CN105770376A - Preparation process of traditional Chinese medicine composition for treating gastroesophageal reflux disease - Google Patents
Preparation process of traditional Chinese medicine composition for treating gastroesophageal reflux disease Download PDFInfo
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- CN105770376A CN105770376A CN201610264454.9A CN201610264454A CN105770376A CN 105770376 A CN105770376 A CN 105770376A CN 201610264454 A CN201610264454 A CN 201610264454A CN 105770376 A CN105770376 A CN 105770376A
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses traditional Chinese medicine composition for treating gastroesophageal reflux disease. The traditional Chinese medicine composition is an active component prepared from Chinese herbal medicines as raw materials, wherein the Chinese herbal medicines include rhizoma cyperi, caulis perillae, fructus aurantii, bulbus fritillariae thunbergii, pericarpium citri reticulatae, rhizoma coptidis, fructus evodiae, cuttle bone, rhizoma polygoni cuspidate and radix glycyrrhizae. Pharmaceutical common auxiliary materials can be added for preparing various oral preparations. The traditional Chinese medicine composition serves as a scientific research preparation in Xiyuan Hospital at present and is remarkable in effect since clinic use. The invention discloses a preparation process for the traditional Chinese medicine composition.
Description
Technical field
The preparation method that the present invention relates to a kind of Chinese medicine composition treating liver stomach wind-cold type gastroesophageal reflux disease.
Background technology
Gastroesophageal reflux disease (gastroesophagealrefluxdisease, GERD) it is that Stomach duodenum content reflux enters esophagus, cause the symptoms such as heartburn, reflux esophagitis (RE) and the histologic lesion beyond the esophagus such as throat, air flue can be caused.It is 10%～20% that epidemiologic data is shown in the GERD sickness rate in western countries and area, the sickness rate in Asia has been raised to 10.5%, along with modern society's work and life stress increase, the sickness rate of China GERD is also increasing year by year, but the current means of diagnosis and treatment of this disease are limited, and recurrent exerbation, has a strong impact on the quality of life of patient.Some patients has been enter into the stage of " intractable ", and research also finds that the recurrent exerbation of GERD symptom and the esophageal carcinoma or carcinoma of gastric cardia and laryngeal carcinoma are relevant.Current proton pump inhibitor (PPIs) is considered as most effective, the most frequently used medicine treating GERD by powerful acid suppression.But, Clinical practice exists following three kinds of situations: 1) the excessive use of PPI: in the patient accepting PPI treatment, some does not also meet corresponding indication, and the excessive use of PPI has become one of whole world clinical problem urgently to be resolved hurrily.2) inhibitory action of gastric acid secretion is caused that plasma gastrin levels moderate raises by the life-time service of PPI: PPIs mostly, and once having researcher to worry, that this is likely to is relevant with gastric tumor generation.Along with PPI is a large amount of, prolonged application, its potential risks also highlight undoubtedly, and use the report of untoward reaction to get more and more about PPIs, and long-term a large amount of PPIs of use are likely to and dangerous.3) intractable Non-erosive reflux disease (NERD) effect is undesirable: the measure of the intractable Non-erosive reflux disease of existing solution (NERD) is in that use larger dose, the PPI of longer time or add use related drugs, but effect is unsatisfactory.Additionally, the medicine such as motilium, cisapride of short digestive tract power, not husky Billy etc. also use with mucosa protection agent such as thiosugar aluminium flake and Fosfalugel (Yamanouchi) etc. in this disease of being everlasting, but it is without the effect directly suppressing reflux.For above-mentioned problems, finding a kind of medicine that can treat GERD very necessary, domestic existing expert invests Chinese herbal medicine aspect sight.
The logical granule (Tojapride) that drops is that Tang Xudong professor is inheriting on the basis of distinguished veteran doctors of TCM Dong Jianhua academician " taste are logical drops theory ", in conjunction with the Chinese medicine compound that more than 20 years clinical experience preferably goes out, common pattern of syndrome for gastroesophageal reflux disease incoordination between the liver and stomach, syndrome of liver-stomach heat, adopt the rule for the treatment of of Shugan Qingre, acupuncture, the Chinese medicines such as selected Rhizoma Coptidis, Fructus Aurantii (parched), Rhizoma Cyperi form, began one's study optimization from 99 years, within 2010, becomes preparation in the Hospital of Xiyuan.Since Clinical practice, due to it, to improve symptom evident in efficacy, the deep favorable comment by patient.
Goal of the invention
This Chinese medicine composition is provided to prepare extraction process
Summary of the invention
One, the composition of Chinese medicine composition
Chinese medicine composition of the present invention, is the composition and effectiveness that raw material is made by the Chinese crude drug of following weight portion:
Caulis Perillae 10-15g, Rhizoma Cyperi 10-15g, Fructus Aurantii (parched) 10-15g, Bulbus Fritillariae Thunbergii 12-18g, Pericarpium Citri Reticulatae 8-12g, Rhizoma Coptidis 6-9g, Os Sepiae 28-32g, Rhizoma Polygoni Cuspidati 7-12g, Fructus Evodiae 2-3g, Radix Glycyrrhizae 3-6g
Rhizoma Cyperi in side, Compendium of Material Medica calls its hardship pungent, micro-, micro-sweet, enters liver, tri-jiao channel, " fragrant and can alter, the how pungent energy of its taste dissipates, and micro-hardship can drop, micro-sweet energy and ", resolving depression of regulating the flow of vital energy, and stomach and alleviating pain, cure mainly incoordination between the liver and stomach, depression of QI；Rhizoma Coptidis, bitter cold, enter the heart, liver, stomach, large intestine channel, pathogenic fire purging, dampness are main, can clearing away liver-fire, liver-fire obtain clearly then not perverse and unreasonable manner violate stomach；Rushing down again stomach-fire, stomach-fire obtains clearly then gastric qi and certainly drops, to receive effect of the heat of removing summer-heat liver stomach；Rhizoma Cyperi (processed), Fructus Aurantii (parched) and Rhizoma Coptidis are monarch drug altogether, and liver stomach is also controlled, leading dispersing the stagnated live-QI to relieve the stagnation of QI, therapeutic method to keep the adverse QI flowing downwards sending down the abnormal ascending QI, the merit of clearing heat to ease the stomach.
Fructus Aurantii, toil, cool, enter lung, spleen, large intestine channel, " medicine origin " is recorded: " " curing mainly secret formula " cloud: broken hardness in the epigastrium painful abdominal mass, profit is gas in the heart, reduces phlegm, and helps digestion ", has the therapeutic method to keep the adverse QI flowing downwards, row expectorant, effect of removing food stagnancy；Caulis Perillae, Xin Gan, tepor, enter spleen, stomach, lung three warp, regulating qi-flowing for harmonizing stomach, Shu Yu pain relieving；Pericarpium Citri Reticulatae, arduous, warm, enter spleen, lung meridian, regulate the flow of vital energy and in, drying dampness to eliminate phlegm；Three medicines are minister, coordinate Rhizoma Cyperi (processed), to strengthen the power of depressed liver-energy dispersing and QI regulating stomach function regulating；Rhizoma Polygoni Cuspidati, bitter, be slightly cold, return liver and gall warp, promoting blood circulation to remove blood stasis, clearing away heat-damp and promoting diuresis, match for minister and Rhizoma Coptidis, strengthen the heat of liver heat removing stomach and merit that hardship drops.
Fructus Evodiae, arduous, warm, enter liver, stomach warp, warming middle-JIAO to relieve pain, dampness of regulating the flow of vital energy, cure mainly the disease such as vomiting acid regurgitation, coldness of ZANG-organ vomiting and diarrhoea, as adjuvant drug, Fructus Evodiae is double four use of merit simply, and one dispersing the stagnated live-QI to relieve the stagnation of QI, so that irritability bar reaches, pent-up must be opened；One using corrigent is cold with Rhizoma Coptidis (processed), make pathogenic fire purging and without the cool fraud held back；One takes the use of its therapeutic method to keep the adverse QI flowing downwards, with regulating the stomach and sending down the abnormal ascending QI；One can lead Rhizoma Coptidis to enter Liver Channel.It is classics recipe Zuojin Wan with Rhizoma Coptidis compatibility, receives clearing away liver-fire altogether, the effect of stopping nausea and vomiting by lowering the adverse flow of QI.Endoconcha Sepiae, salty, tepor, enter liver, kidney channel, there is the effects such as antacid, hemostasis, dehumidifying, arrogate to oneself the disease such as acid regurgitation, haematemesis for the treatment of for stomachache；Bulbus Fritillariae Thunbergii, bitter, cold, " detailed outline is picked up any lost article from the road " calls its energy " removing toxic substances profit expectorant, open lung qi dispersing gas ", and has the merit of antacid；Two medicines are all adjuvant drug, are adjuvant drug altogether, strengthen effect of relieving gastric hyperacidity to alleviate stomachache.
Radix Glycyrrhizae and in, coordinating the actions of various ingredients in a prescription, for making medicine.
Function cures mainly:
Relieving depressed liver and clearing heat, regulating the stomach and sending down the abnormal ascending QI.Demonstrate,proving for gastroesophageal reflux disease syndrome of liver-stomach heat, disease is seen heartburn, acid regurgitation, retrosternal pain, belch, noisy, stomachache or flatulence, early satiety, foreign body in pharynx sense, emotion agitation or depressed, fullness and distention in the chest and hypochondrium or distending pain etc., red tongue or slightly red, Tai Bai or slightly Huang, stringy pulse.
Two, Chinese medicine composition preparation method
1. treat the traditional Chinese medicine particle method step of gastroesophageal reflux disease:
(1) Rhizoma Cyperi 300 grams, Caulis Perillae 300 grams, Fructus Aurantii (parched) 300 grams, Bulbus Fritillariae Thunbergii 300 grams, Pericarpium Citri Reticulatae 225 grams, Rhizoma Coptidis 250 grams, Os Sepiae 750 grams, Rhizoma Polygoni Cuspidati 225 grams, Fructus Evodiae 50 grams and 75 grams of Radix Glycyrrhizae are weighed；
(2) by medical material boiling 2-3 time, merge medicinal liquid, filter, filtrate is condensed into cream, according to clear paste: Icing Sugar: cyclodextrin ratios is amount addition sucrose and the dextrin of 1: 3: 1, makes granule, is drying to obtain to lead to and drops granule.
2. treat the Chinese medicine composition decoction method step of gastroesophageal reflux disease:
(1) Rhizoma Cyperi 120 grams, Caulis Perillae 120 grams, Fructus Aurantii (parched) 120 grams, Bulbus Fritillariae Thunbergii 120 grams, Pericarpium Citri Reticulatae 80 grams, Rhizoma Coptidis 60 grams, Os Sepiae 200 grams, Rhizoma Polygoni Cuspidati 80 grams, Fructus Evodiae 20 grams and 30 grams of Radix Glycyrrhizae are weighed；
(2) by medical material boiling 2-3 time, merging medicinal liquid, filter, concentration obtains decoction.
3. treat the Chinese medicinal composition capsules method step of gastroesophageal reflux disease:
(1) Rhizoma Cyperi 150 grams, Caulis Perillae 150 grams, Fructus Aurantii (parched) 150 grams, Bulbus Fritillariae Thunbergii 150 grams, Pericarpium Citri Reticulatae 120 grams, Rhizoma Coptidis 120 grams, Fructus Evodiae 40 grams, Os Sepiae 300 grams, Rhizoma Polygoni Cuspidati 120 grams and 100 grams of Radix Glycyrrhizae are weighed；
(2) by pulverizing medicinal materials, boiling 2-3 time, merge medicinal liquid, filter, filtrate is condensed into paste, dry, wear into fine powder, load capsule.
Three, Chinese medicine composition preparation technology
1. extraction process
Water puies forward part, and former extraction process does not clearly add water the parameters such as multiple, extraction time, extraction time；New technology has investigated the above-mentioned parameter impact on main pharmacodynamics constituents extraction rate, specify that best extraction process by water, namely adds 6～water of 10 times amount, extracts 2～3 times, each 0.5～2 hour.Guarantee effective component extraction rate.
2. volatile oil inclusion technique
Relevant parameter in the not clear and definite volatile oil inclusion technique of former technique, new technology is through investigating, it is determined that the ratio 1: 6～10 of oil content and beta-schardinger dextrin-, inclusion temperature 40～80 DEG C, 1～3 hour inclusion time, it is ensured that the quality of inclusion complex and stability.
3. moulding process
Former technique is granulated for extracting the extruding of extractum wet method, medicine differs bigger with the ratio of adjuvant, particularly dry run is slower, cause that the production cycle is also longer, boiling granulating technology is adopted to prepare granule after process modification, reduce the consumption of adjuvant in preparation, decrease the time of particle drying, reduce the cost of production.
3.1 selections extracting extractum ratio
Dropping granule extraction process according to logical, extracting the proportion of extractum after concentrating is 1.36～1.38, and extractum is more sticky, and the extractum that concentration process is attached in concentration tank is more, loses bigger.Adopting boiling granulating technology, extractum is than recanalization in the scope of 1.15～1.30, and extractum loss is few, it is preferable that rear discovery extractum is when 1.15～1.25, and granulating efficiency is better.
The determination of 3.2 medicines and auxiliary material proportion
According to EXPERIMENTAL DESIGN specification, determine the consumption of adjuvant in preparation, with the melting of granule, hygroscopicity, granularity etc. for investigating point, investigate the impact on granulation such as the air quantity of boiling flowing in the out temperature of hot blast, the atomization compressed air pressure of medicinal liquid, the granularity of parent nucleus powder body and fluidising chamber respectively, it is determined that medicine and auxiliary material proportion.
3.3 process ration researchs
Test will latter two technique contrast before changing, result adopts one-step palletizing technology, and extractum relative density is reduced to 1.15～1.25, and the ratio of medicine and adjuvant is reduced to 1: 1～2, baking temperature and drying time are the most obvious, are reduced to 2～3 hours by original 20～24 hours.The pellet hardness prepared is moderate, and epigranular, hence it is evident that shorten the production cycle reduces production cost.
Four, the experiment condition in this experiment, object, method and result and the former logical comparison dropping granule
1. experimental technique
(1) making of RE rat model: what this time experiment adopted is internationally recognized esophagus duodenum side to side anastomosis art, cardia shaping+pylorus ligation+gastrojejunostomy before relatively and cardia steel ring are inserted fixation and are more easy to operation, more meet the feature of mixed reflux, mortality rate is lower, the inflammation of the pathological tissue that reflux thing causes becomes apparent from, higher with the pathology damage goodness of fit that clinic causes.
(2) RE disease is in conjunction with the evaluation of rat model: previously in the logical experimentation dropping granule, simply simple copy RE disease rat model, meet disease pathology feature, but it is not involved with Syndrome in TCM marquis, and the advantage of Chinese medicine is in that dialectical treatmert, the logical clinical studies show dropping granule it is advantageous that the patient to syndrome of incoordination between liver and stomach/syndrome of liver-stomach heat card is evident in efficacy.This model is based upon on the basis of the RE disease model generally acknowledging that degree is higher, superposition folder tail stimulus method sets up RE syndrome of liver-stomach heat card disease in conjunction with rat model, and by subjective and objective indexs such as body weight, feed, amount of drinking water, grip, esophagus pathological tissue, the mental status, this disease combination model done overall merit, result shows, this model meets the card Hou Tedian of clinical RE syndrome of liver-stomach heat card, and concrete outcome is in Table 1-table 4.
Postoperative three weeks front and back body weight change of table 1RE rat model
Note: compare with sham operated rats, * P < 0.05, * * P < 0.01；Compare with model group, #P < 0.05, ##P < 0.01
The front and back food-intake change in postoperative three weeks of table 2RE rat model
Note: compare with sham operated rats, * P < 0.05, * * P < 0.01；Compare with model group, #P < 0.05, ##P < 0.01
Postoperative three weeks front and back amounts of drinking water of table 3RE rat model
Note: compare with sham operated rats, * P < 0.05, * * P < 0.01；Compare with model group, #P < 0.05, ##P < 0.01
The front and back grip change in postoperative three weeks of table 4RE rat model
Note: compare with sham operated rats, * P < 0.05, * * P < 0.01；Compare with model group, #P < 0.05, ##P < 0.01
2. the comparison of the old and new's technique
Table 1 is logical drops the impact on RE rat model Small intestine advance activity of the granule different process
Note: compare with model group, * represents that p < 0.05, * * represents p < 0.01；
Analyzing: from table 1 it follows that compare with model group, mosapride group, new technology group, all there were significant differences in propelling rate for former technique group (P < 0.01-0.05)；New technology group compares with former technique group does not have difference (P > 0.05), and small intestinal peristalsis is advanced the impact having facilitation by prompting mosapride, new technology, former technique.
The impact that RE rat model gastric emptying is moved by table 2 Chinese medicine
Note: compare with model group, * represents that p < 0.05, * * represents p < 0.01；
Analyze: from Table 2, it can be seen that compare with model group, omeprazole group, mosapride group, new technology group, former technique group all have significant difference (P < 0.05)；New technology group and former technique group, former technique group mosapride group, new technology group and mosapride group, comparing between two between group and do not have significant difference (P > 0.05), prompting mosapride, new technology, former technique all can promote gastric emptying.
Table 3RE rat model medication front and back food-intake change in three weeks
Note: compare with model group, * represents that p < 0.05, * * represents p < 0.01；
Analyze: from table 3 it is observed that after rat medication 1 week, respectively organize and compare without significant difference (P > 0.05) with model group；After medication after 2 weeks, 3 weeks, each medication group compares with model group statistically significant (P < 0.01-0.05) respectively, and new technology group compares with former technique group does not have significant difference (P > 0.05).Prompting mosapride, new technology, former technique have orectic effect, and three kinds of medicines start onset all after oral administration for 2 weeks, and after oral, 3 weeks effects are obvious.
Table 4RE rat model medication front and back amount of drinking water change in three weeks
Note: compare with model group, * represents that p < 0.05, * * represents p < 0.01；
Analyze: as can be seen from Table 4, compare with model group, after rat medication 1 week, 2 weeks, each administration group amount of drinking water no significant difference (P > 0.05)；After medicine 3 weeks, each medication group compared with model group variant (P < 0.01-0.05), and new technology group compares with former technique group does not have significant difference (P > 0.05).
Table 5RE rat model medication front and back grip change in three weeks
Note: compare with model group, * represents that p < 0.05, * * represents p < 0.01；Comparing with new technology group, ※ represents that p < 0.05, ※ ※ represents p < 0.01
Analyzing: as can be seen from Table 5, after medicine 1 week, in grip, new technology group compares variant (P < 0.05) with former technique group, points out new technology namely to can obviously improve rat muscular strength at the initial stage of taking；After medicine 2 weeks, 3 weeks, each medication group and model group comparing difference notable (P < 0.01), new technology group, former technique group compared and are not significantly different from (P > 0.05-0.01).
3. the comparison of the extraction process combined with drug effect
The logical granule that drops adopted new technology has been carried out the research of multiple effect experiment, and including digestive tract power aspect, such as gastric emptying experiment, intestinal propulsion experiment, antiinflammatory aspect, such as acetic acid twisting experiment, the experiment of formaldehyde induced pain, hot-plate analgesia experiment；Immunology, as ear swelling test, multiple experimentatioies such as carbon particle clearance test and immune organ weight coefficient, drop granule curative effect from multi-angle observe logical.In side, result shows, intestinal propulsion experiment at display power, the acetic acid twisting experiment of anti-inflammatory and antalgic and hot-plate analgesia experiment, in the ear swelling experiment of immunologic function aspect, all showing that the more former side in new technology side has good effect (P < 0.05～0.01), meanwhile, new side is reducing gastric juice amount, improve pH value and the promotion pepsinia aspect also ratio effect of former side more preferably (P < 0.05) in stomach, specific as follows:
3.1. intestinal propulsion experiment (Intestinal propulsive rate=advance distance/small intestinal total length × 100%)
Result shows, in intestinal propulsion, compares with normal group, Xin Fanggao, middle dosage group all significantly raised (P < 0.05～0.01), compare with former side's group, dosage group difference more significant (P < 0.05) in new side, be specifically shown in table 1.
The logical impact dropping Granules on Mouse Small intestine advance activity of table 1
Note: compare with normal group, * P < 0.05, * * P < 0.01；Compare with former side's group, #P < 0.05, ##P < 0.01
3.2. Mouse Stomach emptying experiment (gastric residual rate=gastric residual solids sticks with paste weight/stomach full weight × 100%)
Result shows, compared with normal group, Xin Fanggao, middle dosage group gastric residual rate substantially reduce (P < 0.05, P < 0.01)；Compare with former side's group, the high, medium and low dosage equal no difference of science of statistics of gastric residual rate (P > 0.05) in new side, it was shown that new side gastric emptying effect is not better than former side's group, is specifically shown in table 2.
The logical impact dropping Granules on Mouse gastric emptying of table 2
Note: compare with normal group, * P < 0.05, * * P < 0.01
3.3 mice acetic acid twisting analgesic experiments (analgesia percentage rate=(the average writhing number of times of matched group-administration group writhing number of times)/matched group writhing number of times × 100%)
Result shows, in 15m in writhing number of times, compared with normal group, Xin Fanggao, middle dosage group all significantly reduce (P < 0.01), it was shown that logical drop granule and has certain analgesic effect.Comparing with former side's group, Xin Fanggao, middle dosage group all reduce, difference statistically significant (P < 0.01), it was shown that new side analgesic effect is better than former side's group (being specifically shown in table 3).
Table 3 is logical drops granule acetic acid twisting experimental result
Note: compare with normal group, * P < 0.05, * * P < 0.01；Compare with former side's group, #P < 0.05, ##P < 0.01
3.4. mouse hot-plate analgesic experiment (after administration, mice licks the sufficient time before starting to lick sufficient time and administration, and after namely comparing administration, the pain threshold of mice is with or without being extended).
Result shows, compared with normal group, 1h after administration, in new side, dosage group pain threshold substantially increases (P < 0.05)；Compared with former side's group, after administration during 1h, in new side, dosage group pain threshold increases, difference statistically significant (P < 0.05), and prompting new side group is more effective than former side's group antipyretic-antalgic, is specifically shown in table 4.
Table 4 is logical drops the impact of Granules on Mouse hot-plate analgesia
Note: compare with normal group, * P < 0.05；Compare with former side's group, #P < 0.05
3.5. the logical impact (before first phase, 5min, the second phase 20-30min, record data for licking foot duration summation) dropping granule PARA FORMALDEHYDE PRILLS(91,95) induced mice pain.
Result shows, during first phase, compares with normal group, the middle and high dosage in new side, former side's group, and aspirin group mice licks foot duration and reduces, difference statistically significant (P < 0.05-0.01)；Phase time when second, new side dosage low, middle, former side's group, aspirin group mice licks sufficient time decreased, difference statistically significant (P < 0.05-0.01)；Comparing with former side's group, first phase and the second phase, in new side, the equal mice of low dose group licks the foot time and significantly reduces (P < 0.05), and the anti-inflammatory and analgesic effect of mice is better than former side's group by prompting new side group, is specifically shown in table 5.
The logical impact dropping granule PARA FORMALDEHYDE PRILLS(91,95) induced mice pain of table 5
Note: compare with normal group, * P < 0.05, * * P < 0.01；Compare with former side's group, #P < 0.05, ##P < 0.01
The impact (swelling=(auris dextra-left ear)/left ear × 100%, it is suppressed that swelling rate=(blank group average swelling-average swelling of administration group)/average swelling × 100% of blank group) of Granules on Mouse ear swelling drops in 3.6 mice caused by dimethylbenzene xylene ear swelling-Tong
Result shows, in ear swelling degree, compared with normal group, in new side, dosage, aspirin group all significantly reduce (P < 0.05, P < 0.01)；Comparing with former side's group, in new side, decrease in dose is substantially (P < 0.05), is specifically shown in table 6.
Table 6 mice caused by dimethylbenzene xylene ear swelling suppresses the impact of mice ear with the logical granule that drops
Note: compare with normal group, * P < 0.05, * * P < 0.01；Compare with former side's group, #P < 0.05, ##P < 0.01
3.7 nonspecific immunity experiment (phagocyte imdex K=(lgOD2-lgOD10)/(t10-t2)
Result shows, compares with normal group, and in new side, dosage group, former side's group, cyclophosphamide group K value increase, significant difference (P < 0.05-0.01)；Comparing with former side's group, new side group is without significant change (P > 0.05), and prompting new side group and former side all have certain effect strengthening immune function of mice, are specifically shown in table 7.
Table 7 carbon particle clearance test
Note: compare with normal group, * P < 0.05, * * P < 0.01
3.8 immune organ impact experiment (thymus index=chest gland weight/body weight；Spleen index=spleen weight/body weight；Phagocytic index α=k1/3× body weight/(chest gland weight+spleen weight)
Result shows, compares with normal group, and each medication group phagocytic index all significantly raises (P < 0.05-0.01)；Comparing with former side's group, the high, medium and low dosage group in new side is all significantly raised, no significant difference (P > 0.05), and immune function of mice effect is better than former side's group by prompting new side group, is specifically shown in table 8.
Table 8 immune organ weighing results
Note: compare with normal group, * P < 0.05, * * P < 0.01
3.9 gastric analysis experiments
Result shows, compared with normal group, in new side, in dosage group, omeprazole group and omeprazole newly side, dosage group gastric juice pH, total acidity gastric juice, the total secretory volume of gastric juice all significantly reduce (P < 0.05-0.01)；In new side, dosage group gastric juice amount reduces, new side high and low dose group, and in omeprazole newly side, dosage group gastric juice amount increases (P < 0.05-0.01)；The middle and high dosage group pepsinia in new side increases (P < 0.05-0.01), is specifically shown in table 9.
Table 9 reflux esophagitis rat gastric analysis is tested
Note: compare with normal group, * P < 0.05, * * P < 0.01；Compare with former side's group, #P < 0.05, ##P < 0.01；Compare with dosage group in new side, ※ P < 0.05, ※ ※ P < 0.01.
Claims (6)
1. treating a Chinese medicine composition for gastroesophageal reflux disease, it is by the drug effect component that the Chinese crude drug of following weight portion is that raw material is made:
Caulis Perillae 10-15g, Rhizoma Cyperi 10-15g, Fructus Aurantii (parched) 10-15g, Bulbus Fritillariae Thunbergii 12-18g, Pericarpium Citri Reticulatae 8-12g, Rhizoma Coptidis 6-9g, Os Sepiae 28-32g, Rhizoma Polygoni Cuspidati 7-12g, Fructus Evodiae 2-3g, Radix Glycyrrhizae 3-6g.
2. Chinese medicine composition according to claim 1, wherein drug effect component is the Chinese crude drug of following row weight portion is that raw material is made:
Rhizoma Cyperi 12, Caulis Perillae 12, Fructus Aurantii (parched) 12, Bulbus Fritillariae Thunbergii 12, Pericarpium Citri Reticulatae 9, Rhizoma Coptidis 10, Fructus Evodiae 2, Rhizoma Polygoni Cuspidati 9, Os Sepiae 30 and Radix Glycyrrhizae 3.
3. Chinese medicine composition according to claim 1 and 2, the traditional Chinese medicinal material raw materials wherein preparing drug effect component also increases one or more Chinese medicines following: Flos Inulae, the Rhizoma Atractylodis Macrocephalae, Radix Adenophorae (Radix Glehniae), Bulbus Fritillariae Cirrhosae, Poria, Radix Curcumae, Radix Salviae Miltiorrhizae, Fructus Amomi, Folium Nelumbinis, the Rhizoma Pinelliae or Fructus Aurantii Immaturus.
4. the preparation method treating the Chinese medicine composition of gastroesophageal reflux disease, its step is:
(1) raw material of following weight portion is weighed: Rhizoma Cyperi 12-15, Caulis Perillae 12-15, Fructus Aurantii (parched) 10-15, Bulbus Fritillariae Thunbergii 12-18, Pericarpium Citri Reticulatae 8-12, Rhizoma Coptidis 6-12, Fructus Evodiae 2-4, Os Sepiae 20-30, Rhizoma Polygoni Cuspidati 8-12 and Radix Glycyrrhizae 3-10；
(2) add the soak by water of 6～10 times amount, extract 2～3 times, each 0.5～2 hour.The ratio 1: 6～10 of oil content and beta-schardinger dextrin-, inclusion temperature 40～80 DEG C, 1～3 hour inclusion time, boiling granulating technology is adopted to prepare granule, extractum proportion is in the scope of 1.15～1.30, melting with granule, hygroscopicity, granularities etc. are for investigating point, investigate the out temperature of hot blast respectively, the compressed air pressure of atomization medicinal liquid, in the granularity of parent nucleus powder body and fluidising chamber, the air quantity of boiling flowing etc. are on the impact granulated, determine medicine and auxiliary material proportion, extractum relative density is 1.15～1.25, the ratio of medicine and adjuvant reduces to 1: 1～2, baking temperature and drying time are 2～3 hours.
5. Chinese medicine composition preparation method according to claim 4, wherein the traditional Chinese medicinal material raw materials of step (1) is following weight portion:
Rhizoma Cyperi 12, Caulis Perillae 12, Fructus Aurantii (parched) 12, Bulbus Fritillariae Thunbergii 12, Pericarpium Citri Reticulatae 9, Rhizoma Coptidis 10, Fructus Evodiae 2, Rhizoma Polygoni Cuspidati 9, Os Sepiae 30 and Radix Glycyrrhizae 3.
6. the Chinese medicine composition preparation method according to claim 4 or 5, the traditional Chinese medicinal material raw materials wherein preparing drug effect component also increases one or more Chinese medicines following: Flos Inulae, the Rhizoma Atractylodis Macrocephalae, Radix Adenophorae (Radix Glehniae), Bulbus Fritillariae Cirrhosae, Poria, Radix Curcumae, Radix Salviae Miltiorrhizae, Fructus Amomi, Folium Nelumbinis, the Rhizoma Pinelliae or Fructus Aurantii Immaturus.
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| CN112717045A (en) * | 2021-01-25 | 2021-04-30 | 上海长征医院 | Traditional Chinese medicine compound composition for treating refractory gastroesophageal reflux |
| CN114832078A (en) * | 2022-03-27 | 2022-08-02 | 浙江省立同德医院 | Traditional Chinese medicine composition for spleen deficiency and dampness retention type PPI (PPI-dependent gastroesophageal reflux disease) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112717045A (en) * | 2021-01-25 | 2021-04-30 | 上海长征医院 | Traditional Chinese medicine compound composition for treating refractory gastroesophageal reflux |
| CN114832078A (en) * | 2022-03-27 | 2022-08-02 | 浙江省立同德医院 | Traditional Chinese medicine composition for spleen deficiency and dampness retention type PPI (PPI-dependent gastroesophageal reflux disease) |
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