CN104739905A - Fennel oral preparation as well as preparation method and new application thereof - Google Patents
Fennel oral preparation as well as preparation method and new application thereof Download PDFInfo
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- CN104739905A CN104739905A CN201510080635.1A CN201510080635A CN104739905A CN 104739905 A CN104739905 A CN 104739905A CN 201510080635 A CN201510080635 A CN 201510080635A CN 104739905 A CN104739905 A CN 104739905A
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- fructus foeniculi
- preparation
- laparotomy
- fennel
- functional rehabilitation
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Abstract
The invention discloses a fennel oral preparation as well as a preparation method and new application thereof. The new application of fennel disclosed by the invention is application of the fennel in preparation of medicines for promoting intestinal function recovery of open abdomen operation. The medicine prepared by employing the new application is a medicine prepared from an effective dose of fennel as an active component and added pharmaceutically acceptable auxiliary materials. Through the fennel oral preparation, the fennel is capable of shortening postoperative exhaust time, defecation time and hospital stay, shortening parenteral nutrition time, and relieving intestinal discomfort, and is beneficial to general diet in early recovery, and a new choice is provided for clinical acceleration of intestinal function recovery of open abdomen operation.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to the novelty teabag that Fructus Foeniculi promotes laparotomy rear intestinal functional rehabilitation, and Fructus Foeniculi oral formulations and preparation method.
Background technology
Patient Yi Fasheng paralytic ileus (being once called as " enteroparalysis ") after abdominal, it all has material impact for postoperative recovery and disease cost.From 5% to 25% not etc., but after abdominal, ileac incidence rate is the highest, higher than modes such as laparoscopic surgery and female operations for the incidence rate of research display postoperative ileus.The prolongation of hospital stays, not only increases cost, but also relevant to the increase of the severe complications such as such as pneumonia, nosocomial infection, deep venous thrombosis, also reduces mobility and the satisfaction of patient.Therefore promote the recovery of postoperative intestinal function, reducing postoperative ileus is one of important objectives of nursing management of perioperative.
A summary from Premier Perspective data base has added up about 1/6 inpatient of the U.S., report the generation of postoperative ileus time the hospital stays increase by 30% and significantly add medical expense simultaneously.The cause of disease of postoperative ileus still has arguement, may contain many factors, comprises gastrointestinal inflammation reaction, neurogenic and drug induccd mechanism.Ileac acute stage generally owing to neurogenic mechanism, because peritoneum excitation causes caused by vagus nerve stimulation; Duration is usually owing to inflammatory stress caused by tissue injury; Drug induccd mechanism mainly refers to the use of perioperative opioid drug.Above-mentioned three mechanism finally all activate and are distributed widely in gastrointestinal μ-opiate receptor, inhibit Auerbach's plexus to discharge acetylcholine, disturb the enterokinesia of normal rhythmicity, the substitute is inharmonic enterokinesia, do not have a progradation.On the other hand, the disorder of postoperative intestinal edema and Smooth myoelectricity physiological function is also one of reason of postoperative ileus.Existing multiple method is for reducing postoperative ileus incidence rate at present, comprises use laparoscopic surgery, chew gum, and early postoperation is taken food, and the medicine such as neostigmine and Aiweimopan.
Fructus Foeniculi is all considered to safe Chinese crude drug for a long time, is used to treatment vomiting, constipation, dyspepsia, dysmenorrhea etc.It is found that Fructus Foeniculi can trace back to zoopery remote to the impact of intestinal function, but nonetheless, its concrete physiological mechanism is illustrated not yet.The possible mechanism of current research one of disclosing is principle active component---the anethole of Fructus Foeniculi, and it acts on Dopaminergic receptors, and gastrointestinal smooth muscular spasm is removed in mediation, regulates digestive system function.Zeller A is reported in Fructus Foeniculi immersion the effective ingredient detected in Fructus Foeniculi, and this also just explains Fructus Foeniculi used in why this research and has the drug effect of Fructus Foeniculi itself for tea-drinking.One comprises 125 neonatal placebo-controlled trials that are random, double blinding and shows, and the incidence rate accepting the neonate colitis symptoms of Fructus Foeniculi oil preparation treatment is starkly lower than placebo group, and difference has statistical significance.Some basic research also report that Fructus Foeniculi can suppress antibacterial in intestinal and fungus, thus have the effect for the treatment of gastroenteritis.
But there is no oral for Fructus Foeniculi for promoting the relevant report of laparotomy rear intestinal functional rehabilitation.
Summary of the invention
First technical problem solved by the invention is to provide a kind of new medicine use of Fructus Foeniculi.Be specifically related to the application of Fructus Foeniculi in the oral drugs promoting laparotomy rear intestinal functional rehabilitation.
The pharmaceutical usage of Fructus Foeniculi of the present invention, mainly for after malignant tumor laparotomy, or after benign disease abdominal, but does not comprise and has carried out damaging gastral operation in digestive tract operation or art.
Especially, be after gynecologic malignant tumor laparotomy after malignant tumor laparotomy.Concrete, gynecologic malignant tumor is cervical cancer, ovarian cancer, carcinoma of endometrium, sarcoma of uterus etc.
Especially, benign disease abdominal is the uterectomy of benign disease.
Application such use, the medicine of preparation be with the Fructus Foeniculi of effective dose for active component, add the oral formulations that customary adjuvant is pharmaceutically prepared from.Wherein, the every preparation unit of described preparation in crude drug, containing Fructus Foeniculi 5 ~ 10 grams.
Second technical problem solved by the invention is to provide a kind of pharmaceutical composition promoting laparotomy rear intestinal functional rehabilitation, especially for the pharmaceutical composition after gynecologic malignant tumor laparotomy, its main active is the Fructus Foeniculi of effective dose, adds the preparation that customary adjuvant is pharmaceutically prepared from; All can prepare according to the conventional method of pharmaceutical field.Active component can also with addition of promoting that the medicine of postoperative function of intestinal canal recovery increases the effect of Synergistic.
Described customary adjuvant comprises the diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc. of pharmaceutical field routine.
For the ease of application, on the basis of crude drug, pharmaceutically acceptable adjuvant can be added and makes conventional oral formulations.As powder, capsule, tablet, granule, oral liquid, for tea-drinking etc.For the application characteristic of medicine of the present invention, additionally provide the preparation method of this pharmaceutical composition.As:
Method one: Fructus Foeniculi is ground into fine powder, mixing powder;
Method two: Fructus Foeniculi is ground into fine powder, encapsulated capsule;
Method three: Fructus Foeniculi spice is ground into fine powder, tabletting tablet;
Method four: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, granule;
Method five: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, encapsulated capsule;
Method six: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, tabletting tablet;
Method seven: after Fructus Foeniculi water boiling and extraction, make oral liquid;
Method eight: by Fructus Foeniculi soak by water or the water soaking by water temperature at least 40 DEG C, filter to get filtrate and obtain for tea-drinking.
Application said method all can realize the object promoting or improve laparotomy rear intestinal functional rehabilitation, but because of the convenience of application and the easy of preparation, more inventor is made into and uses for tea-drinking.
Detailed description of the invention
Experimental technique described in following embodiment, if no special instructions, is conventional method; Described reagent and material, if no special instructions, all can obtain from commercial channels.
Embodiment:
1 data and method
1.1 physical data present inventor Zhao Xia teach, the grand doctor of horse has carried out Fructus Foeniculi oral formulations in December, 2013 to 2014 and test the relevant clinical of the impact of postoperative intestinal function recovery year August, and the patient participating in testing is from the patient accepting the gynecologic malignant tumor abdominals such as cervical cancer, ovarian cancer, carcinoma of endometrium.Age was between 20 years old to 70 years old.Exclusion standard comprises: 1. can not complete oral Fructus Foeniculi for tea-drinking; 2. the treatment of other short intestinal function recovery is received; 3. preoperative namely have in intestinal obstruction and art have intestinal injury; 4. operation relates to epigastrium internal organs; 5. namely preoperative have hepatic renal dysfunction, and merge other disease being not suitable for participating in this clinical trial (as inflammatory bowel, digestive tract ulcer, chronic constipation etc.).This content of the test fully informs participant, and signs Informed Consent Form.
The patient that 1.2 methods meet inclusive criteria is probabilistically assigned to test group and matched group by the mode of table of random number, and odd number is test group, accepts Fructus Foeniculi and treats for tea-drinking, and even number is matched group, accepts the treatment of oral warm water.One day before surgery, all patients all accept without slag half liquid food, and mechanical INTESTINAL CLEANSING (sodium phosphates oral solution 21.6g NaH
2pO
4+ 4.3gNa
2hPO
4, time kind
, coordinate 700ml water to take).Preoperative 30 minutes through vein preventive use antibiotic.All operations are all implemented under general anesthesia, and with midazolam, sufentanil, propofol induction, vein and suction combined anesthesia maintain.Muscle relaxant uses vecuronium bromide.Operation all adopts center straight cut, and art formula is radical hysterectomy or panhysterectomy and pelvic lymph node and para-aortic lymph node sampling art, and ovarian cancer patients adds row omentum majus and appendectomy.Finally sew up and close basin peritoneum.All patients all accept similar postoperative care, comprise in postoperative 48 hours and bundle bellyband, ondansetron emesis, and conventional use anesthesia analgesia pump, just gives nonsteroidal analgesic if desired.Postoperative routine is carried out mechanical expectoration and is encouraged patient's out-of-bed activity as early as possible.Postoperative medicine or naturopathy, such as opioid receptor antagonists or the ultrasound physiotherapy etc. not using promotion intestinal function recovery.For reducing bias as far as possible, postoperative eating pattern is also relatively fixing: first post-operative day gives liquid diet for the first time early morning, then gives semi-liquid diet until passage of gas by anus.Semi-solid diet is given after passage of gas by anus.Routine gives parenteral nutrition after surgery, until patient can tolerate semi-solid foodstuff.Test Fructus Foeniculi used purchased from Naruhito, Chengdu hall pharmacy.Every glass of Fructus Foeniculi to be brewed by 5g Fructus Foeniculi and 130ml boiled water for tea-drinking and forms, and get filtrate and naturally cool to about 40 DEG C, patient drinks filtrate.Test group patient drinks Fructus Foeniculi for tea-drinking, every day twice from first post-operative day morning, each one glass, takes in 10 minutes.Matched group patient is then correspondingly simultaneously commensurability drinks synthermal warm water.Two groups of patients all cut out Fructus Foeniculi for tea-drinking or warm water after passage of gas by anus first.
Major fate's index of 1.3 measurement index tests comprises postoperative micturition time first, defecation time first, postoperative hospital day etc.Aerofluxus first, the defecation time of patient is inquired by special messenger, to reduce bias in test.Secondary final result index comprises the tolerance situation of patient, the incidence rate of postoperative ileus, parenteral nutrition time, other complication etc.Cut out Fructus Foeniculi for after tea-drinking, test group patient will check Liver and kidney merit, and contrast with preoperative Liver and kidney merit index.
1.4 statistical method statistical analysis adopt SPSS 19.0 and STATA 12.0 software.Measurement data adopts means standard deviation or median (range) to represent, adopts variance analysis to add up; Enumeration data is described as constituent ratio or rate ratio, adopts X 2 test or rank test.Computation of mean values difference (MD) respectively, 95% confidence interval (95%CI) of relative risk (RR) and correspondence.Think that difference has statistical significance when P is less than 0.05.
2 results
2.1 liang of group ordinary circumstances relatively have 231 patients and participate in this research, and wherein 169 finally enter research, test group 84, matched group 85.In 169 patients, have 4 matched group patients and 6 test group patients to be excluded because of not meeting inclusive criteria in process of the test, reason is intestinal injury and postoperatively enter intensive care unit and can not take medicine in art.Therefore, that finally includes statistical analysis in amounts to 159 people, matched group 81 people, test group 78 people.Between two groups, physical data compares, and no significant difference has comparability, the results are shown in Table 1.
A table 1 liang group patient physical data compares
amean ± standard deviation (SD)
brepresent (n%)
cother represents hematopathy, chronic nephropathy, hepatopathy etc.
2.2 liang of postoperative intestinal function recovery situations of group compare and the final result index of two groups of patient's gastrointestinal function recovery are compared, result display postoperative micturition time first, the first defecation time of test group, postoperative hospital day and parenteral nutrition time all comparatively matched group shorten, difference has statistical significance (P<0.01), the results are shown in Table 2.
The comparison of intestinal function recovery after table 2 liang group operation in patients
amean ± standard deviation (SD)
The situation of gastrointestinal complication and other complication after two groups of operation in patients compares by the comparison of 2.3 liang of group post-operative complication, the incidence rate of matched group gastrointestinal complication is apparently higher than test group, difference has statistical significance (P<0.01) (table 2), and DVT, infection, incision complication no significant difference (P=0.744) between two groups, the results are shown in Table 3.Wherein the diagnostic criteria of DVT is Vascular Ultrasonography prompting deep venous thrombosis, and the diagnostic criteria of infection is that body temperature increases to over 38.5 DEG C and body fluid or the cultivation of cervical secretions positive, and incision complication comprises disruption of wound, liquefied fat causes healing delay etc.
The comparison of table 3 liang group operation in patients infectious-related complication
brepresent (n%)
cother complication represents DVT, infection, incision complication.
To sum up, the present invention adopts the function of intestinal canal restitution after Fructus Foeniculi promotion abdominal operation in patients remarkable, and patient all can well tolerable Fructus Foeniculi.Test group compared with matched group, the postoperative (53.1 ± 11.3vs.64.2 ± 13.6hours of evacuation time first; P<0.001), defecation time (4.3 ± 1.0vs.5.4 ± 1.2days first; P<0.001), postoperative hospital day (5.6 ± 1.2vs.6.7 ± 2.0days; P<0.001), all significantly shorten.Matched group intestinal obstruction incidence rate comparatively test group obviously increases (RR, 2.6; 95%CI, 1.5-4.5; P=0.001).Oral Fructus Foeniculi can promote the postoperative intestinal function recovery of patients with gynecologic malignancies, reduces complication, and safety tolerance.
The present invention is based on Chinese medicine Fructus Foeniculi with the patient after gynecologic malignant tumor abdominal for object of study, adopt randomized controlled trial, find that oral Fructus Foeniculi has clear and definite improvement facilitation to the patient's intestinal function recovery after gynecologic malignant tumor abdominal: have the Proportion of patients of ileus symptoms in matched group higher than test group, the time of matched group patient parenteral nutrition, comparatively test group was longer, all indirectly reflecting test group Intestinal Mucosal Injury in Patients Undergoing functional rehabilitation obtains faster, general diet can be tolerated quickly, thus leave hospital quickly, reduce the hospital stays.And do not observe and take Fructus Foeniculi for the case occurring untoward reaction after tea-drinking, check Liver and kidney merit index and preoperative index zero difference after test group operation in patients, drug safety is high.
Visible by above-mentioned test, Fructus Foeniculi is not only confined to the laparotomy rear intestinal functional rehabilitation being applied to the gynecologic malignant tumors such as cervical cancer, ovarian cancer, carcinoma of endometrium, sarcoma of uterus, also be applicable to the patient of benign disease abdominal, but do not comprise carried out digestive tract operation or art in damage gastral operation.To sum up, Fructus Foeniculi is applied to preparation and promotes that the public that is applied as in the oral drugs of laparotomy rear intestinal functional rehabilitation provides a kind of selection newly.
Claims (9)
1. Fructus Foeniculi promotes the application in the oral drugs of laparotomy rear intestinal functional rehabilitation in preparation.
2. purposes according to claim 1, is characterized in that: for after malignant tumor laparotomy after described laparotomy, or after benign disease abdominal, but does not comprise and carried out damaging gastral operation in digestive tract operation or art.
3. purposes according to claim 2, is characterized in that: for after gynecologic malignant tumor laparotomy after described malignant tumor laparotomy;
Preferably, described gynecologic malignant tumor is cervical cancer, ovarian cancer, carcinoma of endometrium, sarcoma of uterus;
Preferably, described benign disease abdominal is the uterectomy of benign disease.
4. the purposes according to any one of claim 1-3, is characterized in that: described medicine be with the Fructus Foeniculi of effective dose for active component, add the oral formulations that customary adjuvant is pharmaceutically prepared from.
5. purposes according to claim 4, is characterized in that: the every preparation unit of described preparation in crude drug, containing Fructus Foeniculi 5 ~ 10 grams.
6. promote the pharmaceutical composition of laparotomy rear intestinal functional rehabilitation, it is characterized in that: it be with the Fructus Foeniculi of effective dose for active component, add the preparation that customary adjuvant is pharmaceutically prepared from.
7. the pharmaceutical composition of promotion laparotomy rear intestinal functional rehabilitation according to claim 6, is characterized in that: the every preparation unit of described preparation in crude drug, containing Fructus Foeniculi 5 ~ 10 grams.
8. the preparation method of the pharmaceutical composition of the promotion laparotomy rear intestinal functional rehabilitation described in claim 6 or 7, is characterized in that: step is as follows:
Method one: Fructus Foeniculi is ground into fine powder, mixing powder;
Method two: Fructus Foeniculi is ground into fine powder, encapsulated capsule;
Method three: Fructus Foeniculi spice is ground into fine powder, tabletting tablet;
Method four: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, granule;
Method five: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, encapsulated capsule;
Method six: after Fructus Foeniculi water boiling and extraction, concentrated extracting solution makes granule, tabletting tablet;
Method seven: after Fructus Foeniculi water boiling and extraction, make oral liquid;
Method eight: by Fructus Foeniculi soak by water or the water soaking by water temperature at least 40 DEG C, filter to get filtrate and obtain for tea-drinking.
9. promote the pharmaceutical composition of laparotomy rear intestinal functional rehabilitation, it is characterized in that: the medicine recovered with the Fructus Foeniculi of effective dose and the postoperative function of intestinal canal of promotion, for active component, adds the preparation that customary adjuvant is pharmaceutically prepared from.
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Citations (3)
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|---|---|---|---|---|
| US20030129260A1 (en) * | 2002-01-08 | 2003-07-10 | Watson Tommy Stanley | Herbal formulation |
| CN102008524A (en) * | 2010-12-09 | 2011-04-13 | 中国人民解放军第四军医大学 | Application of volatile oil of foeniculum vulgare Mill. to preparation of medicament for preventing postoperative abdominal adhesion |
| CN105267262A (en) * | 2014-06-10 | 2016-01-27 | 四川江茂医药发展有限公司 | Food, medicine or health care product composition composed of common fennel volatile oil |
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2015
- 2015-02-15 CN CN201510080635.1A patent/CN104739905A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030129260A1 (en) * | 2002-01-08 | 2003-07-10 | Watson Tommy Stanley | Herbal formulation |
| CN102008524A (en) * | 2010-12-09 | 2011-04-13 | 中国人民解放军第四军医大学 | Application of volatile oil of foeniculum vulgare Mill. to preparation of medicament for preventing postoperative abdominal adhesion |
| CN105267262A (en) * | 2014-06-10 | 2016-01-27 | 四川江茂医药发展有限公司 | Food, medicine or health care product composition composed of common fennel volatile oil |
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| 任红亮等: "中西医结合治疗肠梗阻168例体会", 《中原医刊》 * |
| 杨秀平: "小茴香干热敷防治术后腹胀", 《广西中医药》 * |
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Application publication date: 20150701 |
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