CN100536881C - Gel for treating hemorrhoidal anus and rectum diseases, and its preparation method - Google Patents
Gel for treating hemorrhoidal anus and rectum diseases, and its preparation method Download PDFInfo
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- CN100536881C CN100536881C CNB2006100199400A CN200610019940A CN100536881C CN 100536881 C CN100536881 C CN 100536881C CN B2006100199400 A CNB2006100199400 A CN B2006100199400A CN 200610019940 A CN200610019940 A CN 200610019940A CN 100536881 C CN100536881 C CN 100536881C
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Abstract
A medicine in the form of gel for treating internal pile, external pile, mixed pile and fissure in gelling agent is prepared from 9 Chinese-medicinal materials including amber, borneol, borax, pearl, etc, 9 Chemicals including monoglyceride stearate, white vaseline, glycerin, VC, etc, and distilled water. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of gel for the treatment of hemorrhoidal anus and rectum diseases, specifically, this drug regimen is mainly used in the various internal hemorrhoid of treatment, external hemorrhoid, mixed hemorrhoid and anal fissure.The invention still further relates to a kind of preparation method of this medicine.
Background technology
Hemorrhoid are surgical common disease, frequently-occurring disease, and the therapeutic purposes of hemorrhoid are to eliminate symptom, and asymptomatic hemorrhoid need not treatment, and Symptomatic hemorrhoid can be eliminated symptom through non-operative treatment more than 80%.Pharmacotherapy occupies critical role in the treatment of hemorrhoid, Chinese medicine preparation is because evident in efficacy and low toxic and side effects extensively is subjected to expert and patient's favorable comment.The Chinese medicine preparation of treatment hemorrhoid has ointment, suppository, patch, ointment, lotion, oral formulations etc. on the market, and manufacturer is also numerous.The hemorrhoid class ointment of selling on the domestic market at present of controlling mainly contains MAYINGLONG MUSK HEMORRHOID UNGUENTUM, the safe ointment of anus, hemorrhoid-eliminating paste, jiuhua plaster, bear's gall ointment etc.Patent documentation also discloses the multiple hemorrhoid externally-applied ointment of controlling, as Chen Rong and the special efficacy hemorrhoids ointment described in the CN1076863A and Wang Zhibo ZHICHUANG GAO described in the CN1319410 or the like.These medicines have heat-clearing and toxic substances removing more, effects such as reducing swelling and alleviating pain, removing the necrotic tissue and promoting granulation, but have the undesirable deficiencies such as easy pollution clothes and skin that go up with use of hemostasis and pain-relieving effect.
Summary of the invention
The objective of the invention is in order to remedy the deficiencies in the prior art, a kind of gel of more effective treatment treatment hemorrhoidal anus and rectum diseases is provided for people, not only bioavailability height, evident in efficacy, effect are rapidly, toxicity is extremely low in this agent, and do not have greasy, easily be coated with exhibition, not pollution clothes and skin.
Another object of the present invention provides this preparation method of controlling the hemorrhoid gel, and this method technology is simple, easy operating, is suitable for suitability for industrialized production.
The objective of the invention is to realize by following technical proposals.
Artificial Moschus---the refreshment of having one's ideas straightened out, promoting blood circulation and detumescence, dysmenorrhea fetal abortion.Fragrance is walked to scurry, the current twelve regular channels, the priming power sick institute that goes directly.
Borneolum Syntheticum---have one's ideas straightened out heat clearing away, pain relieving; But external erosion prevention and muscle growing.
Artificial Calculus Bovis---relieving convulsion is had one's ideas straightened out, heat-clearing and toxic substances removing.
Folium Callicarpae Macrophyllae---hemostasis and pain-relieving, the detumescence of becoming silted up of loosing.
Succinum---tranquillizing the mind by relieving convulsion, promoting blood circulation to remove blood stasis, inducing diuresis for treating stranguria syndrome.
Margarita---calm the nerves endogenous wind stopping, heat clearing away, detoxifcation, granulation promoting.
Catechu---change the silt hemostasis, promoting tissue regeneration and ulcer healing.
Calamina---improving acuity of vision and removing nebula, the convergence granulation promoting.
Borax---heat clearing away expectorant, anticorrosion.
Medicine of the present invention is made by following component, and consumption is a weight portion:
| Succinum | 0.05～1.0 |
| Borneolum Syntheticum | 20～50 |
| Borax | 5～20 |
| Folium Callicarpae Macrophyllae | 60～120 |
| Margarita | 1～5 |
| Calamina | 30～70 |
| The artificial Calculus Bovis | 0.5～5 |
| Catechu | 30～80 |
| The artificial Moschus | 0.5～5 |
| Glyceryl monostearate | 20～50 |
| Stearic acid | 30～70 |
| White vaseline | 30～80 |
| Liquid paraffin | 30～70 |
| Glycerol | 50～80 |
| Sodium lauryl sulphate | 1～20 |
| Hydroxypropyl emthylcellulose | 10～40 |
| Ethyl hydroxybenzoate | 0.1～10 |
| Vitamin C | 5～20 |
| Distilled water | 500～600 |
Preferred manufacturing prescription of the present invention is as follows: consumption is a weight portion:
| Succinum | 0.05～0.5 |
| Borneolum Syntheticum | 20～40 |
| Borax | 8～15 |
| Folium Callicarpae Macrophyllae | 80～120 |
| Margarita | 1～4 |
| Calamina | 40～60 |
| The artificial Calculus Bovis | 0.5～2 |
| Catechu | 40～70 |
| The artificial Moschus | 0.5～3 |
| Glyceryl monostearate | 20～40 |
| Stearic acid | 40～60 |
| White vaseline | 40～70 |
| Liquid paraffin | 35～60 |
| Glycerol | 60～80 |
| Sodium lauryl sulphate | 1～10 |
| Hydroxypropyl emthylcellulose | 10～30 |
| Ethyl hydroxybenzoate | 0.5～5 |
| Vitamin C | 10～20 |
| Distilled water | 520～580 |
Main component of the present invention is a mineral drug, and absorbing difficulty is the common problem of mineral drug existence, and the drug absorption key that to be drug effect brought into play.In order to increase drug absorption, at first must reduce the particle diameter of medicine.The modern purification of tcm extractive technique of process using of the present invention is prepared the key component in the prescription, and its step comprises: at first, with succinum, Borneolum Syntheticum, Margarita, artificial Moschus, Calamina, catechu pulverize separately, cross 200 mesh sieves.The second, take by weighing Folium Callicarpae Macrophyllae, decoct each 1h with 14 times of water gagings 3 times in 100 ℃.The decocting liquid that decocts for above-mentioned 3 times is merged, leave standstill, spend the night, filter next day, and it is 1.13 that filtrate is concentrated into relative density, and temperature is 60 ℃, adds 95% medicinal alcohol and make and contain the alcohol amount and reach 60%, 0～4 ℃ of cold preservation 24h, filters, and reclaims ethanol, dry Folium Callicarpae Formosanae extractum.The 3rd, with hydroxypropyl emthylcellulose, 14 parts of glycerol, ethyl hydroxybenzoate, vitamin C and 220 parts of distilled water mix homogeneously, get gel-type vehicle.The 4th, join in the step 3 gained gel-type vehicle after being scattered in artificial Calculus Bovis's suspendible in 160 parts of distilled water, gel-type vehicle is hydroxypropyl emthylcellulose, glycerol, ethyl hydroxybenzoate, vitamin C and distilled water, mix homogeneously.The 5th, after Margarita fine powder, artificial Moschus, Calamina fine powder, the catechu fine powder of step 1 gained be pre-mixed, directly join and continue to grind mixing in the step 4 gained mixed powder.The 6th, get Borax, step 2 gained Folium Callicarpae Formosanae extractum, be dissolved in 50 parts of glycerol, sodium lauryl sulphate and the 174 parts of distilled water at 80 ℃, 80 ℃ of insulations are standby.The 7th, glyceryl monostearate, stearic acid, white vaseline and liquid paraffin are heated to 85～86 ℃ of fusings, to be cooled after 75 ℃, add step 1 gained succinum, Borneolum Syntheticum, after the dissolving step 6 gained mixed powder is slowly added wherein, be stirred to cooling.The 8th, step 7 gained mixed powder is slowly joined in the step 5 gained mixed powder, stir.
The present invention compares with existing Technology, has the following advantages and effect:
1, adopt the modern refining extractive technique of Chinese medicine that the key component in the prescription is prepared, diameter of aspirin particle is reduced greatly, be easy to see through mucosa and enter tissue, obviously improved the absorbance and the bioavailability of medicine, the pharmacological action effect of main effective ingredient is significantly higher than conventional formulation.
2, the present invention fills a prescription rationally.Each drug distribution of filling a prescription is extremely wide, aboundresources.
3. dosage form advanced person of the present invention, no greasy, easily be coated with exhibition, not pollution clothes and skin, make things convenient for the patient to use.
4, the pharmaceutical research result shows: the present invention has significantly antibacterial, antiinflammatory, promotion ulcer healing and pain relieving, anastalsis.Extracorporeal bacteria inhibitor test shows, the present invention surgical infection common pathogen (especially staphylococcus epidermidis, beta hemolytic streptococcus, Bacillus proteus and bacillus pyocyaneus) is had obviously press down, bactericidal action; Dichlorodiphenyl Acetate of the present invention causes rat crissum ulcer the effect of obvious promotion ulcer healing, acute inflammation is early stage due to the xylol ooze out with swelling and Dichlorodiphenyl Acetate due to early stage hyperfunction the oozing out of capillary permeability of acute inflammation obvious inhibitory action is arranged, and can suppress obviously that rat granuloma is swollen to be formed; The present invention 640,1280 and 2560mg/kgbw obviously reduce acetic acid induced mice pain writhing response, and slip can reach 42.7%, 50.2% and 40.2% respectively; The present invention 320,640 and 1280mg/kgbw can obviously shorten the mouse tail bleeding time, and LVFS is respectively 21.0%, 31.8% and 37.5%, and pain relieving, the more traditional hemorrhoid medicine of anastalsis significantly strengthen.
5, the toxicologic study result shows, toxicity of the present invention is extremely low, drug safety.Anaphylaxis, irritation test and acute toxicity test show that the present invention does not have sensitization and zest, do not see tangible acute toxicity effect.Long term toxicity test shows, the present invention 0.17,0.38,0.92g/kgbw (be equivalent to 0.26,0.60,1.44 gram crude drug/kgbw respectively, the clinical plan consumption of behaving 16,36,86 times) do not find obvious toxic-side effects in 4 weeks of continuous use.
The specific embodiment
Medicine embodiment consumption of the present invention following (weight portion):
A kind of gel for the treatment of hemorrhoidal anus and rectum diseases, its preparation process is:
1,, crosses 200 mesh sieves with succinum, Borneolum Syntheticum, Margarita, artificial Moschus, Calamina, catechu pulverize separately;
2, take by weighing Folium Callicarpae Macrophyllae, decoct each 1h 3 times in 100 ℃ with 14 times of water gagings.The decocting liquid that decocts for 3 times is merged, leave standstill, spend the night, filter next day, and it is 1.13 that filtrate is concentrated into relative density, and temperature is 60 ℃, adds 95% medicinal alcohol and make and contain the alcohol amount and reach 60%, 0～4 ℃ of cold preservation 24h, filters, and reclaims ethanol, dry Folium Callicarpae Formosanae extractum;
3,, get gel-type vehicle with hydroxypropyl emthylcellulose, 14 parts of glycerol, ethyl hydroxybenzoate, vitamin C and 220 parts of distilled water mix homogeneously;
4, join in the step 3 gained gel-type vehicle after artificial Calculus Bovis's suspendible being scattered in 160 parts of distilled water, gel-type vehicle is hydroxypropyl emthylcellulose, glycerol, ethyl hydroxybenzoate, vitamin C and distilled water, mix homogeneously;
5, Margarita fine powder, artificial Moschus, Calamina fine powder, the catechu fine powder of step 1 gained is pre-mixed after, directly join and continue to grind mixing in the step 4 gained mixed powder;
6, get Borax, step 2 gained Folium Callicarpae Formosanae extractum, be dissolved in 50 parts of glycerol, sodium lauryl sulphate and the 174 parts of distilled water at 80 ℃, 80 ℃ of insulations are standby;
7, glyceryl monostearate, stearic acid, white vaseline and liquid paraffin are heated to 85～86 ℃ of fusings, to be cooled after 75 ℃, add step 1 gained succinum, Borneolum Syntheticum, after the dissolving step 6 gained mixed powder is slowly added wherein, be stirred to cooling;
8, step 7 gained mixed powder is slowly joined in the step 5 gained mixed powder, stir.
Distilled water of the present invention is 500～600 parts, and distillation moisture adds the people three times, and adding distil water is 220 parts in step 3, and adding distil water is 160 parts in step 4, and adding distil water is 174 parts in step 6; Glycerol is 50～80 parts, adds 14 parts in step 3, adds 50 parts in step 6.
The present invention is evident in efficacy, toxicity is extremely low, drug safety, now pharmacological toxicology is learned result of study and is reported as follows:
Table 1 the present invention is to minimum inhibitory concentration (the inoculation bacterium amount: 10 of surgical infection common pathogen
3CFU/mL)
Table 2 the present invention is to minimum bactericidal concentration (the inoculation bacterium amount: 103CFU/mL) of surgical infection common pathogen
Table 3 Dichlorodiphenyl Acetate of the present invention cause rat crissum ulcer influence (
± SD, n=12)
Annotate: compare with blank substrate matched group,
*P＜0.05,
*P＜0.01.
Table 4 xylol of the present invention cause mice auricle swelling influence (
± sD, n=13)
Annotate: compare with blank substrate matched group,
*P＜0.05,
*P＜0.01.
The influence that the mouse peritoneal capillary permeability that causes table 5 Dichlorodiphenyl Acetate of the present invention increases (
± sD, n=13)
Annotate: compare with blank substrate matched group,
*P＜0.05,
*P＜0.01.
Table 6 the present invention to the swollen influence that forms of rat granuloma (
± SD, n=10)
Annotate: compare with blank substrate matched group,
*P＜0.05,
*P＜0.01.
Table 7 Dichlorodiphenyl Acetate of the present invention cause mouse writhing reaction influence (
± SD, n=10)
Annotate: compare with blank substrate matched group,
*P＜0.01.
Table 8 the present invention to the influence in mouse tail bleeding time (
± SD, n=13)
Annotate: compare with blank substrate matched group,
*P＜0.05,
*P＜0.01
Table 9 skin allergy sensitization of the present invention rate
Annotate: sensitization rate=(erythema example number+edema example number)/number of animals * 100%
Claims (10)
1, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases is characterized in that, the gel that it is made by the following weight parts proportion raw material:
Succinum 0.05～1.0
Borneolum Syntheticum 20～50
Borax 5～20
Folium Callicarpae Macrophyllae 60～120
Margarita 1～5
Calamina 30～70
The artificial Calculus Bovis 0.5～5
Catechu 30～80
The artificial Moschus 0.5～5
Glyceryl monostearate 20～50
Stearic acid 30～70
White vaseline 30～80
Liquid paraffin 30～70
Glycerol 50～80
Sodium lauryl sulphate 1～20
Hydroxypropyl emthylcellulose 10～40
Ethyl hydroxybenzoate 0.1～10
Vitamin C 5～20
Distilled water 500～600.
2, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.05～0.5
Borneolum Syntheticum 20～40
Borax 8～15
Folium Callicarpae Macrophyllae 80～120
Margarita 1～4
Calamina 40～60
The artificial Calculus Bovis 0.5～2
Catechu 40～70
The artificial Moschus 0.5～3
Glyceryl monostearate 20～40
Stearic acid 40～60
White vaseline 40～70
Liquid paraffin 35～60
Glycerol 60～80
Sodium lauryl sulphate 1～10
Hydroxypropyl emthylcellulose 10～30
Ethyl hydroxybenzoate 0.5～5
Vitamin C 10～20
Distilled water 520～580.
3, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.1
Borneolum Syntheticum 28
Borax 9
Folium Callicarpae Macrophyllae 95
Margarita 1.0
Calamina 55
The artificial Calculus Bovis 0.6
Catechu 44.5
The artificial Moschus 0.5
Glyceryl monostearate 40
Stearic acid 53
White vaseline 56.3
Liquid paraffin 45.5
Glycerol 68
Sodium lauryl sulphate 3.5
Hydroxypropyl emthylcellulose 25
Ethyl hydroxybenzoate 1.0
Vitamin C 14
Distilled water 550.
4, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.1
Borneolum Syntheticum 30
Borax 11.5
Folium Callicarpae Macrophyllae 102
Margarita 3
Calamina 48
The artificial Calculus Bovis 1.0
Catechu 46
The artificial Moschus 1.1
Glyceryl monostearate 30
Stearic acid 50
White vaseline 49.8
Liquid paraffin 50
Glycerol 76
Sodium lauryl sulphate 7
Hydroxypropyl emthylcellulose 18
Ethyl hydroxybenzoate 1.5
Vitamin C 13
Distilled water 552.
5, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.2
Borneolum Syntheticum 36
Borax 8
Folium Callicarpae Macrophyllae 110
Margarita 3
Calamina 46
The artificial Calculus Bovis 1.5
Catechu 52
The artificial Moschus 1.4
Glyceryl monostearate 20.5
Stearic acid 47
White vaseline 48
Liquid paraffin 60.5
Glycerol 70
Sodium lauryl sulphate 5
Hydroxypropyl emthylcellulose 23.6
Ethyl hydroxybenzoate 3
Vitamin C 18
Distilled water 536.3.
6, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.15
Borneolum Syntheticum 40
Borax 14
Folium Callicarpae Macrophyllae 80
Margarita 2.5
Calamina 55
The artificial Calculus Bovis 2.15
Catechu 40
The artificial Moschus 2
Glyceryl monostearate 35
Stearic acid 60
White vaseline 40
Liquid paraffin 60
Glycerol 55
Sodium lauryl sulphate 2
Hydroxypropyl emthylcellulose 10
Ethyl hydroxybenzoate 3
Vitamin C 8
Distilled water 581.2.
7, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.12
Borneolum Syntheticum 38
Borax 15
Folium Callicarpae Macrophyllae 88
Margarita 4.2
Calamina 47
The artificial Calculus Bovis 0.8
Catechu 60
The artificial Moschus 2.6
Glyceryl monostearate 32.8
Stearic acid 65
White vaseline 50
Liquid paraffin 40
Glycerol 63
Sodium lauryl sulphate 10
Hydroxypropyl emthylcellulose 30.2
Ethyl hydroxybenzoate 2
Vitamin C 20
Distilled water 520.5.
8, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.6
Borneolum Syntheticum 35
Borax 10
Folium Callicarpae Macrophyllae 100
Margarita 1.4
Calamina 30
The artificial Calculus Bovis 1.3
Catechu 48
The artificial Moschus 4
Glyceryl monostearate 25.6
Stearic acid 35
White vaseline 74.4
Liquid paraffin 42
Glycerol 65
Sodium lauryl sulphate 4.7
Hydroxypropyl emthylcellulose 13
Ethyl hydroxybenzoate 0.6
Vitamin C 6
Distilled water 593.4.
9, a kind of gel for the treatment of hemorrhoidal anus and rectum diseases according to claim 1 is characterized in that the proportioning of following parts by weight of raw materials is:
Succinum 0.08
Borneolum Syntheticum 32
Borax 7
Folium Callicarpae Macrophyllae 85
Margarita 1.5
Calamina 52
The artificial Calculus Bovis 2.57
Catechu 50
The artificial Moschus 2.25
Glyceryl monostearate 32
Stearic acid 53
White vaseline 52
Liquid paraffin 46.9
Glycerol 50
Sodium lauryl sulphate 5.5
Hydroxypropyl emthylcellulose 26
Ethyl hydroxybenzoate 6
Vitamin C 9
Distilled water 577.2.
10, a kind of described a kind of preparation method for the treatment of the gel of hemorrhoidal anus and rectum diseases of claim 1 that realizes comprises the following steps:
A, with succinum, Borneolum Syntheticum, Margarita, artificial Moschus, Calamina, catechu pulverize separately, cross 200 mesh sieves;
B, take by weighing Folium Callicarpae Macrophyllae, decoct each 1h 3 times in 100 ℃ with 14 times of water gagings, the decocting liquid of 3 decoctions is merged, leave standstill, spend the night, filter next day, and it is 1.13 that filtrate is concentrated into relative density, temperature is 60 ℃, add 95% medicinal alcohol and make the alcohol amount of containing reach 60%, 0～4 ℃ of cold preservation 24h, filter, reclaim ethanol, the dry Folium Callicarpae Formosanae extractum that gets;
C, with hydroxypropyl emthylcellulose, glycerol, ethyl hydroxybenzoate, vitamin C and distilled water mix homogeneously, gel-type vehicle;
D, join in the step C gained gel-type vehicle after being scattered in artificial Calculus Bovis's suspendible in the distilled water, gel-type vehicle is hydroxypropyl emthylcellulose, glycerol, ethyl hydroxybenzoate, vitamin C and distilled water, mix homogeneously;
After E, the Margarita fine powder with the steps A gained, artificial Moschus, Calamina fine powder, catechu fine powder are pre-mixed, directly join and continue to grind mixing in the step D gained mixed powder;
F, get Borax, step B gained Folium Callicarpae Formosanae extractum, be dissolved in glycerol, sodium lauryl sulphate and the distilled water 80 ℃ of insulations at 80 ℃;
G, glyceryl monostearate, stearic acid, white vaseline and liquid paraffin are heated to 85～86 ℃ of fusings, to be cooled after 75 ℃, add steps A gained succinum, Borneolum Syntheticum, after the dissolving step F gained mixed powder is added wherein, be stirred to cooling;
H, step G gained mixed powder is joined in the step e gained mixed powder, stir.
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| CNB2006100199400A CN100536881C (en) | 2006-08-08 | 2006-08-08 | Gel for treating hemorrhoidal anus and rectum diseases, and its preparation method |
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|---|---|---|---|
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| CN100536881C true CN100536881C (en) | 2009-09-09 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101152166B (en) * | 2007-09-06 | 2010-12-08 | 武汉大学 | Isoliquirtigenin gelling agent for treating hemorrhoids and method of preparing the same |
| CN102670849B (en) * | 2011-03-18 | 2013-11-27 | 浙江科技学院 | Anal fistula suppository |
| CN103028042A (en) * | 2011-09-29 | 2013-04-10 | 陈金奎 | Care product used for shortening external hemorrhoid recovery time and shortening anus rupture healing time |
| CN103393724B (en) * | 2013-08-13 | 2015-05-20 | 杨海娟 | Ointment for treating perianal abscess and preparation method thereof |
| CN105148024B (en) * | 2015-10-09 | 2018-11-13 | 刘桂沅 | Chemicals curing piles ointment machin manufacture craft |
| CN112999339A (en) * | 2019-12-19 | 2021-06-22 | 陕西康乐实业有限公司 | Lysozyme gel and preparation method and application thereof |
| CN113521166B (en) * | 2020-12-02 | 2022-05-03 | 马应龙药业集团股份有限公司 | A cream for treating anorectal diseases such as hemorrhoid, and its preparation method |
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2006
- 2006-08-08 CN CNB2006100199400A patent/CN100536881C/en active Active
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