.5～2.5;
In described drug extract, the weight ratio of Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae is 3 ﹕ 3 ﹕ 2 ﹕ 2 ﹕ 2 ﹕ 2 ﹕ 1.2 ﹕ 1;
In described diluent, the weight ratio of starch, dextrin, lactose is 3 ﹕ 1 ﹕ 1.
10. the tablet of claim 1 to 9 any one, its route of administration is oral.
The tablet of 11. claim 1 to 9 any one, its route of administration is buccal or swallows.
The preparation method of the tablet of 12. 1 kinds of claim 1 to 11 any one, comprises the following steps:
A) extract: by Flos Lonicerae, Fructus Forsythiae, Rhizoma Belamcandae, Radix Isatidis, Radix Scrophulariae, Radix Ophiopogonis, Radix Platycodonis, Radix Glycyrrhizae extracting in water, obtain water extraction liquid, the concentrated rear extractum that obtains;
B) prepare granule: after the extractum heating that step a) is obtained, add diluent, stir, with appropriate suitable wetting agent soft material processed, the granulation of sieving, the dry rear granule that obtains;
C) prepare tablet: in granule b) obtaining in step, add appropriate disintegrating agent, lubricant, mix rear tabletting.
The preparation method of 13. claim 12, described step a) in:
The amount that adds water is 8～12 times of medical material weight.
The preparation method of 14. claim 12, described step a) in: the amount that adds water is 10 times of medical material weight.
The preparation method of 15. claim 12, described step a) in, extraction time is 1～4 time.
The preparation method of 16. claim 12, described step a) in, extraction time is 2 times.
The preparation method of 17. claim 12, described step a) in, extraction time is 1～4 hour.
The preparation method of 18. claim 12, described step a) in, extraction time is 2 hours.
The preparation method of 19. claim 12, described step a) in, concentrated mode is concentrating under reduced pressure.
The preparation method of 20. claim 12, described step b) in:
The temperature of extractum heating is 60 DEG C.
The preparation method of 21. claim 12, described step b) in: described wetting agent is ethanol.
The preparation method of 22. claim 12, described step b) in: described wetting agent is that concentration is 50% alcoholic solution.
The preparation method of 23. claim 12, described step b) in: after soft material processed cross 14 mesh sieves granulate.
The preparation method of 24. claim 12, described step b) in: drying condition is 50～70 DEG C.
The preparation method of 25. claim 12, described step b) in: drying condition is 60 DEG C.
The preparation method of 26. claim 12, described step b) in: the step that also comprises granulate after dry.
The preparation method of 27. claim 26, described granulate step is that dry granule is crossed to 18 order granulate.
The preparation method of 28. claim 12, described step c) in:
The amount of the disintegrating agent adding be the granule that b) obtains of step weight 4～8%; The amount of the lubricant adding be the granule that b) obtains of step weight 0.5～1.5%.
The preparation method of 29. claim 12, described step c) in:
The amount of the disintegrating agent adding be the granule that b) obtains of step weight 6%; The amount of the lubricant adding be the granule that b) obtains of step weight 1%.
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| CN1739677A (en) * | 2005-08-25 | 2006-03-01 | 叶耀良 | Houjiling prepn for treating throat diseases and its use |
| WO2011000150A1 (en) * | 2009-06-30 | 2011-01-06 | 河北以岭医药研究院有限公司 | A medicinal composition for the treatment of bronchitis and preparation thereof |
| CN101947285B (en) * | 2010-08-30 | 2012-01-04 | 刘利霞 | Buccal tablet for treating chronic pharyngitis |
| CN102406827B (en) * | 2010-11-25 | 2014-06-25 | 中国人民解放军第四军医大学 | Pharyngitis chewable tablets and molding process thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1739677A (en) * | 2005-08-25 | 2006-03-01 | 叶耀良 | Houjiling prepn for treating throat diseases and its use |
| WO2011000150A1 (en) * | 2009-06-30 | 2011-01-06 | 河北以岭医药研究院有限公司 | A medicinal composition for the treatment of bronchitis and preparation thereof |
| CN101947285B (en) * | 2010-08-30 | 2012-01-04 | 刘利霞 | Buccal tablet for treating chronic pharyngitis |
| CN102406827B (en) * | 2010-11-25 | 2014-06-25 | 中国人民解放军第四军医大学 | Pharyngitis chewable tablets and molding process thereof |
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