CN101940696B - Method for preparing Chinese medicinal compound Zengshengping - Google Patents
Method for preparing Chinese medicinal compound Zengshengping Download PDFInfo
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Abstract
The invention provides a method for preparing Chinese medicinal compound Zengshengping. The method improves the preparation process for the conventional similar medicament; and the produced medicament has controllable quality and accords with the medicament standard, and the treatment effect of the medicament is superior to that of a product prepared by the original method, so the method can be used for providing a more effective and safer medicament with more stable quality. The invention also provides the Chinese medicinal compound Zengshengping prepared by adopting the method.
Description
Technical field
The present invention relates to a kind of method for preparing of Chinese medicine compound, particularly be directed against multiple cancer, alimentary canal inflammation, have the method for preparing of the Chinese medicine compound zengshengping tablet of effects such as heat-clearing and toxic substances removing and blood stasis-eliminating and stagnation-dissipating.
Background technology
The compound Chinese medicinal preparation zengshengping tablet is made up of 6 flavor prescriptions: Radix Sophorae Tonkinensis, Rhizoma Bistortae, Sonchus brachyotus DC., Cortex Dictamni, Spica Prunellae and Rhizoma Dioscoreae Bulbiferae.Zengshengping tablet is mainly used in illness before treatment upper gastrointestinal precancerous lesion and the cancer clinically, and the esophageal carcinoma of middle and advanced stage, carcinoma of gastric cardia, colon cancer etc. are had good mitigation; The patient carries out prophylactic treatment after being used for cancer postoperative and radiotherapy, can prevent recurrence and transfer, and the raising cure rate (Zhu Yingkang etc. the 22 routine short term effects researchs of hypertrophy plain film treatment stage tract cancer disease, Guangxi medical science, 2000,22 (2): 314-316; Pan Qinghui, Li Aien, Lin Yuzong. the application of hypertrophy plain film in esophageal carcinoma radiotherapy, Colleges Of Traditional Chinese Medicine Of Fujian's journal, 2005,15 (6): 14; Wang Junxian, Zhou Erfu, Ding Zhenwei, Wang Jixin, Guo Liping. hypertrophy plain film treatment epitheliosis of esophageal cells 108 examples, Chinese experimental pharmacology of Chinese medical formulae magazine, 1997,3 (1): 28-30; Li Hongyi, Liu Duanqi, Zhang Fengzhou. the clinical multicenter double blind control of hypertrophy plain film treatment esophagus and stomach disorder is observed. the Gansu traditional Chinese medical science, 1994,7 (3): 25-26).Zengshengping tablet not only shows in zoopery and clinical research has significantly anticancer and protective effect on cancer risk to multiple cancer; And diseases such as gastritis, digestive tract ulcer there is curative effect (Mu Xiuhua preferably; Height is turned on. the 62 routine clinical observations of zengshengping tablet treatment chronic superficial gastritis; The Hebei traditional Chinese medical science, 2003,25 (2): 145-146; Xu Hongji, old full rub-a-dub. hypertrophy plain film treatment chronic atrophic gastritis 15 examples are known from experience medical science forum of basic unit, 2005,9 (11): 1051; Cheng Wanqiang, Wang Wentao. zengshengping tablet treatment oral ulcer 38 examples, Chinese practical Chinese and western medicine magazine, 2001,14 (4): 747), can improve body's immunological function, have tangible immunoregulation effect.
The medium people of Lin Pei discloses a kind of method for making of Chinese medicine canceration shutoff agent (have in this prescriptions of Chinese medicine Herba indigoferae Pseudotinctoriae different with zengshengping tablet) of similar zengshengping tablet in application number is 90109821.3 patent application.Specific as follows: getting 8-12 part Cortex Dictamni powder, to be broken into fine powder subsequent use.3-6 part Rhizoma Dioscoreae Bulbiferae, 18-25 part Spica Prunellae, 17-21 part Rhizoma Bistortae, 17-23 part Herba Patriniae, 18-24 part Radix Sophorae Tonkinensis Chinese medicine of the five flavours are all put in the container, added suitable quantity of water, decocted 2 hours; Filtering liquid medicine; Medicinal residues add suitable quantity of water again, decoct leaching medicinal liquid waste 1.5 hours.The medicinal liquid that merges secondary, being evaporated to relative density is the extractum of 1.20-1.45 (50 ℃ of heat are surveyed); With subsequent use Cortex Dictamni fine powder and concentrated extract uniform mixing, add an amount of excipient and process various dosage forms at last.Up to now, do not see that other document public reported adopt different medical materials and Different Preparation to prepare similar medicine.
Therefore, there is at present demand to the new method that is used to prepare the Chinese medicine compound zengshengping tablet.
Summary of the invention
In order to solve the problems of the technologies described above, an object of the present invention is to provide the method for preparing of Chinese medicine compound zengshengping tablet, said method can provide and meet drug standard, quality controllable, medicine that curative effect is better.Another object of the present invention provides the Chinese medicine compound zengshengping tablet that adopts this method for preparing and produce.
The objective of the invention is to realize through following technical scheme:
On the one hand, the present invention provides the method for preparing of Chinese medicine compound zengshengping tablet, said method comprising the steps of:
1) get 210 gram Cortex Dictamni, it is subsequent use that wherein 70-140 gram is ground into fine powder;
2) get 420 Keshan Radix Sophorae Tonkinensis decocte with water 2 times, each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), and drying under reduced pressure below 60 ℃ becomes dried cream, pulverizes, and is subsequent use;
3) get 100 gram Rhizoma Dioscoreae Bulbiferaes, 420 gram Sonchus brachyotus DC., 420 gram Rhizoma Bistortaes, 420 gram Spica Prunellaes and step 1) residue without the Cortex Dictamni of pulverizing; Decocte with water 2 times; 2 hours for the first time, 1.5 hours for the second time, collecting decoction; Filter, filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃);
4) in the thick paste of step 3), add Cortex Dictamni fine powder and the step 2 of step 1)) the Radix Sophorae Tonkinensis dried cream powder, mixing, oven dry below 80 ℃, pulverizing.
Preferably, the step 2 of said method) and in the step 3), 10 times of water gagings are all adopted in each decocte with water.
Preferably, said method also comprises in the product that step 4) obtains and adds appropriate amount of auxiliary materials, processes various dosage forms.Further preferably, said dosage form includes but not limited to tablet, capsule, pill and powder.
Wherein, said method comprises that also in the product that step 4) obtains, adding adjuvant makes the gross mass of product and adjuvant reach 300 grams.
Preferably, said method also comprises in the product that step 4) obtains and to add starch as adjuvant, and processes granule after drying with debita spissitudo ethanol, granulate, and tabletting is processed tablet.
Preferably, in the said method step 1), it is subsequent use that the 105g Cortex Dictamni powder is broken into fine powder.
On the other hand, the present invention provides the Chinese medicine compound zengshengping tablet that adopts method for preparing.
Preferably, the dosage form of said Chinese medicine compound zengshengping tablet includes but not limited to tablet, capsule, pill, drop pill, granule and powder.
Below be detailed description of the present invention:
The present invention provides a kind of new preparation method on the method for preparing basis of existing similar medicine, according to the specific embodiment of the present invention, this method comprises:
Get part Cortex Dictamni (70-140g) and be ground into fine powder, subsequent use; Radix Sophorae Tonkinensis decocte with water 2 times, each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), and drying under reduced pressure (below 60 ℃) becomes dried cream, pulverizes, and is subsequent use.Four flavor and remaining Cortex Dictamni such as all the other Rhizoma Bistortaes, decocte with water 2 times, 2 hours for the first time; 1.5 hours for the second time, collecting decoction filtered; Filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), adds above-mentioned Cortex Dictamni fine powder and Radix Sophorae Tonkinensis dried cream powder, mixing; Oven dry (below 80 ℃) is pulverized.It is an amount of to add excipient, processes various dosage forms.Preferably, it is an amount of to add starch, processes granule with debita spissitudo ethanol, drying, granulate, tabletting, bag film-coat.
The inventive method and nineteen ninety patent (application number: there were significant differences for the preparation technology of the similar medicine that 90109821.3) is provided, and is mainly reflected in:
1) in the method for preparing of the disclosed similar medicine of nineteen ninety patent, what wherein medical material adopted simply is Herba Patriniae, and method for preparing of the present invention adopts Sonchus brachyotus DC. to be used for substituting Herba Patriniae;
Sonchus brachyotus DC., the dry herb for the feverfew Herba Sonchi Oleracei has heat-clearing and toxic substances removing, a function of the evacuation of pus of invigorating blood circulation.Pharmacological research shows that it has antitumor, blood pressure lowering, cholesterol reducing, arrhythmia, prevents and treats the hepatitis isoreactivity, has certain inhibitory action to common infectious pathogenic bacterium such as staphylococcus aureus, Pseudomonas aeruginosa, bacillus subtilises.
Herba Patriniae, the dry herb for Valerianaceae plant Patrinia scabiosaefolia Fisch or patrima villosa has the function of heat-clearing and toxic substances removing, removing blood stasis and expelling pus.
Herba Patriniae is two kinds of different medicines with Sonchus brachyotus DC., though its nature and flavor, return through curing mainly close part with function, and incomplete same.The Herba Patriniae cold nature, bitter in the mouth and suffering though have antipyretic and antidote functions, more is good at blood circulation promoting and blood stasis dispelling, analgesic effect, the clinical acute appendicitis that are applied to treat more.Sonchus brachyotus DC. is cold in nature, and bitter in the mouth is good at antipyretic and antidote functions, and clinical treatment hypochondriac pain, carbuncle sore are satisfactory for result.
2) in method for preparing of the present invention, the Cortex Dictamni of the amount of the 1/3-2/3 that has an appointment makes into to extract from direct pulverizing;
3) mixed extraction of Radix Sophorae Tonkinensis from former preparation technology made independent extraction into; And when when the first time of Radix Sophorae Tonkinensis, decocting time was by mixed extraction 2 hours make into to extract separately 1.5 hours; In addition, newly-increased drying under reduced pressure becomes dried cream after Radix Sophorae Tonkinensis is extracted into thick paste separately, and the step of pulverizing.
Experiment finds that new method provided by the invention can heavily be controlled at 0.3g with the sheet of tablet; And content of matrine is about the 0.25-0.80mg/ sheet in the medicine under the situation of the heavy 0.3g of sheet; Majority is controlled at the 0.40-0.80mg/ sheet, can reach the ministry standard of medicine, and drug quality is guaranteed; Thereby solved in the former technology and can not sheet heavily be controlled at 0.3g, the technological deficiency that matrine content is low.
Simultaneously, experiment showed, the medicine of using production method preparation provided by the present invention, aspect drug effect, be superior to the similar medicine of former prepared equally.Therefore, technical scheme provided by the present invention is superior to prior art, can be people a kind of more effective, safer, medicine that quality is more stable is provided.
In sum, compared with prior art, the present invention provides a kind of novel method for preparing through improving the existing preparation technology of medicine and adopting the different raw materials medicine.The drug quality that adopts the method to produce is controlled, meet drug standard, and curative effect is superior to former method for making products obtained therefrom.Therefore, technical scheme provided by the present invention obviously is superior to prior art, the Chinese medicine compound zengshengping tablet of can be used to provide more effective, safer, quality is more stable.
The specific embodiment
Below in conjunction with the specific embodiment the present invention is further described in detail, the embodiment that provides has been merely and has illustrated the present invention, rather than in order to limit scope of the present invention.
Embodiment 1: the preparation of Chinese medicine compound zengshengping tablet and similar pharmaceutical preparations
Following method for making is with reference to 1000 recipe quantity dispensing in the hypertrophy plain film drug standard.
Zengshengping tablet method for making provided by the invention (method for making 1):
Get Cortex Dictamni 10Sg and be ground into fine powder, subsequent use; The 420g Radix Sophorae Tonkinensis adds 10 times of amounts of water respectively, 10 times of amounts decoct secondary, and each 1.5 hours, collecting decoction filtered, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃), and drying under reduced pressure (below 60 ℃) becomes dried cream, pulverizes, and is subsequent use.100 gram Rhizoma Dioscoreae Bulbiferaes, 420 gram Sonchus brachyotus DC., 420 gram Rhizoma Bistortaes, 420 gram Spica Prunellae and remaining Cortex Dictamni 105g add 10 times of amounts of water respectively, 10 times of amounts decoct 2 times, and 2 hours for the first time, 1.5 hours second time; Collecting decoction filters, and filtrate decompression is concentrated into the thick paste that relative density is 1.30-1.35 (50 ℃); Add above-mentioned Cortex Dictamni fine powder and Radix Sophorae Tonkinensis dried cream powder, mixing, oven dry (below 80 ℃); Pulverize, weigh, i.e. pharmaceutical preparations A.
Zengshengping tablet method for making (method for making 2) with reference to prior art:
Get Cortex Dictamni 210g, it is subsequent use to be ground into fine powder.Get each 420g of Rhizoma Dioscoreae Bulbiferae 100g, Radix Sophorae Tonkinensis, Sonchus brachyotus DC., Rhizoma Bistortae and Spica Prunellae again, put in the container, add 10 times of amounts of water, mix decocting 2 hours, leaching medicinal liquid, medicinal residues add the water of 10 times of amounts again, decoct leaching medicinal liquid waste 1.5 hours.Twice filtrating is merged, be evaporated to the extractum of relative density 1.30 to 1.35 (50 ℃ of heat are surveyed).With subsequent use Cortex Dictamni fine powder and spissated extractum uniform mixing, weigh at last, promptly get pharmaceutical preparations B.
The method for making of the similar medicine of zengshengping tablet in the prior art (method for making 3):
Get Cortex Dictamni 210g, it is subsequent use to be ground into fine powder.Get each 420g of Rhizoma Dioscoreae Bulbiferae 100g, Radix Sophorae Tonkinensis, Herba Patriniae, Rhizoma Bistortae and Spica Prunellae again, put in the container, add 10 times of amounts of water, mix decocting 2 hours, leaching medicinal liquid, medicinal residues add the water of 10 times of amounts again, decoct leaching medicinal liquid waste 1.5 hours.Twice filtrating is merged, be evaporated to the extractum of relative density 1.30 to 1.35 (50 ℃ of heat are surveyed).With subsequent use Cortex Dictamni fine powder and spissated extractum uniform mixing, weigh at last, promptly get pharmaceutical preparations C.
Adopt the medical material (except the Herba Patriniae in the method for making 3) in identical source; Prepare medicine according to above-mentioned 3 kinds of methods respectively; Obtain different prepared products; Wherein method for making 1 corresponding prepared product is labeled as prepared product A, and method for making 2 corresponding prepared products are labeled as prepared product B, and method for making 3 corresponding prepared products are labeled as prepared product C.
Adopt the medical material of 5 batches of separate sources (the different places of production/batch) respectively, every batch of medical material prepares medicine respectively in a manner described, and its receipts amount is as shown in table 1.
Receipts amount (the unit: g) of 1000 tablet recipe amount zengshengping tablets and similar medicine under the different method for makings of table 1
Annotate: prepared product A group is compared with prepared product B group, C group respectively, and all there is significant difference (P＜0.01) in the receipts amount.
According to the drug standard of hypertrophy plain film, the mixed gross mass of the pharmaceutical preparations of 1000 tablet recipe amounts and adjuvant should be 300g.By the pharmaceutical preparations of method for making provided by the invention (method for making 1) preparation, control adjuvant amount can be controlled at 300g with 1000 gross weight, meets drug standard.And the pharmaceutical preparations of method for making 2 and 3 preparations, weight has exceeded standard when not adding adjuvant, does not meet drug standard.So method for making 1 more can meet drug standard than the medicine of method for making 2,3 preparations.
Embodiment 2: the preparation of Chinese medicine compound zengshengping tablet and similar medicinal tablet
According to the tablet standard of hypertrophy plain film, the dosage of embodiment 1 should make 1000 of hypertrophy plain films, the heavy 0.3g/ sheet of sheet, and every contains matrine 0.25～0.80mg.
Method for making provided by the invention can reach the requirement of hypertrophy plain film drug standard, and concrete method for making is: it is an amount of that the prepared product A of gained among the embodiment 1 is added starch, processes granule with 95% ethanol, drying, and granulate is pressed into 1000, and sheet weight 0.3g/ sheet promptly gets tablet A.
Can't reach the heavy requirement with the sheet number of sheet in the drug standard simultaneously with reference to the method for making of the hypertrophy plain film of prior art and the similar medicinal tablet of zengshengping tablet, therefore respectively get half amount prepared product B and the C heavy and sheet numeral system of control strip two kinds of tablets fully respectively.
The tablet method for making that control strip is heavy: with the prepared product B of gained among the embodiment 1 and partly measuring of C, add 10% (W/W) starch respectively, process granule with 95% ethanol, drying, granulate is pressed into the 0.3g/ sheet, promptly gets tablet B and tablet C.
The tablet method for making of control strip number: the prepared product B of gained among the embodiment 1 and the residue half of C are measured, and it is an amount of to add starch respectively, processes granule with 95% ethanol, drying, and granulate is pressed into 500, obtains tablet b and tablet c respectively.
5 kinds of tablets are carried out the content matrine to be measured.The concrete grammar of assay is following: measure with reference to HPLC (2005 editions appendix ID of Chinese Pharmacopoeia).
Chromatographic condition and system suitability test: use octadecylsilane chemically bonded silica to be filler: be mobile phase with methanol-0.36% potassium phosphate buffer (using phosphoric acid to regulate pH value is 3.0) (10: 90); The detection wavelength is 210nm, and number of theoretical plate calculates by the matrine peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the matrine reference substance, adds water and process every 1ml and contain 0.05mg solution, promptly gets.
The preparation of need testing solution: get these article under the weight differential item, porphyrize, precision takes by weighing about 3 amounts, puts in the 100ml measuring bottle, adds liquor ammoniae fortis 3ml, shakes up, and places 10 minutes.Add water and make dissolving and be diluted to scale, shake up, left standstill 1 hour, filter; Precision is measured subsequent filtrate 20ml, puts in the separatory funnel, extracts (20,15,15ml) 3 times with the chloroform jolting, merges chloroform liquid; Water 10ml washing, water layer extracts 2 times with the chloroform jolting, each 5ml; Merge chloroform liquid, put 70 ℃ of water bath methods, residue adds the mutual-assistance dissolving of flowing, and is transferred in the 5ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, and promptly gets.
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly get.
Content of matrine is following in the gained drug single:
Content of matrine (unit: the mg/ sheet) in the zengshengping tablet of table 2 a heavy 0.3g and the similar medicinal tablet
Annotate: the matrine content of tablet A group is organized (P＜0.01) apparently higher than tablet B group and tablet C, and all at 0.25～0.80mg, meets the tablet standard.
Can know that by table 2 matrine content of tablet B group and tablet C group sample is not only low than the A group, and inwhole conformance with standard.
(the unit: the mg/ sheet) of content of matrine in zengshengping tablet that table 3 control strip numeral system gets and the similar medicinal tablet
Annotate: the matrine content of tablet A group all is higher than tablet B group and tablet C group, and its difference has statistical significance (P＜0.05).
Can know by embodiment 2; Hypertrophy plain film according to method for making preparation provided by the invention; Its matrine content is apparently higher than hypertrophy plain film and the similar medicinal tablet of zengshengping tablet with reference to prior art for preparing, and by the hypertrophy plain film of method for making preparation provided by the invention recipe quantity, sheet is heavy and matrine content on all meet drug standard, and with reference to the hypertrophy plain film and the similar medicinal tablet of zengshengping tablet of prior art for preparing; Not only matrine content is low; And can't satisfy the heavy requirement of recipe quantity and sheet in the drug standard simultaneously, as satisfy that sheet is important to be asked, the underproof situation of matrine content then possibly appear.
Embodiment 3: different prepared products are to the influence of Eca109 esophageal cancer cell transplanted tumor in nude mice
1. experiment material
1.1 medicine
Prepared product A1, B1 and the C1 of preparation among the embodiment 1.
1.2 cell strain
Human esophagus cancer cell strain Eca109 purchases in rich intelligent this biological medicine Science and Technology Ltd..
1.3 animal
The female nude mice of BALB/C (nu/nu), 6 ages in week are available from Beijing Vital River Experimental Animals Technology Co., Ltd..
2. experimental technique
2.1 set up Eca109 cell transplanted tumor in nude mice model
External recovery, cultivation Eca109 cell are collected the logarithmic (log) phase auxocyte, and 1000r/min is centrifugal, serum-free DMEM culture medium washing 2 times, and cell counting is cultivated keynote cell concentration to 1 * 10 with the DMEM that does not contain serum
7Cell/ml.
Get 48 female nude mices of BALB/C, press the above-mentioned oncocyte of the right axil subcutaneous vaccination of 0.2ml/ Mus, modeling.
The modeling nude mice is divided into 4 groups at random, 1 group of matched group, administration, 2 groups of administrations, 3 groups of administrations, 12 every group.Beginning in the 2nd day after the modeling, gastric infusion.Matched group gives normal saline every day.Administration gives prepared product A1 1 group of every day, and administration gives prepared product B1 2 groups of every days, and administration gives prepared product C1 3 groups of every days, and dosage is 4g/kg.From tumor grew, every 10d weighed, and measured the tumor size, more than handle carry out 60d continuously after, take off cervical vertebra and put to death nude mice, peel off lump.
2.2 tumor size and medicine suppression ratio
From the tumor naked eyes visible from, every 10d presses Li Shi method [V (mm with the major diameter L (mm) of vernier caliper measurement tumor and the maximum transverse diameter W (mm) of vertical direction
3)=L * W
2/ 2] calculate gross tumor volume.Calculate tumour inhibiting rate [(the average tumor volume of the average tumor volume/matched group of 1-administration group) * 100%].
3. experimental result
Each organizes 12 nude mices of modeling, and administration respectively occurs 1 because of the dead nude mice of operation for 1 group and 2 groups.
The different prepared products of table 4 are to the influence of Eca109 cell transplanted tumor in nude mice tumor volume (the 20th day)
| Group | Number of animals | Gross tumor volume (unit: mm 3) | Tumour inhibiting rate (%) |
| Matched group | 12 | 106.5±31.0 | 0 |
| 1 group of administration | 11 | 73.9±25.7 ★ | 30.6 |
| 2 groups of administrations | 11 | 79.6±24.7 ★▲ | 25.3 |
| 3 groups of administrations | 12 | 83.9±17.4 ★▲ | 21.2 |
Annotate:
★Representative is compared with matched group, P＜0.05;
▲Representative is compared P＞0.05. for 1 group with administration
Can know that by table 4 gross tumor volume that administration is 1,2,3 groups all is significantly less than matched group (P＜0.05), and the gross tumor volume of 1 group of administration is less than 2 groups of administrations and 3 groups, but difference not significantly (P＞0.05).This result shows, tests the 20th day, adopt the pharmaceutical preparations of three kinds of method for making preparations that Eca109 cell transplanted tumor in nude mice tumor volume is all had the obvious suppression effect, but tumor killing effect difference is not remarkable between each administration group.
The different prepared products of table 5 are to the influence of Eca109 cell transplanted tumor in nude mice tumor heavy (the 60th day)
| Group | Number of animals | Tumor weight (unit: g) | Tumour inhibiting rate (%) |
| Matched group | 12 | 0.415±0.148 | 0 |
| 1 group of administration | 11 | 0.222±0.081 ★★ | 46.5 |
| 2 groups of administrations | 11 | 0.291±0.071 ★▲ | 29.9 |
| 3 groups of administrations | 12 | 0.33±0.064 ▲ | 20.5 |
Annotate:
★Representative is compared with matched group, P＜0.05;
★ ★Representative is compared with matched group, P＜0.01;
▲Representative is compared P＜0.05 for 1 group with administration.
Can know that by table 5 tumor of 1 group of administration and 2 groups heavily is starkly lower than matched group (P＜0.05); The tumor that administration is 3 groups heavily is lower than matched group, but difference not significantly (P＞0.05).The tumor that administration is 1 group heavily is starkly lower than 2 groups of administrations and 3 groups (P＜0.05).This result shows that to testing the 60th day, each administration group all demonstrates tumor-inhibiting action, and wherein 1 group and 2 groups tumor-inhibiting actions of administration are remarkable, and the tumor-inhibiting action of prepared product A1 obviously is superior to prepared product B1 and C1.
Can find out that from these group data the similar medicine of the zengshengping tablet of three kinds of method for making gained and zengshengping tablet all has the effect of the inhibition esophageal carcinoma (Eca109).During the short-term administration, three kinds of prepared products do not have significant difference on drug effect; During long term administration, obviously be superior to existing method for making gained zengshengping tablet and the similar medicine of zengshengping tablet by method for making gained zengshengping tablet curative effect provided by the invention.
Embodiment 4: the influence that the mouth neoplasm that different prepared products bring out DMBA takes place
1. experiment material
1.1 medicine
Prepared product A1, B1 and the C1 of preparation among the embodiment 1.
1.2 animal
Male golden yellow gopher, body weight 100～120g purchases the animal center in epidemic research institute of China Preventive Medicial Science Institute.
2. experimental technique
Get 80 male golden yellow gophers, be divided into 4 groups at random, wherein matched group is 1 group, 3 groups of administration groups, every group equal 20.Not administration of matched group only is coated with the 0.5%DMBA acetone solution, 3 times weekly, is coated with altogether 6 times; The administration group except that pressing the modeling of matched group mode, also in modeling every day gastric infusion 4.0g/kg, altogether 10 weeks of administration, wherein administration gives prepared product A1 for 1 group, administration gives prepared product B1 for 2 groups, administration gives prepared product C1 for 3 groups.
Experiment finishes the back and puts to death animal, counting mouth neoplasm number, and measure each tumor body volume, calculate suppression ratio (the average tumor number of the suppression ratio 1=matched group-average tumor number of administration group)/average tumor number of matched group; Suppression ratio 2=(the average tumor volume of the matched group-average tumor volume of administration the group)/average tumor volume of matched group.
3. experimental result
In the experimentation, owing to reasons such as filling stomach errors, administration has an animal dead for 2 groups.
The influence that the mouth neoplasm that the different prepared products of table 6 bring out DMBA takes place
Annotate:
★Representative is compared P＜0.05 with matched group tumor number;
▲1 group of tumor number of representative and administration is compared P＜0.05.
■Representative is compared P＜0.05 with matched group tumor volume;
※1 group of tumor volume of representative and administration is compared P＜0.05.
Can be known that by table 6 the tumor number of 1 group of administration and 2 groups all significantly is lower than matched group (P＜0.05), the tumor number that administration is 3 groups is lower than matched group, but difference not significantly (P＞0.05), and the tumor number of 1 group of administration is starkly lower than 3 groups of administrations (P＜0.05); The tumor volume of 3 groups of administration groups all is significantly less than matched group (P＜0.05), and the tumor volume of 1 group of administration is significantly less than 2 groups of administrations and 3 groups (P＜0.05).This presentation of results, for the mouth neoplasm that DMBA brings out, 3 kinds of prepared products all have inhibitory action to tumor generation and growth, and wherein, the zengshengping tablet drug effect that makes by method for making provided by the invention obviously is superior to other two kinds of prepared products.
Embodiment 5: the antiinflammatory action of different prepared products
1. experiment material
1.1 medicine
Prepared product A1, B1 and the C1 of preparation among the embodiment 1.
1.2 animal
Select the adult healthy male SD rat for use, body weight 170 ± 24g, animal is provided by laboratory animal portion of Beijing Medical University.
2. experimental technique
Modeling; Above-mentioned 40 SD rats are anaesthetized with 1% pentobarbital, the sterilization of hypogastric region QUMAO, it is subcutaneous that the aseptic cotton balls of 50mg is implanted the left side groin, sew up wound.
Administration: after the operation above-mentioned 40 SD rats are divided into 4 groups at random, 10 every group, begin gastric infusion behind the 1h, every day 1 time, one week of continuous irrigation stomach.。
Matched group gives normal saline, and administration gives prepared product A1 for 1 group, and administration gives prepared product B1 for 2 groups, and administration gives prepared product C1 for 3 groups.The dosage of 3 groups of administration groups is 4g/kg.Took out the granuloma induced by implantation of cotton pellets tissue on the 8th day, 60 ℃ of oven dry are weighed in drying baker.With claim weight deduct the raw cotton ball weight and promptly get granulomatous weight.
3. experimental result
The different prepared products of table 7 are to granulomatous influence
Annotate:
★Representative is compared with matched group, P＜0.05.
Can be known that by table 7 the granuloma weight of 2 groups of administration groups and 3 groups all is starkly lower than matched group, the granuloma that administration is 1 group weighs less than matched group, but difference not significantly (P＞0.05).In addition, the granuloma weight of 2 groups of administrations and 3 groups all is lower than 1 group of administration, but difference not significantly (P＞0.05).This result shows that each prepared product all has antiinflammatory action, and antiphlogistic effects difference is not remarkable.
In sum, the zengshengping tablet for preparing by method for making provided by the invention meets the drug standard requirement, has solved the uncontrollable problem of zengshengping tablet quality in the prior art.On curative effect, zengshengping tablet anticancer effect provided by the invention obviously is superior to the zengshengping tablet or the similar medicine of zengshengping tablet that make by prior art, and its antiphlogistic effects and the latter two do not have significant difference yet.Therefore generally speaking, Chinese medicine compound zengshengping tablet quality provided by the invention is better, curative effect is more excellent.
Embodiment 6: the preparation of zengshengping tablet tablet
With the pharmaceutical preparations A of gained among the embodiment 1, it is an amount of to add starch, and (60-100%) processes granule with debita spissitudo ethanol, drying, and granulate, tabletting, bag film-coat or sugar-coat promptly get.
Embodiment 7: the preparation of zengshengping tablet capsule
Pharmaceutical preparations A with gained among the embodiment 1 adds an amount of starch and magnesium stearate, and (60-100%) processes granule with debita spissitudo ethanol, drying, and granulate encapsulatedly promptly gets.
Embodiment 8: the preparation of zengshengping tablet pill
With the pharmaceutical preparations A of gained among the embodiment 1, every 100g fine powder adds refined honey 80-100g and processes concentrated honeyed pill, promptly gets.
Embodiment 9: the preparation of zengshengping tablet powder
With the pharmaceutical preparations A of gained among the embodiment 1, grind, mixing, packing promptly gets.
Claims (8)
1. the method for preparing of Chinese medicine compound zengshengping tablet said method comprising the steps of:
1) get 210 gram Cortex Dictamni, it is subsequent use that wherein 70-140 gram is ground into fine powder;
2) get 420 Keshan Radix Sophorae Tonkinensis decocte with water 2 times, each 1.5 hours, collecting decoction filtered, and relative density was the thick paste of 1.30-1.35 when filtrate decompression was concentrated into 50 ℃, and drying under reduced pressure below 60 ℃ becomes dried cream, pulverizes, and is subsequent use;
3) get 100 gram Rhizoma Dioscoreae Bulbiferaes, 420 gram Sonchus brachyotus DC., 420 gram Rhizoma Bistortaes, 420 gram Spica Prunellaes and step 1) residue without the Cortex Dictamni of pulverizing; Decocte with water 2 times; 2 hours for the first time, 1.5 hours for the second time, collecting decoction; Filter, relative density was the thick paste of 1.30-1.35 when filtrate decompression was concentrated into 50 ℃;
4) in the thick paste of step 3), add Cortex Dictamni fine powder and the step 2 of step 1)) the Radix Sophorae Tonkinensis dried cream powder, mixing, oven dry below 80 ℃, pulverizing.
2. method for preparing as claimed in claim 1, wherein, said method also comprises in the product that step 4) obtains and adds appropriate amount of auxiliary materials, processes various dosage forms.
3. method for preparing as claimed in claim 2, wherein, said dosage form is selected from tablet, capsule, pill and powder.
4. like each described method for preparing among the claim 1-3, wherein, said method comprises that also in the product that step 4) obtains, adding adjuvant makes the gross mass of product and adjuvant reach 300 grams.
5. like each described method for preparing among the claim 1-3, wherein, said method also comprises and in the product that step 4) obtains, adds starch as adjuvant, and processes granule after drying with debita spissitudo ethanol, granulate, and tabletting is processed tablet.
6. like each described method for preparing among the claim 1-3, wherein, said method step 1) in, it is subsequent use that the 105g Cortex Dictamni powder is broken into fine powder.
7. the quality that adds water like each described method for preparing among the claim 1-3, wherein, said method step 2) and in the step 3) during decocte with water is 10 times of quality of medicinal material.
8. the Chinese medicine compound zengshengping tablet for preparing like each said method among the claim 1-7.
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| CN102188590B (en) * | 2011-04-27 | 2016-08-03 | 天津康晨瑞信医药集团有限公司 | A kind of Zengshengping dispersing tablet composition and preparation method thereof |
| CN102188587B (en) * | 2011-04-27 | 2016-08-03 | 天津康晨瑞信医药集团有限公司 | A kind of Zengshengping effervescent tablet composition and preparation method thereof |
| CN102188588B (en) * | 2011-04-27 | 2016-08-03 | 天津康晨瑞信医药集团有限公司 | A kind of hyperplasia relieving granule composition and preparation method thereof |
| CN104965046A (en) * | 2015-07-17 | 2015-10-07 | 江苏天晟药业有限公司 | Quality control method for cosmetics containing traditional Chinese medicinal ingredients |
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|---|---|---|---|---|
| CN1062656A (en) * | 1990-12-20 | 1992-07-15 | 中国医学科学院肿瘤研究所 | The preparation technology of canceration shutoff agent " zengshengping tablet " |
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| CN1062656A (en) * | 1990-12-20 | 1992-07-15 | 中国医学科学院肿瘤研究所 | The preparation technology of canceration shutoff agent " zengshengping tablet " |
Non-Patent Citations (1)
| Title |
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| 孙燕等.增生平片抗癌、防癌作用的研究.《中西医结合防治肿瘤》.1995,238. * |
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