CN103877307B

CN103877307B - A kind of pharmaceutical composition for preventing and treating chemotherapy induced stomatitis and its application

Info

Publication number: CN103877307B
Application number: CN201410091282.0A
Authority: CN
Inventors: 王娟; 朱鲲
Original assignee: Qingdao Stomatological Hospital
Current assignee: Qingdao Stomatological Hospital
Priority date: 2014-03-13
Filing date: 2014-03-13
Publication date: 2017-07-07
Anticipated expiration: 2034-03-13
Also published as: CN103877307A

Abstract

The invention discloses a kind of pharmaceutical composition for preventing and treating chemotherapy induced stomatitis and its application, the pharmaceutical composition is prepared from by the traditional Chinese medicinal material raw materials of following weight portion：It is black lead a cow 24 33 parts, 24 33 parts of trident bitter root, 6 12 parts of RHIZOMA ARISAEMATIS, 28 40 parts of oldenlandia diffusa, 48 parts of costus root, 15 25 parts of alkanet, 15 25 parts of the sterculia seed, 8 15 parts of honey-fried licorice root.The pharmaceutical composition has the advantages that effect is significant for the prevention of chemotherapy induced stomatitis disease, while cost accounting is low, patient medication interdependence is high.

Description

A kind of pharmaceutical composition for preventing and treating chemotherapy induced stomatitis and its application

Technical field

The invention belongs to technical field of Chinese medicine, in particular to a kind of drug regimen for preventing and treating chemotherapy induced stomatitis Thing and its application.

Background technology

Be tumor patient receive in chemotherapy process more typically, one of most painful toxic and side effect.Patient's pathological change of oral cavity area sticks Film is congested, is dispersed in the soft small white spots of dimpling matter, and rear white point fusion forms leukasmus.Clinical cardinal symptom is spontaneous in oral cavity Property acutely burn, oedema, ulcer, sharp ache occur, influence patient speaks and takes food.Its pain degree not only influences patient's People and quality of life are taken the photograph in nutrition, can also induce parotitis, even tympanitis, severe systemic infection.

It is reported that the incidence of the concurrent stomatitis of patients undergoing chemotherapy is up to 66%, it is higher up to 88%.Immunity of organism work(after chemotherapy The energy system of being faced upward, Neutrophilic granulocytopenia or shortage, saliva of buccal cavity secretion are reduced, and pH value changes, it is impossible to effective to suppress Intraoral bacterium, oral cavity self purification declines, and causes halitosis, destroys internal environment of oral cavity, causes mucous membrane of mouth to be damaged and forms mouth Chamber ulcer.Oral mucositis decline the quality of life of patient, not only increase the pain on the body of patient, return patient's Psychology poses a big pressure, and reduces the confidence of patient for treatment, influences the carrying out of chemotherapy.Therefore, by oral cavity during chemotherapy Take positive prevention and reduce the incidence of disease of oral mucositis, this has vital meaning to the life quality for improving patient Justice.

Chemotherapy induced stomatitis are clinically prevented and treated at present to relieve pain, keep oral cleaning, replenishing vitamins, anti-infective etc. to suit the medicine to the illness Based on treatment.Recently have also appeared the application of the medicines such as mucosa protection agent, cell factor.In these therapeutic schemes, some uses More complicated, the then price having costly, is unfavorable for clinical spread.

The content of the invention

In view of the deficiencies in the prior art, it is an object of the invention to provide a kind of drug regimen for preventing and treating chemotherapy induced stomatitis Thing and application., used as the secret prescription handed down in the family from generation to generation for treating canker sore, it is in the prevention for chemotherapy induced stomatitis for the pharmaceutical composition Effect is significant, and have the advantages that easy to use, cost is low, determine that it is a kind of chemotherapeutic mouth of preventing and treating after clinical application for many years The specific medicament of the scorching disease in chamber.

The object of the present invention is achieved like this：

A kind of pharmaceutical composition for preventing and treating chemotherapy induced stomatitis, it is by the traditional Chinese medicinal material raw materials preparation comprising following weight portion Into：Silene adenantha Franch 24-33 parts, 24-33 parts of trident bitter root, RHIZOMA ARISAEMATIS 6-12 parts, oldenlandia diffusa 28-40 parts, costus root 4-8 parts, alkanet 15-25 parts, sterculia seed 15-25 parts, honey-fried licorice root 8-15 parts.

Preferably, the pharmaceutical composition of preventing and treating chemotherapy induced stomatitis as described above, it by following weight portion Chinese medicine Raw material is prepared from：Silene adenantha Franch 27-29 parts, 27-29 parts of trident bitter root, RHIZOMA ARISAEMATIS 8-10 parts, oldenlandia diffusa 32-35 Part, costus root 5-7 parts, alkanet 18-22 parts, sterculia seed 18-22 parts, honey-fried licorice root 10-12 parts.

In a most preferred embodiment of the invention, the pharmaceutical composition of preventing and treating chemotherapy induced stomatitis as described above It is prepared from by the traditional Chinese medicinal material raw materials of following weight portion：28 parts of Silene adenantha Franch, 28 parts of trident bitter root, 9 parts of RHIZOMA ARISAEMATIS, spend in vain 33 parts of HERBA HEDYOTIS DIFFUSAE, 6 parts of costus root, 20 parts of alkanet, 20 parts of the sterculia seed, 11 parts of honey-fried licorice root.

By experimental study find, pharmaceutical composition of the present invention for chemotherapy induced stomatitis therapeutic effect very Significantly, therefore, second object of the present invention is to provide a kind of pharmaceutical applications, i.e. aforementioned pharmaceutical compositions to prepare preventing and treatingization Application in the medicine of the property treated stomatitis.In pharmaceutical applications, the pharmaceutical composition can be prepared as oral formulations, it is also possible to prepare It is external preparation.Oral formulations therein include oral liquid, tablet, capsule, granule；External preparation therein include creme, Spray.

Compared with prior art, pharmaceutical composition of the present invention has the following advantages that and marked improvement：(1) pre- chemical defence The effect is significant of the property treated stomatitis：Medicine of the present invention is used while chemotherapy, result is that oral mucositis incidence is low, occurred The patient of stomatitis, its mucosa ulcer lesser extent.(2) spend few, it is easy to use：The pharmaceutical composition by some it is conventional in Medicinal raw material is prepared from, oral, therefore cost accounting is low, and patient not only spends few, and medication interdependence is high.

Specific embodiment

The following is specific embodiment of the invention, technical scheme is done and is further described, but it is of the invention Protection domain be not limited to these embodiments.It is every to be included in this hair without departing substantially from the change of present inventive concept or equivalent substitute Within bright protection domain.

It should be noted that the traditional Chinese medicinal material raw materials that the embodiment of the present invention is used have following source：Silene adenantha Franch is selected The root of pinkwort gland flower silene aprica Silene adenantha Franch..Trident bitter root is planted from Rutaceae Evodia The dry root of thing evodia lepta Evodia lepta (Spreng.) Merr..RHIZOMA ARISAEMATIS is from the aroid tiger palm The dry tuber of Pinellia pedatisecta Schott.Oldenlandia diffusa is selected from madder wort oldenlandia diffusa Hedyotis diffusaWilld.'s dries herb.Costus root selects feverfew banksia rose Aucklandia lappa Decne. dry root.Alkanet is from the dry of comfrey lithospermum euchromum Royle Arnebia euchroma (Royle) Johnst. Dry.Dry mature seed of the sterculia seed from Sterculiaceae xylophyta sterculia seed Sterculia lychnophora Hance. Honey-fried licorice root selects dicotyledon pulse family Leguminosae Radix Glycyrrhizae Glycyrrhiza uralensis Fisch., swollen fruit Radix G.inflata Bat., or the root and rhizome of glycyrrhiza glabra G.glabra L. is baked and obtained with honey.

Embodiment 1

Crude drug prescription：Silene adenantha Franch 280g, trident bitter root 280g, RHIZOMA ARISAEMATIS 90g, oldenlandia diffusa 330g, wide wood Fragrant 60g, alkanet 200g, sterculia seed 200g, honey-fried licorice root 110g.

Preparation method：Weigh the Silene adenantha Franch of recipe quantity, trident bitter root, RHIZOMA ARISAEMATIS, oldenlandia diffusa, costus root, Alkanet, the sterculia seed and honey-fried licorice root, clean impurity elimination, dry, and crush；Above-mentioned graininess medicinal material is added water again covers powder 2cm, soaked Bubble 1-1.2h, pulls out during medicinal material puts multi-function extraction tank and adds water to cook secondary, first time 10 times of water of amount of totalling medicinal material, decocts 2h, takes decocting liquid, filtration, second totalling medicinal material, 8 times of water of amount, decocts 1h, takes decocting liquid twice and merges, and filtration is concentrated into 90 DEG C When relative density for 1.15g/mL concentrate；Concentrate is set to 0 into -5 DEG C of deepfreeze 24h, the drainage that liquid adds 0.3% will be refrigerated Agent diatomite, filtration, filtrate is further concentrated to every milliliter of crude drug amount containing 8g, sets to 0-5 DEG C of deepfreeze 24h, and refrigeration liquid filtration is obtained Liquid.

Embodiment 2

Crude drug prescription：Silene adenantha Franch 240g, trident bitter root 250g, RHIZOMA ARISAEMATIS 100g, oldenlandia diffusa 350g, wide wood Fragrant 60g, alkanet 180g, sterculia seed 150g, honey-fried licorice root 120g.

Preparation method：Weigh the Silene adenantha Franch of recipe quantity, trident bitter root, RHIZOMA ARISAEMATIS, oldenlandia diffusa, costus root, Alkanet, the sterculia seed and honey-fried licorice root, clean impurity elimination, dry, and crush；Above-mentioned graininess medicinal material is added water again covers powder 2cm, soaked Bubble 1-1.2h, pulls out during medicinal material puts multi-function extraction tank and adds water to cook secondary, first time 8 times of water of amount of totalling medicinal material, decocts 2h, Decocting liquid is taken, is filtered, second totalling medicinal material, 8 times of water of amount decoct 1h, take decocting liquid twice and merge, and filtration is concentrated into 90 DEG C of phases It is the concentrate of 1.15g/mL to density；Concentrate is set to 0 into -5 DEG C of deepfreeze 24h, the filter aid silicon that liquid adds 0.3% will be refrigerated Diatomaceous earth, filtration, filtrate is further concentrated to every milliliter of crude drug amount containing 8g, sets to 0-5 DEG C of deepfreeze 24h, by refrigeration liquid filtration, obtains medicine Liquid.

Embodiment 3

Crude drug prescription：Silene adenantha Franch 300g, trident bitter root 330g, RHIZOMA ARISAEMATIS 120g, oldenlandia diffusa 400g, wide wood Fragrant 80g, alkanet 250g, sterculia seed 200g, honey-fried licorice root 100g.

Preparation method：Weigh the Silene adenantha Franch of recipe quantity, trident bitter root, RHIZOMA ARISAEMATIS, oldenlandia diffusa, costus root, Alkanet, the sterculia seed and honey-fried licorice root, clean impurity elimination, dry, and crush；Above-mentioned graininess medicinal material is added water again covers powder 2cm, soaked Bubble 1-1.2h, pulls out during medicinal material puts multi-function extraction tank and adds water to cook secondary, first time 8 times of water of amount of totalling medicinal material, decocts 2h, Decocting liquid is taken, is filtered, second totalling medicinal material, 6 times of water of amount decoct 1h, take decocting liquid twice and merge, and filtration is concentrated into 90 DEG C of phases It is the concentrate of 1.15g/mL to density；Concentrate is set to 0 into -5 DEG C of deepfreeze 24h, the filter aid silicon that liquid adds 0.3% will be refrigerated Diatomaceous earth, filtration, filtrate is further concentrated to every milliliter of crude drug amount containing 9g, sets to 0-5 DEG C of deepfreeze 24h, by refrigeration liquid filtration, obtains medicine Liquid.

The liquid of the present invention of embodiment 4 prevents and treats the effectiveness study of chemotherapy induced stomatitis

Infusion in Patients with Digestive 63, foundation-free mouth disease.Wherein male 34, women 29, average age 52.8 ± 3.1 years old；Stomach cancer 26, colorectal cancer 37.All patients need to receive 5 FU 5 fluorouracil chemotherapy that (5 FU 5 fluorouracil makes It is 2.0~2.5g/m of each cycle chemotherapy with total amount³).All tumor patients are randomly divided into test group (32) and control group (31 Example), two groups of patient ages, sex, there are no significant for physical situation comparing difference.

Control group patient uses cooperatively vitamin B complex tablet (Guangdong Hengjian Pharmaceutical Co., Ltd. in first day from chemotherapy is started Production, Chinese medicines quasi-word H44021164), 2 pieces/times, 3 times/day.Test group patient from start chemotherapy first day use cooperatively according to Liquid 10rnL prepared by the formulation and technology of the embodiment of the present invention 1, containing slowly being swallowed (after the meal) after gargling 2-3min, 3 times/day, while connection Close vitamin B complex tablet, 2 pieces/times, 3 times/day.Two groups of equal continuous uses 1 week.

The order of severity that therapeutic process observation portacaval mucositis occur, with reference to the graduated scale of WHO cancer therapy drug toxicities Brigadier's portacaval mucositis are divided into following 5 degree by weight reaction：

0 degree：Mucous membrane is normal；I degree：Mucous membrane erythema, without pain or ulcer；II degree：Mucous membrane erythema ulcer is obvious, pain, energy Enter semi-fluid；III degree：Than II degree substantially, pain can only enter liquid diet to mucous membrane erythema ulcer；IV degree：Sharp ache, ulcer is melted Synthesize big sheet, it is impossible to take food, need the supportive treatments such as parenteral nutrition.

Two groups of patient's oral mucositis incidences compare：There is stomatitis 3, incidence 10.0% in Chinese medicine group；Control group Generation stomatitis 20, incidence is 69.0%.

Number of cases two groups of patient's oral mucositis occurs and light and heavy degree is relatively shown in Table 1.Can be seen by the result of the test of table 1 Go out, test group will occur the patient only 5 of stomatitis, incidence 15.6% after chemotherapy；And have 20 generations after control group chemotherapy Stomatitis, incidence is 64.5%, wherein there is more than III degree stomatitis up to 8, hence it is evident that more than test group.

Number of cases 1 two groups of patient's oral mucositis of table occurs and light and heavy degree compares (example)

Claims

1. it is a kind of prevent and treat chemotherapy induced stomatitis pharmaceutical composition, it is characterised in that：Described pharmaceutical composition is by following weight The traditional Chinese medicinal material raw materials of part are prepared from：28 parts of Silene adenantha Franch, 28 parts of trident bitter root, 9 parts of RHIZOMA ARISAEMATIS, oldenlandia diffusa 33 11 parts of part, 6 parts of costus root, 20 parts of alkanet, 20 parts of the sterculia seed and honey-fried licorice root.

2. application of the pharmaceutical composition described in claim 1 in the medicine for preparing preventing and treating chemotherapy induced stomatitis.

3. application according to claim 2, it is characterised in that：Described medicine is oral formulations or/and external preparation.

4. application according to claim 3, it is characterised in that：Described oral formulations are oral liquid, tablet, capsule or particle Agent.

5. application according to claim 3, it is characterised in that：Described external preparation is creme or spray.