CN1857563A - Colon locating administrated dragon's blood preparation and its application - Google Patents
Colon locating administrated dragon's blood preparation and its application Download PDFInfo
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- CN1857563A CN1857563A CN 200610010781 CN200610010781A CN1857563A CN 1857563 A CN1857563 A CN 1857563A CN 200610010781 CN200610010781 CN 200610010781 CN 200610010781 A CN200610010781 A CN 200610010781A CN 1857563 A CN1857563 A CN 1857563A
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Abstract
The present invention relates to colon locating administrated dragon's blood preparation and its application, and belongs to the field of medicine prepare and application. The colon locating administrated dragon's blood preparation consists of dragon's blood 30-90 wt% and supplementary material 70-10 wt%, and the supplementary material includes one or several of filler, disintegrating agent and lubricant. The filler is starch, microcrystalline cellulose, dextrin or lactose; the disintegrating agent is CMS-Na or L-HPC; and the lubricant is magnesium or talcum powder. The preparation process includes producing intermediate product, and coating with colon coating or filling granule into colon coating. The present invention has the advantages of high curative effect, no toxic side effect, taking convenience, etc. and is used in treating chronic colitis.
Description
Technical field:
The present invention relates to a kind of colon locating administrated dragon's blood preparation and application thereof, belong to pharmaceutical preparation and medicinal application field.
Background technology:
Sanguis Draxonis is the resin that the fat xylem is processed into through extraction that contains of liliaceous plant Dracaena cochinchinensis Dranaena cochinchinensis (Lour.) S.C.Chen, be conventional Chinese medicine, the diffusing addiction of invigorating blood circulation, the analgesic therapy hemostasis, the expelling pus and promoting granulation effect is mainly used in traumatic injury, addiction blood is had a pain, women's coagulation of QI-blood, traumatic hemorrhage, decubital ulcer does not close up for a long time.
Chronic colitis is the general name of one group of disease, and it comprises specificity and non-specific two big classes, though all kinds of colitis is variant, basic pathology is colonic mucosa hyperemia, edema, fragility increase, easily hemorrhage.Clinical manifestation is based on stomachache, diarrhoea, borborygmus, abdominal distention, tenesmus, stool band mucus or pus and blood, also there are constipation or diarrhoea alternately to occur, touching, the outbreak repeatedly of the course of disease, long then many decades of short then several months, because digestive functional disturbance, source of nutrition deficiency, can occur becoming thin, anemia, weak even weak, severe patient Chang Bingfa intestinal massive hemorrhage, intestinal perforation even canceration, serious threat is to people's life health.
By literature search, do not see the open report identical with the present invention.
Summary of the invention:
The object of the present invention is to provide a kind of through clinical trial, treatment colitis effective colon locating administrated dragon's blood preparation and application thereof.
Colon locating administrated dragon's blood preparation of the present invention is by the medicine of following raw material with percentage by weight proportioning preparation: Sanguis Draxonis 30-90%, adjuvant 70-10%; Wherein: adjuvant comprises one or more in filler, disintegrating agent, the lubricant.Filler is starch, microcrystalline Cellulose, dextrin, lactose; Disintegrating agent is carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC); Lubricant is magnesium stearate, Pulvis Talci.
The preparation method of colon locating administrated dragon's blood preparation comprises operation and the film coating operation of using the conventional formulation technology to produce intermediate products, wherein:
A. prepare the Sanguis Draxonis intermediate products
Sanguis Draxonis is crushed to the regulation fineness, mixes with the percentage by weight proportioning of Sanguis Draxonis 30-90%, adjuvant 70-10%; Making granule below 90 ℃.Be prepared into tablet, capsule and micropill more according to a conventional method respectively.Wherein: adjuvant comprises one or more in filler, disintegrating agent, the lubricant; Filler is starch, microcrystalline Cellulose, dextrin, lactose; Disintegrating agent is carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose; Lubricant is magnesium stearate, Pulvis Talci.
B. the film coating operation is: utilize film-coated technique, at the external molten coating material of colon of wrapping of the intermediate products that prepare, this coating material can make the medicine form that is kept perfectly for the small intestinal weak acid environment at the stomach acidity environment of pH0.0-1.0 and pH6.0-6.8, not disintegrate release, and disintegrate release rapidly behind the colon position of medicine arrival pH7.0-8.0, and then performance curative effect.The coating material adopts the molten coating premixing auxiliary material of commercially available colon.
C. for capsule preparations, also can be filled directly into commercially available colon colloidal sol capsule by the granule that will prepare in the above-mentioned a step and obtain.
Colon locating administrated dragon's blood preparation of the present invention can discharge medicine in the disintegrate of colonic pathological change position, and the effect of performance topical therapeutic can be used as the application for the treatment of the chronic colitis medicine.
For reaching effect of the present invention, preparation of the present invention is carried out external slaking test, specific practice is as follows:
Get the colon locating administrated dragon's blood preparation of specified quantity, method according to Chinese Pharmacopoeia disintegration is checked, checks 2 hours in simulated gastric fluid (0.1mol/L hydrochloric acid solution), and hanging basket is taken out, behind distilled water wash, check 3 hours in phosphate buffer (pH6.8), in above-mentioned two media, preparation all must not have disintegration phenomenon, hanging basket is taken out, behind distilled water wash, in phosphate buffer (pH7.8-8.0), check the whole disintegrates of planted agent in 1 hour.Result of the test shows that preparation of the present invention meets the requirements.
Advantages such as the present invention has good effect, has no side effect, taking convenience can be used as the application of treatment chronic colitis.
The specific embodiment:
One, the preparation of Dragonis sanguis preparation (the same prior art of method and operating condition)
Embodiment 1: the Sanguis Draxonis tablet
Get Sanguis Draxonis 100 grams (25.8%) and be ground into fine powder, add microcrystalline Cellulose 260 grams (67%), carboxymethyl starch sodium 10 grams (2.6%), granulate with starch 10 gram (2.6%) preparation starch slurries, add magnesium stearate 2 grams (0.5%), Pulvis Talci 6 grams (1.5%), mixing, be pressed into 1000, check plain sheet friability, qualified back is according to the described method inclusion of summary of the invention part enteric coating, promptly.Every contains Sanguis Draxonis 0.1g.
Embodiment 2: the Sanguis Draxonis tablet
Get Sanguis Draxonis 300 grams (77.3%) and be ground into fine powder, add microcrystalline Cellulose 60 grams (15.5%), carboxymethyl starch sodium 10 grams (2.6%), granulate with starch 10 gram (2.6%) preparation starch slurries, add magnesium stearate 2 grams (0.5%), Pulvis Talci 6 grams (1.5%), mixing, be pressed into 1000, check plain sheet friability, qualified back is according to the described method inclusion of summary of the invention part enteric coating, promptly.Every contains Sanguis Draxonis 0.3g.
Embodiment 3: the Sanguis Draxonis tablet
Get Sanguis Draxonis 320 grams (82.5%) and be ground into fine powder, add microcrystalline Cellulose 20 gram (5.15%) dextrin 20 grams (5.15%), low-substituted hydroxypropyl cellulose 10 grams (2.6%) are granulated with starch 10 gram (2.6%) preparation starch slurries, add magnesium stearate 2 grams (0.5%), Pulvis Talci 6 grams (1.5%), mixing is pressed into 1000, checks plain sheet friability, qualified back is according to the described method inclusion of summary of the invention part enteric coating, promptly.Every contains Sanguis Draxonis 0.32g.
Embodiment 4: dragon's blood capsule
Get Sanguis Draxonis 150 grams (81.5%), be ground into fine powder, add starch 28 grams (15.2%), carboxymethyl starch sodium 3 grams (1.6%), lactose 3 gram (1.6%) mix homogeneously, make granule with starch slurry, pack into colon colloidal sol capsule or with coating after the conventional capsule filling is made 1000, promptly.Every contains Sanguis Draxonis 0.15g.
Embodiment 5: dragon's blood capsule
Substantially with embodiment 4.Difference is Sanguis Draxonis 300 grams (86.3%), starch 36 grams (10.3%), carboxymethyl starch sodium 6 grams (1.7%), lactose 6 grams (1.7%).
Embodiment 6: dragon's blood capsule
Substantially with embodiment 4.Difference is Sanguis Draxonis 320 grams (89.3%), starch 26 grams (7.3%), carboxymethyl starch sodium 6 grams (1.7%), lactose 6 (1.7%) grams.
Embodiment 7: the Sanguis Draxonis micropill prepares substantially with the Sanguis Draxonis tablet, and difference is only for being tabletting, but makes pill.
Two, the application of colon locating administrated dragon's blood preparation (present embodiment is example with the capsule, but the effect of micropill, tablet is all identical with present embodiment)
1, clinical observation on the therapeutic effect
Adopt the method for treatment cross-reference to observe, select to meet the 128 routine patients that include the case critical field in by " new Chinese medicine clinical research guideline " and observe in doctor hospital of Xishuangbanna, Yunnan Province state Dai Nationality.
2, the Therapeutic Method and the course of treatment
Each 8-12 grain, three times on the one, the child is cut down according to the circumstance, and general 5 days is a course of treatment, serve on 10 days at most.
3, case choice criteria
According to " new Chinese medicine clinical research guideline " and the 1994-06-28 of State Administration of Traditional Chinese Medicine issue, " People's Republic of China's Chinese medicine industry standard " that 1995-01-01 implements " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " selected to meet the 128 routine different syndromes patients that include the case critical field in and is the object of observation.
4, get rid of the case standard
All do not classify the object of observation as with reference to what " new Chinese medicine clinical research guideline " got rid of one of case standard.
5, diagnostic criteria
With reference to the 1994-06-26 of State Administration of Traditional Chinese Medicine issue, " People's Republic of China's Chinese medicine industry standard " " disease of tcm diagnosis criterion of therapeutical effect " of 1995-01-01 reality formulated following standard.
A. defecate thin or as water sample, stomachache borborygmus, fear of cold lack of appetite.White, slippery and moist fur, relaxed and soft pulse.
B. stomachache is promptly rushed down, and rushes down down urgently, and stool being yellowish-brown is dirty smelly, and burning sensation of the anus can be with heating.Red tongue, yellow and greasy fur, soft and rapid pulse.
C. abdominal distention distending pain is defecated smelly as lost ovum, rushes down the back alleviation of pain, and is indigestion and loss of appetite, belching and acid regurgitation.The tongue fur dirt, or thick greasy, rolling pulse.
D. the increased borborygmus and diarrhea of suffering from abdominal pain is not whenever freely sent out because of feelings will, and it is slow to rush down the back pain, red tongue, white and thin fur, stringy pulse.
C. big loose stool is thin, accompanies indigestion food, and oil-feed is greasy slightly then just time increases, with spiritlessness and weakness.Pale tongue, white and thin fur, thready pulse.
E. rise morning and have loose bowels, stool accompanies indigestion food, umbilicus abdomen cold type of pain, and happiness is warm, coldness of the body with chills.Light red tongue is fat, and tongue is white, deep-thready pulse.
6, observation index
A, safety observation
General physical examination, blood, urine, stool routine examination inspection, liver, kidney function test.
B, health giving quality observation
Related symptoms and sign (symptom, picture of the tongue, pulse condition), lab testing.
7, efficacy assessment standard
According to the 1994-06-28 of State Administration of Traditional Chinese Medicine issue, " People's Republic of China's Chinese medicine industry standard " " disease of tcm diagnosis and treatment criterion standard " that 1995-01-01 implements formulated following criterion of therapeutical effect.
1, recovery from illness: symptom, sign disappear.
2, produce effects: symptom, sign are improved.
3, effective: symptom, sign have improvement, but not obvious.
4, invalid: symptom, sign do not have improvement.
8, observed result
A. physical data
Table one: outpatient service and inpatient's comparison sheet
| Case load | Clinic case | Inpatient |
| 128 | 56(43.75％) | 72(56.25％) |
Table two case load, sex, age distribution table
| Total routine number | Sex | Sex example number | Age distribution (year) | ||
| 7-14 | 15-40 | 41-55 | |||
| 128 | The man | 69 | 22 | 35 | 12 |
| The woman | 59 | 18 | 23 | 18 | |
Table three course of disease comparison sheet
| Total routine number | ＜June | June | 1 year | More than 1 year |
| 128 | 36 | 52 | 27 | 13 |
B. total effects is observed table
| The example number | The recovery from illness number | The produce effects number | Significant figure | Invalid number | Total effective rate |
| 128 | 74 | 33 | 18 | 3 | 97.66％ |
C. cardinal symptom observation of curative effect
| Cardinal symptom | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
| Defecate thin or as water sample | 97 | 87 | 8 | 2 | 0 | 100％ |
| The stomachache borborygmus, the fear of cold lack of appetite | 53 | 33 | 11 | 7 | 2 | 96.23％ |
| Stomachache is promptly rushed down, and rushes down urgent down | 61 | 30 | 16 | 15 | 0 | 100％ |
| Stool being yellowish-brown is dirty smelly, burning sensation of the anus | 70 | 49 | 18 | 3 | 0 | 100％ |
| Heating | 18 | 18 | 0 | 0 | 0 | 100％ |
| The abdominal distention distending pain, stool is as losing ovum | 88 | 70 | 15 | 3 | 0 | 100％ |
| Rush down the back alleviation of pain, indigestion and loss of appetite, belching and acid regurgitation | 93 | 51 | 21 | 16 | 5 | 94.62％ |
| The stomachache borborygmus are had loose bowels, are rushed down the back pain and delay | 42 | 32 | 7 | 3 | 0 | 100％ |
| Big loose stool is thin, accompanies indigestion food | 112 | 93 | 12 | 4 | 3 | 97.32％ |
| It is greasy to take food, and times of defecation increases, spiritlessness and weakness | 77 | 51 | 14 | 7 | 5 | 93.51％ |
| Rise morning and have loose bowels, indigestion food is arranged | 26 | 9 | 9 | 5 | 3 | 88.46％ |
| Umbilicus abdomen cold type of pain, happiness is warm, coldness of the body with chills | 34 | 11 | 9 | 7 | 7 | 79.41％ |
D. sign and curative effect situation
| Project | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
| Picture of the tongue | 128 | 76 | 20 | 9 | 23 | 82.03％ |
| Pulse condition | 128 | 57 | 34 | 9 | 28 | 78.13％ |
E. safety observation index
Comparison sheet before and after blood, urine, stool routine examination and hepatic and renal function inspection, the treatment:
| Project | The example number | Before the treatment | After the treatment | ||
| Positive constant | Unusually several | Positive constant | Unusually several | ||
| Routine blood test | 60 | 45 | 15 | 60 | 0 |
| Routine urinalysis | 70 | 70 | 0 | 70 | 0 |
| Stool routine examination | 128 | 0 | 128 | 125 | 3 |
| Liver function | 90 | 79 | 11 | 90 | 0 |
| Renal function | 90 | 85 | 5 | 89 | 1 |
F. conclusion
According to clinical observation result, colon locating administrated dragon's blood preparation can discharge medicine in the disintegrate of colonic pathological change position, and the effect of performance topical therapeutic is to the chronic colitis special effect.Dragon's blood capsule reaches 97.66% to the totall effective rate in clinical treatment that is diagnosed as chronic colitis.
Colon locating administrated dragon's blood preparation is to being diagnosed as chronic colitis because of being invaded by exogenous pathogen, or eating and drinking without temperance, the internal injury diet, dysfunction of the spleen in transportation, stool is thin or as water sample due to the conduction mistake department, suffers from abdominal pain and promptly rushes down, rush down urgent down, stool being yellowish-brown is dirty smelly, burning sensation of the anus, heating, the abdominal distention distending pain, stool as lose ovum, the stomachache increased borborygmus and diarrhea, rushing down symptoms such as the back pain is slow all has the good curing effect.The stomachache borborygmus, are rushed down the back alleviation of pain at the fear of cold lack of appetite, and are indigestion and loss of appetite, belching and acid regurgitation, and big loose stool is thin, indigestion food, it is greasy take food, the times of defecation increase, symptoms such as spiritlessness and weakness all have certain therapeutical effect.Rise morning and have loose bowels, the happiness of umbilicus abdomen cold type of pain is warm, and symptoms such as coldness of the body with chills all have the improvement effect.Do not see and cause leukocyte, thrombocytopenia and liver, renal function injury.Because of Sanguis Draxonis is a blood circulation promoting medicine, be not used for the anemia of pregnant woman, in the pill taker except that the anemia of pregnant woman, do not find toxic and side effects.
According to clinical observation result, dragon's blood capsule reaches 97.66% to the totall effective rate in clinical treatment that is diagnosed as chronic colitis, is the active drug of treatment chronic colitis.The choice drug that can be used as the treatment chronic colitis clinically uses.
Claims (2)
1, a kind of colon locating administrated dragon's blood preparation is characterized in that this drug-delivery preparation is followed these steps to prepare with the percentage by weight proportioning by raw material:
A. Sanguis Draxonis 30-90%, adjuvant 70-10%; Wherein: adjuvant comprises one or more in filler, disintegrating agent, the lubricant; Filler is starch, microcrystalline Cellulose, dextrin, lactose; Disintegrating agent is for being carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose; Lubricant is magnesium stearate, Pulvis Talci;
B. prepare the Sanguis Draxonis intermediate products: Sanguis Draxonis is crushed to the regulation fineness, mixes with the percentage by weight proportioning of Sanguis Draxonis 30-90%, adjuvant 70-10%; Make granule below 90 ℃, be prepared into tablet, capsule and micropill more according to a conventional method respectively;
C. middle product is carried out film coating: utilize film-coated technique, at intermediate products tablet for preparing and the external molten coating premixing auxiliary material of commercially available colon of wrapping of micropill, for capsule preparations, be filled directly into commercially available colon colloidal sol capsule by the granule that will prepare among the above-mentioned steps b and obtain.
2, the purposes of the said colon locating administrated dragon's blood preparation of claim 1 is characterized in that said preparation can discharge medicine in the disintegrate of colonic pathological change position, and the effect of performance topical therapeutic can be used as the application for the treatment of the chronic colitis medicine through clinical verification.
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| CN 200610010781 CN1857563A (en) | 2006-03-29 | 2006-03-29 | Colon locating administrated dragon's blood preparation and its application |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103566055A (en) * | 2013-09-26 | 2014-02-12 | 许力宏 | Callicarpa nudiflora pellet capsule as well as preparation method thereof |
| CN114652788A (en) * | 2022-05-05 | 2022-06-24 | 云南云河药业股份有限公司 | New use of compound dragon's blood |
| CN115501200A (en) * | 2022-09-22 | 2022-12-23 | 北京英茂药业有限公司 | Film-coated premix of dragon blood, preparation method, application and preparation thereof |
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2006
- 2006-03-29 CN CN 200610010781 patent/CN1857563A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103566055A (en) * | 2013-09-26 | 2014-02-12 | 许力宏 | Callicarpa nudiflora pellet capsule as well as preparation method thereof |
| CN103566055B (en) * | 2013-09-26 | 2014-09-24 | 许力宏 | Callicarpa nudiflora pellet capsule as well as preparation method thereof |
| CN114652788A (en) * | 2022-05-05 | 2022-06-24 | 云南云河药业股份有限公司 | New use of compound dragon's blood |
| CN114652788B (en) * | 2022-05-05 | 2023-09-19 | 云南云河药业股份有限公司 | Application of compound dragon's blood in preparing medicine for preventing and treating gastrointestinal mucosa injury |
| CN115501200A (en) * | 2022-09-22 | 2022-12-23 | 北京英茂药业有限公司 | Film-coated premix of dragon blood, preparation method, application and preparation thereof |
| CN115501200B (en) * | 2022-09-22 | 2023-08-22 | 北京英茂药业有限公司 | Film coating premix of dragon's blood and preparation method, application and preparation thereof |
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