CN100421648C - Hydrocortisone clyster agent and method for preparing the same - Google Patents
Hydrocortisone clyster agent and method for preparing the same Download PDFInfo
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- CN100421648C CN100421648C CNB2006100409663A CN200610040966A CN100421648C CN 100421648 C CN100421648 C CN 100421648C CN B2006100409663 A CNB2006100409663 A CN B2006100409663A CN 200610040966 A CN200610040966 A CN 200610040966A CN 100421648 C CN100421648 C CN 100421648C
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- hydrocortisone
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Abstract
The invention discloses a loosening enema and preparing method of kao hydrate, which comprises the following parts in each 6000ml: 9.0-11.0g kao hydrate, 11.6-14.2g Tween-80, 81.0-99.0g CMC-Na, 2.1-2.7g aethylum hydroxybenzoicum and pure water. the preparing method comprises the following steps: allocating 7.2-8.8% Tween-80; stirring; dissolving; adding kao hydrate to stir evenly; allocating 4.5-5.5% aethylum hydroxybenzoicum; boiling; adding CMC-Na; bulking; adding purified water to stir evenly.
Description
Technical field
The present invention relates to a kind of enema and preparation method thereof, be specifically related to a kind of hydrocortisone enema that is used for the treatment of ulcer rectum, sigmoiditis and preparation method thereof.
Background technology
Ulcerative colitis (knot of bursting) is classified as one of modern difficult treatment by World Health Organization (WHO), it is the not clear and definite as yet rectum of a kind of reason or sigmoid colon, descending colon, even the seriality inflammation of involving transverse colon, ascending colon and caecum mucosa (or Submucosa), its clinical characters is repeated relapsing diarrhoea (mucus bloody purulent stool) and stomachache, and may be with General Symptomies such as heating or joint aches.This disease is difficult for radical cure, and often delay is difficult, and the course of disease is long, brings very big misery to the patient.In recent years, the sickness rate of China obviously raises, and the morbidity be rejuvenation trend, chronic phase, also have certain canceration rate.
Often adopt sulfasalazine (SASP) at this class disease at present, it is mainly tablet, is the medicine that is applied to ulcerative colitis the earliest, and it must play a role under the colon bacteria effect.The shortcoming of SASP maximum is possible produce multiple serious adverse reaction, comprises bone marrow depression, liver function damage, pancreatitis or male sterility etc.Homemade SASP suppository only is used for proctitis, and contingent untoward reaction is the same.Curative effect differs between each patient of application back, and at present domestic only have a tame pharmaceutical factory to produce market supply limited (Suzhou District is out of stock for a long time).
Adopt enema treatment distal colorectal enteritis, site of action is dark, not only can reach rectum, and can enter sigmoid colon, both can act on proctitis, also can act on sigmoiditis, even can further go deep into, act on descending colon, even can reach transverse colon, therefore adopt the enema therapeutic effect better for the knot of bursting.But, the mesalazine enema of import is only arranged in the market, its Main Ingredients and Appearance is a 5-aminosalicylic acid, and price is very expensive, and each 60ml enema need spend 200 yuans, and will use 1-2 time every day, and continuous 6-8 is after week, and progressively decrement is kept application again; Therefore, domestic most patient can't bear this cost.
Summary of the invention
The present invention seeks to provides a kind of good effect, low-cost enema at rectum, sigmoiditis in the knot pathological changes of bursting.
For achieving the above object, the technical solution used in the present invention is: a kind of hydrocortisone enema, form by purified water solvent and active ingredient mixing, and wherein, in every 6000ml enema, active ingredient is:
Hydrocortisone 10.0g;
Tween 80 12.9g;
CMC-Na 90.0g；
Ethyl hydroxybenzoate 2.4g.
Related content in the technique scheme is explained as follows:
1, in the such scheme, step of preparation process is:
The preparation of employing the following step:
(1), formulates preparation total amount, preparation hydrocortisone, tween 80, CMC-Na, ethyl hydroxybenzoate and purified water;
(2), add the full dose tween 80 in for 7.2%～8.8% purified water of preparation total amount, stir at volume, dissolving;
(3), obtain to add the full dose hydrocortisone in the solution, fully stir evenly in above-mentioned steps (2);
(4), in addition in 4.5%～5.5% the purified water of volume, add the full dose ethyl hydroxybenzoate, boil for the preparation total amount, after the dissolving again and above-mentioned steps (3) obtain solution and mix, stir;
(5), in addition in 58.5%～71.5% the purified water of volume, add full dose CMC-Na for the preparation total amount, place fully expand after, again and above-mentioned steps (4) obtain solution and mix;
(6), at last add purified water to preparing total amount, stirring promptly gets product.
In the above-mentioned step of preparation process, described " preparation total amount " is meant the total amount of the hydrocortisone enema of preparing preparation.
2, such scheme, each composition is explained as follows in the prescription:
Hydrocortisone also claims cortisol, hydrocortisone, and molecular formula is C
21H
30O
5, be principal agent in the present invention.
Tween 80 (trade name), chemistry polysorbate 80 by name, molecular formula is C
64H
124O
26, its proportion is 1.06-1.09, is wetting agent, its effect is to make the principal agent microgranule moistening by water, to increase the main hydrophilic of hydrophobicity, increases stability of formulation.
CMC-Na, chemistry sodium carboxymethyl cellulose by name is the agent of macromolecule suspending, its effect is to increase the viscosity of disperse medium to reduce the sedimentation velocity of microgranule, increases stability of formulation.
Ethyl hydroxybenzoate (trade name), chemistry ethylparaben by name, molecular formula is C
9H
10O
3, being nontoxic, tasteless, odorless, pharmaceutical preservative that chemical property is stable, its effect is to prevent microbial contamination.
Purified water is the stable liquid preparation common solvent that does not influence the performance of medicine color of nontoxic, tasteless, odorless, nonirritant and chemical property.
The present invention is a kind of enema, and the coloclysis topical application has the advantage of direct resistive connection intestinal mucosa inflammation.Hydrocortisone belongs to interenin, its pharmacotoxicological effect, mechanism and issuable side effect or untoward reaction, and all same adrenocortical hormone promptly may reach the purpose of treatment inflammation by mechanism such as inflammation-inhibiting media.This medicine also may be absorbed into blood by intestinal mucosa, produce general action, but owing to be the coloclysis topical application, due to general action (comprising side effect or untoward reaction etc.) all obviously be less than oral or injection, through clinical practice over 20 years, example is inferior surplus in the of 14000, except that individual patient generation edema of lower limbs (can disappear after the drug withdrawal), does not meet other untoward reaction.
Using method of the present invention is:, face with preceding elder generation medicinal liquid shaken up with pack into the medicinal liquid of 60ml of quantitative bottle with coloclysis, the cylindric head of bottle cap is inserted anus gently after, medicinal liquid extruded get final product.For avoiding the medicinal liquid outflow, buttocks should omit bed hedgehopping, and stirs position, takes a nap 20-30 minute.Winter, cool excessively for avoiding medicinal liquid, should be with the pre-temperature of medicinal liquid near using behind the body temperature.
Clinical practice situation of the present invention: over 20 years, example is inferior surplus in the of 14000 through clinical practice, has obtained very satisfied clinical efficacy, and effective percentage reaches 98%, and model case has:
Case one: open * *, woman, 27 years old, Pan Men residential district, Suzhou 6-502, outpatient service number 300333780 (on December 28th, 2005).December in 2005 outpatient service for the first time on the 21st, stool band mucus (blood is arranged sometimes) 2～3 times/day, defecation feels that not to the utmost the companion suffers from abdominal pain indistinct April the lower-left, it is invalid repeatedly to go to a doctor, locate line the court's outpatient service afterwards.The court's enteroscopy: (as seen mucous membrane of rectum hyperemia, edema are dispersed in rotten to the corn point to proctitis, and exudate is arranged, other mucosa normal findings of colon), routine blood test is normal, erythrocyte sedimentation rate 4mm/hr, C-reactive protein 3.65mg%, usefulness hydrocortisone enema 200ml * 2,60ml is coloclysis once a day.In December in 2005 outpatient service for the second time on the 28th, the stool frequency is kept to 1～2 time/day, and mucus disappears, and stomachache alleviates, and requires to continue the medicine-feeding treatment, hydrocortisone enema 200ml * 3, coloclysis once a day.
Case two: Yuan *, the man is 20 years old, unmarried.Admission number 300231279.Stomachache and diarrhoea are 3 years repeatedly, the stool band blood streak, and tenesmus, defecation are felt not to the utmost, enteroscopy: the colon Crohn disease.Biopsy is learned: (sigmoid colon) severe chronic inflammation.With hydrocortisone enema 60ml once a day after the coloclysis, defecation is felt not to the utmost and being clearly better, and uses repeatedly over nearly 3 years, all can obtain effect, and obvious adverse reaction does not take place.
Case three: old * *, woman, 43 years old.Suffer from ulcerative colitis for many years, the intestinal mirror: based on sigmoid colon, rectum, a plurality of ulcer hyperemia of mucosa.The main suit: times of defecation is many, and sticking ripple hemafecia is arranged, and through using hydrocortisone enema 60ml 2 weeks of retention enema, symptom is obviously improved, and times of defecation reduces, and mucosanguineous feces disappears, colonoscopy: second colorectum ulcer takes a turn for the better.
Case four: leaf * *, woman, 62 years old.Because of " movable repeatedly back chest distress and palpitation symptoms 1 year increases the weight of half a day " is admitted to hospital.Discharge diagnosis is 1, coronary heart disease, angina pectoris 2, inflammatory bowel 3, cholelithiasis.This patient's readme often has constipation with dry stool freely not accompany mucus and blood after being admitted to hospital, and the enteroscopy that carries out is shown: inflammatory bowel.With hydrocortisone enema 60ml once a day, qN. of SASP anus bolt connects ten days.The sense of patient's constipation abdominal distention alleviates, and stool does not see mucus, blood.Follow up a case by regular visits to after leaving hospital and show the defecation sx.After, repeated multiple times outpatient service is once joined and is got the hydrocortisone enema and carry out enema treatment.Present circumstances is stable, asymptomatic recurrence.
Case five: old * *, woman, life in 1969.First visit on October 20 in 2004: the patient suffer from diarrhoea 1 year surplus, companion's borborygmus, the time abdominal part dull pain is arranged, defecate 2～3 times on the one, as many as 4～5 times/day catches cold and the greasy back of edible oil sx, once obeys antibiotic and symptomatic treatment and handles, and owes effect.Do not do enteroscopy (patient's refusal), routine inspection of excrement: yellow, matter is rotted, and is surplus no abnormal.Handle: with hydrocortisone enema 60ml retention enema 1 time/day * day, after treatment, stool transfers to normal, once a day, is shaped, and does not have stomachache.The patient is careful in one's diet and controls, warming, recurrence more so far.
Case six: open * *, the woman, nineteen fifty-two gives birth to.First visit on April 21 in 2004: patient's borborygmus, diarrhoea 2 years are surplus, outbreak repeatedly, and 3～4 times on the one, The stool is completely mashed does not have sticking freezing and hemafecia, and no tenesmus often has stomachache before the defecation.Once enteroscopy prompting: descending colon contrafluxion, edema, earlier after in, western medicine owes to imitate.Physical examination: become thin, cardiopulmonary are no abnormal, full abdomen is soft, the not enlargement of liver spleen, and the murphy sign feminine gender, mcBurney point does not have tenderness, and the light tenderness of left lower quadrant is not laid one's hand on and enclosed mass, no rebound tenderness.Handle: with hydrocortisone enema 60ml, gentamycin 80,000 μ retention enemas, 1 time/day * 7 days.April 28, patient's diarrhoea was kept to 1～2 time on the one, but still unshaped, stomachache alleviates.Handle: with hydrocortisone enema 60ml, gentamycin 80,000 μ retention enemas, 1 time/day * 7 days.After two weeks, stool is normal through retention-enema treatment for the patient, once a day, is shaped, and does not have stomachache, not recurrence in a year so far.
The present invention has compared following advantage with the medicine of existing treatment ulcer rectum, sigmoiditis:
1, good effect, clinical practice are over 20 years, and Most patients through this product coloclysis for several times, promptly obtains obvious curative effects after oral medicine is failed to respond to any medical treatment; Adhere to using 4-6 after week, more patient obtains consolidating curative effect, and effective percentage reaches 98%.
2, the present invention is cheap, only 3.90 yuan/time of expensess for medicine, if adopt the horizontal amine pyridine of homemade willow nitrogen suppository plug anus to want at least more than 6.00 yuan/time, and site of action is shallow; Want 200 yuan/time if adopt import mesalazine coloclysis.Therefore, this product has high curative effect/price ratio.
3, the present invention is easy to use, and this product is disposable use preparation, reads using method or after medical personnel give directions, and can need not be in hospital or go hospital's coloclysis by patient's enema treatment voluntarily.
4, few side effects of the present invention, contingent side effect of this product and contraindication are identical with adrenocortical hormone, and owing to be that local coloclysis uses, significantly reduced whole body and absorbed the issuable side effect in back.
The specific embodiment
Below in conjunction with drawings and Examples the present invention is further described:
Embodiment one: a kind of hydrocortisone enema, form by purified water solvent and active ingredient mixing, and wherein, in every 6000ml enema, active ingredient is:
Hydrocortisone 10.0g;
Tween 80 12.9g;
CMC-Na 90.0g；
Ethyl hydroxybenzoate 2.4g.
Adopt following processing step preparation:
(1), to formulate the preparation total amount be 6000ml, prepares hydrocortisone 10.0g, tween 80 12.9g, CMC-Na90.0g, ethyl hydroxybenzoate 2.4g and purified water;
(2), install 500ml (be about preparation total amount 8.3%), add tween 80 12.9g therein, stir, dissolving with the measuring cup of 1000ml;
(3), in above-mentioned steps (2) obtains solution, add hydrocortisone 10.0g again, fully stir evenly;
(4), in addition with beaker adorn 300ml (for the preparation total amount 5%) purified water, add ethyl hydroxybenzoate 2.4g therein, boil, pour into again after the dissolving in the measuring cup of above-mentioned 1000ml, the solution that obtains with above-mentioned steps (3) mixes, and stirs;
(5), in addition with the purified water of rustless steel barreled 4000ml (be about preparation total amount 66.7%), add CMC-Na90.0g therein, place fully expand after, also pour into the mixed solution in the measuring cup of above-mentioned steps (4) acquisition in the stainless steel cask again;
(6), at last add purified water to preparing total amount 6000ml, stirring promptly gets product.
The foregoing description only is explanation technical conceive of the present invention and characteristics, and its purpose is to allow the personage who is familiar with this technology can understand content of the present invention and enforcement according to this, can not limit protection scope of the present invention with this.All equivalences that spirit is done according to the present invention change or modify, and all should be encompassed within protection scope of the present invention.
Claims (2)
1. hydrocortisone enema is characterized in that: mixed by purified water solvent and active ingredient and form, wherein, in every 6000ml enema, active ingredient is:
Hydrocortisone 10.0g;
Tween 80 12.9g;
CMC-Na 90.0g；
Ethyl hydroxybenzoate 2.4g.
2. the preparation method of hydrocortisone enema according to claim 1 is characterized in that: adopt the following step preparation:
(1), formulates preparation total amount, preparation hydrocortisone, tween 80, CMC-Na, ethyl hydroxybenzoate and purified water;
(2), add the full dose tween 80 in for 7.2%～8.8% purified water of preparation total amount, stir at volume, dissolving;
(3), obtain to add the full dose hydrocortisone in the solution, fully stir evenly in above-mentioned steps (2);
(4), in addition in 4.5%～5.5% the purified water of volume, add the full dose ethyl hydroxybenzoate, boil for the preparation total amount, after the dissolving again and above-mentioned steps (3) obtain solution and mix, stir;
(5), in addition in 58.5%～71.5% the purified water of volume, add full dose CMC-Na for the preparation total amount, place fully expand after, again and above-mentioned steps (4) obtain solution and mix;
(6), at last add purified water to preparing total amount, stirring promptly gets product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100409663A CN100421648C (en) | 2006-08-15 | 2006-08-15 | Hydrocortisone clyster agent and method for preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100409663A CN100421648C (en) | 2006-08-15 | 2006-08-15 | Hydrocortisone clyster agent and method for preparing the same |
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| Publication Number | Publication Date |
|---|---|
| CN1907260A CN1907260A (en) | 2007-02-07 |
| CN100421648C true CN100421648C (en) | 2008-10-01 |
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| CNB2006100409663A Expired - Fee Related CN100421648C (en) | 2006-08-15 | 2006-08-15 | Hydrocortisone clyster agent and method for preparing the same |
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| CN106821970A (en) * | 2017-03-10 | 2017-06-13 | 重庆西南医院 | A kind of Enema liquid and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1110554A (en) * | 1994-04-28 | 1995-10-25 | 华西医科大学附属第一医院 | Ulcer suppository |
| US6013670A (en) * | 1996-06-06 | 2000-01-11 | Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. | Use of alkanoyl L-carnitines for the therapeutical treatment of chronic inflammatory bowel diseases |
| CN1678309A (en) * | 2002-08-26 | 2005-10-05 | S.L.A.制药有限公司 | Tropical formulation comprising at least 5% of metronidazole in white petrolatum and its use in the anal and rectal region |
-
2006
- 2006-08-15 CN CNB2006100409663A patent/CN100421648C/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1110554A (en) * | 1994-04-28 | 1995-10-25 | 华西医科大学附属第一医院 | Ulcer suppository |
| US6013670A (en) * | 1996-06-06 | 2000-01-11 | Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. | Use of alkanoyl L-carnitines for the therapeutical treatment of chronic inflammatory bowel diseases |
| CN1678309A (en) * | 2002-08-26 | 2005-10-05 | S.L.A.制药有限公司 | Tropical formulation comprising at least 5% of metronidazole in white petrolatum and its use in the anal and rectal region |
Non-Patent Citations (6)
| Title |
|---|
| 三种灌肠剂治疗左半结肠溃疡性结肠炎疗效观察. 马洪升等.临床内科杂志，第16卷第3期. 1999 |
| 三种灌肠剂治疗左半结肠溃疡性结肠炎疗效观察. 马洪升等.临床内科杂志，第16卷第3期. 1999 * |
| 微型灌肠剂的研究现状. 路枚.中国药业，第10卷第8期. 2001 |
| 微型灌肠剂的研究现状. 路枚.中国药业，第10卷第8期. 2001 * |
| 溃疡性结肠炎的药物治疗. 郑方算.新医学，第27卷第9期. 1996 |
| 溃疡性结肠炎的药物治疗. 郑方算.新医学，第27卷第9期. 1996 * |
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