CN1428165A - Chinese medicine positioning preparation for curing ulcerative colitis - Google Patents
Chinese medicine positioning preparation for curing ulcerative colitis Download PDFInfo
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- CN1428165A CN1428165A CN01143446A CN01143446A CN1428165A CN 1428165 A CN1428165 A CN 1428165A CN 01143446 A CN01143446 A CN 01143446A CN 01143446 A CN01143446 A CN 01143446A CN 1428165 A CN1428165 A CN 1428165A
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- ulcerative colitis
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- 239000003814 drug Substances 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title claims abstract description 27
- 206010009900 Colitis ulcerative Diseases 0.000 title claims abstract description 23
- 201000006704 Ulcerative Colitis Diseases 0.000 title claims abstract description 23
- 239000002775 capsule Substances 0.000 claims abstract description 28
- 210000001072 colon Anatomy 0.000 claims abstract description 28
- 150000001875 compounds Chemical class 0.000 claims abstract description 7
- 210000002784 stomach Anatomy 0.000 claims abstract description 3
- 229940079593 drug Drugs 0.000 claims description 23
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- 238000000576 coating method Methods 0.000 claims description 19
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 12
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- 230000001419 dependent effect Effects 0.000 claims description 10
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- LMEKQMALGUDUQG-UHFFFAOYSA-N azathioprine Chemical compound CN1C=NC([N+]([O-])=O)=C1SC1=NC=NC2=C1NC=N2 LMEKQMALGUDUQG-UHFFFAOYSA-N 0.000 description 2
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
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Abstract
The present invention relates to a Chinese medicine location preparation for curing ulcerative colitis. It is formed from colon location capsule and Chinese medicine compound preparation for curing ulcerative colitis which is held in the capsule. Said capsule does not disintegrated in the stomach and small intestine, and in the colon region whose pH value is greater than or equal to 7.8 it is disintegrated, and the medicine can be released. Said invention can effectively raise the biological utilization rate of the medicine, and its therapeutic effect is obvious. After the prescription of said medicine is changed, it can be used for curing other disease of colon region.
Description
Technical field
The invention belongs to the form of Chinese drug technical field, particularly be applied to treat the dosage form of colitis.
Background technology
(ulcerartive colitis is a kind of agnogenic chronic colitis UC) to ulcerative colitis, is called chronic non-specific ulcerative colitis traditionally, or ulcerative colitis.This disease is current the trend that increases gradually, belongs to a kind of difficult and complicated illness,
After this disease was shown effect first, about 10% patient can be eased, and can keep 15 years.Other has 10% patient can continue to suffer from the mobile colon inflammation for a long time.Other Most patients (80%) then can be alleviated with outbreak and replace, and do not heal for a long time.But the canceration in late period makes us very frightened.Secular consumption and torment cause intensive spirit and body infringement to the patient.
Still do not have specific treatment at present, Western medicine commonly used has sulfasalazine (SASP) or its active ingredient 5-aminosalicylic acid (5-ASA), adrenocortical hormone and immunosuppressant (azathioprine, Ismipur, methotrexate etc.), metronidazole etc.The common preparation and the curative effect of these medicines are:
1, adrenocortical hormones.But inflammation-inhibiting and immunoreation mainly by the intravenous drip administration, are applicable to severe patient, and to symptom control effectively, late result certainly, can not reduce relapse rate, so only suitable short application use.
2, salicylic acid preparation.General with sulfasalazine (a kind of prodrug), after this medicine was oral, major part entered colon, being discharged 5-aminosalicylic acid by the decomposition of colon bacterium works, reduce inflammatory reaction, this medicine is to keep the main active drug of alleviating primary disease, but the prolonged application gastrointestinal side effect is heavier.
3, immunosuppressant.Azathioprine and Ismipur act on the T lymphocyte, suppress immunoreation, inflammation-inhibiting reaction, but adhib six months produce effects, so gastrointestinal side-effect and bone marrow depression side effect are serious.
4, antibacterials.The common broad-spectrum antibiotic, as ampicillin, cephalosporins and fluorine quinolione class, metronidazole is also used.Mainly be applicable to the secondary infection patient.
5, antidiarrheal.As diphenoxylate etc., the main diarrhoea that suppresses, the absorption that moisturizes improves dewatering symptom.
Many in recent years scholars adopt 5-ASA anus bolt or topical remedy's coloclysis, because local drug concentration is higher, and it is more of a specified duration to hold time, curative effect is obviously improved, and systemic adverse reactions reduces, and has advantages such as effect is direct, curative effect is rapid, is extensively adopted by domestic clinical treatment UC.
Because of primary disease easily recurs, need long-term prescription, side effect has greatly just influenced the use of chemicals.Most patients require Chinese traditional treatment, traditional prescription that the treatment by Chinese herbs ulcerative colitis has a lot of employing decoctions to take, and general effect is undesirable, and gastrointestinal tract is also had certain side effect.Adopt the herbal drug enema in treatment ulcerative colitis, have advantages such as quick-acting, safe, existing at present plurality of Chinese coloclysis compound preparation is used for the clinical treatment ulcerative colitis, but the treatment means of herbal enema is very inconvenient, influences the compliance of patient treatment.
Summary of the invention
The objective of the invention is to propose a kind of Chinese medicine colon location preparation, the prescription for the treatment of ulcerative colitis Chinese medicine is combined with the colon location preparation Technology for overcoming the weak point of existing Chinese medicine preparation treatment ulcerative colitis.Accurate positioning of the present invention, evident in efficacy, have no side effect, counterweight, in, slight ulcerative colitis all has positive effect.The treatment that makes ulcerative colitis is safety, effectively but also easy to use not only, can improve the compliance of extensive patients treatment, brings very big convenience for patient's treatment.
The present invention proposes a kind of Chinese medicine positioning preparation for curing ulcerative colitis, it is characterized in that, Chinese medicine compound by colon site-specific drug and interior dress treatment ulcerative colitis is formed, and capsule not disintegrate in stomach, small intestinal is in the colon position disintegrate of alkaline (pH value is more than or equal to 7.8), discharge medicine.
Said location capsule can adopt following two kinds of different process modes to make:
One: directly use PH dependent form colon site-specific drug, this capsule is to adopt the preparation of knot enteric solubility polyacrylic resin.
Its two: adopt common capsule for medicine, at this capsule outer wrapping one deck PH dependent form (knot enteric solubility) thin film, this film coating liquid composition can adopt any prescription in following three prescriptions:
Prescription one: acrylic resin: ethanol 1.83%～2.75%: diethyl phthalate 94.85%～99.00%: Pulvis Talci 0.86%～1.30%: 0.73%～1.10%.
Prescription two: polymethacrylates EUDRAGIT
S 100:4.80%～7.20%, Pulvis Talci: triethyl citrate 2.40%～3.60%: water 0.48%～0.72%: isopropyl alcohol 4.00%～6.00%: 82.48%～99.60%.
Prescription three: polymethacrylates EUDRAGIT
FS 30D:33.28%～49.20%, glyceryl monostearate: Tween 80 0.36%～0.54%: titanium dioxide 0.36%～0.54%: FD﹠amp 0.72%～1.08%; C iron oxide yellow: water 0.72%～1.08%: 48.04%～64.56%.
Above-mentioned prescription all can use conventional tablet coating apparatus and method for to make ideal colon site-specific drug easily.
The said built-in Chinese crude drug of the present invention comprises: among Radix Sophorae Flavescentis, Radix Sanguisorbae, the Radix Pulsatillae, the Cortex Phellodendri any one or more than one, in Pseudobulbus Bletillae (Rhizoma Bletillae), Indigo Naturalis, Radix Glycyrrhizae, Galla Chinensis, Rhizoma Coptidis, Fructus Mume, the Radix Astragali, the Herba Taraxaci any one or more than one make the compound recipe that contains flavour of a drug more than three kinds or three kinds altogether.
The amount ranges of above-mentioned each medicine:
| Flavour of a drug | Amount ranges (g/ day) |
| Radix Sophorae Flavescentis | ????4.5-9 |
| Radix Sanguisorbae | ????9-15 |
| Pseudobulbus Bletillae (Rhizoma Bletillae) | ????6-15 |
| Indigo Naturalis | ????1.5-3 |
| Radix Glycyrrhizae | ????3-6 |
| Galla Chinensis | ????3-6 |
| The Radix Astragali | ????9-30 |
| Fructus Mume | ????6-12 |
| Rhizoma Coptidis | ????2-5 |
| The Radix Pulsatillae | ????9-15 |
| Herba Taraxaci | ????9-1.5 |
| Cortex Phellodendri | ????2-12 |
The concrete preparation method of a kind of Chinese medicine positioning preparation for curing ulcerative colitis that the present invention proposes can may further comprise the steps;
1) at first existing Chinese medicine ulcerative colitis coloclysis prescription is screened, select to determine flavour of a drug, the consumption model of each medicine
Enclose;
2) with drying, pulverizing, granulation, mixing behind said flavour of a drug water or the ethanol extraction;
3) directly be loaded into then the location capsule in, be formed in not disintegrate under the acid condition, at pH value more than or equal to 7.8 o'clock
The colon site-specific drug of beginning disintegrate.
Characteristics of the present invention and beneficial effect:
The present invention combines the preparation process technology of herbal enema compound preparation with conlon targeting knot medicine.The patient can guarantee that medicine discharges at the colon position exactly, makes medicine act on whole colon behind oral said preparation.
Accurate positioning of the present invention, evident in efficacy, have no side effect, counterweight, in, slight ulcerative colitis all has positive effect; Simultaneously,, compare, make sufferer place drug level higher, and can keep certain hour, improved curative effect, reduced systemic adverse reactions with ordinary preparation owing to be the conlon targeting topical.
The treatment that the present invention makes ulcerative colitis is safety, effectively but also easy to use not only, can improve the compliance of extensive patients treatment, brings very big convenience for patient's treatment.By the mode of oral administration, reach the effect of retention enema to the colitis treatment, simplified treatment means, bring great convenience for doctor, trouble both sides.
The present invention changes behind the prescription also other pathological changes applicable to treatment colon position.
The specific embodiment
Embodiment 1: get Radix Sophorae Flavescentis 150 gram, Radix Glycyrrhizae 60 grams, Radix Sanguisorbae 150 grams and close and fry in shallow oil, soft extracts and 60 gram Rhizoma Bletillae powder mix homogeneously, drying, 60 mesh sieves, the conventional capsule of packing into, the capsule loading amount is 0.6 gram/grain.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopt acrylic resin 50 grams, ethanol 2200 grams, diethyl phthalate 25 grams, Pulvis Talci 24 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 75%.
Embodiment 2: gets Cortex Phellodendri 120 gram, Radix Sophorae Flavescentis 150 grams, Radix Sanguisorbae 150 grams, Radix Glycyrrhizae 60 grams and closes and fry in shallow oil, and dry 60 mesh sieves of crossing of soft extracts, the colon site-specific drug of packing into, the capsule loading amount is 0.6 gram/grain.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 71%.
Embodiment 3: get Radix Sanguisorbae 120 grams, Cortex Phellodendri 120 gram decoctings, the soft extracts drying with Pseudobulbus Bletillae (Rhizoma Bletillae) 200 gram mixings, is crossed 60 mesh sieves, and the conventional capsule of packing into is adorned 0.6 gram for every.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts polymethacrylates EUDRAGIT
S 100:65 gram, Pulvis Talci 32 grams, triethyl citrate 5.8 grams, water 55 grams, isopropyl alcohol 900 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 88%.
Embodiment 4: get Radix Sophorae Flavescentis, the Radix Astragali, each 250 gram of Cortex Phellodendri, close and fry in shallow oil, the soft extracts drying is crossed 60 mesh sieves, and the conventional capsule of packing into is adorned 0.6 gram for every.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts polymethacrylates EUDRAGIT
FS30D:400 gram, glyceryl monostearate 4.6 grams, Tween 80: 4.8 grams, titanium dioxide 9.2 grams, FD﹠amp; C iron oxide yellow 8.9 grams, water 580 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 85%.
Embodiment 5: the Radix Pulsatillae 150 grams, Rhizoma Coptidis, 50 grams, Cortex Phellodendri 120 grams close and fry in shallow oil, and the soft extracts drying is crossed 60 mesh sieves, and in the colon site-specific drug of packing into, the capsule loading amount is 0.6 gram/grain.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 80%.
Embodiment 6: get Fructus Mume 150 gram, Galla Chinensis 100 grams, Cortex Phellodendri 150 grams and close and fry in shallow oil, the soft extracts drying is crossed 60 mesh sieves, and the conventional capsule of packing into No. 0 is adorned 0.6 gram for every.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts polymethacrylates EUDRAGIT
S 100:66 gram, Pulvis Talci: 30 grams, triethyl citrate: 6.5 grams, water: 60 grams, isopropyl alcohol: 920 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 86%.
Embodiment 7: get Radix Sophorae Flavescentis 120 gram, Radix Astragali 200 grams, Herba Taraxaci 150 grams and close and fry in shallow oil, the soft extracts drying is crossed 60 mesh sieves, and the conventional capsule of packing into is adorned 0.6 gram for every.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts polymethacrylates EUDRAGIT
FS 30D:430 gram, glyceryl monostearate: 4.8 grams, Tween 80: 5.0 grams, titanium dioxide: 9.6 grams, FD﹠amp; C iron oxide yellow: 9.6 grams, water: 560 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 95%.
Embodiment 8: get Radix Sophorae Flavescentis 150 gram, Indigo Naturalis 60 grams, Radix Sanguisorbae 150 grams and close and fry in shallow oil, the soft extracts drying is crossed 60 mesh sieves, the conventional capsule of packing into, and the capsule loading amount is 0.6 gram/grain.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts acrylic resin: 62 grams, ethanol: 2300 grams, neck diethyl phthalate: 28 grams, Pulvis Talci: 24 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 75%.
Embodiment 9: gets Cortex Phellodendri 120 gram, Radix Sophorae Flavescentis 120 grams, Radix Sanguisorbae 150 grams and closes and fry in shallow oil, and dry 60 mesh sieves of crossing of soft extracts, the colon site-specific drug of packing into, the capsule loading amount is 0.6 gram/grain.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 93%.
Embodiment 10: get the Radix Astragali 200 gram, Rhizoma Coptidis 50 grams, Galla Chinensis 60 grams, Radix Sanguisorbae 150 grams and close and fry in shallow oil, the soft extracts drying is crossed 60 mesh sieves, the conventional capsule of packing into, and the capsule loading amount is 0.6 gram/grain.Outsourcing PH dependent form conlon targeting coating membrane, coating solution adopts acrylic resin: 58 grams, ethanol: 2240 grams, neck diethyl phthalate: 27 grams, Pulvis Talci: 25 grams.Through clinical trial, oral every day secondary, each 5,7 days is a course of treatment.Observe 1-4 the course of treatment, total effective rate is 95%.
Claims (8)
1, a kind of Chinese medicine preparation for the treatment of ulcerative colitis, it is characterized in that: the Chinese medicine compound by colon site-specific drug and interior dress treatment ulcerative colitis is formed, capsule not disintegrate in stomach, small intestinal, pH value more than or equal to 7.8 alkaline colon position disintegrate, discharge medicine.
2, Chinese medicine colon location preparation according to claim 1 is characterized in that: said location capsule directly adopts pH value more than or equal to the colon site-specific drug that began disintegrate at 7.8 o'clock.
3, Chinese medicine colon location preparation according to claim 1, it is characterized in that: said location capsule adopts common capsule for medicine, again at this capsule outer wrapping one deck PH dependent form coating membrane, this coating membrane begins disintegrate at pH value in more than or equal to 7.8 solution.
4, Chinese medicine colon location preparation according to claim 3 is characterized in that: said coating membrane material is: acrylic resin: ethanol 1.83%～2.75%: neck diethyl phthalate 94.85%～99.00%: Pulvis Talci 0.86%～1.30%: 0.73%～1.10%.
5, Chinese medicine colon location preparation according to claim 3 is characterized in that: said coating membrane material is: polymethacrylates EUDRAGIT
S 100:4.80%～7.20%, Pulvis Talci: triethyl citrate 2.40%～3.60%: water 0.48%～0.72%: isopropyl alcohol 4.00%～6.00%: 82.48%～99.60%.
6, according to the described Chinese medicine colon location preparation of claim 3, it is characterized in that: said coating membrane material is: polymethacrylates EUDRAGIT
FS 30D:33.28%～49.20%, glyceryl monostearate: Tween 80 0.36%～0.54%: titanium dioxide 0.36%～0.54%: FD﹠amp 0.72%～1.08%; C iron oxide yellow: water 0.72%～1.08%: 48.04%～64.56%.
7, Chinese medicine colon location preparation according to claim 1, it is characterized in that: said built-in Chinese crude drug comprises: among Radix Sophorae Flavescentis, Radix Sanguisorbae, the Radix Pulsatillae, the Cortex Phellodendri any one or more than one, in Pseudobulbus Bletillae (Rhizoma Bletillae), Indigo Naturalis, Radix Glycyrrhizae, Galla Chinensis, Rhizoma Coptidis, Fructus Mume, the Radix Astragali, the Herba Taraxaci any one or more than one make the compound recipe that contains flavour of a drug more than three kinds or three kinds altogether.
8, a kind of preparation method of Chinese medicine colon location preparation according to claim 1 is characterized in that: comprise following concrete steps;
The screening of (1) at first writing out a prescription selects the coloclysis prescription of existing treatment ulcerative colitis to determine flavour of a drug, the amount ranges of each medicine;
(2) drying, pulverizing, granulation, mixing behind flavour of a drug water of saying or the ethanol extraction;
(3) directly be loaded into then the location capsule in, be formed in not disintegrate under the acid condition, at pH value more than or equal to the colon site-specific drug that began disintegrate at 7.8 o'clock.
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| CNB011434465A CN1236791C (en) | 2001-12-28 | 2001-12-28 | Chinese medicine positioning preparation for curing ulcerative colitis |
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| CNB011434465A CN1236791C (en) | 2001-12-28 | 2001-12-28 | Chinese medicine positioning preparation for curing ulcerative colitis |
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Denomination of invention: Chinese medicine positioning preparation for curing ulcerative colitis Effective date of registration: 20170614 Granted publication date: 20060118 Pledgee: Beijing ustron Tongsheng financing Company limited by guarantee Pledgor: Beijing Zhonghui Pharmaceutical Industry Co., Ltd. Registration number: 2017990000486 |
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