CN116726104B - Traditional Chinese medicine composition for preventing and treating radioactive oral mucositis and preparation method thereof - Google Patents

Traditional Chinese medicine composition for preventing and treating radioactive oral mucositis and preparation method thereof Download PDF

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CN116726104B
CN116726104B CN202310927327.2A CN202310927327A CN116726104B CN 116726104 B CN116726104 B CN 116726104B CN 202310927327 A CN202310927327 A CN 202310927327A CN 116726104 B CN116726104 B CN 116726104B
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root
chinese medicine
traditional chinese
medicine composition
oral mucositis
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CN116726104A (en
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蔡小慧
郭珊
陈润
刘芬玉
何书情
平亚楠
郭小琼
陈婷娟
洪逊强
曾春雨
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TCM-INTEGRATED HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/21Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/804Rehmannia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/80Scrophulariaceae (Figwort family)
    • A61K36/808Scrophularia (figwort)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964Anemarrhena
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P39/00General protective or antinoxious agents
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for preventing and treating radioactive oral mucositis and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components: 20-25g of roughhaired holly root, 10-15g of gypsum, 15-20g of prepared rehmannia root, 5-10g of rhizoma anemarrhenae, 10-15g of radix scrophulariae, 5-10g of medicinal cyathula root and 5-10g of raw licorice. The preparation method of the traditional Chinese medicine composition comprises the following steps: weighing roughhaired holly root, gypsum, prepared rehmannia root, rhizoma anemarrhenae, radix scrophulariae, medicinal cyathula root and raw licorice according to the formula amount; decocting the weighed medicines with water to obtain a Chinese medicinal liquid; filtering the Chinese medicinal liquid, and packaging into bag. The traditional Chinese medicine composition can prevent and treat radioactive oral mucositis, has small stimulation and no dependence, relieves pain of patients, and improves the quality of life of the patients.

Description

Traditional Chinese medicine composition for preventing and treating radioactive oral mucositis and preparation method thereof
Technical Field
The invention relates to a traditional Chinese medicine and a preparation method thereof, in particular to a traditional Chinese medicine composition for preventing and treating radioactive oral mucositis. The invention also relates to a preparation method of the traditional Chinese medicine group.
Background
Head and neck tumor is a kind of ten malignant tumors affecting the health of residents in China, which is caused by the high incidence of the tumors in various provinces in south China and south China. Radiation therapy is the first treatment method, and the survival rate of 5 years is 80%. Radiation therapy inevitably damages normal tissues and organs, causing various kinds of radiation damage. Radioactive oral mucositis (Radiotherapy-inducedoralmucositis, RTOM) is the most common adverse reaction in the radiotherapy process of patients with nasopharyngeal carcinoma, and the incidence rate is 46% -78.1%. RTOM not only cause pain, feeding difficulties and malnutrition to the patient, but also cause oral infections, parts of the patient even interrupt radiation therapy, resulting in prolonged hospitalization and affecting the quality of life of the patient.
At present, no specific medicine is used for treating the radioactive oral mucositis, and the treatment measures mainly comprise nutrition supply, pain control and secondary infection prevention, and have poor curative effect.
Disclosure of Invention
Aiming at the technical problems, the first aim of the invention is to provide a traditional Chinese medicine composition for preventing and treating radioactive oral mucositis, which can prevent and treat radioactive oral mucositis, has little stimulation and no dependence, reduces pain of patients and improves the life quality of patients.
The second aim of the invention is to provide a preparation method of the traditional Chinese medicine composition for preventing and treating radioactive oral mucositis, and the composition prepared by the method has good curative effect and is convenient to store and carry.
The first object of the invention is achieved by the following technical scheme: a traditional Chinese medicine composition for preventing and treating radioactive oral mucositis comprises the following components: 20-25g of roughhaired holly root, 10-15g of gypsum, 15-20g of prepared rehmannia root, 5-10g of rhizoma anemarrhenae, 10-15g of radix scrophulariae, 5-10g of medicinal cyathula root and 5-10g of raw licorice.
Further, the traditional Chinese medicine composition comprises the following components: 22-25g of roughhaired holly root, 12-15g of gypsum, 15-18g of prepared rehmannia root, 5-10g of rhizoma anemarrhenae, 10-15g of radix scrophulariae, 8-10g of medicinal cyathula root and 5-8g of raw licorice.
Further, the traditional Chinese medicine composition comprises the following components: 24g of roughhaired holly root, 15g of gypsum, 15g of prepared rehmannia root, 9g of rhizoma anemarrhenae, 12g of radix scrophulariae, 9g of medicinal cyathula root and 6g of raw licorice.
The second object of the invention is achieved by the following technical scheme: the preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) Weighing roughhaired holly root, gypsum, prepared rehmannia root, rhizoma anemarrhenae, radix scrophulariae, medicinal cyathula root and raw licorice according to the formula amount;
(2) Decocting the medicine weighed in the step (1) with water to prepare a Chinese medicine aqua;
(3) Filtering the Chinese medicinal liquid, and packaging into bag.
Further, in the step (2), the boiling time is 10-15 minutes.
Compared with the prior art, the invention has the following beneficial effects:
1. The traditional Chinese medicine composition for preventing and treating the radioactive oral mucositis can prevent and treat the radioactive oral mucositis, has small stimulation and no dependence, and improves the life quality of the radioactive oral mucositis.
2. The traditional Chinese medicine composition disclosed by the invention can improve pathogenic fire toxin of radiation and has a protective effect on mucous membrane injury caused by radiotherapy. The Chinese medicinal composition can complement each other with radiotherapy, and can reduce toxic and side effects caused by the treatment while treating tumors so as to improve the immunity of patients and relieve side effects and pains of the patients after the radiotherapy.
The root of Ilicis Asprellae is the root and stem of the plant of the family Ilicis Purpureae; bitter, sweet and cool in nature, enter lung, spleen and stomach meridians. Clearing heat and detoxicating, promoting fluid production to quench thirst, inducing diuresis for removing edema, removing blood stasis and relieving pain are monarch drugs, and act on the etiology and pathogenesis characteristics of the nasopharyngeal carcinoma after radiotherapy. Gypsum, gypsum, radix rehmanniae Preparata, is sweet and warm in nature to nourish kidney and supplement yin, and is used as a ministerial drug; the two herbs are combined together to clear fire and nourish water, and the deficiency and excess are taken into account. Rhizoma anemarrhenae helps gypsum to clear stomach fire; radix scrophulariae, radix rehmanniae Preparata, assists in nourishing kidney yin and clearing away deficiency fire, and is used as an adjuvant drug. Achyranthes root, radix Achyranthis bidentatae is an assistant drug for guiding blood heat downward and tonifying liver and kidney. The formula can clear and tonify, and the principal aspects are that clearing is mainly adopted, so that stomach heat is cleared, kidney yin is nourished, and all the symptoms are self-healed. The medicines are combined to achieve the purpose of treating the radioactive oral mucositis.
3. The preparation method of the traditional Chinese medicine composition disclosed by the invention is used for decocting in proper time, so that the medicine components in the raw materials can be kept more conveniently, and the prepared composition is convenient to carry and store.
Description of the embodiments
The technical scheme of the present invention will be described in further detail below with reference to the specific embodiments, but the present invention is not limited thereto.
Example 1
Weighing 20g of roughhaired holly root, 10g of gypsum, 15g of prepared rehmannia root, 10g of rhizoma anemarrhenae, 15g of radix scrophulariae, 10g of medicinal cyathula root and 10g of raw liquorice, pouring into a pot, decocting with slow fire for 10 minutes, decocting into about 200mL of Chinese medicinal liquid, filtering with a 50-80 mesh screen to remove filter residues, bagging the liquid, and storing in a refrigerator.
Example 2
25G of roughhaired holly root, 15g of gypsum, 18g of prepared rehmannia root, 5g of rhizoma anemarrhenae, 10g of radix scrophulariae, 8g of medicinal cyathula root and 5g of raw liquorice.
The preparation method is the same as in example 1.
Example 3
24G of roughhaired holly root, 15g of gypsum, 15g of prepared rehmannia root, 9g of rhizoma anemarrhenae, 12g of radix scrophulariae, 9g of medicinal cyathula root and 6g of raw licorice.
The preparation method is the same as in example 1.
Application example
In order to examine the efficacy of the traditional Chinese medicine composition, 20 patients with nasopharyngeal carcinoma for radiation therapy of 2021 month 1 to 2022 month 3 are selected, and are divided into an odd group and an even group according to the starting time sequence of radiation therapy, wherein the odd group is a control group, 10 patients are total, and the even group is an experimental group, and 10 patients are total. Both groups of patients employed conventional radical radiotherapy. The control group was nursed by conventional means, rinsed with vitamin B12, 6 times daily. The experimental group used the traditional Chinese medicine composition prepared in example 3 to rinse the mouth, a small amount of solution was added into the mouth during rinsing, the lips were closed, the upper and lower teeth were slightly opened, the liquid was passed through the interproximal area, the pressure was lightly applied, and then the cheeks and lips were driven, so that the solution could fully contact the mucosal surface of the oral cavity in the oral cavity, and at the same time the tongue was moved, so that the mouthwash could freely contact each part of the oral cavity and repeatedly rinse several times. Then the head is lifted up for 15s and then spitted out. Gargling time; 6 times daily (before and after dinner in the morning) each time lasting for 3-5 minutes, 30-40mL each time.
Beginning after radiotherapy, two groups of oral mucosa were observed weekly for the extent of radioactivity. Prior to intervention, the sex, age, regimen, dose, and cycle of the two groups were comparable. The results after intervention show that the effect of the experimental group is obviously better than that of the control group. As shown in table 1 (data is statistics made the third week after radiotherapy):
Remarks: radioactive oral mucositis is classified as grade 5 according to World Health Organization (WHO) standards. Level 0: the mucous membrane is normal and unchanged; stage 1: the mucous membrane has congestion, slight pain, and no influence on eating; 2 stages: mucous membrane presents sheet inflammation with inflammatory serum secretion, moderate pain, and can enter semifluid diet; 3 stages: the mucous membrane is in a fusion fiber sheet shape, is obviously serious and is accompanied with severe pain, and can only enter fluid diet; 4 stages: mucous membranes have bleeding, ulcers and necrosis manifestations, and are difficult to eat.
Table 1 comparison of the efficacy of the control and experimental groups
Classification of group Level 0 radioactive oral mucositis 1-Level radioactive oral mucositis Level 2 radioactive oral mucositis Grade 3 radioactive oral mucositis Grade 4 radioactive oral mucositis
Control group (n=10) 0 0 4 6 0
Experiment set (n=10) 1 3 6 0 0
Therefore, the traditional Chinese medicine composition prepared by the invention can play a role in preventing oral mucositis, can also promote healing or reduction of oral cavity to a great extent, most patients can eat normally in the treatment process, and a small part of patients can eat semi-fluid food.
In addition, patients were given oral mucositis grading, pain scores, oral condition assessment criteria assessment (OAG) weekly during radiotherapy, once weekly in three months after radiotherapy, oral mucositis grading, pain scores, oral condition assessment criteria, oral mucosal healing time.
Compared with a control group, after the oral mucositis time delay occurs at the beginning of patients in the experimental group, the average onset time is 14.80+/-0.84 days, and the average onset time in the control group is 12.40+1.82 days, wherein P is less than 0.05; the oral cavity OAG score (12.20+/-2.28) of the patient in the experimental group is obviously lower than that of the patient in the control group (17.20+/-1.30), and P is less than 0.01, so that the severity of oral mucositis of the patient can be reduced to a certain extent; and the average oral mucositis of the patients in the experimental group is recovered to be below grade 1 (38.80+/-2.17) which is far shorter than that of the patients in the control group (45.60+/-1.94), and P is less than 0.01.
Therefore, the traditional Chinese medicine composition provided by the application can reduce the incidence rate of radioactive oral mucositis of patients, delay the occurrence time of oral mucositis of patients after radiotherapy, accelerate the wound healing speed and improve the life quality of patients when being used for gargling. .

Claims (5)

1. A gargle traditional Chinese medicine composition for preventing and treating radioactive oral mucositis is characterized by being prepared from the following components: 20-25g of roughhaired holly root, 10-15g of gypsum, 15-20g of prepared rehmannia root, 5-10g of rhizoma anemarrhenae, 10-15g of radix scrophulariae, 5-10g of medicinal cyathula root and 5-10g of raw licorice.
2. The mouthwash traditional Chinese medicine composition for preventing and treating radioactive oral mucositis according to claim 1, which is characterized by being prepared from the following components: 22-25g of roughhaired holly root, 12-15g of gypsum, 15-18g of prepared rehmannia root, 5-10g of rhizoma anemarrhenae, 10-15g of radix scrophulariae, 8-10g of medicinal cyathula root and 5-8g of raw licorice.
3. The mouthwash traditional Chinese medicine composition for preventing and treating radioactive oral mucositis according to claim 1 or 2, which is characterized by being prepared from the following components: 24g of roughhaired holly root, 15g of gypsum, 15g of prepared rehmannia root, 9g of rhizoma anemarrhenae, 12g of radix scrophulariae, 9g of medicinal cyathula root and 6g of raw licorice.
4. A method for preparing a mouthwash traditional Chinese medicine composition for preventing and treating radioactive oral mucositis according to any one of claims 1 to 3, which is characterized by comprising the following steps:
(1) Weighing roughhaired holly root, gypsum, prepared rehmannia root, rhizoma anemarrhenae, radix scrophulariae, medicinal cyathula root and raw licorice according to the formula amount;
(2) Decocting the medicine weighed in the step (1) with water to prepare a Chinese medicine aqua;
(3) Filtering the Chinese medicinal liquid, and packaging into bag.
5. The method for preparing a gargle Chinese medicinal composition for preventing and treating radioactive oral mucositis according to claim 4, wherein in the step (2), the time of decocting is 10-15 minutes.
CN202310927327.2A 2023-07-27 2023-07-27 Traditional Chinese medicine composition for preventing and treating radioactive oral mucositis and preparation method thereof Active CN116726104B (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1136455A (en) * 1996-03-01 1996-11-27 汪毅 Compound lozenge of Anemone rivularis
CN104800369A (en) * 2015-04-15 2015-07-29 苏州市天灵中药饮片有限公司 Traditional Chinese medicine liquid for treating oral ulcer and preparation method of traditional Chinese medicine liquid
CN105213807A (en) * 2015-10-30 2016-01-06 王栩 Be used for the treatment of the medicine of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1136455A (en) * 1996-03-01 1996-11-27 汪毅 Compound lozenge of Anemone rivularis
CN104800369A (en) * 2015-04-15 2015-07-29 苏州市天灵中药饮片有限公司 Traditional Chinese medicine liquid for treating oral ulcer and preparation method of traditional Chinese medicine liquid
CN105213807A (en) * 2015-10-30 2016-01-06 王栩 Be used for the treatment of the medicine of type of hyperactivity of fire caused by deficiency of YIN recurrent oral ulceration

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
中医药治疗复发性口腔溃疡临床分析;颜学清;《亚太传统医药》;-;20140805;第10卷(第15期);第63-64页 *
小儿口糜验案3则;朱国强;《新中医》;19960715(第07期);第39-40页 *

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