CN104998179A - Pharmaceutical composition for prevention of rectal carcinoma radioactive skin damage and application thereof - Google Patents

Abstract

The invention discloses a pharmaceutical composition for prevention of rectal carcinoma radioactive skin damage and an application thereof; the pharmaceutical composition is prepared from an active component and auxiliary materials; the active component is prepared by water extraction and alcohol precipitation of the following traditional Chinese medicine raw materials in parts by weight: 13-20 parts of potentilla fulgens wall, 12-18 parts of tribulus terrestris, 12-18 parts of mandarin orange seed, 13-20 parts of abelmoschus crinitus wall, 21-30 parts of herba lycopi, 21-30 parts of white atractylodes rhizome, 6-12 parts of fructus amomi, and 10-20 parts of herba hyperici. The pharmaceutical composition not only can delay the generation of radioactive skin damage, ensure smooth performing of radiation therapy and improve tolerability of patient skins on the cumulative dose of radiation, but also can promote healing of radioactive skin damage wound surfaces.

Description

A kind of pharmaceutical composition and application thereof preventing rectal cancer radiation skin injury

Technical field

The invention belongs to technical field of traditional Chinese medicine preparation, prevent pharmaceutical composition of rectal cancer radiation skin injury and its preparation method and application in particular to a kind of.

Background technology

Radiotherapy is the main method of Rectal Carcinomaafter Combined Therapy, and it kills and wounds, inhibition tumor cell also has damage to human normal tissue while breeding.Curing dermal radio lesions is the common complication of radiotherapy patient, for skin microangiopathies under radiation exposure causes a class complication of skin-nourishing obstacle and inflammatory reaction then.Research shows, after skin accepts radiation exposure for a long time, Dermal microvessel endothelial damages, cause microthrombusis widely and microcirculation disturbance in blood capillary, the compact siro spinning technology of blood vessel endothelium is destroyed simultaneously, vessel inner blood composition is caused to exosmose, cause the infringement of local organization, skin rubefaction, itch, pigmentation, thickening coarse, pore is slightly black, moist decortication, vesicle can be there is time serious, then ulceration, rotten to the corn, pain etc., even cause patient radiation to treat and be forced to interrupt, cause patient can not carry out the radiotherapy of rule, affect therapeutic effect (Barlund M, Forozan P, Kononen J, et a1.Detecting activation ribosomal protein S6 kinase by complementalry.DNA and tissue microarray analysis [J] .J Natl Cancer lnst, 2000, 92 (15): 1252.).As can be seen here, radiation skin injury is then inevitable complication in treatment, and severe patient can the damage of concurrent anal canal mucosa, affects the quality of life of patient, is even forced to stopped treatment.Therefore in radiation therapy process, the control of radiation skin injury normally has great importance for radiocurable.

Summary of the invention

The object of the present invention is to provide and a kind ofly prevent pharmaceutical composition of rectal cancer radiation skin injury and its preparation method and application.This pharmaceutical composition can not only delay the generation of radiation skin injury, ensures radiocurablely to carry out smoothly, improves the toleration of patient skin to radiation accumulated dose, and can promote radiation skin injury wound healing.

In order to realize object of the present invention, inventor, by furtheing investigate folk remedy and improving, finally obtains following technical scheme:

A kind of pharmaceutical composition preventing rectal cancer radiation skin injury, this pharmaceutical composition is made up of active component and adjuvant, and wherein said active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 13-20 part, Fructus Tribuli 12-18 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 12-18 part, Hibiscus cancellatus Roxb. 13-20 part, Herba Lycopi 21-30 part, Rhizoma Atractylodis Macrocephalae 21-30 part, Fructus Amomi 6-12 part, Herba Hyperici 10-20 part.

Preferably, the pharmaceutical composition of prevention rectal cancer radiation skin injury described above, wherein said active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 15-17 part, Fructus Tribuli 14-16 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 14-16 part, Hibiscus cancellatus Roxb. 15-17 part, Herba Lycopi 24-26 part, Rhizoma Atractylodis Macrocephalae 24-26 part, Fructus Amomi 8-10 part, Herba Hyperici 14-16 part.

In a prepreerence embodiment of the present invention, the pharmaceutical composition of prevention rectal cancer radiation skin injury described above, wherein said active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 16 parts, Fructus Tribuli 15 parts, Citrus chachiensis Hort. (C．Suavissima Tanaka) 15 parts, Hibiscus cancellatus Roxb. 16 parts, Herba Lycopi 25 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, Fructus Amomi 9 parts, Herba Hyperici 15 parts.

It should be noted that, traditional Chinese medicinal material raw materials source of the present invention is as follows: the dry root of Folium potentillae velutinae (Radix Potentillae Fulgentis) rosaceous plant velutinous cinquefoil Potentilla griffithii Hook.f.var.velutina Card..Fructus Tribuli selects the dry mature fruit of zygophyllaceae plant Fructus Tribuli Tribulus terrestris L..Citrus chachiensis Hort. (C．Suavissima Tanaka) selects the dry seed of rutaceae Citrus reticulata Blanco cv. Chachiensis Citrus chachiensis Hort..Hibiscus cancellatus Roxb. selects Malvaceae plant to become mildewed the dried floral of Radix seu folium abelmoschi moschati Abelmoschus crinitus Wall..Herba Lycopi selects the dry aerial parts of labiate hair leaf lycopus lucidus Lycopus lucidus Turcz.var.hirtus Regel.The dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz. selected by the Rhizoma Atractylodis Macrocephalae.Fructus Amomi selects the dry mature fruit of zingiberaceous plant Fructus Amomi Amomum villosum Lour..Herba Hyperici selects the dry herb of the Hypericum ascyron L. of Garcinia maingayii hypericum ascyron.

In addition, the preparation method of the pharmaceutical composition of prevention rectal cancer radiation skin injury of the present invention is as follows:

(1) traditional Chinese medicinal material raw materials Folium potentillae velutinae (Radix Potentillae Fulgentis) 13-20 part, Fructus Tribuli 12-18 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 12-18 part, Hibiscus cancellatus Roxb. 13-20 part, Herba Lycopi 21-30 part, Rhizoma Atractylodis Macrocephalae 21-30 part, Fructus Amomi 6-12 part and Herba Hyperici 10-20 part is got, decoct with water and extract 2-5h, decocting liquid adds ethanol after concentrated makes volume alcohol content reach 70-78%, 2-8 DEG C of cold preservation 12-48 hour, filter, filtrate recycling ethanol is also concentrated, dry, obtains Chinese medicine dried cream powder;

(2) fully swollen in distilled water by carbomer, add glycerol and propylene glycol, laurocapram grinding makes moistening, and add triethanolamine and grind to form clear gel substrate, heating in water bath is to 68-73 DEG C;

(3) get Chinese medicine dried cream powder prepared by step (1), and get tween 80 and mixed with propylene glycol, after heating for dissolving, this medicinal liquid is joined in gel-type vehicle prepared by step (2), stir, adding distil water standardize solution, continue to stir, obtain gel.

A large amount of clinical practices finds; for the patient that radiation skin injury occurs; gel of the present invention can prevent wound surface dry; keep wound surface moistening, be conducive to wound granulation tissue growth, simultaneously available protecting wound surface epithelial tissue granule; prevent mummification necrosis and cause skin island to be lost; promote the hypertrophy of fibrous tissue simultaneously, be conducive to wound surface epithelization and healing, play the effect for the treatment of skin acute radiation reaction.

Detailed description of the invention

Be below specific embodiments of the invention, technical scheme of the present invention is done to describing further, but protection scope of the present invention be not limited to these embodiments.Every do not deviate from the present invention's design change or equivalent substituting include within protection scope of the present invention.

Embodiment 1: the preparation of Chinese medicine dried cream powder

Prescription: Folium potentillae velutinae (Radix Potentillae Fulgentis) 1.6kg, Fructus Tribuli 1.5kg, Citrus chachiensis Hort. (C．Suavissima Tanaka) 1.5kg, Hibiscus cancellatus Roxb. 1.6kg, Herba Lycopi 2.5kg, Rhizoma Atractylodis Macrocephalae 2.5kg, Fructus Amomi 0.9kg, Herba Hyperici 1.5kg.

Preparation method: the above-mentioned traditional Chinese medicinal material raw materials getting recipe quantity, cleans roguing, adds water and cover powder 2cm, soak 1-1.2h, pull medical material out and put during multi-functional extractions is filled with and decoct with water secondary, first time totalling medical material 12 times amount purified water, decoct 3h, get decocting liquid, filter, second time adds up the purified water of medical material 10 times amount, decoct 2h, get twice decocting liquid to merge, filter, when being concentrated into 65 DEG C, relative density is the concentrated solution of 1.05; Add ethanol to make to reach 75% containing alcohol volumn concentration, 5 DEG C of cold preservation 24 hours, filter, filtrate recycling ethanol is also concentrated into thick paste, lyophilization, obtains Chinese medicine dried cream powder.

Embodiment 2: the preparation of Chinese medicine gel

Prescription: Chinese medicine dried cream powder 10g, Acritamer 940: 10g, propylene glycol 200g, laurocapram 10g, triethanolamine 10g, tween 80: 10g, adding distil water is to 1000g.

Be spread on by carbomer in appropriate distilled water, fully swelling, add the propylene glycol of glycerol and half recipe quantity, laurocapram grinding makes moistening, adds triethanolamine and grinds to form clear gel substrate, heating in water bath to 70 DEG C.After getting the mixed with propylene glycol heating for dissolving of Chinese medicine dried cream powder (preparing according to the formulation and technology of embodiment 1), tween 80 and second half recipe quantity, join in gel-type vehicle by this medicinal liquid, slow quickening stirs, and adding distil water is to 1000g, continue to stir, obtain golden transparent gel.Do not add Chinese medicine dried cream powder, by same process prepare for Blank gel.

Embodiment 3: the clinical application research of the pharmaceutical composition of Chinese herb on the prevention rectal cancer radiation skin injury

Be diagnosed as capable radiocurable patient 45 example of rectal cancer, man 26 example, female 19 example, 52 ~ 73 years old age, average 57.4 ± 6.9 years old.Be divided into test group 22 example and matched group 23 example after patient selection at random, the sex of two groups of patients, age, the state of an illness, without significant difference, have comparability.Two groups of patients all adopt the radiotherapy of 3DRT scheme, radiotherapy apparatus is Siemens's clinac, ray type is 6MV-X line and 9mev β ray, 1 ~ week, 5 continuous radiotherapy 5 times weekly, be weekly a cycle, in radiotherapy 6 cycle, prescribed dose is 50Gy/15 time, every 2 weeks check CT in Patients During Radiotherapy, assessment therapeutic effect.Test group patient is before radiotherapy after 4h and radiotherapy, and the Traditional Chinese medicine gel using embodiment 2 formulation and technology to prepare is coated with outward, 2 times/d, is cleaned gently by previous ointment cotton swab before each medication.Traditional Chinese medicine gel is coated with thickness 3 ~ 5mm outward; The scope of smearing is greater than irradiation field edge 1cm.Matched group patient is before radiotherapy after 4h and radiotherapy, and the Blank gel using embodiment 2 technique to prepare is coated with outward, 2 times/d, gives 1 ︰ 5000 potassium permanganate solution demibain, 2 times/d after radiotherapy simultaneously.Observe two groups of patients and the time of radiation skin injury and the healing time of radiation skin injury occur.Result of the test shows, the test group generation radiation skin injury time is later than matched group (P < 0.05), radiation skin injury healing time is shorter than matched group (P < 0.01), and difference has statistical significance.

The radiation skin injury time occurs a table 1 liang group patient and healing time compares

Compare with matched group, ^*p < 0.05, ^*p < 0.01.

Claims (5)

1. one kind is prevented the pharmaceutical composition of rectal cancer radiation skin injury, this pharmaceutical composition is made up of active component and adjuvant, it is characterized in that: described active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 13-20 part, Fructus Tribuli 12-18 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 12-18 part, Hibiscus cancellatus Roxb. 13-20 part, Herba Lycopi 21-30 part, Rhizoma Atractylodis Macrocephalae 21-30 part, Fructus Amomi 6-12 part, Herba Hyperici 10-20 part.

2. the pharmaceutical composition of prevention rectal cancer radiation skin injury according to claim 1, is characterized in that: described active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 15-17 part, Fructus Tribuli 14-16 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 14-16 part, Hibiscus cancellatus Roxb. 15-17 part, Herba Lycopi 24-26 part, Rhizoma Atractylodis Macrocephalae 24-26 part, Fructus Amomi 8-10 part, Herba Hyperici 14-16 part.

3. the pharmaceutical composition of prevention rectal cancer radiation skin injury according to claim 2, is characterized in that: described active component is prepared through water extract-alcohol precipitation by the traditional Chinese medicinal material raw materials of following weight portion and obtains: Folium potentillae velutinae (Radix Potentillae Fulgentis) 16 parts, Fructus Tribuli 15 parts, Citrus chachiensis Hort. (C．Suavissima Tanaka) 15 parts, Hibiscus cancellatus Roxb. 16 parts, Herba Lycopi 25 parts, the Rhizoma Atractylodis Macrocephalae 25 parts, Fructus Amomi 9 parts, Herba Hyperici 15 parts.

4. prevent a preparation method for the pharmaceutical composition of rectal cancer radiation skin injury, it is characterized in that, the method comprises the steps:

(1) traditional Chinese medicinal material raw materials Folium potentillae velutinae (Radix Potentillae Fulgentis) 13-20 part, Fructus Tribuli 12-18 part, Citrus chachiensis Hort. (C．Suavissima Tanaka) 12-18 part, Hibiscus cancellatus Roxb. 13-20 part, Herba Lycopi 21-30 part, Rhizoma Atractylodis Macrocephalae 21-30 part, Fructus Amomi 6-12 part and Herba Hyperici 10-20 part is got, decoct with water and extract 2-5h, decocting liquid adds ethanol after concentrated makes volume alcohol content reach 70-78%, 2-8 DEG C of cold preservation 12-48 hour, filter, filtrate recycling ethanol is also concentrated, dry, obtains Chinese medicine dried cream powder;

(2) fully swollen in distilled water by carbomer, add glycerol and propylene glycol, laurocapram grinding makes moistening, and add triethanolamine and grind to form clear gel substrate, heating in water bath is to 68-73 DEG C;

(3) get Chinese medicine dried cream powder prepared by step (1), and get tween 80 and mixed with propylene glycol, after heating for dissolving, this medicinal liquid is joined in gel-type vehicle prepared by step (2), stir, adding distil water standardize solution, continue to stir, obtain gel.

5. the application of the traditional Chinese medicinal material raw materials compositions according to claim 1-3 in the medicine of preparation control rectal cancer radiation skin injury.