CN1163241C - Compound Tournefortia monrana granules preparation and preparation thereof process - Google Patents

Abstract

The present invention relates to a compound tournefortia granule preparation and a preparation method thereof. The preparation of the present invention is used for treating psoriasis. The preparation method comprises the following steps: lithospermum and red sage root are respectively extracted by ethanol according to the raw material proportioning to be concentrated into extract for use; common prism tuber and zedoary are added to water, and then, volatile oil and a medicinal solution are extracted for use; subsequently, smoked plum and white ringworm bark are respectively decocted to obtain two medicinal solutions, and then, the three medicinal solutions are mixed to be filtered and concentrated into clear paste to be mixed with the extract; dextrin and starch are added to the mixture to be evenly mixed and dried into dry paste; the dry paste is pulverized and sieved, powdered sugar is added to the pulverized dry paste to be evenly mixed, and then, ethanol whose concentration is 70% is added to the mixture to be granulated, dried and finished, the volatile oil which is dissolved in ethanol is sprayed in the granules to be sealed for two hours to obtain the preparation of the present invention. The preparation of the present invention can obviously inhibit the mitosis of epithelial cells and promote the formation of the epidermal granular layer; moreover, the preparation has obvious inhibiting action for chronic nonspecific inflammation reaction.

Description

Psoriatic medicine of a kind of treatment and preparation method

The present invention relates to A61J 3/00 class medicament and preparation method, psoriatic oral drugs of a kind of treatment and preparation method.

Psoriasis is dermatology common disease, frequently-occurring disease.The homeliness type person is in the influence beauty treatment of women's head-ornaments portion, and the frequent desquamation of extremity trunk, pruritus cause very big misery to the patient, and heavy type can make patient disable or death as joint type, pustule type or erythrodermic, also is one of disease the most thorny in the department of dermatologry.China's psoriasis prevalence is about 1.56 ‰, and the north is high, and south is low.Its morbidity is relevant with heredity, infection, immunity etc.It is generally acknowledged and be mostly gene and hereditary diseases associated.This disease medicine for external use is keratoplastics, corticosteroid hormone, its salts etc.Innerlich anwenden is immunosuppressant such as methotrexate, and this medication is imitated reliable, but the medulla hematopoietic system of inhibition and hepatic insufficiency are arranged, and tretinoin also is an active drug, but but teratogenesis, cheilitis, alopecia, palm sole of the foot desquamation and hypertriglyceridemia etc.; Corticosteroid hormone to psoriasis vulgaris also effectively but drug withdrawal can cause pustule type and erythrodermic psoriasis soon and side effect such as hypertension, diabetes, digestive tract ulcer is hemorrhage are arranged; Cyclosporin A, this medicine price is expensive, can cause hypertension, kidney merit obstacle etc.; Side effect such as the Chinese medicine compound Pilulae Indigo Naturalis has diarrhoea, have blood in stool.Primary disease is not still had the effectively preventing measure both at home and abroad at present, existing medicine all has certain side effect.

The object of the present invention is to provide a kind of curative effect height, side effect little, be easy to preserve, form of Chinese drug easy to carry, treat psoriatic medicine and preparation method.

Proportioning raw materials: Radix Arnebiae (Radix Lithospermi) 15-30, Radix Salviae Miltiorrhizae 10-20g, Fructus Mume 10-20g, rhizoma sparganic 10-15g, Rhizoma Curcumae 10-15g, Cortex Dictamni 10-20g.

Preparation technology: by proportioning raw materials respectively with Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae with ethanol extraction, to be condensed into extractum standby; Rhizoma sparganic, Rhizoma Curcumae added 10 times in water amount is extracted volatile oil, medicinal liquid is standby; Get Fructus Mume and Cortex Dictamni again and add 10 times of amounts of water and 8 times of amounts respectively, each decocted two hours, merged twice medicinal liquid and above-mentioned medicinal liquid, filtered and be concentrated into clear paste, merged with above-mentioned extractum, added dextrin, starch is mixed, and vacuum drying is to dried cream; Pulverize, sieve, with the Icing Sugar mixing, be that wetting agent is granulated with 70% ethanol; Drying, granulate, spray into the volatile oil of dissolve with ethanol, airtight two hours, packing promptly.

Theoretical and experience provides the basis of prescription according to Chinese medicine

Etiology and pathogenesis: the psoriasis traditional Chinese medical science claims " white arrange ", how because of feelings will internal injury, and obstruction of QI, strongly fragrant fire-transformation of a specified duration, or intemperance of taking food, taste are become estranged, functional activity of QI being not smooth, strongly fragrant heat-transformation of a specified duration, scorchingly hot lying prostrate in nutrient blood, multiple wind-engaging pyretic toxicity is evil and fall ill.If disease is shown effect for a long time or repeatedly, then cloudy blood is consumed, and is qi-blood disharmony, and wind or passages through which vital energy circulates retardance are given birth in dryness-transformation, and QI and blood is condensed, failure of skin and muscle to be nourished.Radix Arnebiae (Radix Lithospermi) sweet in the mouth cold in nature has the merit of removing pathogenic heat from blood and toxic substance from the body in the side.Radix Salviae Miltiorrhizae cold nature bitter in the mouth, but blood circulation promoting and blood stasis dispelling, and again can removing heat from blood be to heat in blood and there is the stagnant card of the stasis of blood particularly suitable.Rhizoma sparganic, Rhizoma Curcumae are shared with removing blood stasis, circulation of qi promoting.The Fructus Mume sour in the mouth can promote the production of body fluid that moisturizing holds concurrently and restrain and prevent circulation of qi promoting too, makes circulation of qi promoting and does not just hinder.The Cortex Dictamni heat-clearing and toxic substances removing, dispelling wind for relieving itching.All medicines share has clearing away heat and cooling blood, the merit of regulating qi to disperse stagnation.Be mainly used in blood stasis, the white arrange of blood-heat type, the white arrange of blood-dryness type is also had curative effect preferably.

Embodiment:

Proportioning raw materials 1: Radix Arnebiae (Radix Lithospermi) 15-25g, Radix Salviae Miltiorrhizae 10-20g, Fructus Mume 10-20g, rhizoma sparganic 10-15g, Rhizoma Curcumae 10-15g, Cortex Dictamni 10-20g.

Proportioning 2 is formed: Radix Arnebiae (Radix Lithospermi) 15-30g, Radix Salviae Miltiorrhizae 10-20g, Fructus Mume 10-20g, rhizoma sparganic 10-15g, Rhizoma Curcumae 10-15g, Rhizoma Smilacis Glabrae 15-25g.

Proportioning 3 is formed: Radix Arnebiae (Radix Lithospermi) 20-30g, Radix Angelicae Sinensis 10-20g, Fructus Mume 10-20g, rhizoma sparganic 10-15g, Rhizoma Curcumae 10-15g, Rhizoma Smilacis Glabrae 15-25g.

Preparation technology: get the raw materials ready by the above-mentioned raw materials proportioning respectively; At first wherein Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae ethanol extraction three times, extracting solution filters, and filtrate recycling ethanol is concentrated into relative density 1.33～1.35 (55～60 ℃), and extractum is standby; Other gets rhizoma sparganic, Rhizoma Curcumae two flavor medicines and adds 10 times of amounts of water, extracts volatile oil earlier and handles 4 hours, and volatile oil, medicinal liquid are standby; Get Fructus Mume and Cortex Dictamni two flavor medicines again and add 10 times of amounts of water for the first time, add 8 times of amounts of water for the second time, each decocted two hours; Merge twice medicinal liquid and above-mentioned medicinal liquid, filter and be evaporated to relative density 1.33～1.35 (50～60 ℃), clear paste; Merge with above-mentioned extractum, add dextrin, starch is mixed, vacuum drying is made dried cream to water content below 5%; Pulverize, cross 100 mesh sieves, add 100 purpose cane sugar powder mixings, the ethanol with 70% is that wetting agent is granulated; Drying, granulate, spray into the volatile oil of dissolve with ethanol, airtight two hours, make finished product, packing is promptly.

Taking dose: treat one time 5 gram of psoriatic medicine, three times on the one, warm boiled water, a course of treatment 8 Mondays.

This prescription in No.1 Clinical College, China Medical Univ.'s department of dermatologry clinical practice nearly 30 years demonstrates fabulous curative effect to the psoriatic.Wherein we have treated 100 routine patients with psoriasis vulgaris at strict the observation.

Therapeutic effect

Recovery from illness 10 examples (10%) among the 100 routine patients, produce effects 30 examples (30%), effective 40 examples (40%), total effective rate 80%; And use in this medicine treatment psoriasis process and do not see apparent side effect.

Diagnostic criteria

1) tcm diagnosis, dialectical standard and according to

1. blood-heat type psoriasis

Main symptom: the erythra color is scarlet, and squama is thicker, and new rash constantly occurs

Accompanied symptoms: A, dry mouth and tougue

B, dry stool dark coloured urine

C, red tongue, yellowish fur

D, stringy and rolling pulse or number

Above main symptom possesses, and the accompanied symptoms binomial is promptly diagnosable

2. blood stasis type psoriasis

Main symptom: the erythra plumpness, color is dark red

Accompanied symptoms: A, purplish tongue or see the petechia ecchymosis

B, hesitant pulse or thin slow

Above main symptom possesses, and one of accompanied symptoms is promptly diagnosable

2) Western medicine diagnose standard and foundation

According to Chen Hongduo chief editor " skin cypridology " the 4th edition, People's Health Publisher,, psoriasis vulgaris diagnostic criteria in 1997.

(1) erythema, pimple or maculopapule

(2) cover silvery white squama

(3) petechial hemorrhage phenomenon (+)

(4) position: erythra generation whole body is sent out scalp, extremity well and is stretched side, especially patella ulnaris and lumbosacral region everywhere.

(5) subjective symptoms: pruritus in various degree

More than indispensable (4) (5), (1) (2) (3) reference standard.

The phase of carrying out: constantly have new erythra color flushing, isomorphic response (+) to occur

Stable phase: stable disease, do not have new erythra substantially and occur, original skin lesion slowly develops, and erythra constantly enlarges, and squama is more.

The efficacy determination index

Be divided into level Four according to the Ministry of Public Health provisions for new drugs approval

Recovery from illness: skin lesion disappears more than 95%, does not itch, and Syndrome in TCM all disappears

Produce effects: skin lesion disappears more than 70, does not itch substantially, and Syndrome in TCM is obviously improved

Effectively: skin lesion disappears more than 30%, and pruritus alleviates, and Syndrome in TCM has improvement

Invalid: skin lesion is not seen obviously and is disappeared, and still itches, and Syndrome in TCM is not seen improvement

Function according to this medicine cures mainly, and has carried out following pharmacodynamics test research; The pharmacodynamics zoopery is the result prove: treat psoriatic medicine and can obviously suppress epithelial mitosis, promote granular layer of epidermis to form, and reaction has the obvious suppression effect to chronic nonspecific inflammation.

Toxicity summary before clinical:

(1) acute toxicity test

1, once irritate stomach for mice and give maximum volume, Cmax is treated psoriatic medicine, and dosage is 212.5g/kg, and toxic reaction does not appear in mice, and none example is dead.

2, give the LD50 and the 95% credible 13.1-11.5g/Kg that is limited to of the psoriatic medicine of mice once abdominal cavity injection compound treatment.

(2) long term toxicity test

This test objective is to estimate treats psoriatic medicine for Wistar rat oral gavage 100g/kg, 40g/kg, 2.04g/kg, and administration is 6 days weekly, six months toxic reaction of successive administration.The experimental session rat does not have death, all Non Apparent Abnormality performances such as the general state of animal, outward appearance sign, behavioral activity, feces character, the hematuria routine, the repeatedly inspection of every indexs such as blood biochemical and liver, renal function is no abnormal, and main organs index administration group and blank group relatively do not have significant difference.Organize diet, the dynamic change of weight body of rat fully and do not have significant difference.

Test shows that the following dosage of 100g/kg does not have the cumulative toxicity reaction, is the safe dose scope.

Claims (2)

1, the psoriatic medicine of a kind of treatment is characterized in that it is made by the following weight proportion raw material: Radix Arnebiae (Radix Lithospermi) 15-30g, Radix Salviae Miltiorrhizae 10-20g, Fructus Mume 10-20g, rhizoma sparganic 10-15g, Rhizoma Curcumae 10-15g, Cortex Dictamni 10-20g.

2, the preparation method of the psoriatic medicine of treatment according to claim 1 is characterized in that: with Radix Arnebiae (Radix Lithospermi), Radix Salviae Miltiorrhizae ethanol extraction three times, extracting solution filters, filtrate recycling ethanol, be concentrated into relative density 1.33～1.35 (55～60 ℃), get extractum, standby; Other gets rhizoma sparganic, Rhizoma Curcumae adds 10 times of amounts of water, earlier by the PROCESS FOR TREATMENT of extracting volatile oil 4 hours, volatile oil, medicinal liquid, standby; Get Fructus Mume and Cortex Dictamni again, add for the first time 10 times of amounts of water, add 8 times of amounts of water for the second time, each decocted two hours, merge twice medicinal liquid and above-mentioned medicinal liquid, filter and be evaporated to relative density 1.33～1.35 (50～60 ℃), clear paste, merge with above-mentioned extractum, add dextrin, starch is mixed, vacuum drying is made dried cream to water content below 5%; Pulverizing, cross 100 mesh sieves, add 100 purpose cane sugar powder mixings, is that 70% ethanol is the wetting agent granulation with concentration; Drying, granulate, spray into the volatile oil of dissolve with ethanol, airtight two hours promptly.