CN103845485A - Snake gall and dried tangerine peel capsule medicinal composition and preparation method thereof - Google Patents
Snake gall and dried tangerine peel capsule medicinal composition and preparation method thereof Download PDFInfo
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- CN103845485A CN103845485A CN201410052249.7A CN201410052249A CN103845485A CN 103845485 A CN103845485 A CN 103845485A CN 201410052249 A CN201410052249 A CN 201410052249A CN 103845485 A CN103845485 A CN 103845485A
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- pericarpium citri
- citri reticulatae
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Abstract
The invention relates to a snake gall and dried tangerine peel capsule medicinal composition and a preparation method thereof. The snake gall and dried tangerine peel capsule medicinal composition provided by the invention is prepared from dried tangerine peel, snake gall juice with a proper amount of auxiliary materials. The composition is quick in active component dissolving velocity and high in bioavailability.
Description
Technical field
The present invention relates to a kind of field of pharmaceutical preparations, be specifically related to a kind of snake bile with orange peel pharmaceutical composition and preparation method thereof.
Background technology
Fel Serpentis is sweet, bitter, cold, nontoxic; for a kind of conventional Chinese medicine; its function is promoting the circulation of QI and reducing phlegm, call prisoners in after letting them out for exercise dry, liver heat removing and eyesight improving, suppressing the hyperactive liver be flame-out; its main effective ingredient is cholyltaurine and sodium salt, thus often with the content number of cholyltaurine and sodium salt determine Fel Serpentis quality good or not [comparative study of cholyltaurine content assaying method in Fel Serpentis. to one. Shi Chaozhou. Chinese Journal of Modern Applied Pharmacy .2000.06.28].
Pericarpium Citri Reticulatae is conventional Chinese medicine, has the effect such as regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm, for diseases such as fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.One of main effective ingredient of Pericarpium Citri Reticulatae is Pericarpium Citri Reticulatae glycosides, have another name called hesperidin, there is antibacterial and anti-inflammation functions, to pleuritis, pulmonary tuberculosis etc. effective in cure [effect of Pericarpium Citri Reticulatae effective ingredient in respiratory system research. Wen Gaoyan. Zhou Xianmei. modern combination of Chinese and Western medicine impurity .2011.Jan.20 (3)].
Snake bile with orange peel is made up of Fel Serpentis and Pericarpium Citri Reticulatae (steaming), cures mainly activating QI to eliminate phlegm, the stomach function regulating that dispels the wind, and for turbid phlegm obstructing in the lung, stomach-QI being unable to descend normally, cough, vomiting etc.
The method for making of snake bile with orange peel, for Pericarpium Citri Reticulatae is ground into fine powder, mixes, is dried, pulverizes, sieves with Fel Serpentis at present, incapsulates and get final product.This preparation method, because the adsorption of medicated powder greatly affects the stripping of Fel Serpentis effective ingredient, affects the clinical use curative effect of this medicine.
Chinese crude drug contributes to the stripping of effective ingredient and the performance of herbal medicine efficacy through rational grinding and processing, differing texture medical material is after pulverizing in various degree, there is very big-difference in the release of its effective ingredient, it is generally acknowledged that the release that pulverizing medicinal materials must thinner effective ingredient is better, but in Chinese medicine preparation is produced, the degree of grinding that increases Chinese crude drug can increase Chinese medicine preparation production cost greatly, also can cause medical material loss simultaneously, reduce productive rate, therefore grasp pulverizing medicinal materials degree is the more scabrous problem of field of traditional Chinese always.
Summary of the invention
Inventor is through a large amount of experimental studies; a kind of snake bile with orange peel pharmaceutical composition and preparation method thereof is provided; this snake bile with orange peel pharmaceutical composition; can significantly improve the stripping of Bile Salts in Pericarpium Citri Reticulatae glycosides and Fel Serpentis in Pericarpium Citri Reticulatae; can effectively reduce again medical material loss, reduce production costs.
The invention provides a kind of snake bile with orange peel pharmaceutical composition, be made up of Fel Serpentis, Pericarpium Citri Reticulatae and PVP K30, its unit dose is: Fel Serpentis 19mg, and Pericarpium Citri Reticulatae 295mg, PVP K30 11.8mg, wherein Pericarpium Citri Reticulatae is for steaming Pericarpium Citri Reticulatae.
The present invention also provides a kind of preparation method of snake bile with orange peel pharmaceutical composition, it is characterized by: Pericarpium Citri Reticulatae is ground into powder, and PVP K30 is mixed with 3% aqueous solution, as binding agent, Pericarpium Citri Reticulatae powder is carried out to spray granulation, and then spraying adds Fel Serpentis, dry, encapsulated and get final product.
Wherein, Pericarpium Citri Reticulatae smashing fineness is all to sieve by No. seven, and contains and can be no less than 95% powder by No. eight sieves.
In snake bile with orange peel prescription, need the stripping situation of the effective ingredient of the medical material Pericarpium Citri Reticulatae of pulverizing in simulated gastric fluid by studying, select the degree of grinding of medical material Pericarpium Citri Reticulatae, make it to meet clinical needs, reduce medical material loss, can reduce production costs as far as possible again.
test the selection of 1 Pericarpium Citri Reticulatae degree of grinding
1, Pericarpium Citri Reticulatae (steaming) 19g is ground into different fineness by the preparation of sample, mixes respectively with Fel Serpentis 295g, dry, pulverize, and makes 1000, incapsulates:
| Sample | Pericarpium Citri Reticulatae degree of grinding |
| Capsules A | Can, all by No. four sieves, be no more than 60% powder but be mixed with by No. five sieves |
| Capsule B | Can all sieve by No. five, and contain and can be no less than 95% powder by No. six sieves |
| Capsule C | Can all sieve by No. six, and contain and can be no less than 95% powder by No. seven sieves |
| Capsule D | Can all sieve by No. seven, and contain and can be no less than 95% powder by No. eight sieves |
| Capsule E | Can all sieve by No. eight, and contain and can be no less than 95% powder by No. nine sieves |
Note: four, five, six, seven, eight, No. nine sieves are Chinese Pharmacopoeia Special screen.
2, testing index and method: dissolution determination is with reference to the little agar diffusion method of Chinese Pharmacopoeia version in 2010 two dissolution determination methods the 3rd method.Take simulated gastric fluid as dissolution medium, rotating speed 100r/min, 37 ℃ ± 0.5 ℃ of temperature.In 45 min sampling 5ml, with 0.45 μ m microporous filter membrane filtration filter, get subsequent filtrate, measure stripping quantity.
Dilute hydrochloric acid 16.4ml is got in the preparation of simulated gastric fluid, and add water about 800ml and pepsin 10g, shake up rear thin up and become 1000ml.
Index for examination composition: (1)
hesperidin
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; Take acetonitrile-0.1% phosphoric acid solution (22: 78) as mobile phase; Detection wavelength is 284nm.Number of theoretical plate calculates and should be not less than 3000 by Pericarpium Citri Reticulatae glycosides peak.
The preparation of reference substance solution: get Pericarpium Citri Reticulatae glycosides reference substance appropriate, accurately weighed, add methanol and make the solution of every 1ml containing 0.1mg, to obtain final product.
Algoscopy: accurate reference substance solution and the each 20 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures, and to obtain final product.
sodium taurocholate:
Chromatographic condition and system suitability: take eight alkyl silane bonded silica gels as filler; Take acetonitrile-0.1% phosphoric acid solution (24:76) as mobile phase; Detecting wavelength is 203 nm; Number of theoretical plate calculates and should be not less than 3000 by sodium taurocholate peak.
The preparation of reference substance solution: get sodium taurocholate reference substance appropriate, accurately weighed, add mobile phase and make the solution of every 1ml containing 0.12mg, to obtain final product.
Algoscopy: accurate reference substance solution and the each 20 μ l of need testing solution of drawing respectively, injection liquid chromatography, measures, and to obtain final product.
the snake bile with orange peel stripping quantity (n=10) of different degrees of grinding
| Sample | The average stripping quantity of Hesperidin (mg/ grain) | The average stripping quantity of sodium taurocholate (mg/ grain) |
| Capsules A | 11.6 | 0.49 |
| Capsule B | 12.3 | 0.52 |
| Capsule C | 12.7 | 0.53 |
| Capsule D | 15.6 | 0.56 |
| Capsule E | 13.0 | 0.52 |
In theory, Chinese medicine is pulverized carefullyyer, and larger with the contact surface of solvent, diffusingsurface is also larger, so diffusion velocity is also faster, effective ingredient stripping is faster.But can find out from the above results, it not is more carefully better that Pericarpium Citri Reticulatae is pulverized, effective ingredient result of extraction the best of capsule D Pericarpium Citri Reticulatae and Fel Serpentis, the above-mentioned effective ingredient dissolution of capsule E declines on the contrary.
two, add the impact of adjuvant on drug-eluting
Although the effective ingredient stripping quantity of above-mentioned sample capsules D Pericarpium Citri Reticulatae increase, Fel Serpentis effective ingredient by Pericarpium Citri Reticulatae powder Adsorption Effect the stripping of Fel Serpentis effective ingredient.Meanwhile, above-mentioned prepared capsule filling mobility is poor, affects capsule-filling, and content uniformity is larger, cannot guarantee the quality of product.Therefore, intend adopt binding agent carry out spray granulation, after add the dry mode of Fel Serpentis, improve the mobility of product capsule filling, reduce the adsorption of Pericarpium Citri Reticulatae powder to Fel Serpentis effective ingredient simultaneously.
the preparation of sample:effectively becoming the best smashing fineness of stripping to pulverize Pericarpium Citri Reticulatae by above-mentioned Pericarpium Citri Reticulatae (can be all by No. seven sieve, and contain and can be no less than 95% powder by No. eight sieves), add 4% binding agent of Pericarpium Citri Reticulatae medicated powder amount, binding agent is made to aqueous solution adopts respectively the mode of mist projection granulating to granulate, after again spraying add Fel Serpentis, dry, incapsulate.
the impact (n=3) that adopts different binding agents to granulate on effective ingredient
| Binder concn | The average stripping quantity of Hesperidin (mg/ grain) | The average stripping quantity of sodium taurocholate (mg/ grain) |
| 5% starch slurry | 12.2 | 0.47 |
| 3% hypromellose | 13.0 | 0.61 |
| 3% PVP K30 | 15.6 | 0.78 |
| 3% sodium carboxymethyl cellulose | 12.9 | 0.63 |
| 3% low-substituted hydroxypropyl cellulose | 13.4 | 0.59 |
Above-mentioned test shows; except starch slurry is as binding agent, outside effective ingredient stripping quantity declines to some extent, other effective ingredient are better stripping all; wherein 3% PVP K30 not only makes Pericarpium Citri Reticulatae glycosides stripping quantity increase, and makes the stripping quantity of sodium taurocholate in Fel Serpentis have significantly raising simultaneously.
By selecting the degree of grinding of Pericarpium Citri Reticulatae, add the specific adjuvant of special ratios and adopt specific preparation technology, the stripping that had both improved Fel Serpentis effective ingredient sodium taurocholate, has improved again the stripping of Pericarpium Citri Reticulatae glycosides in Pericarpium Citri Reticulatae, improves clinical efficacy simultaneously.
Adopt spray granulation technique to prepare snake bile with orange peel, can improve the stripping of the effective ingredient of snake bile with orange peel, guarantee the quality of product.
The specific embodiment
embodiment 1 snake bile with orange peel pharmaceutical composition
Get steaming Pericarpium Citri Reticulatae 295g and be ground into powder, smashing fineness is can be all by No. seven sieves, and contain and can be no less than 95% powder by No. eight sieves, getting PVP K30 11.8g is mixed with 3% aqueous solution, as binding agent, Pericarpium Citri Reticulatae powder is carried out to mist projection granulating, spraying adds Fel Serpentis 19g again, dry, encapsulatedly make 1000 and get final product.
test example 1 snake bile with orange peel pharmaceutical composition phlegm-dispelling functions research
1 material
1.1 medicines and reagent
Snake bile with orange peel A: according to the method for making preparation of a regulation of Chinese Pharmacopoeia version in 2010;
Snake bile with orange peel pharmaceutical composition B: according to embodiment 1 method preparation;
Ammonium chloride: Juhua Group Co. provides;
Phenol red: the Shanghai henry biological company limited of doing.
1.2 animal
ICR mice, body weight 18～23g, male and female half and half, are provided by greenery pharmacy Experimental Animal Center.
2 methods and result
With reference to [Li Yikui. herbal pharmacology experimental methodology [M]. Shanghai: Shanghai science tech publishing house, 1991:320] the method experiment modeling of eliminating the phlegm.Mice is divided into 4 groups at random, 10 every group.Fasting 20h before experiment, freely drinks water.Matched group gavage (ig.) give equal-volume water; Administration 1 time before ammonium chloride group ig.1g/kg(experiment); Snake bile with orange peel A group and B organize all according to ig.2.1g/kg.The 1st the sky, each administration in afternoon 1 time, 60min after administration in morning next day, the phenol red normal saline solution 0.7ml of lumbar injection (ip.) 0.25%, after 30min, put to death mice, face upward position and be fixed on operation plate, cut off skin in neck, separate trachea, under larynx, insert intubate, fix with silk thread ligation, with 5% NaHCO
3rinse, wash altogether 3 times, each 0.5ml, merges 3 times cleaning mixture, adds 50% alcoholic solution and is settled to 10ml, and the centrifugal 10min of 3000 rpm, measures absorption value in 546nm.Calculate phenol red concentration according to phenol red standard curve, the results are shown in Table 1.
The impact of table 1 snake bile with orange peel compositions B on phenol red secretion (
± s, n=10)
| Group | Dosage (g/kg) | Phenol red concentration (mg/L) |
| Normal group | ? | 0.716±0.253 |
| Ammonium chloride group | 1 | 1.703±0.562*** |
| Snake bile with orange peel A | 2.1 | 1.016±0.314* |
| Snake bile with orange peel pharmaceutical composition B | 2.1 | 1.692±0.346*** |
Note: with matched group comparison, * P<0.05, * * * P<0.001
As shown in Table 1, snake bile with orange peel gastric infusion can make mice trachea secrete phenol red amount obviously to be increased, and through t check, with matched group comparison, difference has significant statistical significance, especially snake bile with orange peel pharmaceutical composition B.Snake bile with orange peel pharmaceutical composition B phlegm-dispelling functions provided by the invention is obviously better than snake bile with orange peel A, suitable with positive drug control group ratio.
Claims (3)
1. a snake bile with orange peel pharmaceutical composition, is made up of Fel Serpentis, Pericarpium Citri Reticulatae and PVP K30, and its unit dose is: Fel Serpentis 19mg, and Pericarpium Citri Reticulatae 295mg, PVP K30 11.8mg, wherein Pericarpium Citri Reticulatae is for steaming Pericarpium Citri Reticulatae.
2. a preparation method for snake bile with orange peel pharmaceutical composition, is characterized by: Pericarpium Citri Reticulatae is ground into powder, and PVP K30 is mixed with 3% aqueous solution, as binding agent, Pericarpium Citri Reticulatae powder is carried out to spray granulation, and then spraying adds Fel Serpentis, dry, encapsulated and get final product.
3. preparation method according to claim 2, is characterized by: Pericarpium Citri Reticulatae smashing fineness is all to sieve by No. seven, and contains and can be no less than 95% powder by No. eight sieves.
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| CN201410052249.7A CN103845485B (en) | 2014-02-17 | 2014-02-17 | A kind of snake bile with orange peel pharmaceutical composition and preparation method thereof |
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| CN103845485A true CN103845485A (en) | 2014-06-11 |
| CN103845485B CN103845485B (en) | 2016-10-05 |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1456285A (en) * | 2003-03-21 | 2003-11-19 | 毛友昌 | Preparation of snake gallbladder and tangerine peel dispersed tablets |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1456285A (en) * | 2003-03-21 | 2003-11-19 | 毛友昌 | Preparation of snake gallbladder and tangerine peel dispersed tablets |
Non-Patent Citations (1)
| Title |
|---|
| 国家药典委员会: "《中华人民共和国药典 2010年版 一部》", 31 January 2010, 中国医药科技出版社 * |
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