CN101695512B - Banlangen buccal tablet and preparation method thereof - Google Patents
Banlangen buccal tablet and preparation method thereof Download PDFInfo
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- CN101695512B CN101695512B CN2009100663193A CN200910066319A CN101695512B CN 101695512 B CN101695512 B CN 101695512B CN 2009100663193 A CN2009100663193 A CN 2009100663193A CN 200910066319 A CN200910066319 A CN 200910066319A CN 101695512 B CN101695512 B CN 101695512B
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Abstract
The invention relates to a Banlangen buccal tablet and a preparation method thereof. The Banlangen buccal tablet contains the following components: 80-120 parts of Banlangen, 10-45 parts of flavouring agent, 0.1-1 part of lubricating agent and 120-170 parts of golden buckwheat rhizome. The preparation method comprises the following steps of: during production, weighing the banlangen firstly, decocting twice by adding water, merging decoction, filtering, concentrating the filtrate until the density is 1.05-1.25g/cm<3>, adding ethanol to ensure that the content of the ethanol reaches 50-60 percent, standing, taking supernate, recycling the ethanol and concentrating to form an extract with the density of 1.30-1.33g/cm<3>; adding the flavouring agent and the lubricating agent, uniformly mixing, drying, crushing, adding ethanol granulations, drying for the second time until the water content ranges from 1.5 to 5 percent, and finally tabletting. The buccal tablet can be used for preventing and treating viral influenza, reaches the cure rate of 64.6 percent when used for treating acpuei pharyngitis, chronic pharyngitis, acute tonsillitis and other diseases, achieves the total effective rate of 97.6 percent, has good durative effect which is obviously better than that of like products, is convenient to take and is suitable for various crowds.
Description
One, technical field:
The present invention relates to a kind of Chinese medicine composition, particularly relate to a kind of Banlangen buccal tablet and preparation method thereof.
Two, background technology:
Radix Isatidis has the effect of anti-influenza, antiviral, heat-clearing and toxic substances removing and removing heat from blood sore-throat relieving; But mostly prior dosage form is granule, tablet, oral liquid etc.; Granule carries and take equal inconvenience, and is short in Local Residence Time such as oral cavity, throats during tablets, is unfavorable for eliminating oral cavity, pharyngeal pathogen; Be difficult to alleviate local inflammation, curative effect is not obvious.
Notification number is that CN1233399C, the patent No. are that 200310119261.7 patent document discloses a kind of isatis root effervescence tablet agent and preparation method thereof; This method adopts microwave extracting and alcohol deposition method to obtain Radix Isatidis effective site; Adopt ethylene glycol parcel carbon dioxide source, need microwave extracting, technology is complicated; The effective ingredient content that makes is not high, awaits improving.
Three, summary of the invention:
The technical problem that the present invention will solve is: provide that a kind of drug effect is better, clinical practice is convenient, suitable crowd is wide, the Banlangen buccal tablet that especially suitable child uses;
The present invention also provides the method for preparing of this Banlangen buccal tablet.
Technical scheme of the present invention:
A kind of Banlangen buccal tablet contains following bulk drugs, Radix Isatidis 80-120 part, correctives 10-45 part, lubricant 0.1-1 part.
Described Banlangen buccal tablet also contains Rhizoma Fagopyri Dibotryis 120-170 part.
Said correctives is the mixture that mannitol or sorbitol 5-30 part, sucrose 9-15 part, aspartame 0.5-2.5 part, Mentholum 0.1-1 part are formed, and said lubricant is the mixture that silicon dioxide 0.05-0.5 part, magnesium stearate 0.05-0.5 part are formed.
Said correctives is the mixture that mannitol or sorbitol 5-30 part, aspartame 1-5 part and Mentholum 0.1-1 part are formed, and said lubricant is the mixture that silicon dioxide 0.05-0.5 part and magnesium stearate 0.05-0.5 part are formed.
Radix Isatidis 90-110 part in the described Banlangen buccal tablet.
Radix Isatidis 90-110 part, Rhizoma Fagopyri Dibotryis 130-160 part in the described Banlangen buccal tablet.
Also contain correctives citric acid 0.3-1.8 part in the described Banlangen buccal tablet.
The production method of said Banlangen buccal tablet, step is: take by weighing the mixture of Radix Isatidis or Radix Isatidis and Rhizoma Fagopyri Dibotryis, the decocte with water secondary; Add for the first time the water that 7-9 doubly measures, decoct 2-3h, add the water that 5-7 doubly measures for the second time; Decoct 1-2h; Merge decoction liquor twice, filter, filtrating is concentrated into density 1.05-1.25g/cm
3, add ethanol and make the ethanol mass content reach 50-60%, leave standstill and make deposition, get supernatant, reclaim ethanol, being condensed into density is 1.30-1.33g/cm
3Clear paste; In said clear paste, add correctives, lubricant, mix homogeneously, drying is pulverized, and sieves, and adds alcohol granulation, and redrying to moisture mass content is between 1.5-5%, and tabletting promptly gets Banlangen buccal tablet.
Said baking temperature is 40-60 ℃, and the order number is the 80-100 order during said sieving, and the weight ratio that adds the amount of alcohol and the back medicine that sieves during granulation is 6-12%.
Pharmacology analysis of the present invention:
Radix Isatidis is called indigo-blue, Isatis indigotica Fort (Indigofera tinctoria L, Baphicanthus cusia (nees) Brem. Polygonum tinctorium Ait) root, indigo root; Feeble QI, little sweet back of distinguishing the flavor of is pained.Cold in nature, hardship, GUIXIN, stomach warp; Cure mainly heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, sore-throat relieving eliminating stagnation.
Rhizoma Fagopyri Dibotryis: antipyretic, another name Herba Polygoni cymosi, day Semen Fagopyri Esculenti, Radix Et Rhizoma Fagopyri Tatarici, Radix Et Rhizoma Fagopyri Tatarici; Cool in nature, little suffering, puckery is returned lung meridian; Cure mainly heat-clearing and toxic substances removing, removing heat from the lung and dissipating phlegm is used for the cough due to lung-heat, and laryngopharynx swelling and pain has the effect of removing heat from the lung and dissipating phlegm, throat.
After the two share with Radix Isatidis and Rhizoma Fagopyri Dibotryis, drug effect was complementary, except the function of having strengthened Radix Isatidis heat clearing away, detoxifcation, sore-throat relieving eliminating stagnation, treatment laryngopharynx swelling and pain, had also increased the new effect of clearing away lung-heat, relieving cough and resolving phlegm, and the compatibility effect is obvious.
Positive beneficial effect of the present invention:
(1) Banlangen buccal tablet of the present invention, the employing Radix Isatidis is a main component, is equipped with suitable excipients and processes buccal tablet; Make full use of the effect of Radix Isatidis heat-clearing and toxic substances removing, removing heat from blood sore-throat relieving, medicine prolongs in Local Residence Time such as oral cavity, throats during containing, and buccal tablet is slowly dissolving in the oral cavity; Absorb through Sublingual and oral mucosa, help the improvement of local symptom, have advantages such as absorption is fast, onset is rapid, no liver first-pass effect; Better than oral formulations drug effects such as existing Radix Isatidis granule, tablet and oral liquids; Use more conveniently, can prevent and treat viral influenza, especially laryngopharyngeal diseasess such as tonsillitis, parotitis and laryngopharynx swelling and pain are had clinical effectiveness preferably; Clinical trial shows; Banlangen buccal tablet reaches 64.6% to the cure rate of diseases such as treatment acute pharyngitis, chronic pharyngitis, acute tonsillitis, and total effective rate reaches 97.6%, and curative effect obviously is superior to like products such as Herba Pileae Scriptae Tabellae.
(2) after the two share with Radix Isatidis and Rhizoma Fagopyri Dibotryis, than single during with Radix Isatidis dosage reduce relatively, except strengthening Radix Isatidis heat clearing away, detoxifcation, sore-throat relieving eliminating stagnation, treat outside the function of laryngopharynx swelling and pain, also increased the effect of clearing away lung-heat, relieving cough and resolving phlegm; Synergism is remarkable, and suitable crowd is wider.
(3) have only identification qualitatively in the existing Radix Isatidis granule quality standard, do not have quantitative levels to measure.The quality standard of Banlangen buccal tablet of the present invention not only has identification qualitatively, but two indexs of also quantitative assay nitrogen content and indirubin content help quality control, can guarantee product quality.
The main performance index of product of the present invention and relevant test data.
(4) the present invention is except that selecting main component, and through meticulous screening adjuvant, the buccal tablet mouthfeel that adopts suitable method to prepare is good, does not have abnormal flavour, and the patient takes like a shot, and is particularly suited for children taking.In the high-incidence season of epidemic virus flu, can carry, compare with granule and take more conveniently, be that the ideal of flu prophylactic is selected.In addition, this buccal tablet is compared with oral formulations, also has storage, the more convenient characteristics of transportation.
(5) buccal tablet of the present invention shows through acute toxicity test, and toxicity is little, and safety range is big, is convenient to promote.
Clinical statistics data of the present invention:
This statistical data is the use contrast situation of Banlangen buccal tablet and Herba Pileae Scriptae Tabellae.
This observation group observes patient's 596 examples altogether, Banlangen buccal tablet group 422 examples wherein, Herba Pileae Scriptae Tabellae (pharmaceutical factory produces in the river) group 172 examples.Male's 404 examples wherein, women's 192 examples.The range of age was from 5 years old to more than 70 year old.Mostly the state of an illness is laryngopharyngeal diseasess such as acute pharyngitis, chronic pharyngitis acute stage, acute tonsillitis; The course of disease does not wait from 1 day by 7 days, has comparability between two groups of patients' age, the course of disease, the sex.
Group technology: case sum 596 examples are divided into treatment group (Banlangen buccal tablet group) 422 example and matched group (Herba Pileae Scriptae Tabellae group) 172 examples at random.
1, method of administration
The Banlangen buccal tablet group: each 1～2 containing, 10～20 of every days, 7 days was 1 course of treatment, write down patients clinical symptom and sign every day.
The Herba Pileae Scriptae Tabellae group: each 1～2 containing, 10～20 of every days, 7 days was 1 course of treatment, write down patients clinical symptom and sign every day.
2, observed and recorded method
By the clinical study design requirement, unified form is made itemized record, conscientiously finishes writing case.Should note observing untoward reaction, and tracing study.After the off-test, can not alter case history arbitrarily.
3, statistical result
Statistics adopts the Ridit analytic process, and statistical data is handled through Ridit, u=12.96, P＜0.01.Can find out that from above-mentioned statistical result the Banlangen buccal tablet curative effect obviously is superior to Herba Pileae Scriptae Tabellae.
4, model case
(1) Meng XX, man, 48 years old, cadre, the Dong Minglu of Zhengzhou City.Red 2 days of dry laryngopharynx, red and swollen heat pain, body of the tongue limit point.The chronic pharyngitis medical history is previously arranged.Dialectical is the anemopyretic acute pharyngitis, and treatment is with heat-clearing and toxic substances removing, and the removing heat from blood relieving sore throat and diminishing swelling gives Banlangen buccal tablet of the present invention, each 2, advise its polydipsia water every day 5 times, and pastille 4 days, symptom is obviously improved, and continues again to take medicine, and treats clinical recovery 7 days.
(2) open XX, woman, 26 years old, cadre, healthy road, Luoyang City.Because of heating, pharyngeal pain, drying, scorching hot, pharyngeal odynophagia, it is many to play pharyngeal secretions morning, companion's retch prescription on individual diagnosis of being admitted to hospital in 2 days.Be diagnosed as acute pharyngitis, give containing of Banlangen buccal tablet of the present invention, every day containing 10-20 sheet, logotype 4 days, above-mentioned symptom disappears, body temperature is normal, the pharyngeal cavity of having a medical check-up does not have hyperemia, routine blood test is normal, cures.
(3) king X, man, 23 years old, university students, the scape Hua Lu of Luoyang City.Because of the pharyngeal prescription on individual diagnosis of being admitted to hospital in 1 day of swelling and ache, be diagnosed as acute pharyngitis (anemopyretic), give Banlangen buccal tablet of the present invention, each 2, serve on 3 days every day 5 times, above-mentioned symptom obviously alleviates, and body temperature is normal.One week back check pharyngeal cavity does not have obvious hyperemia, and all diseases are known and removed and recover.
(4) model X, woman, 14 years old, student, Zhengzhou City's Jinshui District.Because of the pharyngeal prescription on individual diagnosis of being admitted to hospital in 1 day of swelling and ache.Examine and be acute pharyngitis, give Banlangen buccal tablet of the present invention, every day containing 10-20 sheet, logotype 4 days.Transference cure, body temperature is normal, and pharyngeal cavity does not have hyperemia when having a medical check-up, and recovers.
(5) Lee X, man, 29 years old, Zhengzhou City's latitude five tunnel.Because of there was an abrupt change in weather, the heresy that is affected by the cold is just felt dry pharynx, pharyngeal the swelling and ache of continuing, dysphagia, pain, heating when swallowing, 38.5 ℃ of body temperature.Be diagnosed as acute tonsillitis.Give Banlangen buccal tablet of the present invention, each 2,2 hours 1 time, every day containing 10-20 sheet, logotype 3 days.The pharyngeal pain symptom of patient disappears, and secretions disappears on the tonsil, body temperature is normal, continues containing after 2 days, and it is normal that the tonsil of enlargement recovers, and it is normal to check routine blood test.
(6) Zhao XX, the man, 24 years old, the student, the forest zone is closed in the Luoyang City.Uncomfortable because of pharyngeal pain, the prescription on individual diagnosis of being admitted to hospital of generating heat of shivering with cold.Be diagnosed as acute tonsillitis, it is oral to give Banlangen buccal tablet of the present invention, every day containing 10-20 sheet, logotype 4 days, above-mentioned symptom disappears, routine blood test is normal, cures.
The Banlangen buccal tablet acute toxicity test
(1) experiment purpose is observed the dosis tolerata of Banlangen buccal tablet to animal, measures the clinical consumption multiple of accessible people, understands the safety range of medicine, for the safety of this medicine is made an appraisal.
(2) test material Banlangen buccal tablet: every heavy 0.5g, contain Radix Isatidis crude drug 1.0g, clinical consumption is 20 (containing crude drug 20g) on the 1st, containing of gradation.Extract concentrated solution with the Radix Isatidis that does not contain the tablet adjuvant during test, contain crude drug 2.0g/ml, medicament is provided by this institute preparation research department, lot number 970927.
Mice: the Kunming kind, body weight 18-22g, Henan Province's medical experiment animal center provides, the quality certification number: No. the 01st, the moving word in Henan.
(3) test method is got 40 of mices, and male and female half and half are divided equally 2 groups immediately; The administration group is irritated stomach 200% (g/ml contains crude drug) Radix Isatidis concentrated solution 0.3ml/10g, administration 3 times (front and back 2 minor ticks 6 hours) in 24 hours; Day administration total amount 180g/kg (crude drug), fasting is 12 hours before the perfusion, and matched group is irritated the distilled water of stomach with capacity; Observe variations such as the activity of respectively organizing mice after the administration in 7 days, drinking-water, feces, hair color, body weight; After 7 days animal is all put to death, observe the variation of main organs such as its heart, liver, spleen, lung, kidney, carry out pathologic finding in case of necessity.
(4) the appetite minimizing appears individually in result of the test drug group mice during administration, and activity weakens and the soft stool phenomenon, and it is normal that drug withdrawal recovered after 12 hours.Two treated animals are at equal Non Apparent Abnormalities in aspect such as the form of main organs such as drinking-water, hair color, body weight, feces and the heart, liver, spleen, lung, kidney, size, smoothnesss, and two treated animal body weight change see the following form.
The Banlangen buccal tablet acute toxicity test is to the influence of mice body weight
Compare with matched group
*P＞0.05
(5) the brief summary Banlangen buccal tablet can not done LD through prerun
50, can only do maximum tolerance multiple.But Cmax and volume by administration are given mouse stomach; The mtd test result is 180g/kg (containing crude drug); 600 times (people calculates by body weight 60kg) of day dosage of behaving, after the administration in 7 days two treated animals do not see death and other abnormal response, though drug group individual animal appetite reduces in 12 hours after administration, activity weakens; But the body weight no significant difference possibly be due to the medicine irritation stomach of big volume.
The prompting of this experimental result: Banlangen buccal tablet does not have tangible acute toxicity effect to mice.
Four, the specific embodiment:
Embodiment 1: the Banlangen buccal tablet crude drug sees the following form 1, representes with weight portion.
Method for making: take by weighing Radix Isatidis, the decocte with water secondary, the decocting that adds 8 times of amounts for the first time boils 2.5h, and the decocting that adds 6 times of amounts for the second time boils 1.5h, merges decoction liquor twice, filters, and filtrating is concentrated into density 1.15g/cm
3, add ethanol and make the ethanol mass content reach 55%, leave standstill and make deposition, get supernatant and reclaim ethanol, being condensed into density is 1.30g/cm
319 parts of clear paste; In said clear paste, add all the other crude drug, mix homogeneously, drying is pulverized, and crosses 90 mesh sieves, adds alcohol granulation, and the weight ratio that adds the alcoholic acid amount and the back medication amount of sieving is 8%; Carry out redrying then, baking temperature is 50 ℃, to the moisture mass content below 5%, tabletting, every heavily be 0.5 the gram, every contains Radix Isatidis crude drug crude drug 1.0g.
Embodiment 2: the Banlangen buccal tablet composition is seen table 1.
Method for making: take by weighing Radix Isatidis, the decocte with water secondary, the decocting that adds 7 times of amounts for the first time boils 2h, and the decocting that adds 5 times of amounts for the second time boils 1h, merges decoction liquor twice, filters, and filtrating is concentrated into density 1.05g/cm
3, add ethanol and make the ethanol mass content reach 50%, leave standstill and make deposition, get supernatant and reclaim ethanol, being condensed into density is 1.30g/cm
317 parts of clear paste; In said clear paste, add all the other crude drug, mix homogeneously, drying is pulverized, and crosses the 80-100 mesh sieve, adds alcohol granulation, and the weight ratio that adds the alcoholic acid amount and the back medication amount of sieving is 6%; Carry out redrying then, baking temperature is 60 ℃, to moisture mass content 1.5%, tabletting, every weight and contain the raw material dose with the example 1.
Embodiment 3: the Banlangen buccal tablet composition is seen table 1.
Method for making: take by weighing Radix Isatidis, the decocte with water secondary, the decocting that adds 9 times of amounts for the first time boils 3h, and the decocting that adds 7 times of amounts for the second time boils 2h, merges decoction liquor twice, filters, and filtrating is concentrated into density 1.25g/cm
3, add ethanol and make the ethanol mass content reach 60%, leave standstill and make deposition, get supernatant and reclaim ethanol, being condensed into density is 1.33g/cm
321 parts of clear paste; In said clear paste, add all the other crude drug, mix homogeneously, drying is pulverized, and crosses the 80-100 mesh sieve, adds alcohol granulation, and the weight ratio that adds the alcoholic acid amount and the back medication amount of sieving is 12%; Carry out redrying then, baking temperature is 60 ℃, to moisture mass content 1.5%, tabletting, every weight and contain the raw material dose with the example 1.
Embodiment 4: the Banlangen buccal tablet composition is seen table 1.
Method for making: take by weighing Radix Isatidis and Rhizoma Fagopyri Dibotryis, the decocte with water secondary, the decocting that adds 8 times of amounts for the first time boils 2.5h, and the decocting that adds 6 times of amounts for the second time boils 1h, merges decoction liquor twice, filters, and filtrating is concentrated into density 1.15g/cm
3, add ethanol and make the ethanol mass content reach 55%, leave standstill and make deposition, get supernatant and reclaim ethanol, being condensed into density is 1.32g/cm
320 parts of clear paste;
In said clear paste, add all the other crude drug, mix homogeneously, drying is pulverized, and crosses the 80-100 mesh sieve, adds alcohol granulation, and the weight ratio that adds the alcoholic acid amount and the back medication amount of sieving is 8%; Carry out redrying then, baking temperature is 40-60 ℃, is dried to the moisture mass content below 3%, tabletting, and every heavily is 0.5 gram, every contains Radix Isatidis crude drug, Rhizoma Fagopyri Dibotryis crude drug 2.5g altogether.
Other embodiment crude drug and consumption are seen table 1,2,3,4, and method for preparing no longer repeats with embodiment 1 or embodiment 4.
Table 1
Table 2
Table 3
Table 4
Claims (5)
1. a Banlangen buccal tablet is characterized in that: be made up of Radix Isatidis 80-120 part, Rhizoma Fagopyri Dibotryis 120-170 part, correctives 10-45 part, lubricant 0.1-1 part following bulk drugs.
2. Banlangen buccal tablet according to claim 1 is characterized in that: wherein Radix Isatidis 90-110 part, Rhizoma Fagopyri Dibotryis 130-160 part.
3. a Banlangen buccal tablet is characterized in that: be made up of 100 parts of Radix Isatidis, 150 parts of Rhizoma Fagopyri Dibotryiss, 7 parts in mannitol, 13 parts of sucrose, 0.9 part of aspartame, 0.4 part of Mentholum, 0.15 part of silicon dioxide, 0.4 part of magnesium stearate following bulk drugs.
4. the production method of a Banlangen buccal tablet, it is characterized in that: crude drug consists of Radix Isatidis 80-120 part, Rhizoma Fagopyri Dibotryis 120-170 part, correctives 10-45 part, lubricant 0.1-1 part; Take by weighing the mixture of Radix Isatidis and Rhizoma Fagopyri Dibotryis, the decocte with water secondary adds the water that 7-9 doubly measures for the first time, decocts 2-3h, adds the water that 5-7 doubly measures for the second time, decocts 1-2h, merges decoction liquor twice, filters, and filtrating is concentrated into density 1.05-1.25g/cm
3, add ethanol and make the ethanol mass content reach 50-60%, leave standstill and make deposition, get supernatant, reclaim ethanol, being condensed into density is 1.30-1.33g/cm
3Clear paste; In said clear paste, add correctives, lubricant, mix homogeneously, drying is pulverized, and sieves, and adds alcohol granulation, and redrying to moisture mass content is between 1.5-5%, and tabletting promptly gets Banlangen buccal tablet; Said baking temperature is 40-60 ℃, and the order number is the 80-100 order during said sieving.
5. the production method of Banlangen buccal tablet according to claim 4 is characterized in that: the weight ratio that adds the amount of alcohol and the back medicine that sieves during granulation is 6-12%.
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| CN105998107A (en) * | 2016-07-15 | 2016-10-12 | 成都大学 | Championella-radix isatidis buccal tablet and preparation method thereof |
| CN114470108A (en) * | 2022-02-22 | 2022-05-13 | 徐昊 | Compound isatis root buccal tablet and processing method thereof |
| CN114404463B (en) * | 2022-02-22 | 2023-05-05 | 重庆市国信医药有限公司 | Preparation process of radix isatidis buccal tablet |
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Inventor after: Sun Jianxun Inventor after: Chai Zhanxin Inventor after: Guan Runhong Inventor after: Cui Aijiao Inventor after: Wei Lijun Inventor after: Chang Hong Inventor after: Cao Chenxiang Inventor before: Chai Zhanxin Inventor before: Guan Runhong Inventor before: Xin Junmiao Inventor before: Wei Lijun Inventor before: Chang Hong Inventor before: Wang Weiwei |
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Free format text: CORRECT: INVENTOR; FROM: CHAI ZHANXIN GUAN RUNHONG XIN JUNMIAO WEI LIJUN CHANG HONG WANG WEIWEI TO:SUN JIANXUN CHAI ZHANXIN GUAN RUNHONG CUI AIJIAO WEI LIJUN CHANG HONG CAO CHENXIANG |