CN1660259A - Chinese traditional medicine for treating imitable bowel syndrome and preparation method - Google Patents
Chinese traditional medicine for treating imitable bowel syndrome and preparation method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine treating irritable bowel syndrome, which comprises Pennyroyal and Radix Paeoniae Alba or Radix Paeonia Rubra in a ratio of 1:80-180. It is effective to diarrhea dominant irritable bowel syndrome and has low side-effect and better safety,also,it is convenient to took and carrying.The present invention also discloses the preparation method of this chinese medicine.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, relate in particular to a kind of Chinese medicine for the treatment of irritable bowel syndrome and preparation method thereof.
Background technology
Irritable bowel syndrome (Irritable Bowel Syndrome, IBS) be the modal functional disease of gastrointestinal tract, refer to one group and comprise that stomachache, abdominal distention, bowl evacuation habit and stool character are unusual, Mucous Stool, continue to exist or outbreak repeatedly, and lack the syndrome that morphology and biochemical abnormal change can be supported explanation.The west statistics accounts for the patient's of Gastroenterology dept. 20%～40%, and domestic statistics accounts for digestive tract out-patient's 13%-52%.But the cause of disease and pathogenesis to irritable bowel syndrome also imperfectly understand so far, and the purpose of its treatment mainly is to eliminate patient's misgivings, improves symptom, improves the quality of living.
At chemical prescription face, the research of at present clinical relevant irritable bowel syndrome medicine commonly used is divided into two aspects: being the end-organ treatment on the one hand, mainly is at specific symptom; Being the maincenter treatment on the other hand, mainly is the symptom of eliminating irritable bowel syndrome by the specific nerve conduction of pharmaceutical intervention central nervous system.The medicine of end-organ treatment has that loperamide, benzene second piperazine are stung, naloxone etc.; Medicine such as the depression and the antianxiety drugs etc. of maincenter treatment.Though above various kinds of drug can be alleviated some symptom of irritable bowel syndrome, in application, exist and can't effect a radical cure, side effect is big, and individual variation is obvious, shortcomings such as medical expense height.
Aspect Chinese medicine, the tradition traditional Chinese medical science belongs to irritable bowel syndrome and has loose bowels, categories such as constipation, stomachache, dysentery, melancholia, abdominal mass are poly-, intestinal Bleach, think that it can be by the diseases caused by exogenous pathogenic factor pathogen, internal injury diet feelings will, plain body weakness, old prolonged illness, reasons such as overstrain cause, common clinically stagnation of liver-QI, insufficiency of the spleen, suffer from a deficiency of the kidney, stagnate, card such as blood stasis, and the assorted card of holding concurrently is arranged more, and lays particular stress on difference.It can be divided into two kinds, three kinds or eight kinds of pattern of syndrome according to different classification method, be divided into diarrhea-type, constipation type, mixed type three types usually, wherein common with diarrhea-type again.Chinese medicine has shown good prospect in the treatment irritable bowel syndrome, " treatment by Chinese herbs irritable bowel syndrome 56 examples " are arranged as Zhejiang combination of Chinese and Western medicine magazine 2002 the 12nd the 2nd phase of volume, 2000 the 21st the 5th phases of volume of the Jiangsu traditional Chinese medical science have " treatment by Chinese herbs irritable bowel syndrome 47 examples " etc.Aspect the traditional Chinese medical science rule of treatment, the most commonly used with soothing liver and strengthening spleen, the kidney warming of regulating the flow of vital energy; Secondly for heat clearing away, blood stasis dispelling, YIN nourishing, invigorate blood circulation etc.The report that treatment such as the method that adopts acupuncture, massage, acupoint injection therapy, electricity irritation, application compress cake is also arranged, but its operation is very inconvenient, the patient needs more to be carried out to medical institutions with good conditionsi, perhaps influences patient's action, and this has limited its clinical practice to a great extent.For diarrhea type irritable bowel syndrome, belong to " diarrhea " category, how to take advantage of spleen and cause dysfunction of the spleen in transportation because of depression of liver-QI, the liver failing to maintain the normal flow of QI, edema with the liver involved, have stagnation of liver-QI and insufficiency of the spleen symptom concurrently more, it is treated based on dispersing the stagnated live-QI to relieve the stagnation of QI, invigorating the spleen and benefiting QI.Though clinical Chinese medicinal formulae commonly used such as tongxieyao formula, SHENLING BAISHU SAN, banxia xiexin decoction, XIAOQINGLONG TANG etc. can be added and subtracted with disease, curative effect may be also good, but decoction is in that the aspect such as to carry, take all very inconvenient, the process of boiling medicine is consuming time longer, especially for the diarrhea-type patient, often demonstrate,prove easily delay treatment because of mostly being anxious, and mouthfeel is bad, patient's compliance is also poor; In addition, not only very inconvenient if boil medicine for patient oneself, also can cause curative effect not good enough because of reasons such as its misoperations.Aspect Chinese patent medicine, commonly used have Spleen Invigorating and Intestine Tonifying Pill, HUOXIANG ZHENGQI SHUI, HUOXIANG ZHENGQI YE, HUOXIANG ZHENGQI RUANJIAONANG, an ageratum drop pill etc., but these medicines all are not to be primarily aimed at irritable bowel syndrome and development product, and curative effect also is not very desirable when the above-mentioned irritable bowel syndrome of treatment.
Summary of the invention
Purpose of the present invention just provides a kind of Chinese medicine for the treatment of irritable bowel syndrome, and this medicine is for the diarrhea type irritable bowel syndrome determined curative effect, and side effect is little, and safety is good, and takes and carry all very convenient.
Another object of the present invention provides a kind of preparation method of Chinese medicine of above-mentioned treatment irritable bowel syndrome.
The technical solution adopted for the present invention to solve the technical problems is: a kind of Chinese medicine for the treatment of irritable bowel syndrome, it contains following materials of weight proportions medicine: 1 part of Oleum menthae and the 80-180 part Radix Paeoniae Alba/Radix Paeoniae Rubra.
The preferred weight proportioning of the crude drug that contains in the above-mentioned Chinese medicine is: 1 part of Oleum menthae and the 100-160 part Radix Paeoniae Alba/Radix Paeoniae Rubra.Further the preferred weight proportioning is: 1 part of Oleum menthae and the 130 parts of Radix Paeoniae Alba/Radix Paeoniae Rubra.
The needed pharmaceutic adjuvant of medicine that can also contain promising preparation different dosage form in the Chinese medicine of above-mentioned treatment irritable bowel syndrome, as can add lubricant such as magnesium stearate, Pulvis Talci, polyethylene glycol substances etc. when preparing tablet or hard capsule, filler such as starchy material, dextrin, sucrose, lactose, mannitol, calcium sulfate etc., disintegrating agent such as microcrystalline Cellulose, low-substituted hydroxypropyl cellulose etc., binding agent such as ethyl cellulose, polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, gelatin, ethanol, modified starch etc.; Can add each vegetable oil, lecithin, Cera Flava, glycerol, Polyethylene Glycol, propylene glycol, isopropyl alcohol, Nipagin ester series etc. during the preparation soft capsule.
Dosage form preferred tablet, hard capsule or the soft capsule etc. of the Chinese medicine of above-mentioned treatment irritable bowel syndrome.
The preparation method of Chinese medicine of above-mentioned treatment irritable bowel syndrome comprises the steps:
(1) extracts the Radix Paeoniae Alba/Radix Paeoniae Rubra: the Radix Paeoniae Alba or the Radix Paeoniae Rubra medical material of getting described proportioning, adding 6-10 times of water gaging decocts extraction 2-4 time and filtrate is concentrated into the about 1.10-1.20 of relative density, adding 2-4 doubly measures the alcoholic solution of 80-95%, staticly settled 12-48 hour, filter, with filtrate recycling ethanol and be concentrated into the about 1.10-1.20 of relative density, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3-5 and doubly measures ethyl acetate extraction 2-4 time, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder;
(2) make preparation: get the Oleum menthae of described proportioning, with behind the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder mixing of making of (1) step routinely technology make various preparations, get final product.
Wherein, extract in the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that makes in above-mentioned (1) step, content of paeoniflorin can reach more than 10% (g/g).It can be made with extra care by the following method: the alcoholic solution that adds 2-5 amount 75-85% in the described Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder makes dissolving, filters, and then with filtrate recycling ethanol and be concentrated into the about 1.10-1.20 of relative density, spray drying gets final product; In the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that makes with this method, content of paeoniflorin can reach more than 30% (g/g).In order to obtain the higher Radix Paeoniae Alba of paeoniflorin content/Radix Paeoniae Rubra extract powder, also can be further refining by other method.
The further preferred soft capsule of the dosage form of the Chinese medicine of above-mentioned treatment irritable bowel syndrome, it is by the soft capsule content that comprises above-mentioned raw materials medicine (Oleum menthae and the Radix Paeoniae Alba/Radix Paeoniae Rubra) and overlay on its surperficial soft capsule shell formation; And also contain any one or a few pharmaceutic adjuvant that is selected from vegetable oil, soybean phospholipid, Cera Flava, glycerol, Polyethylene Glycol, propylene glycol or the isopropyl alcohol etc. in the soft capsule content; Contain 3 parts of gelatin and 0.8-2.4 part glycerol in the soft capsule shell.
Can also contain in sorbic acid, acrylic resin II, acrylic resin III, water, titanium dioxide, sodium hydroxide, sucrose, ethyl hydroxybenzoate, methyl hydroxybenzoate or the propylparaben etc. any one or a few in the above-mentioned soft capsule shell.
The preferred ingredient of above-mentioned soft capsule: wherein, the component of the crude drug that contains in the soft capsule content is: 1 part of Oleum menthae, the 100-160 part Radix Paeoniae Alba/Radix Paeoniae Rubra, 1.5-3 part bean plant oil, 0.02-0.08 part soybean phospholipid and 0.02-0.08 part Cera Flava; The component of soft capsule shell is: 3 parts of gelatin, 1.2-1.8 part glycerol, 0.6-1.0 part acrylic resin II, 0.2-0.6 part acrylic resin III, 0.008-0.012 part ethyl hydroxybenzoate, 0.18-0.24 part sodium hydroxide, 2-3 part water.
The further preferred ingredient of above-mentioned soft capsule: wherein, the component of the crude drug that contains in the soft capsule content is: 1 part of Oleum menthae, the 130 parts of Radix Paeoniae Alba/Radix Paeoniae Rubra, 2.2 parts of bean plant oil, 0.05 part of soybean phospholipid and 0.05 part of Cera Flava; The component of soft capsule shell is: 3 parts of gelatin, 1.5 parts of glycerol, 0.8 part of acrylic resin II, 0.4 part of acrylic resin III, 0.01 part of ethyl hydroxybenzoate, 0.21 part of sodium hydroxide, 2.5 parts of water.
If necessary, on above-mentioned soft capsule surface, can also wrap one deck enteric solubility film coating, to make the enteric soft capsules agent.
The preparation method of the Chinese medicinal soft capsule agent of above-mentioned treatment irritable bowel syndrome comprises the steps:
(1) extracts the Radix Paeoniae Alba/Radix Paeoniae Rubra: the Radix Paeoniae Alba or the Radix Paeoniae Rubra medical material of getting described proportioning, adding 6-10 times of water gaging decocts extraction 2-4 time and filtrate is concentrated into the about 1.10-1.20 of relative density, adding 2-4 doubly measures the alcoholic solution of 80-95%, staticly settled 12-48 hour, filter, with filtrate recycling ethanol and be concentrated into the about 1.10-1.20 of relative density, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3-5 and doubly measures ethyl acetate extraction 2-4 time, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to 55-60 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, after making dissolving and mixing, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that (1) step makes again while stirring, continue to stir 20-60 minute until adding the back, make abundant mixing, leave standstill more than 8 hours standby after colloid mill;
(3) preparation cushion compound: the sodium hydroxide solution of preparation 3-10% is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 20-60 minute, left standstill 40-120 minute, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 40-100 minute, under stirring condition, be heated to 80-85 ℃ and be incubated 30-60 minute, the gelatin that adds described proportioning again, glycerol and ethyl hydroxybenzoate, continue heating and stir gelatin is dissolved fully, insulation is 30-60 minute under 80-85 ℃ of condition, evacuation is removed part water, makes wherein moisture Control at optimum range, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 10 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of certain specification, gets final product.
Wherein, extract in the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that makes in above-mentioned (1) step, content of paeoniflorin can reach more than 10% (g/g).It can be made with extra care by the following method: the alcoholic solution that adds 2-5 amount 75-85% in the described Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder makes dissolving, filters, and then with filtrate recycling ethanol and be concentrated into the about 1.10-1.20 of relative density, spray drying gets final product; In the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that makes with this method, content of paeoniflorin can reach more than 30% (g/g).In order to obtain the higher Radix Paeoniae Alba of paeoniflorin content/Radix Paeoniae Rubra extract powder, also can be further refining by other method.
If necessary, also can wrap one deck enteric solubility film coating on above-mentioned Manufactured soft capsule surface, to make the enteric solubility soft capsule according to the art for coating of routine.
The Oleum menthae of being mentioned among the present invention, for the fresh stem of labiate Herba Menthae Mentha haplocalyx Briq. or leaf through vapor distillation, freezing again, part is taken off the volatile oil that brain processing obtains, i.e. 2000 editions Oleum menthae that recorded of Chinese Pharmacopoeia.Its quality should meet the Chinese Pharmacopoeia standard: wherein contain total alcohol amount by Mentholum (C
10H
20O) calculate, must not be less than 50.0% (g/g).
Oleum menthae can be bought from legal production of raw medicine producer, also can be according to the method described above, and own the extraction from the Chinese crude drug Herba Menthae makes.
The Radix Paeoniae Alba of being mentioned among the present invention is for the dry root of cohosh Radix Paeoniae Paeonia lactiflora Pall. processes from strand; The Radix Paeoniae Rubra of being mentioned among the present invention is the dry root of cohosh Radix Paeoniae Paeonia lactiflora Pall. or river Radix Paeoniae Rubra Paeonia veitchii Lynch..The two quality all should meet the Chinese Pharmacopoeia standard, wherein: contain peoniflorin (C in the Radix Paeoniae Alba
23H
28O
11) must not be less than 0.80% (g/g), contain peoniflorin (C in the Radix Paeoniae Rubra
23H
28O
11) must not be less than 1.80% (g/g).
Compared with prior art, the invention has the beneficial effects as follows: (1), choice of drug Oleum menthae of the present invention and the Radix Paeoniae Alba/Radix Paeoniae Rubra are as the crude drug scientific composition, by certain weight proportion composition, prove through animal experiment and clinical trial, have effects such as dispersing the stagnated live-QI to relieve the stagnation of QI, antalgic and inflammation relieving, regulating QI antidiarrheal, with strong points when being used to prevent and treat diarrhea type irritable bowel syndrome, determined curative effect; Particularly has good especially effect through preferred prescription.(2), Oleum menthae and the Radix Paeoniae Alba/Radix Paeoniae Rubra are Chinese medicine commonly used in the medicine of the present invention, and through the pharmacological toxicology evidence, its toxic and side effects is little, and safety is good.(3), medicine of the present invention is in preparation process, adopt the Radix Paeoniae Alba/Radix Paeoniae Rubra medical material in the rational extraction process processing crude drug, can fully extract effective ingredient wherein, and minimizing impurity, improve content of effective, dose is less after making preparation, and patient is easy to accept, and can improve patient's compliance to a certain extent.In addition, make behind the suitable preparation its take and carry all comparatively convenient.
Mainly contain in the Oleum menthae menthol (Menthol, 40-60%), menthone compositions such as (Menthone): have wind dispelling, regulate the flow of vital energy, effect such as resolving depression, antiinflammatory, analgesia, effects such as excited preventing or arresting vomiting, antidepressant are arranged.Mainly contain peoniflorin compositions such as (Paeoniflorin) in the Radix Paeoniae Alba/Radix Paeoniae Rubra: the Radix Paeoniae Alba has functions such as nourishing blood to suppress the hyperactive liver, astringing YIN to stop sweating, relieving spasm to stop pain, also can be used for treating other diseases such as rheumatoid arthritis, systemic lupus erythematosus (sle) and autoimmune disease; Radix Paeoniae Rubra has clearing away heat and cooling blood, functions such as eliminating stasis to stop pain, and effect such as also have spasmolytic, calmness, antibiotic, antiinflammatory simultaneously, protect the liver can be used for treating diseases such as coronary heart disease, acute cerebral thrombosis formation, acute jaundice type viral hepatitis; The side effect of the Radix Paeoniae Alba/Radix Paeoniae Rubra is less, and good safety and toleration are arranged.Medicine of the present invention share Oleum menthae and the Radix Paeoniae Alba/Radix Paeoniae Rubra, science collocation, the merit of long memorial liver resolving depression, antalgic and inflammation relieving, regulating QI antidiarrheal altogether.
For confirming the curative effect of medicine of the present invention, filter out more excellent scheme, investigate the safety of medicine of the present invention simultaneously, for clinical application provides theoretical foundation, the inventor has carried out investigations such as the trial test of animal pharmacodynamics, animal acute toxicity test and clinical treatment test to it, the method and the result of the test of employing are as follows:
One, (medicine of the present invention is to the influence of rat intestine irritable syndrome diarrhoea model) investigated in the trial test of animal pharmacodynamics
1. experiment material
1.1 medicine
The medicine of the present invention that different material medicine proportioning is made dilutes with edible oil for self-control.The positive control drug imodium is Xian-Janssen Pharmaceutical Ltd.'s product.
1.2 animal
56 of SD rats, male, body weight 180 ± 20g is available from Institute of Experimental Animals, Chinese Academy of Medical Sciences.
2. experimental technique
2.1 animal grouping situation
Rat is divided into 7 groups at random, every group 8, to be blank group (irritate stomach give edible oil 1ml/100g), positive drug group (imodium 2mg/kg), Oleum menthae and the Radix Paeoniae Alba form proportioning by crude drug is to establish three experimental grouies (the 1st to 3 group) in 1: 100,1: 130,1: 160, other establishes Herba Menthae line of oils (the 4th group) and Radix Paeoniae Alba group (the 5th group, by the method preparation of extracting the Radix Paeoniae Alba/Radix Paeoniae Rubra among the present invention).By intend clinical administration dosage 10 times every day gastric infusion 1 time, successive administration 6 days.After administration every day 1 hour, according to the modeling of Restraint Stress rat intestine irritable syndrome (IBS) diarrhoea model.The grouping situation sees Table 1:
Table 1 animal grouping situation and dosage
| Group | Oleum menthae (g/kg) | The Radix Paeoniae Alba (crude drug, g/kg) |
| Blank (edible oil) | ????0 | ????0 |
| Positive drug (imodium) | ????0 | ????0 |
| ????1 | ????0.1 | ????10 |
| ????2 | ????0.1 | ????13 |
| ????3 | ????0.1 | ????16 |
| ????4 | ????0.1 | ????0 |
| ????5 | ????0 | ????20 |
2.2 Restraint Stress rat intestine irritable syndrome (IBS) diarrhoea model
Draw every day and respectively organize the SD rat behind the medicine, irritate stomach respectively and give its two hind leg of constraint behind the Oleum Ricini 0.1ml/100g, make it handicapped, dysphoria causes certain stress stimulation.So after the modeling in continuous 6 days, rat is put into the metabolic cage that is lined with filter paper respectively, per hour change absorbent paper 1 time, record defecation incubation period, diarrhea rate, loose stool rate.
3. experimental result
Each group of medicine of the present invention all can obviously prolong Oleum Ricini and cause rat diarrhoea incubation period, obviously reduces the accumulative total number of times of suffering from diarrhoea, and acts on minimumly being maintained until behind the medicine 2 hours; Reduce loose stool rate, effect can be maintained until behind the medicine 6 hours.With blank group comparing difference significantly (P＜0.05), the results are shown in Table 2, table 3.
Table 2 pair Oleum Ricini causes influence (the 1) (n=8 of rat diarrhoea model; X ± s)
| Group | Suffer from diarrhoea incubation period (min) | Add up to suffer from diarrhoea number of times | ||
| ????1h | ????2h | ????6h | ||
| Blank imodium 12345 | 23.3±11.7 58.2±30.4 *45.9±29.1 *53.9±24.1 *52.6±22.0 *48.9±19.1 *45.6±28.0* | ??3.1±1.5 ??1.4±1.2 *??1.5±0.5* ??1.5±0.5* ??1.6±1.5 *??1.7±0.5 *??1.6±1.5 * | ??5.6±2.1 ??2.9±1.9 *??3.4±2.1* ??3.4±2.1* ??3.7±2.5 *??4.0±2.1* ??4.3±2.5* | ??6.7±2.4 ??4.3±2.1 *??4.6±2.7 *??5.2±2.7 *??5.0±3.1 *??6.0±3.7 ??5.0±3.1* |
Annotate: compare * P＜0.05 with model group.
Table 3 pair Oleum Ricini causes influence (the 2) (n=8 of rat diarrhoea model; X ± s)
| Group | The accumulative total loose stool rate | ||
| ????????1h | ????????2h | ?????????6h | |
| Blank imodium 12345 | ????0.39±0.15 ????0.18±0.14 *????0.33±0.18 ????0.27±0.34* ????0.18±0.23 *????0.26±0.18* ????0.30±0.34 | ????0.59±0.19 ????0.29±0.13 *????0.38±0.30 *????0.40±0.40 *????0.30±0.26 *????0.46±0.30 *????0.60±0.40 | ????0.61±0.18 ????0.39±0.14 *????0.38±0.27 *????0.41±0.27 *????0.36±0.25 *????0.46±0.27 *????0.60±0.27 |
Annotate: compare * P＜0.05 with model group.
4. conclusion
Medicine of the present invention is inhibited to rat intestine irritable syndrome diarrhoea model due to the Oleum Ricini, and prompting this product has the effect of good treatment irritable bowel syndrome.
Two, the animal safety test is investigated
In order to study the safety of medicine of the present invention, for clinical application provides theoretical foundation, the inventor has carried out investigations such as acute toxicity test to it, and result of the test is as follows:
The toxicity of Oleum menthae is very little, can not survey LD when irritating stomach
50, its maximum tolerated dose is greater than 4000mg/kg, and this dosage is more than 670 times of human clinical's common dose; LD during lumbar injection
50=1144.9 ± 78.5mg/kg.
The Radix Paeoniae Alba and Radix Paeoniae Rubra all are traditional Chinese medical science tradition medicines commonly used, in practice in 1,100, have not found its toxicity and apparent side effect.The modern medicine acute toxicology studies show that its oral administration safety is big.
Result through the pharmacological toxicology experimental study is: (method of extracting the Radix Paeoniae Alba/Radix Paeoniae Rubra in by process for preparing medicine of the present invention makes, down together) LD for mouse mainline and lumbar injection Radix Paeoniae Alba extract
50Be respectively 159mg/kg (being equivalent to the about 12.2g/kg of raw medicinal herbs) and 230mg/kg (being equivalent to the about 17.7g/kg of raw medicinal herbs); The about 3000mg/kg of feeding mice Radix Paeoniae Alba extract (being equivalent to the about 230g/kg of raw medicinal herbs) does not see obvious poisoning symptom, does not have dead yet.Chronic toxicological study result shows: it does not have overt toxicity to each important organ of mice.Rat and Canis familiaris L. give 3 various dose Radix Paeoniae Alba extracts (every day, stomach was raised 50mg/kg, 1000mg/kg, 2000mg/kg, and the 5-200 of the maximum dose level that is equivalent to be grown up doubly) 30 days and 90 days, and no overt toxicity damages, and shows that this poison of drug is low, safety range is big.Three to cause test all negative; In Pa Fulin reproductive toxicity test (test of teratogenesis fetus) research, dosage does not still have teratogenesis during up to 2160mg/kg, to the survival of tire Mus, outward appearance and histoorgan grow, skeleton development do not have obvious influence.In addition, the Radix Paeoniae Alba is usually used in antiabortive in the traditional Chinese medical science, so the prompting Radix Paeoniae Alba may also be applicable to pregnant patient, its safety is comparatively reliable.
The maximum tolerated dose of Radix Paeoniae Rubra (extract that makes by the method for extracting the Radix Paeoniae Alba/Radix Paeoniae Rubra in the process for preparing medicine of the present invention) mouse mainline is greater than 50g/kg (raw medicinal herbs), and the maximum tolerated dose of mouse stomach is greater than 280g/kg (raw medicinal herbs).
Oral administration gavage medicine of the present invention (by the crude drug Oleum menthae: Radix Paeoniae Alba proportioning is 1: 130) mouse stomach LD
50=8670mg/kg, this dosage are about 300 times of human clinical's common dose.
Above toxicity test results suggest: poisonous side effect of medicine of the present invention is less, and is safe.
Three, the clinical observation of Drug therapy irritable bowel syndrome of the present invention
1, clinical data
1.1 case choice criteria
1.1.1 irritable bowel syndrome (diarrhea-type) diagnostic criteria
Work out with reference to national chronic diarrhea academic discussion clinical diagnosis reference standard in 1986:
(1) stomachache, abdominal distention, diarrhoea are more than 2 years, with general neurosis shape.
(2) ordinary circumstance is good, and nothing is become thin and generated heat, and abdominal tenderness is only found in system's health check-up.
(3) repeatedly stool routine and cultivation (at least three times) are all negative, and excrement is occulted blood and tested feminine gender.
(4) X line barium enema inspection does not have positive the discovery, or colon has excitation.
(5) fibro-colonoscope is normal, and the part patient moving is hyperfunction, and mucus increases, and it is unusual not have obvious mucosa, and histological examination is normal substantially.
(6) blood, routine urinalysis are normal, and erythrocyte sedimentation rate is normal
(7) parasite medical histories such as no dysentery, schistosomicide, test of cure is invalid.
1.1.2 case is included standard in
(1) meets irritable bowel syndrome (diarrhea-type) diagnostic criteria.
(2) sex in age 18-60 year.
1.1.3 case exclusion standard
(1) intestinal organic disease (tumor, inflammation, congenital anomaly, malabsorption syndrome etc.).
(2) gestation or women breast-feeding their children have drug allergy history or allergic constitution person at under-18s or more than 60 years old the age.
(3) merge serious primary disease such as the heart, brain, liver, kidney and hemopoietic system, psychotic.
Accepted associated treatment in (4) two weeks, judgement person may affect the treatment.
(5) medication in accordance with regulations, do not meet the standard of including in, can't judge that curative effect or data are not congruent and will affect the treatment or safety judgement person.
(6) participate in other clinical trial person.
1.2 physical data
All case is all from January, 2003 to 2003 year outpatient service in November or inpatient.Be divided into treatment group and matched group at random by the prescription on individual diagnosis order, male 11 examples in 20 examples, women 9 examples are organized in treatment; The oldest 43 years old minimum 25 years old, average 35.51 years old; The course of disease is the shortest 2 years, and is the longest 5 years, average 3.27 ± 1.36 years.In matched group 20 examples, male 8 examples, women 12 examples; The oldest 45 years old, minimum 23 years old, average 36.96 years old, the course of disease 2.2 years～5.5 years, average 3.85 ± 1.03 years.Two groups of patient's age, sex, medical histories are learned the processing no significant difference by statistics, have comparability.
2, Therapeutic Method
Adopt the method for double blinding dual analog, the treatment group gives medicine of the present invention (crude drug of this medicine consists of: Oleum menthae 100g, Radix Paeoniae Alba 13000g, bean plant oil 220g, soybean phospholipid 5g, Cera Flava 5g, make 1000 soft capsules), and is oral, 3 times on the 1st, 2/time; Matched group waits the made soft capsule oral of dosage single Oleum menthae, and 3 times on the 1st, 2/time, be 1 month the course of treatment.
3, efficacy assessment standard
Adopt symptom rank scores standard (seeing Table 4).
Table 4 symptom rank scores standard scale
| Symptom | Do not have | Gently | In | Heavy |
| Diarrhoea | 0 minute | Stool is shaped, every day 1-2 time (2 minutes) | It is shapeless to defecate, every day 3-4 time (4 minutes) | Just shapeless, every day is (6 minutes) more than 5 times |
| Stomachache | 0 minute | Little stomachache does not influence routine work (2 minutes) | Heavier stomachache, but can adhere to work (4 minutes) | Tormina can't be adhered to work (6 minutes) |
| Abdominal distention | 0 minute | Abdominal distention occasionally, but spontaneous remission after half an hour (1 minute) | Abdominal distention, but spontaneous remission after 1 hour (2 minutes) | Expanding can not spontaneous remission, need take medicine (3 minutes) |
| Poor appetite | 0 minute | Do not have appetite, but keep former appetite (1 minute) | Appetite, appetite reduces by 1/3 (2 minutes) than before sick | No appetite, appetite reduces more than 2/3 (3 minutes) than before sick |
| Weak | 0 minute | Easily tired, but can (1 minute) competent at a job | Limbs fatigue, not anti-lasting work (2 minutes) | Lassitude, not competent work (3 minutes) |
| Insomnia | 0 minute | Insomnia (1 minute) occasionally | Sleeping difficult, easily wake up (2 minutes) of sleeping night | Difficulty falling asleep, the dreaming often and waking easily of sleeping night (3 minutes) |
| Anxiety | 0 minute | Anxiety (1 minute) occasionally | Sometimes emotional lability, easy anxiety still can automatic control (2 minutes) | Often anxiety is difficult to oneself's control (3 minutes) |
Record treatment forward and backward symptom total mark (addition of every symptom mark) adopts integration to carry out the curative effect assessment than method.
(1) clinical cure: transference cure, observe and follow up a case by regular visits to two weeks and do not have recurrence.
(2) produce effects: clinical symptoms is obviously improved, and symptom integral is than 〉=70%.
(3) effective: clinical symptoms takes a turn for the better to some extent, and symptom integral is than 〉=30%,＜70%.
(4) invalid: clinical symptoms does not have obvious improvement, even increase the weight of, symptom integral is than＜30%.
4, therapeutic outcome (seeing Table 5)
The two groups of curative effects in table 5 treatment back relatively
Group n clinical cure (%) produce effects (%) is (%) invalid (%) total effective rate (%) effectively
Treatment organizes 20 2 (10) 9 (45) 8 (40) 1 (5) 95
Matched group 20 07 (35) 7 (35) 6 (30) 70
Annotate: there is the significance meaning two groups of total effective rate contrasts of statistical procedures P＜0.01.
Conclusion: by above result as can be known, the total effective rate of Drug therapy irritable bowel syndrome of the present invention (diarrhea-type) is 95%, has compared significant significant difference with single with the curative effect of Oleum menthae.Illustrate that medicine of the present invention has the obvious treatment effect to irritable bowel syndrome (diarrhea-type).
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment one
Present embodiment is a hard capsule, and the crude drug component of its capsule 's content is: 1 part of Oleum menthae, 130 portions of Radix Paeoniae Albas.
Make hard capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 10 times of water gagings decocts extraction 4 times and filtrate is concentrated into relative density about 1.10, the alcoholic solution that adds 2 times of amounts 80%, staticly settled 12 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.10, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3 times of amount ethyl acetate extractions 2 times, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets Radix Paeoniae Alba extract powder;
(2) make preparation: get the Oleum menthae of described proportioning, the Radix Paeoniae Alba extract powder mix homogeneously with (1) step makes incapsulates shell, makes the hard capsule of 0.5g/ grain, gets final product.
Embodiment two
Present embodiment is the enteric hard wafer, and the crude drug component of its capsule 's content is: 1 part of Oleum menthae, 160 portions of Radix Paeoniae Albas, 0.01 part of magnesium stearate.
Make the enteric hard wafer by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 6 times of water gagings decocts extraction 3 times and filtrate is concentrated into relative density about 1.20, the alcoholic solution that adds 4 times of amounts 95%, staticly settled 48 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.20, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 5 times of amount ethyl acetate extractions 4 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 2 times of amounts 85% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.20, spray drying, Radix Paeoniae Alba extract powder;
(2) make preparation: get the Oleum menthae and the magnesium stearate of described proportioning,, make the hard capsule of 0.5g/ grain, get final product with the Radix Paeoniae Alba extract powder mix homogeneously that makes of (1) step, the enteric capsule shell of packing into.
Embodiment three
Present embodiment is the enteric hard wafer, and the crude drug component of its capsule 's content is: 1 part of Oleum menthae, 80 parts of Radix Paeoniae Rubra.
Make the enteric hard wafer by the method that may further comprise the steps:
(1) extracts Radix Paeoniae Rubra: the Radix Paeoniae Rubra medical material of getting described proportioning, adding 8 times of water gagings decocts extraction 2 times and filtrate is concentrated into relative density about 1.15, the alcoholic solution that adds 3 times of amounts 85%, staticly settled 16 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.15, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 4 times of amount ethyl acetate extractions 3 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 5 times of amounts 75% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.10, spray drying, the Radix Paeoniae Rubra extract powder;
(2) make preparation: get the Oleum menthae of described proportioning,, make the hard capsule of 0.5g/ grain, get final product with the Radix Paeoniae Rubra extract powder mix homogeneously that makes of (1) step, the enteric capsule shell of packing into.
Embodiment four
Present embodiment is a film coating tablet, and the crude drug component of its label is: 1 part of Oleum menthae, 180 portions of Radix Paeoniae Albas, 5 parts of corn starchs.
Make tablet by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 7 times of water gagings decocts extraction 3 times and filtrate is concentrated into relative density about 1.15, the alcoholic solution that adds 3 times of amounts 90%, staticly settled 18 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.15, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 4 times of amount ethyl acetate extractions 3 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 4 times of amounts 80% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.15, spray drying, Radix Paeoniae Alba extract powder;
(2) make preparation: get the Oleum menthae and the corn starch of described proportioning, with the Radix Paeoniae Alba extract powder mix homogeneously that (1) step makes, technology is pressed into the label of 0.5g/ sheet routinely, wraps the thin film coating at the sheet wicking surface again, gets final product.
Embodiment five
Present embodiment is the film-coated tablet of enteric solubility, and the crude drug component of its label is: 1 part of Oleum menthae, 100 parts of Radix Paeoniae Rubra.
Make tablet by the method that may further comprise the steps:
(1) extracts Radix Paeoniae Rubra: the Radix Paeoniae Rubra medical material of getting described proportioning, adding 9 times of water gagings decocts extraction 2 times and filtrate is concentrated into relative density about 1.18, the alcoholic solution that adds 4 times of amounts 90%, staticly settled 24 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.15, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 5 times of amount ethyl acetate extractions 2 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 3 times of amounts 80% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.15, spray drying, the Radix Paeoniae Rubra extract powder;
(2) make preparation: get the Oleum menthae of described proportioning, with the Radix Paeoniae Rubra extract powder mix homogeneously that (1) step makes, technology is pressed into the label of 0.5g/ sheet routinely, wraps one deck enteric solubility film coating at the sheet wicking surface again, gets final product.
Embodiment six
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 150 portions of Radix Paeoniae Albas, 2.6 parts of bean plant oil.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1 part of glycerol, 0.009 part of methyl hydroxybenzoate, 1.6 parts of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 8 times of water gagings decocts extraction 3 times and filtrate is concentrated into relative density about 1.10, the alcoholic solution that adds 2 times of amounts 95%, staticly settled 30 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.18, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3 times of amount ethyl acetate extractions 4 times, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 58 ℃, the Oleum menthae that adds described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 1 hour, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 10 hours standby;
(3) preparation cushion compound: get an amount of purified water, the gelatin, glycerol and the methyl hydroxybenzoate that add described proportioning, heating and stirring are dissolved gelatin fully, insulation is 30 minutes under 85 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 29%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment seven
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 140 portions of Radix Paeoniae Albas, 2.4 parts of bean plant oil, 0.07 part of soybean phospholipid, 0.03 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1.5 parts of glycerol, 1 part of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 10 times of water gagings decocts extraction 4 times and filtrate is concentrated into relative density about 1.20, the alcoholic solution that adds 3 times of amounts 85%, staticly settled 36 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.12, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 5 times of amount ethyl acetate extractions 2 times, the combined ethyl acetate extract reclaims ethyl acetate and does near, and the alcoholic solution that adds 2 times of amounts 85% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.18, spray drying, Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 60 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 20 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 8 hours standby;
(3) preparation cushion compound: get an amount of purified water, the gelatin and the glycerol that add described proportioning, heating and stirring are dissolved gelatin fully, insulation is 30 minutes under 85 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 18%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment eight
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 130 portions of Radix Paeoniae Albas, 2.2 parts of bean plant oil, 0.05 part of soybean phospholipid, 0.05 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1.5 parts of glycerol, 0.8 part of acrylic resin II, 0.4 part of acrylic resin III, 0.01 part of ethyl hydroxybenzoate, 0.21 part of sodium hydroxide, 2.5 parts of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 8 times of water gagings decocts extraction 2 times and filtrate is concentrated into relative density about 1.15, the alcoholic solution that adds 3 times of amounts 85%, staticly settled 16 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.15, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 4 times of amount ethyl acetate extractions 3 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 3 times of amounts 80% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.15, spray drying, Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 55 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 30 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 12 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 6.5% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 30 minutes, left standstill 1 hour, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 1 hour, under stirring condition, be heated to about 80 ℃ and be incubated 45 minutes, add the gelatin of described proportioning again, glycerol and ethyl hydroxybenzoate continue heating and stir gelatin is dissolved fully, insulation is 30 minutes under 80 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 30%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment nine
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 100 parts of Radix Paeoniae Rubra, 2.4 parts of bean plant oil, 0.07 part of soybean phospholipid, 0.03 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1.8 parts of glycerol, 0.9 part of acrylic resin II, 0.5 part of acrylic resin III, 0,009 part of ethyl hydroxybenzoate, 0.20 part of sodium hydroxide, 2.6 parts of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts Radix Paeoniae Rubra: the Radix Paeoniae Rubra medical material of getting described proportioning, adding 6 times of water gagings decocts extraction 4 times and filtrate is concentrated into relative density about 1.12, the alcoholic solution that adds 4 times of amounts 80%, staticly settled 12 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.10, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 5 times of amount ethyl acetate extractions 2 times, the combined ethyl acetate extract reclaims ethyl acetate and does near, and the alcoholic solution that adds 4 times of amounts 75% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.20, spray drying, the Radix Paeoniae Rubra extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 60 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Rubra extract powder that (1) step makes again while stirring, continue to stir 20 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 8 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 10% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 20 minutes, left standstill 2 hours, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 100 minutes, under stirring condition, be heated to about 82 ℃ and be incubated 30 minutes, add the gelatin of described proportioning again, glycerol and ethyl hydroxybenzoate continue heating and stir gelatin is dissolved fully, insulation is 45 minutes under 82 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 29%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 10 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment ten
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 160 portions of Radix Paeoniae Albas, 3 parts of bean plant oil, 0.02 part of soybean phospholipid, 0.02 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 2.4 parts of glycerol, 0.6 part of acrylic resin II, 0.3 part of acrylic resin III, 0.008 part of propylparaben, 0.24 part of sodium hydroxide, 2.4 parts of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 10 times of water gagings decocts extraction 3 times and filtrate is concentrated into relative density about 1.18, the alcoholic solution that adds 3 times of amounts 90%, staticly settled 24 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.18, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3 times of amount ethyl acetate extractions 4 times, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 56 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 60 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 12 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 3% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 60 minutes, left standstill 1.5 hours, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 40 minutes, under stirring condition, be heated to about 83 ℃ and be incubated 1 hour, add the gelatin of described proportioning again, glycerol and propylparaben continue heating and stir gelatin is dissolved fully, insulation is 1 hour under 83 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 27%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 10 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment 11
Present embodiment is a soft capsule, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 120 portions of Radix Paeoniae Albas, 2 parts of bean plant oil, 0.03 part of soybean phospholipid, 0.08 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 0.8 part of glycerol, 0.7 part of acrylic resin II, 0.6 part of acrylic resin III, 0.011 part of ethyl hydroxybenzoate, 0.18 part of sodium hydroxide, 2 parts of water.
Make soft capsule by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 7 times of water gagings decocts extraction 4 times and filtrate is concentrated into relative density about 1.16, the alcoholic solution that adds 2 times of amounts 95%, staticly settled 18 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.16, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 4 times of amount ethyl acetate extractions 3 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 3 times of amounts 80% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.16, spray drying, Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 58 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 50 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 10 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 5% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 50 minutes, left standstill 40 minutes, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 50 minutes, under stirring condition, be heated to about 85 ℃ and be incubated 1 hour, add the gelatin of described proportioning again, glycerol and ethyl hydroxybenzoate continue heating and stir gelatin is dissolved fully, insulation is 1 hour under 85 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 27%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, gets final product.
Embodiment 12
Present embodiment is the enteric soft capsules agent, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 180 portions of Radix Paeoniae Albas, 1.5 parts of bean plant oil, 0.08 part of soybean phospholipid, 0.07 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1.2 parts of glycerol, 1 part of acrylic resin II, 0.2 part of acrylic resin III, 0.012 part of ethyl hydroxybenzoate, 0.18 part of sodium hydroxide, 3 parts of water.
Also be surrounded by one deck enteric solubility film coating in dosage surface.
Make the enteric soft capsules agent by the method that may further comprise the steps:
(1) extracts the Radix Paeoniae Alba: the white Peony Root of getting described proportioning, adding 8 times of water gagings decocts extraction 3 times and filtrate is concentrated into relative density about 1.14, the alcoholic solution that adds 3 times of amounts 90%, staticly settled 20 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.14, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 3 times of amount ethyl acetate extractions 4 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 4 times of amounts 75% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.14, spray drying, Radix Paeoniae Alba extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 57 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba extract powder that (1) step makes again while stirring, continue to stir 40 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 12 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 8% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 40 minutes, left standstill 100 minutes, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 80 minutes, under stirring condition, be heated to about 84 ℃ and be incubated 40 minutes, add the gelatin of described proportioning again, glycerol and ethyl hydroxybenzoate continue heating and stir gelatin is dissolved fully, insulation is 40 minutes under 84 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 35%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make enteric soft capsules: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, and art for coating is routinely wrapped one deck enteric solubility film coating on its surface again, gets final product.
Embodiment 13
Present embodiment is the enteric soft capsules agent, wherein:
The crude drug component of soft capsule content is: 1 part of Oleum menthae, 80 parts of Radix Paeoniae Rubra, 2.2 parts of bean plant oil, 0.05 part of soybean phospholipid, 0.05 part of Cera Flava.
Cushion compound is made up of the component of following weight proportion: 3 parts of gelatin, 1.5 parts of glycerol, 0.8 part of acrylic resin II, 0.4 part of acrylic resin III, 0.01 part of ethyl hydroxybenzoate, 0.21 part of sodium hydroxide, 2.5 parts of water.
Also be surrounded by one deck enteric solubility film coating in dosage surface.
Make the enteric soft capsules agent by the method that may further comprise the steps:
(1) extracts Radix Paeoniae Rubra: the Radix Paeoniae Rubra medical material of getting described proportioning, adding 9 times of water gagings decocts extraction 2 times and filtrate is concentrated into relative density about 1.17, the alcoholic solution that adds 4 times of amounts 80%, staticly settled 32 hours, filter, with filtrate recycling ethanol and to be concentrated into relative density about 1.17, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 5 times of amount ethyl acetate extractions 2 times, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 2 times of amounts 85% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density about 1.17, spray drying, the Radix Paeoniae Rubra extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to about 58 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, make dissolving and mixing after, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Rubra extract powder that (1) step makes again while stirring, continue to stir 30 minutes, make mix homogeneously until adding the back, make further mixing after colloid mill, leave standstill more than 12 hours standby;
(3) preparation cushion compound: the sodium hydroxide solution of preparation about 6.5% (g/g) is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 30 minutes, left standstill 60 minutes, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 60 minutes, under stirring condition, be heated to about 82 ℃ and be incubated 45 minutes, add the gelatin of described proportioning again, glycerol and ethyl hydroxybenzoate continue heating and stir gelatin is dissolved fully, insulation is 40 minutes under 82 ℃ of conditions, evacuation is removed part water, makes wherein moisture Control about 30%, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 12 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make enteric soft capsules: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of 0.5g/ grain, and art for coating is routinely wrapped one deck enteric solubility film coating on its surface again, gets final product.
Claims (12)
1, a kind of Chinese medicine for the treatment of irritable bowel syndrome, it contains following materials of weight proportions medicine: 1 part of Oleum menthae and the 80-180 part Radix Paeoniae Alba/Radix Paeoniae Rubra.
2, the Chinese medicine of treatment irritable bowel syndrome according to claim 1 is characterized in that: it contains following materials of weight proportions medicine: 1 part of Oleum menthae and the 100-160 part Radix Paeoniae Alba/Radix Paeoniae Rubra.
3, the Chinese medicine of treatment irritable bowel syndrome according to claim 2 is characterized in that: it contains following materials of weight proportions medicine: 1 part of Oleum menthae and the 130 parts of Radix Paeoniae Alba/Radix Paeoniae Rubra.
4, the Chinese medicine of treatment irritable bowel syndrome according to claim 1 is characterized in that: the dosage form of this Chinese medicine is tablet, hard capsule or soft capsule.
5, the Chinese medicine of treatment irritable bowel syndrome according to claim 4 is characterized in that: the dosage form of this Chinese medicine is a soft capsule, and it is by the soft capsule content that comprises the above-mentioned raw materials medicine and overlay on its surperficial soft capsule shell and constitute; And also contain any one or a few pharmaceutic adjuvant that is selected from vegetable oil, soybean phospholipid, Cera Flava, glycerol, Polyethylene Glycol, propylene glycol or the isopropyl alcohol in the soft capsule content; Contain 3 parts of gelatin and 0.8-2.4 part glycerol in the soft capsule shell.
6, the Chinese medicine of treatment irritable bowel syndrome according to claim 5 is characterized in that: also contain in sorbic acid, acrylic resin II, acrylic resin III, water, titanium dioxide, sodium hydroxide, sucrose, ethyl hydroxybenzoate, methyl hydroxybenzoate or the propylparaben any one or a few in the described soft capsule shell.
7, the Chinese medicine of treatment irritable bowel syndrome according to claim 6 is characterized in that: the component of the crude drug that contains in the described soft capsule content is: 1 part of Oleum menthae, the 100-160 part Radix Paeoniae Alba/Radix Paeoniae Rubra, 1.5-3 part bean plant oil, 0.02-0.08 part soybean phospholipid and 0.02-0.08 part Cera Flava; The component of soft capsule shell is: 3 parts of gelatin, 1.2-1.8 part glycerol, 0.6-1.0 part acrylic resin II, 0.2-0.6 part acrylic resin III, 0.008-0.012 part ethyl hydroxybenzoate, 0.18-0.24 part sodium hydroxide, 2-3 part water.
8, the Chinese medicine of treatment irritable bowel syndrome according to claim 7 is characterized in that: the component of the crude drug that contains in the described soft capsule content is: 1 part of Oleum menthae, the 130 parts of Radix Paeoniae Alba/Radix Paeoniae Rubra, 2.2 parts of bean plant oil, 0.05 part of soybean phospholipid and 0.05 part of Cera Flava; The component of soft capsule shell is: 3 parts of gelatin, 1.5 parts of glycerol, 0.8 part of acrylic resin II, 0.4 part of acrylic resin III, 0.01 part of ethyl hydroxybenzoate, 0.21 part of sodium hydroxide, 2.5 parts of water.
9, the Chinese medicine of treatment irritable bowel syndrome according to claim 7 is characterized in that: described soft capsule surface also is surrounded by one deck enteric solubility film coating.
10, the preparation method of Chinese medicine of the described treatment irritable bowel syndrome of a kind of claim 1 comprises the steps:
(1) extracts the Radix Paeoniae Alba/Radix Paeoniae Rubra: the Radix Paeoniae Alba or the Radix Paeoniae Rubra medical material of getting described proportioning, adding 6-10 times of water gaging decoction extraction 2-4 time and filtrate is concentrated into relative density is 1.10-1.20, adding 2-4 doubly measures the alcoholic solution of 80-95%, staticly settled 12-48 hour, filter, with filtrate recycling ethanol and to be concentrated into relative density be 1.10-1.20, add the NaHCO of the 0.2mol/L of equivalent
3Solution stirs and makes dissolving, adds 3-5 and doubly measures ethyl acetate extraction 2-4 time, and the combined ethyl acetate extract reclaims the ethyl acetate after drying, gets the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder;
(2) make preparation: get the Oleum menthae of described proportioning, with behind the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder mixing of making of (1) step routinely technology make various preparations, get final product.
11, the preparation method of Chinese medicine of the described treatment irritable bowel syndrome of a kind of claim 7 comprises the steps:
(1) extracts the Radix Paeoniae Alba/Radix Paeoniae Rubra: the Radix Paeoniae Alba or the Radix Paeoniae Rubra medical material of getting described proportioning, adding 6-10 times of water gaging decoction extraction 2-4 time and filtrate is concentrated into relative density is 1.10-1.20, adding 2-4 doubly measures the alcoholic solution of 80-95%, staticly settled 12-48 hour, filter, with filtrate recycling ethanol and to be concentrated into relative density be 1.10-1.20, add the NaHCO of the 0.2mol/L of equivalent
3Solution, stirring makes dissolving, add 3-5 and doubly measure ethyl acetate extraction 2-4 time, the combined ethyl acetate extract reclaims the ethyl acetate after drying, and the alcoholic solution that adds 2-5 amount 75-85% again makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density be 1.10-1.20, spray drying, the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder;
(2) preparation soft capsule content: the bean plant oil of getting described proportioning, be heated to 55-60 ℃, the soybean phospholipid and the Cera Flava that add described proportioning, after making dissolving and mixing, add the Oleum menthae of described proportioning, mixing, add the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that (1) step makes again while stirring, continue to stir 20-60 minute until adding the back, make abundant mixing, leave standstill more than 8 hours standby after colloid mill;
(3) preparation cushion compound: the sodium hydroxide solution of preparation 3-10% is standby earlier; Other gets an amount of purified water, the acrylic resin II and the acrylic resin III that add described proportioning, stirred 20-60 minute, left standstill 40-120 minute, add prepared sodium hydroxide solution in advance more while stirring, alkalize and change in the gel pot after 40-100 minute, under stirring condition, be heated to 80-85 ℃ and be incubated 30-60 minute, the gelatin that adds described proportioning again, glycerol and ethyl hydroxybenzoate, continue heating and stir gelatin is dissolved fully, insulation is 30-60 minute under 80-85 ℃ of condition, evacuation is removed part water, makes wherein moisture Control at optimum range, changes over to behind 80 mesh sieves in the steady glue bucket, insulation promptly made glue more than 10 hours under 55-60 ℃ of condition; Then with this glue routinely technology make thickness evenly and to have certain elastic cushion compound standby;
(4) make soft capsule: soft capsule press on soft capsule content and the cushion compound is pressed into the soft capsule of certain specification, gets final product.
12, according to the preparation method of Chinese medicine of claim 10 or 11 described treatment irritable bowel syndromes, it is characterized in that: extracting the Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder that makes in (1) step can be further refining by the following method: the alcoholic solution that adds 2-5 amount 75-85% in the described Radix Paeoniae Alba/Radix Paeoniae Rubra extract powder makes dissolving, filter, then with filtrate recycling ethanol and to be concentrated into relative density be 1.10-1.20, spray drying gets final product.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2004100796671A CN1660259A (en) | 2004-02-05 | 2004-12-22 | Chinese traditional medicine for treating imitable bowel syndrome and preparation method |
| PCT/CN2005/000155 WO2005074952A1 (en) | 2004-02-05 | 2005-02-04 | Chinese medicine for treatment of irritable bowel sysndrome and the preparation thereof |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200410021765 | 2004-02-05 | ||
| CN200410021765.X | 2004-02-05 | ||
| CN2004100796671A CN1660259A (en) | 2004-02-05 | 2004-12-22 | Chinese traditional medicine for treating imitable bowel syndrome and preparation method |
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| Publication Number | Publication Date |
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| CN1660259A true CN1660259A (en) | 2005-08-31 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2004100796671A Pending CN1660259A (en) | 2004-02-05 | 2004-12-22 | Chinese traditional medicine for treating imitable bowel syndrome and preparation method |
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| Country | Link |
|---|---|
| CN (1) | CN1660259A (en) |
| WO (1) | WO2005074952A1 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103585289A (en) * | 2012-08-15 | 2014-02-19 | 四川济生堂药业有限公司 | Pharmaceutical composition for preventing or treating irritable bowel syndrome |
| CN106177062A (en) * | 2016-08-30 | 2016-12-07 | 山西亿科宏泰生物科技有限公司 | A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof |
| IT201700082310A1 (en) * | 2017-07-20 | 2017-10-20 | Gianfranco Caramelli | "Treatment of complex gastrointestinal symptoms associated with IBS (Irritable bowel syndrome) with microencapsulated Peppermint essential oil associated with natural principles" |
| CN107510716A (en) * | 2016-06-17 | 2017-12-26 | 上海凯宝药业股份有限公司 | A kind of pharmaceutical composition for treating intestinal irritable syndrome and its production and use |
| CN109260309A (en) * | 2018-11-20 | 2019-01-25 | 山东罗欣乐康制药有限公司 | A kind of preparation method of the Chinese medicinal composition granules of warm in pain |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10350230B2 (en) | 2015-02-26 | 2019-07-16 | Zuoguang Zhang | Use of albiflorin or pharmaceutically acceptable salt for prevention and/or treatment of irritable bowel syndrome |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1020907C (en) * | 1988-07-29 | 1993-05-26 | 安徽医科大学临床药理研究所 | Extraction process for effective component of paeonia lactiflora |
-
2004
- 2004-12-22 CN CN2004100796671A patent/CN1660259A/en active Pending
-
2005
- 2005-02-04 WO PCT/CN2005/000155 patent/WO2005074952A1/en active Application Filing
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103585289A (en) * | 2012-08-15 | 2014-02-19 | 四川济生堂药业有限公司 | Pharmaceutical composition for preventing or treating irritable bowel syndrome |
| CN107510716A (en) * | 2016-06-17 | 2017-12-26 | 上海凯宝药业股份有限公司 | A kind of pharmaceutical composition for treating intestinal irritable syndrome and its production and use |
| CN107510716B (en) * | 2016-06-17 | 2020-06-30 | 上海凯宝药业股份有限公司 | Pharmaceutical composition for treating irritable bowel syndrome and preparation method and application thereof |
| CN106177062A (en) * | 2016-08-30 | 2016-12-07 | 山西亿科宏泰生物科技有限公司 | A kind of pharmaceutical composition treating irritable bowel syndrome and preparation method thereof |
| IT201700082310A1 (en) * | 2017-07-20 | 2017-10-20 | Gianfranco Caramelli | "Treatment of complex gastrointestinal symptoms associated with IBS (Irritable bowel syndrome) with microencapsulated Peppermint essential oil associated with natural principles" |
| CN109260309A (en) * | 2018-11-20 | 2019-01-25 | 山东罗欣乐康制药有限公司 | A kind of preparation method of the Chinese medicinal composition granules of warm in pain |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2005074952A1 (en) | 2005-08-18 |
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