CN100391528C - Chinese traditional medicine composition for treating infant anorexia and preparation and quality controlling method thereof - Google Patents
Chinese traditional medicine composition for treating infant anorexia and preparation and quality controlling method thereof Download PDFInfo
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- CN100391528C CN100391528C CNB200510056761XA CN200510056761A CN100391528C CN 100391528 C CN100391528 C CN 100391528C CN B200510056761X A CNB200510056761X A CN B200510056761XA CN 200510056761 A CN200510056761 A CN 200510056761A CN 100391528 C CN100391528 C CN 100391528C
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Abstract
The present invention discloses a medical composition for treating infant anorexia, and a preparation method and a quality control method thereof. The medical composition is prepared from the raw medicinal materials according to the proportion by weight: 200 to 240 shares of endothelium corneae gigeriae galli, 110 to 150 shares of alpinia katsumadai, 70 to 100 shares of acanthopanax senticosus, 30 to 50 shares of garlic and 15 to 30 shares of pharbitidis seed. The present invention simultaneously discloses the composition for treating infant anorexia.
Description
Invention field
The present invention relates to the preparation and the method for quality control of a kind of Chinese medicine composition and said composition thereof, particularly a kind of pharmaceutical composition and preparation and method of quality control for the treatment of infantile anorexia.
Background technology
Since the fundamental state policy of China's implementation plan fertility, according to social population's structure investigation, only child's number is more and more in the Chinese children, infantile anorexia is one of modal disease in the pediatric disease, it promptly influences the healthy of infant, also influence simultaneously the intelligence development of infant, this improves the health of the people totally unfavorable to China.At this situation, we sum up in conjunction with distinguished veteran doctors of TCM clinical practice experience and traditional Chinese medicine theory for many years, develop can be rated as children's's appetite promoting and the spleen strengthening want side and preparation and method of quality control.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition; Another object of the present invention provides the preparation method and the method for quality control of this Chinese medicine composition; The 3rd purpose of the present invention provides the application of this pharmaceutical composition in the medicine of preparation treatment infantile anorexia.
The present invention is achieved by the following technical solutions:
The crude drug composition and the proportioning of pharmaceutical composition are as follows:
Endothelium Corneum Gigeriae Galli 200-240 weight portion Semen Alpiniae Katsumadai 110-150 weight portion
Radix Et Caulis Acanthopanacis Senticosi 70-100 weight portion Bulbus Allii 30-50 weight portion Semen Pharbitidis 15-30 weight portion
Wherein the best proportion relation of pharmaceutical composition is:
Endothelium Corneum Gigeriae Galli 200 weight portion Semen Alpiniae Katsumadai 150 weight portions
Radix Et Caulis Acanthopanacis Senticosi 70 weight portion Bulbus Alliis 50 weight portion Semen Pharbitidiss 15 weight portions
Endothelium Corneum Gigeriae Galli 240 weight portion Semen Alpiniae Katsumadai 110 weight portions
Radix Et Caulis Acanthopanacis Senticosi 100 weight portion Bulbus Alliis 30 weight portion Semen Pharbitidiss 30 weight portions
Endothelium Corneum Gigeriae Galli 217 weight portion Semen Alpiniae Katsumadai 130 weight portions
Radix Et Caulis Acanthopanacis Senticosi 87 weight portion Bulbus Alliis 44 weight portion Semen Pharbitidiss 22 weight portions
Press practice of pharmacy, the above-mentioned raw materials medicine can be prepared into various clinical or pharmaceutically acceptable dosage forms, include but not limited to a kind of in the middle of the following dosage form: as: tablet, hard capsule, soft capsule slow releasing tablet, controlled release tablet, slow releasing capsule, controlled release capsule, oral solution, oral suspensions, Orally taken emulsion, mucilage, oral liquid, Emulsion, colloid solution, mixture, tincture, drop, suspendible drop, pill, drop pill, granule, enteric coated granule, powder, powder etc.
The preparation method of aforementioned pharmaceutical compositions oral liquid is:
Endothelium Corneum Gigeriae Galli, Semen Pharbitidis are ground into coarse powder, the Semen Alpiniae Katsumadai fragmentation; The Endothelium Corneum Gigeriae Galli coarse powder adds 12-18 times of water gaging and decocts 1-3 time, each 0.5-1 hour, filters filtrate for later use; Endothelium Corneum Gigeriae Galli medicinal residues and Semen Pharbitidis coarse powder are respectively according to the percolation under fluid extract and the extractum item, doubly measure ethanol with 12-18 and make solvent, carry out percolation, collect the liquid of filtering with the speed of per minute 0.5～2ml, decompression recycling ethanol to relative density is 1.08～1.12 70 ℃ the time, and is standby; Semen Alpiniae Katsumadai extracts volatile oil with vapor distillation, and aqueous solution after the distillation and Endothelium Corneum Gigeriae Galli decocting liquid merge, and be standby; The Semen Alpiniae Katsumadai medicinal residues mix with Semen Pharbitidis medicinal residues, Radix Et Caulis Acanthopanacis Senticosi, Bulbus Allii, add 12-18 times of water gaging and decoct 1-3 time, each 0.5-1 hour, filter, filtrate is incorporated in the above-mentioned decocting liquid, and being concentrated into relative density is 1.02～1.05 in the time of 70 ℃, add sucrose dissolved, filter filtrate cold preservation 40-50 hour, centrifugal, supernatant and Endothelium Corneum Gigeriae Galli and Semen Pharbitidis ethanol extraction, volatile oil, antiseptic and solubilizing agent stir evenly, add the water adjustment, mixing, fill, promptly.
According to present pharmaceutical dosage form development, and the characteristics of pediatric pharmaceuticals, in conjunction with chemical composition analysis, taked to preserve the extraction process of former prescription pharmaceutically active ingredient to the main medicines of several flavors such as Endothelium Corneum Gigeriae Galli Semen Alpiniae Katsumadai, Radix Et Caulis Acanthopanacis Senticosi in the medicine as far as possible.In addition, for guaranteeing effective ingredient, tween 80, Tween-60 or tween 20 are adopted in solubilizing agent, and consumption is a volume ratio 1%, and antiseptic adopts Oleum Citri Reticulatae, and consumption is a volume ratio 2/0,000.
The method of quality control of this pharmaceutical composition comprises a kind of and/or several in the following discrimination method
A, the compositions oral liquid 60ml that gets it filled use chloroform extraction 2-4 time, each 20-40ml, and combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; Other gets Endothelium Corneum Gigeriae Galli control medicinal material 10-15g, adds ethanol 110-140ml, and supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 3: 3: chloroform-ethyl acetate of 0.4-0.8-formic acid was developing solvent, launched, and took out, dry, spray is with the 8-12% sulfuric acid solution, and it is clear to be heated to speckle colour developing at 102-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
B, get Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, add 70-80% ethanol 40-60ml, reflux, extract, 0.5-1.5 hour, filter, filtrate evaporate to dryness, residue add water 8-12ml makes dissolving, adding chloroform extracts 1-3 time, each 8-12ml, combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw control medicinal material solution and respectively reach each the 5 μ l of need testing solution that differentiate under the A item, put on the same silica gel g thin-layer plate respectively, chloroform-methanol with 17-19: 1-3 is developing solvent, launches, and takes out, dry, put under the outer light modulation of this 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical fluorescence speckle;
C, get the plain reference substance of Alpinia japonica (Thunb.) Miq., add methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw reference substance solution 10 μ l, differentiate the need testing solution 5ul under a item, put respectively on same silica gel g thin-layer plate, with 14-16: 3-5: benzene-ethyl acetate of 1-methanol is developing solvent, launches, and takes out, dry, put under the outer light modulation of this 365nm and inspect; In the test sample chromatograph, with the reference substance chromatograph corresponding put, show the fluorescence speckle of same color.
This drug regimen method of quality control comprise following content assaying method
Assay: according to high effective liquid chromatography for measuring
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; The methanol of 25-35: 65-75-0.1% formic acid solution is a mobile phase; The detection wavelength is 342nm; Number of theoretical plate is pressed the isofraxidin peak and is calculated, and should be not less than 2000;
The preparation of reference substance solution: it is an amount of that the phosphorus pentoxide of learning from else's experience is dried to the isofraxidin reference substance of constant weight, accurately claims that adding methanol surely makes the solution that every 1ml contains 10ug, promptly;
The preparation of need testing solution: precision is measured drug composition oral liquid 10ml, adds ethyl acetate extraction 1-3 time, uses ethyl acetate 8-12ml at every turn, merge extractive liquid,, evaporate to dryness is used dissolve with methanol, be transferred in the 2ml measuring bottle and be diluted to scale, shake up, as need testing solution;
Algoscopy: accurate respectively molten and each the 10 μ l of need testing solution of reference substance that draw, inject chromatograph of liquid, measure, promptly;
The every ml of this drug composition oral liquid contains isofraxidin C
11H
10O
5Must not be less than 1ug.
Present composition prescription has taken into full account children's's physiological characteristics, treating both the principal and the secondary aspects of a disease at the same time.Endothelium Corneum Gigeriae Galli is sweet flat in the side, and kind removing food stagnancy stagnates, and strengthening the spleen and stomach is a monarch drug again; Arduous and the temperature of Radix Et Caulis Acanthopanacis Senticosi has the effect of similar Radix Ginseng replenishing QI to invigorate the spleen, the hot fragrant and temperature of Semen Alpiniae Katsumadai, the dampness of being amusing, regulate the flow of vital energy and in, this two flavors medicine is a ministerial drug; Bulbus Allii circulation of qi promoting removing food stagnancy, with Semen Pharbitidis be adjuvant drug altogether.
This drug combination preparation can improve the anorexia situation of Radix Et Rhizoma Rhei Rats with Spleen-deficiency significantly, obviously promotes food ration to increase; Can obviously promote the Rats with Spleen-deficiency body weight gain; And therapeutical effect performance is very fast, acts on the most obviously in a week of insufficiency of the spleen serious symptom, and these results are for clinical efficacy and basis is provided the course of treatment that is defined as a week clinically.
This drug combination preparation can increase the stomachial secretion amount of rat very significantly in addition; Increase the secretory volume of the free and total acid of Rats with Spleen-deficiency stomach very significantly; Can significantly increase the white enzymatic activity of stomach.These results can think that this drug combination preparation treats the pharmacological basis of insufficiency of the spleen anorexia disease.
Following experimental example is used to further specify but is not limited to this as inventing:
Experimental example 1: fry in shallow oil (the soaking) of decocting method and water seaoning goes out the thing comparative test:
(1) decocting method: take by weighing Endothelium Corneum Gigeriae Galli powder (30 orders respectively, down together) 10g is (accurately to 0.01g, down together) three parts add 15 times of water, soak 20 minutes half an hour after fried the boiling before frying in shallow oil, fried secondary, (3000 rev/mins, down together) get decocting liquid 60 ± 5ml thin up to 100ml to get decocting liquid centrifugal 10 minutes, every part of accurate three parts of 20ml that draw, put in the evaporating dish of constant weight, put water bath method, measure by 47 pages of determination of extractives methods of " Chinese Pharmacopoeia nineteen ninety version " appendix.The results are shown in Table 1:
(2) water seaoning: get three parts of Endothelium Corneum Gigeriae Galli powder 10g respectively, total amount of water 65ml (decocting liquid must be measured+the medicinal residues absorption water yield) soaked 5 hours, shake, soak secondary, get soak 50 ± 5ml, centrifugal 10 minutes, draw three parts of photograph decocting methods of 20ml respectively for every part and measure item mensuration down.The results are shown in Table 1.
Other gets respectively, and equal-volume (20ml) is fried in shallow oil, immersion is made protein precipitation reaction and biuret reaction with 10% tannin, and presentation of results all has tangible proteins react.
Table 1 Endothelium Corneum Gigeriae Galli decocting, extractum are relatively
The fried reason of table 1, presentation of results decocting method is approximately higher than water seaoning, and two methods all have tangible proteins react.Consider that in conjunction with producing water seaoning is without decoction, and the production cycle is longer, microorganism is crossed and is easy to growth in preparation process, influences preparation and reaches medicine sanitary standard, so should select decocting method for use.Experimental example 2: ethanol soaks with ethanol and soaks back the frying in shallow oil of decocting, extractum comparative test behind the decocting:
(1) soak with ethanol behind the decocting: get three parts of Endothelium Corneum Gigeriae Galli powder 10g respectively, add 15 times of water, soaked 20 minutes before frying in shallow oil, half an hour after fried the boiling, fried secondary, the leaching decocting liquid gets 50 ± 5ml, centrifugal 10 minutes, get the clear liquid thin up to 100ml, every part of accurate three parts of 20ml that draw fries in shallow oil extractum according to the method mensuration under the 3.1.1.1 decocting method item.The results are shown in Table 2:
Medicinal residues add 15 times of ethanol respectively, soak secondary, each 24 hours, from the time jolting, get soak and filter, reclaim ethanol to 100ml, accurate respectively three parts of the 20ml that draw are according to 3.1.1.1 decocting method item method mensuration down.The results are shown in Table 2:
(2) ethanol soaks the back decocting: get three parts of Endothelium Corneum Gigeriae Galli powder 10g respectively, add 15 times of amount ethanol, soak secondary, each 24 hours, from the time jolting, get soak filtered and recycled ethanol to 100ml, the method that three parts of photograph 3.1.1.1 of the accurate respectively 20ml of absorption decocting goes out under the items is measured.The results are shown in Table 2:
Medicinal residues add 15 times of water gagings respectively, soak 20 minutes before frying in shallow oil, fry in shallow oil to soaking back half an hour, fried secondary, get centrifugal 10 minutes of decocting liquid decocting liquid, be diluted to 100ml, accurate respectively three parts of the 20ml that draw are according to 3.1.1.1 decocting method item method mensuration down.The results are shown in Table 2:
The frying in shallow oil of decocting, extractum be relatively after alcohol leaching and the alcohol leaching behind table 2 decocting:
Table 2 experimental result shows, always fry in shallow oil, extractum and decocting go out the thing amount with decocting after alcohol leaching be height, alcohol extract then is to be earlier high with the alcohol leaching.For the proteinic proposition of main component, look after the proposition of liposoluble constituent simultaneously, should adopt behind the decocting again technology with ethanol extraction.Since the few inconvenient diafiltration of experimental drug material, only relatively with extractum, to determine extraction step.
Experimental example 3: the fried thing comparative test of different amount of water
Get nine parts of Endothelium Corneum Gigeriae Galli powder 10g respectively, per three parts of 10,15,20 times of water gagings soaked 20 minutes before frying in shallow oil, fry in shallow oil to boiling back half an hour fried secondary, centrifugal 10 minutes of decocting liquid, get decocting liquid and dilute respectively or be concentrated into 100ml, every part of accurate three parts of 20ml that draw is according to 3.1.1.1 decocting method item method mensuration down.The results are shown in Table 3:
The fried thing of the different amount of water of table 3 compares:
Table 3 presentation of results, the decocting liquid that adds 10 times of amounts must be measured less, can not its composition is fully fried; 15, the fried amount of 20 times of water is close, gets final product with the decocting system of 15 times of amounts.
Experimental example 4: the fried thing comparative test of different fried times
Take by weighing six parts of Endothelium Corneum Gigeriae Galli powder 10g respectively, per three parts of water when adding 15: 22 times respectively, soaked 20 minutes before frying in shallow oil, fry in shallow oil respectively to boil the back half an hour, one hour, fried secondary, centrifugal 10 minutes of decocting liquid, get the decocting liquid thin up to 100ml, every part of accurate 20ml that draws measures according to the method under the 3.1.1.1 decocting method item.The results are shown in Table 4:
The fried thing of different fried times of table 4 relatively
Because fried time lengthening, increased the aproll amount, add 22 times of decocting systems promptly can be controlled in 1 hour fried halfhour fry in shallow oil amount.
The fried amount of seeing fried half an hour and 1 hour from table 4 result is close, and the fried time is to get final product each half an hour.
Experimental example 5: the extractum comparative test of different ethanol consumptions
Fetch water respectively under the decoction item nine parts of air dried medicinal residues, per three parts add 8,12,15 times of soak with ethanol 24 hours respectively, from the time jolting, leaching soak dilution or be concentrated into 100ml, accurate respectively three parts of the 20ml that draw are according to 3.1.1.1 decocting method item method mensuration down.The results are shown in Table 5:
The extractum of the different ethanol consumptions of table 5 relatively
Table 5 presentation of results, extract content increase to some extent along with the increase of ethanol consumption, also illustrate that in conjunction with the thin layer chromatography inspection the Endothelium Corneum Gigeriae Galli item under 15 times of amounts can carry to the greatest extent substantially, determine with 15 times of amount extractions.
Experimental example 6: oral liquid is to the influence test of Radix Et Rhizoma Rhei Rats with Spleen-deficiency appetite, body weight gain
Choose 78 of body weight 90～120g healthy rats, male and female half and half are divided equally 5 groups by body weight.First group 14, irritate and feed consubstantiality accumulation of pathogenic cold boiled water in contrast, all the other four groups each 16, irritate and feed 15% rhubarb powder suspension 7.5g/ (kg, d), carry out at twice, 6 hours at interval, continuous 7 days (1) extracts wherein one group and matched group comparison, claims a body weight, and claims appetite every day in two days.Found that; Rat produces gradually and suffers from diarrhoea after taking Radix Et Rhizoma Rhei continuously, and appetite reduces or do not eat, and lose weight or increases slowly, severe patient, atrophy is lazy moving, serious towering hair, and then dead the appearance arranged.Cause serious insufficiency of the spleen diarrhea model, normal control group well-grown does not have above-mentioned phenomenon and takes place, and body weight appetite changes.
Table 6 Radix Et Rhizoma Rhei is to rat food ration influence (X ± SD)
Table 7 Radix Et Rhizoma Rhei is to the influence of rat body weight (X ± SD)
Cause Radix Et Rhizoma Rhei the Rats with Spleen-deficiency of type to be divided into 4 groups by body weight again, every group 14, withdraw behind the Radix Et Rhizoma Rhei every day equal volume gavages cold boiled water for one group, be natural recovering group, its excess-three group gavages the oral liquid that this pharmaceutical composition of same dose 30g crude drug in whole/kg makes, powder and the SHENLING BAISHU SAN that this pharmaceutical composition is made respectively, continuous 12 days, claims food ration simultaneously every day, two days one time body weight, the relatively difference of administration group and the body weight of organizing naturally and appetite recovery.Result such as table 8, table 9.
Table 8 preparation of the present invention influences (X ± SD) to insufficiency of the spleen anorexia rat food ration
* with the SHENLING BAISHU SAN group than P＜0.01
Table 9 preparation of the present invention is to the influence of insufficiency of the spleen anorexia rat body weight (X ± SD)
The result shows: oral liquid of the present invention can obviously improve the anorexia situation of Radix Et Rhizoma Rhei Rats with Spleen-deficiency, promote that obviously food ration increases (P＜0.05), and powder of the present invention and appetite promoting and the spleen strengthening tradition name side SHENLING BAISHU SAN are not seen the effect (P＞0.05) that promotes that appetite increases; Oral liquid of the present invention can significantly promote Rats with Spleen-deficiency body weight gain (P＜0.05), though and powder of the present invention and SHENLING BAISHU SAN group are fast than the matched group weight recovery, do not have the visible oral liquid of the present invention of significant difference (being respectively P＞0.05, P＞0.05) and be better than powder of the present invention and appetite promoting and the spleen strengthening name side SHENLING BAISHU SAN aspect the anorexia situation of improving Rats with Spleen-deficiency and the promotion Rats with Spleen-deficiency body weight gain.
Experimental example 7: the administration different phase Rats with Spleen-deficiency weight recovery test of pharmaceutical composition
For understanding administration different phase Rats with Spleen-deficiency weight recovery situation, done the comparison of sequential growth rate between each group.
Table 10 preparation of the present invention is to the influence of Rats with Spleen-deficiency body weight sequential growth rate
The result shows: oral liquid of the present invention is very fast to the therapeutical effect performance of Rats with Spleen-deficiency, and the effect in 6 days of main pro-was obviously measured in 6 days of the bigger recovery of special insufficiency of the spleen situation, and effect difference is not obvious between each group.This effect also is that oral liquid of the present invention is better than powder of the present invention and SHENLING BAISHU SAN.
Experimental example 8: oral liquid is to the influence test of Radix Et Rhizoma Rhei mice with spleen deficiency weight recovery
Table 11 preparation of the present invention is to the influence of the insufficiency of the spleen anorexia mice of Radix Et Rhizoma Rhei body weight (X ± SD)
Table 11 can illustrate that oral liquid of the present invention has the trend that promotes Radix Et Rhizoma Rhei mice with spleen deficiency body weight gain, and the strong SHENLING BAISHU SAN of crossing of this effect.
Experimental example 9: oral liquid is to Radix Et Rhizoma Rhei Rats with Spleen-deficiency gastric juice, and the influence of gastric acid secretion amount and pepsin activity is tested
The Radix Et Rhizoma Rhei Rats with Spleen-deficiency is measured gastric juice, gastric acid secretion amount and pepsin activity respectively after 12 days Drug therapys, before measuring with rat fasting 18～20 hours, continuous water supply.The row pyloric ligation.Organize the drug dose drug administration by injection in duodenum top by each simultaneously, ligation top, meet and close wound, make it free movable, postoperative pulled out eye in 15～18 hours and gets blood with improvement WinshowShi method mensuration serum amylase, cut open the belly and got stomach, collected gastric juice, measure total amount and measure gastric juice free acid and total acid content (representing), measure pepsin activity with the MettShi method with the vinegar-pepper Gu meq number of saliferous/100g body weight by the Ackerman method
[3-4], (representing) with Wen Shi unit/100g body weight.Result such as following each table.
Table 12 preparation of the present invention is to the influence of Rats with Spleen-deficiency gastric juice amount (X ± SD)
* oral liquid of the present invention and powder of the present invention, SHENLING BAISHU SAN group compare P all＞0.05
Table 13 preparation of the present invention is to the Rats with Spleen-deficiency gastric acid influence of output (X ± SD)
* oral liquid of the present invention and powder of the present invention, SHENLING BAISHU SAN group compare P all＜0.05
Table 14 preparation of the present invention is to the active influence of Rats with Spleen-deficiency pepsin (X ± SD)
* oral liquid of the present invention and powder of the present invention, SHENLING BAISHU SAN group compare P all＞0.05
Table 15 preparation of the present invention is to the diastatic influence of Rats with Spleen-deficiency serum (X ± SD)
The result shows: oral liquid of the present invention can increase the gastric secretion (P＜0.001) of Rats with Spleen-deficiency very significantly, SHENLING BAISHU SAN and powder of the present invention also can increase gastric secretion very significantly, but the amplitude that increases not as oral liquid of the present invention is big, illustrates that oral liquid of the present invention promotes that the effect of gastric juice increase is the strongest; Oral liquid of the present invention increases Rats with Spleen-deficiency stomach free acid and total acid secretory volume, be higher than matched group (being respectively P＜0.01, P＜0.001) very significantly, and be higher than SHENLING BAISHU SAN group and powder group of the present invention, show that fully oral liquid of the present invention has the effect of highly significant aspect gastric acid secretion.Powder of the present invention and SHENLING BAISHU SAN show Radix Et Rhizoma Rhei Rats with Spleen-deficiency serum determination of amylase result, no significant difference between each group of moulding and administration, as seen oral liquid of the present invention and this experiment institute reagent thing do not have obvious influence to amylase, measure each medicine to mice with spleen deficiency with method, the normal rat serum amylase is not seen obvious influence yet.
Oral liquid of the present invention can strengthen pepsin activity, compare significant difference (P＜0.05) with matched group, and action intensity is higher than powder of the present invention and SHENLING BAISHU SAN, shows that oral liquid of the present invention also is better than powder of the present invention and SHENLING BAISHU SAN on the enhancing pepsin activity.
Experimental example 10: the influence test that preparation of the present invention increases normal rat body weight
Get 70 of body weight 70～90g healthy rats, male and female half and half, divide equally 7 groups, press grouping and dosage in the table 1, every day, gastric infusion was 1 time, matched group is irritated stomach with the volume distilled water, every the weight of animals of weighing is obtained each class mean and increasing value before and after the successive administration 12 days, administration, the comparable group differences, result such as table 16.
Table 16 preparation of the present invention is to the influence of normal rat body weight (X ± SD)
See from experimental result, oral liquid 10,20 of the present invention, three dosage groups of 40g crude drug in whole/kg are all fast than powder group body weight gain of the present invention; The heavy dose of group of oral liquid of the present invention body weight gain is faster than the body weight gain of the good medicine of commercially available appetite promoting and the spleen strengthening " ZHIERLING " and appetite promoting and the spleen strengthening name side " SHENLING BAISHU SAN " group and normal control treated animal, but be a kind of trend of increasing of promoting, not seeing has significant difference.
With method also to normal mouse and childhood weight of mice done research, the result does not see obvious influence as table yet.
Table 17 preparation of the present invention is to the influence of normal mouse body weight (X ± SD)
Table 18 preparation of the present invention is to the influence of mice body weight childhood (X ± SD)
Specific embodiment is as follows:
Embodiment 1:The preparation of tablet
Get Endothelium Corneum Gigeriae Galli 217g, Semen Alpiniae Katsumadai 130g, Radix Et Caulis Acanthopanacis Senticosi 87g, Bulbus Allii 44g, Semen Pharbitidis 22g, make tablet according to a conventional method.
Embodiment 2:The preparation of capsule
Endothelium Corneum Gigeriae Galli 200kg, Semen Alpiniae Katsumadai 150kg, Radix Et Caulis Acanthopanacis Senticosi 70kg, Bulbus Allii 50kg, Semen Pharbitidis 15kg make capsule according to a conventional method.
Embodiment 3:The preparation of slow releasing tablet
Endothelium Corneum Gigeriae Galli 240kg, Semen Alpiniae Katsumadai 110kg, Radix Et Caulis Acanthopanacis Senticosi 100kg, Bulbus Allii 30k g, Semen Pharbitidis 30kg make slow releasing tablet according to a conventional method.
Embodiment 4:The preparation of Orally taken emulsion
Endothelium Corneum Gigeriae Galli 217kg, Semen Alpiniae Katsumadai 130kg, Radix Et Caulis Acanthopanacis Senticosi 87kg, Bulbus Allii 44kg, Semen Pharbitidis 22kg make Orally taken emulsion according to a conventional method.
Embodiment 5:The preparation oral liquid
Get Endothelium Corneum Gigeriae Galli 217g, Semen Alpiniae Katsumadai 130g, Radix Et Caulis Acanthopanacis Senticosi 87g, Bulbus Allii 44g, the Semen Pharbitidis 22g five tastes, Endothelium Corneum Gigeriae Galli, Semen Pharbitidis are ground into coarse powder, the Semen Alpiniae Katsumadai fragmentation; The Endothelium Corneum Gigeriae Galli coarse powder adds 15 times of water gagings and decocts secondary, each 0.5 hour, filters filtrate for later use; Endothelium Corneum Gigeriae Galli medicinal residues and Semen Pharbitidis coarse powder are respectively according to the percolation under fluid extract and the extractum item (an appendix I of Chinese Pharmacopoeia version in 2000 O), make solvent with 15 times of amount ethanol, speed with per minute 0.5～2ml is carried out percolation, the collection liquid of filtering, decompression recycling ethanol is to relative density 1.08～1.12 (70 ℃), and is standby; Semen Alpiniae Katsumadai extracts volatile oil with vapor distillation, and aqueous solution after the distillation and Endothelium Corneum Gigeriae Galli decocting liquid merge, and be standby; The Semen Alpiniae Katsumadai medicinal residues mix with Semen Pharbitidis medicinal residues, Radix Et Caulis Acanthopanacis Senticosi, Bulbus Allii, add 15 times of water gagings and decoct secondary, each 0.5 hour, filter, filtrate is incorporated in the above-mentioned decocting liquid, is concentrated into relative density 1.02～1.05 (70 ℃), with sucrose 200g dissolving, filter filtrate cold preservation 48 hours, centrifugal, supernatant and Endothelium Corneum Gigeriae Galli and Semen Pharbitidis ethanol extraction, volatile oil, Oleum Citri Reticulatae 0.2ml and tween 80 10ml stir evenly, and add water and adjust total amount to 1000ml, mixing, fill, promptly.Instructions of taking: 3 times on the one, a 10-30ml.
Embodiment 6:Method of quality control
Getting the oral liquid of embodiment 5 gained differentiates: (1) gets this product 60ml, uses chloroform extraction 3 times, each 30ml, and combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Endothelium Corneum Gigeriae Galli control medicinal material 12g, adds ethanol 120ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-ethyl acetate-formic acid (3: 3: 0.5) is developing solvent, launch, take out, dry, spray is with 10% sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) get Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, add 75% ethanol 50ml, reflux, extract, 1 hour, filter, filtrate evaporate to dryness, residue add water 10ml makes dissolving, adding chloroform extracts 3 times, each 10ml, combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), absorption control medicinal material solution respectively reaches each the 5 μ l of need testing solution under the item of [discriminating] (1), put on the same silica gel g thin-layer plate respectively, with chloroform-methanol (19: 1) is developing solvent, launch, take out, dry, put in addition and inspect under the light modulation (365nm).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical fluorescence speckle.
(3) get the plain reference substance of Alpinia japonica (Thunb.) Miq., add methanol and make the solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw the need testing solution 5ul under reference substance solution 10 μ l, [discriminating] (1) item, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-methanol (15: 4: 1) is developing solvent, launch, take out, dry, put in addition and inspect under the light modulation (365nm).In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
Embodiment 7:Method of quality control
Get the oral liquid of embodiment 5 gained, differentiate: (1) gets this product 60ml, uses chloroform extraction 3 times, each 30ml, and combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Endothelium Corneum Gigeriae Galli control medicinal material 12g, adds ethanol 120ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-ethyl acetate-formic acid (3: 3: 0.5) is developing solvent, launch, take out, dry, spray is with 10% sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
(2) get Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, add 75% ethanol 50ml, reflux, extract, 1 hour, filter, filtrate evaporate to dryness, residue add water 10ml makes dissolving, adding chloroform extracts 3 times, each 10ml, combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), absorption control medicinal material solution respectively reaches each the 5 μ l of need testing solution under the item of [discriminating] (1), put on the same silica gel g thin-layer plate respectively, with chloroform-methanol (19: 1) is developing solvent, launch, take out, dry, put in addition and inspect under the light modulation (365nm).In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical fluorescence speckle.
(3) get the plain reference substance of Alpinia japonica (Thunb.) Miq., add methanol and make the solution that every 1ml contains 2mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw the need testing solution 5ul under reference substance solution 10 μ l, [discriminating] (1) item, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetate-methanol (15: 4: 1) is developing solvent, launch, take out, dry, put in addition and inspect under the light modulation (365nm).In the test sample chromatograph, with the reference substance chromatograph corresponding put, show the fluorescence speckle of same color.
Assay: measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Methanol-0.1% formic acid solution (30: 70) is a mobile phase; The detection wavelength is 342nm.Number of theoretical plate is pressed the isofraxidin peak and is calculated, and should be not less than 2000.
The preparation of reference substance solution: it is an amount of that the phosphorus pentoxide of learning from else's experience is dried to the isofraxidin reference substance of constant weight, accurately claims that adding methanol surely makes the solution that every 1ml contains 10ug, promptly.
The preparation precision of need testing solution is measured this product 10ml, adds ethyl acetate extraction 3 times, each 10ml, and merge extractive liquid,, evaporate to dryness is used dissolve with methanol, is transferred in the 2ml measuring bottle and is diluted to scale, shakes up, as need testing solution.
Algoscopy: accurate respectively molten and each the 10 μ l of need testing solution of reference substance that draw, inject chromatograph of liquid, measure, promptly.
The every ml of this product contains isofraxidin (C
11H
10O
5) must not be less than 1ug.
Claims (13)
1. pharmaceutical composition for the treatment of infantile anorexia is characterized in that this pharmaceutical composition is to be made by following raw material medicaments in part by weight:
Endothelium Corneum Gigeriae Galli 200-240 weight portion Semen Alpiniae Katsumadai 110-150 weight portion
Radix Et Caulis Acanthopanacis Senticosi 70-100 weight portion Bulbus Allii 30-50 weight portion Semen Pharbitidis 15-30 weight portion.
2. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition is to be made by following raw material medicaments in part by weight:
Endothelium Corneum Gigeriae Galli 200 weight portion Semen Alpiniae Katsumadai 150 weight portions
Radix Et Caulis Acanthopanacis Senticosi 70 weight portion Bulbus Alliis 50 weight portion Semen Pharbitidiss 15 weight portions.
3. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition is to be made by following raw material medicaments in part by weight:
Endothelium Corneum Gigeriae Galli 240 weight portion Semen Alpiniae Katsumadai 110 weight portions
Radix Et Caulis Acanthopanacis Senticosi 100 weight portion Bulbus Alliis 30 weight portion Semen Pharbitidiss 30 weight portions.
4. pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition is to be made by following raw material medicaments in part by weight:
Endothelium Corneum Gigeriae Galli 217 weight portion Semen Alpiniae Katsumadai 130 weight portions
Radix Et Caulis Acanthopanacis Senticosi 87 weight portion Bulbus Alliis 44 weight portion Semen Pharbitidiss 22 weight portions.
5. as claim 1,2,3 or 4 described pharmaceutical compositions, it is characterized in that said composition is prepared into tablet, hard capsule, soft capsule slow releasing tablet, controlled release tablet, slow releasing capsule, controlled release capsule clinical or that pharmaceutically accept, oral solution, oral suspensions, Orally taken emulsion, mucilage, oral liquid, Emulsion, colloid solution, mixture, tincture, drop, suspendible drop, pill, drop pill, granule, enteric coated granule, powder or powder.
6. the preparation method of drug composition oral liquid as claimed in claim 5 is characterized in that this method may further comprise the steps:
Endothelium Corneum Gigeriae Galli, Semen Pharbitidis are ground into coarse powder, the Semen Alpiniae Katsumadai fragmentation; The Endothelium Corneum Gigeriae Galli coarse powder adds 12-18 times of water gaging and decocts 1-3 time, each 0.5-1 hour, filters filtrate for later use; Endothelium Corneum Gigeriae Galli medicinal residues and Semen Pharbitidis coarse powder are respectively according to the percolation of fluid extract and extractum, doubly measure ethanol with 12-18 and make solvent, carry out percolation, collect the liquid of filtering with the speed of per minute 0.5～2ml, decompression recycling ethanol to relative density is 1.08～1.12 70 ℃ the time, and is standby; Semen Alpiniae Katsumadai extracts volatile oil with vapor distillation, and aqueous solution after the distillation and Endothelium Corneum Gigeriae Galli decocting liquid merge, and be standby; The Semen Alpiniae Katsumadai medicinal residues mix with Semen Pharbitidis medicinal residues, Radix Et Caulis Acanthopanacis Senticosi, Bulbus Allii, add 12-18 times of water gaging and decoct 1-3 time, each 0.5-1 hour, filter, filtrate is incorporated in the above-mentioned decocting liquid, and being concentrated into relative density is 1.02～1.05 in the time of 70 ℃, add sucrose dissolved, filter filtrate cold preservation 40-50 hour, centrifugal, supernatant and Endothelium Corneum Gigeriae Galli and Semen Pharbitidis ethanol extraction, volatile oil, antiseptic and solubilizing agent stir evenly, add the water adjustment, mixing, fill, promptly.
7. the preparation method of the oral liquid of pharmaceutical composition as claimed in claim 6 is characterized in that this method may further comprise the steps:
Endothelium Corneum Gigeriae Galli, Semen Pharbitidis are ground into coarse powder, the Semen Alpiniae Katsumadai fragmentation; The Endothelium Corneum Gigeriae Galli coarse powder adds 15 times of water gagings and decocts 2 times, each 0.5 hour, filters filtrate for later use; Endothelium Corneum Gigeriae Galli medicinal residues and Semen Pharbitidis coarse powder are respectively according to the percolation under fluid extract and the extractum item, make solvent with 15 times of amount ethanol, carry out percolation, collect the liquid of filtering with the speed of per minute 0.5～2ml, decompression recycling ethanol to relative density is 1.08～1.12 70 ℃ the time, and is standby; Semen Alpiniae Katsumadai extracts volatile oil with vapor distillation, and aqueous solution after the distillation and Endothelium Corneum Gigeriae Galli decocting liquid merge, and be standby; The Semen Alpiniae Katsumadai medicinal residues mix with Semen Pharbitidis medicinal residues, Radix Et Caulis Acanthopanacis Senticosi, Bulbus Allii, add 15 times of water gagings and decoct each 0.5 hour 2 times, filter, filtrate is incorporated in the above-mentioned decocting liquid, and being concentrated into relative density is 1.02～1.05 in the time of 70 ℃, with the dissolving of sucrose 200 weight portions, filter filtrate cold preservation 48 hours, centrifugal, supernatant and Endothelium Corneum Gigeriae Galli and Semen Pharbitidis ethanol extraction, volatile oil, antiseptic and solubilizing agent stir evenly, and add the water adjustment, mixing, fill, promptly.
8. as claim 6 or 7 described methods, it is characterized in that antiseptic is Oleum Citri Reticulatae 2/0,000 volume ratios, solubilizing agent is tween 80, Tween-60 or the tween 20 of volume ratio 1%.
9. the method for quality control of oral liquid in the pharmaceutical composition as claimed in claim 5 is characterized in that discrimination method in this method comprises a kind of and/or several in the following discriminating:
A, the compositions oral liquid 60ml that gets it filled use chloroform extraction 2-4 time, each 20-40ml, and combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; Other gets Endothelium Corneum Gigeriae Galli control medicinal material 10-15g, adds ethanol 110-140ml, and supersound process 20-40 minute, filter, filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with 3: 3: chloroform-ethyl acetate of 0.4-0.8-formic acid was developing solvent, launched, and took out, dry, spray is with the 8-12% sulfuric acid solution, and it is clear to be heated to speckle colour developing at 102-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
B, get Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, add 70-80% ethanol 40-60ml, reflux, extract, 0.5-1.5 hour, filter, filtrate evaporate to dryness, residue add water 8-12ml makes dissolving, adding chloroform extracts 1-3 time, each 8-12ml, combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw control medicinal material solution and respectively reach each the 5 μ l of need testing solution that differentiate under the A item, put on the same silica gel g thin-layer plate respectively, chloroform-methanol with 17-19: 1-3 is developing solvent, launches, and takes out, dry, put under the outer light modulation of this 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical fluorescence speckle;
C, get the plain reference substance of Alpinia japonica (Thunb.) Miq., add methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw reference substance solution 10 μ l, differentiate the need testing solution 5ul under a item, put respectively on same silica gel g thin-layer plate, with 14-16: 3-5: benzene-ethyl acetate of 1-methanol is developing solvent, launches, and takes out, dry, put under the outer light modulation of this 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
10. the method for quality control of pharmaceutical composition as claimed in claim 9 is characterized in that discrimination method in this method comprises one or more in the following discriminating:
A, the compositions oral liquid 60ml that gets it filled use chloroform extraction 3 times, each 30ml, and combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; Other gets Endothelium Corneum Gigeriae Galli control medicinal material 12g, adds ethanol 120ml, and supersound process 30 minutes filters, and filtrate evaporate to dryness, residue add methanol 2ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-ethyl acetates of 3: 3: 0.5-formic acid is developing solvent, launches, and takes out, dry, spray is with 10% sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
B, get Radix Et Caulis Acanthopanacis Senticosi control medicinal material 5g, add 75% ethanol 50ml, reflux, extract, 1 hour, filter, filtrate evaporate to dryness, residue add water 10ml makes dissolving, adding chloroform extracts 3 times, each 10ml, combined chloroform liquid dewaters in right amount with anhydrous sodium sulfate, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw control medicinal material solution and respectively reach and differentiate each 5 μ l of a item need testing solution down, put respectively on the same silica gel g thin-layer plate, be developing solvent with 19: 1 chloroform-methanols, launch, taking-up is dried, and puts under the outer light modulation of this 365nm and inspects; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical fluorescence speckle;
C, get the plain reference substance of Alpinia japonica (Thunb.) Miq., add methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw reference substance solution 10 μ l, differentiate the need testing solution 5ul under a item, put respectively on same silica gel g thin-layer plate, with benzene-ethyl acetates of 15: 4: 1-methanol is developing solvent, launches, and takes out, dry, put under the outer light modulation of this 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
11. the oral liquid method of quality control of pharmaceutical composition as claimed in claim 5 is characterized in that the assay in this method is:
Assay: according to high effective liquid chromatography for measuring
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; 30: 70 methanol-0.1% formic acid solution is a mobile phase; The detection wavelength is 342nm; Number of theoretical plate is pressed the isofraxidin peak and is calculated, and should be not less than 2000;
The preparation of reference substance solution: it is an amount of that the phosphorus pentoxide of learning from else's experience is dried to the isofraxidin reference substance of constant weight, accurately claims that adding methanol surely makes the solution that every 1ml contains 10ug, promptly;
The preparation of need testing solution: precision is measured drug composition oral liquid 10ml, adds ethyl acetate extraction 3 times, uses ethyl acetate 10ml at every turn, merge extractive liquid,, evaporate to dryness is used dissolve with methanol, be transferred in the 2ml measuring bottle and be diluted to scale, shake up, as need testing solution;
Algoscopy: accurate respectively molten and each the 10 μ l of need testing solution of reference substance that draw, inject chromatograph of liquid, measure, promptly;
The every ml of this drug composition oral liquid contains isofraxidin C
11H
10O
5Must not be less than 1ug.
12. as claim 1,2, the application of 3 or 4 described pharmaceutical compositions in the medicine of preparation treatment infantile anorexia.
13. the application of pharmaceutical composition as claimed in claim 12 is characterized in that described treatment infantile anorexia is meant increase stomachial secretion amount, stomach is free and the secretory volume of total acid increases the white enzymatic activity of stomach, increases food ration or increases body weight.
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| 高效液相色谱法测定小儿开胃口服液中异嗪皮啶含量. 于超等.中成药，第24卷第12期. 2002 * |
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