CN102698068B - Preparation method for oral nursing solution for preventing oral mucositis caused by chemotherapy - Google Patents
Preparation method for oral nursing solution for preventing oral mucositis caused by chemotherapy Download PDFInfo
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Abstract
The invention discloses a preparation method for oral nursing solution for preventing the oral mucositis caused by chemotherapy, for solving a problem of prevention for the oral mucositis caused by chemotherapy. The raw materials of the oral nursing solution comprise serissa serissoides, fructus ligustri lucidi, ficus virens leaves, sarcandra glabra, radix rehmanniae, radix scrophulariae, radix ophiopogonis, radix adenophorae and rhizoma anemarrhenae; and the preparation method is characterized by comprising the following steps of: (1) distilling the serissa serissoides, the fructus ligustri lucidi, the ficus virens leaves and the sarcandra glabra with steam to obtain a distillate; (2) adding the radix rehmanniae, the radix scrophulariae, the radix ophiopogonis, the radix adenophorae and the rhizoma anemarrhenae in the dregs of the distilled raw material medicines, and decocting with water to obtain a filtrate; (3) centrifuging the filtrate to obtain the supernatant, adding the distillate, adding water for injection, and then performing ultrafiltration; and (4) filling, sterilizing and packaging the ultrafiltrate. Clinical experiments prove that the oral nursing solution prepared by the method disclosed by the invention has characteristics of good curative effect and high safety for preventing the oral mucositis caused by chemotherapy, and is worthy of clinical application and popularization.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to prevent the mouth care liquid and preparation method thereof of oral mucositis due to the chemotherapy.
Background technology
Oral mucositis (Oral Mucositis, OM) be meant the struvite of oral cavity and ulcer reaction, it is comparatively common and one of the severe complications of malignant tumor patient chemotherapy, conventional chemotherapy patient stomatitis incidence rate is up to 40%, and the incidence rate of child patient, tumor of head and neck and combined chemotherapy person's stomatitis is higher.Its cardinal symptom is local pain and gustatory anesthesia, especially with feed, speaking and running into hot and cold, sour, sweet etc. stimulates that afterwards pain is more obvious.It directly influences patient's feed, has brought very big misery to the patient.Simultaneously, therefore also can be and delay treatment, be forced to reduce the dosage of chemotherapeutics, bring adverse influence to prognosis.Serious oral mucositis also is the principal element of lethal infection, and according to relevant bibliographical information, its septicemia of 64% patients undergoing chemotherapy is by due to the oral mucositis.The generation of prevention oral mucositis is also in time treated oral mucositis, to finishing chemotherapy smoothly, reduces complication, and it is significant to ensure that chemotherapy successfully reaches the quality of life of improving the patient.
Up to the present, the method at the prevention of chemotherapy stomatitis mainly is: rinsing the mouth 0.8% allopurinol solution (compound method is allopurinol sheet 2 gram grind into powder+normal saline 250 ml); The rinsing the mouth method is 3 times/d, 20 ml/ time, rinsing the mouth 3 ~ 5 min, and the rinsing the mouth time is after three cold after the meal boiled water are gargled, to begin to end of chemotherapy from chemotherapy.The weak point of this method is: total effective rate is on the low side, probably maintains about 60%.
Summary of the invention
Technical assignment of the present invention is at above the deficiencies in the prior art, and the mouth care liquid and preparation method thereof of oral mucositis due to the sure prevention chemotherapy of a kind of curative effect is provided.
The technical scheme that the present invention solves its technical problem is: a kind of mouth care liquid and preparation method thereof that prevents oral mucositis due to the chemotherapy, described oral nursing liquid raw material comprises 6 ~ 10 parts of Radix Serissae, 8 ~ 15 parts of Fructus Ligustri Lucidi, 8 ~ 15 parts of Folium fici wightianae (Ficus wightiana Wall)s, 6 ~ 10 parts in the Radix Rehmanniae, 6 ~ 10 parts of Radix Scrophulariaes, 8 ~ 15 parts of Radix Ophiopogonis, 6 ~ 10 parts of Radix Adenophorae (Radix Glehniae), 8 ~ 15 parts of the Rhizoma Anemarrhenaes, 3 ~ 6 parts of Herba Sarcandraes is characterized in that its preparation method may further comprise the steps:
(1) Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), Herba Sarcandrae are mixed, add the water of 3 ~ 6 times of weight, collect distillate with steam distillation, distillate is carried out redistillation, it is standby to get rectification liquid;
(2) the crude drug medicinal residues after will distilling add the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), the Rhizoma Anemarrhenae, and the water boiling that adds 4 ~ 6 times of weight decocts 2 times, and each 1 ~ 2 hour, filter, merge filtrate twice;
(3) described filtrate is centrifugal with centrifuge, gets supernatant, adds described rectification liquid, and mix homogeneously adds ultrafiltration after the injection water;
(4) ultrafiltrate fill sealing by fusing under the dust-free sterile condition, 100 ℃ of circulation steam sterilizations 30 minutes, packing.
Preferred version: between step (3) and (4), the active carbon that adds step (3) gained ultrafiltrate weight 0.5% in step (3) gained ultrafiltrate is heated with stirring to and boils, and filters carbon removal to clear and bright, adds ultrafiltration after the injection water.
Wherein said: Radix Serissae is the herb strain of dicotyledon medicine Maguireothamnus speciosus Radix Serissae Serissa serissoides (DC.) Druce or Serissa foetida Serissa japonica (Thunb.) Thunb..The nature and flavor toil; Cool; Nontoxic.Return liver; Spleen channel.Merit can be dispeled the wind; Dampness removing; Heat clearing away; Detoxifcation.
Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait..Nature and flavor are sweet, bitter, cold.Return liver, kidney channel.But the merit nourishing the liver and kidney, black hair makes eye bright.
Folium fici wightianae (Ficus wightiana Wall) is moraceae plants shaft of a writing brush banyan Ficus virens Ait .[F.wightana (Miq.)] leaf of Benth..Sweet in the mouth; Little hardship; Property is put down.But merit heat-clearing and toxic substances removing; Removing damp to relieve itching.
The Radix Rehmanniae is the scrophulariaceae rehmannia glutinosa plant rhizome.Nature and flavor sweetness and bitterness, cold.GUIXIN, liver, kidney channel.But the merit YIN nourishing nourishes blood.
Radix Scrophulariae for Scrophulariaceae Radix Scrophulariae kakudensis Scrophularia kaku densis Franch., is used as medicine with root.Nature and flavor hardship, salty, cold.But the merit YIN nourishing, pathogenic fire reducing, relieving restlessness, detoxifcation.
Radix Ophiopogonis, be the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf) Ophiopogon japonicus (Thunb.) Ker-Gawl..Nature and flavor are sweet, and little hardship is slightly cold.GUIXIN, lung, stomach warp.But the merit YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.
Radix Adenophorae (Radix Glehniae) is the dry root of campanulaceae plant adenophora tetraphylla Adenophora tetraphylla (Thunb.) Fisch. or Radix Adenophorae (Radix Glehniae) Adenophora stricta Miq..Nature and flavor are sweet, are slightly cold.Attach to the lung and stomach meridians.But the merit nourishing YIN and clearing away lung-heat is reduced phlegm, QI invigorating.
The Rhizoma Anemarrhenae is the dry rhizome of liliaceous plant Rhizoma Anemarrhenae Anemarrhena asphodeloides Bunge..Nature and flavor hardship, sweet, cold.Return lung, stomach, kidney channel.But the merit clearing away heat-fire promotes the production of body fluid and moisturizes.
Herba Sarcandrae is the dry Herb of Chloranthaceae plant plait Corallium Japonicum Kishinouye Sarcandra glabra (Thunb.) Nakai.Bitter, hot, flat.GUIXIN, Liver Channel.But the merit clearing away heat and cooling blood, the speckle removing of invigorating blood circulation, dispelling wind and removing obstruction in the collateral.
Composition principle: chemotherapeutics in killing tumor cell to the also toxigenicity effect of histiocyte of molecular marker for increased proliferation, promptly block ribonucleic acid and little formation and utilization of giving birth to element, destroy the growth of mucosal epithelium cell, suppress salivary gland secretion, cause oral mucosa drying, atrophy attenuation, fragility to increase, resist the ability drop of antibacterial, virus, fungus, ulcer then is inflamed.Chemotherapy causes that the characteristics of oral mucositis are pale for the beginning mucosa, indentation appears, the petechia of several grain of rice sizes and blood blister, swelling, the erosion of mucosa ulceration appear then, form one or about 0. 2 cm of several diameters ~ 0. 5 cm ulcer, red and swollen, pain around the ulcer, mucosa is extensively rotten to the corn when serious, can reach pharynx and esophagus, the deep can reach the flesh layer, surface coverage one deck white membranoid substance and slough.In the traditional Chinese medical science, how oral mucositis due to the chemotherapy is by due to the whole body internal organs QI and blood regulatory function obstacle, so oral mucositis is a mark, the pathological changes of internal organs QI and blood is this, and simulataneous insufficiency and excessive is the characteristics of primary disease, but each function fails more after the chemotherapy, violate primary disease often based on deficiency syndrome.It is principle that treatment should be set upright to dispel, eliminating evil should setting about from the clearing away heat-damp and promoting diuresis detoxifcation; Setting upright should be based on Yin-nourishing and body fluid promoting.Get Radix Serissae, Folium fici wightianae (Ficus wightiana Wall) expelling wind and removing dampness, heat-clearing and toxic substances removing in the prescription of the present invention, with eliminating evil; Radix Rehmanniae nourishing YIN and benefiting blood, the Radix Scrophulariae nourishing YIN to lower pathogenic fire, the Fructus Ligustri Lucidi nourishing the liver and kidney, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae) YIN nourishing and the production of body fluid promoting are to set upright; Rhizoma Anemarrhenae clearing away heat-fire, promote the production of body fluid and moisturize, reinforcement and elimination in combination; Herba Sarcandrae clearing away heat and cooling blood speckle removing is started with from blood system; More than all medicines share, play the effect of strengthening vital QI to eliminate pathogenic factors altogether, can prevent oral mucositis due to the chemotherapy.
Compared with prior art, the present invention has following characteristics:
1, reasonable recipe is attached most importance to benefit, relies mainly on prevention;
2, added blood system medicine Herba Sarcandrae, with the removing heat from blood collateral dredging;
3, prepare scheme by the pharmaceutics adjustment, kept effective ingredient as far as possible, and, reduced the medicinal residues impurity in the oral nursing liquid, reduced untoward reaction by centrifugal.
The specific embodiment
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, the crude drug weight proportion: Radix Serissae 6g, Fructus Ligustri Lucidi 8g, Folium fici wightianae (Ficus wightiana Wall) 8g, Radix Rehmanniae 6g, Radix Scrophulariae 6g, Radix Ophiopogonis 8g, Radix Adenophorae (Radix Glehniae) 6g, Rhizoma Anemarrhenae 8g, Herba Sarcandrae 3g.Its preparation method may further comprise the steps:
(1) Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), Herba Sarcandrae are mixed, add the water of 3 times of weight, collect distillate with steam distillation, distillate is carried out redistillation, it is standby to get rectification liquid;
(2) the crude drug medicinal residues after will distilling add the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), the Rhizoma Anemarrhenae, and the water boiling that adds 4 times of weight decocts 2 times, and each 1 hour, filter, merge filtrate twice;
(3) described filtrate is got supernatant with centrifuge centrifugal (300r/min) l0min, adds described rectification liquid, and mix homogeneously adds ultrafiltration after the injection water;
(4) ultrafiltrate fill sealing by fusing under the dust-free sterile condition, 100 ℃ of circulation steam sterilizations 30 minutes, packing.
Embodiment 2, the crude drug weight proportion: Radix Serissae 10g, Fructus Ligustri Lucidi 15g, Folium fici wightianae (Ficus wightiana Wall) 15g, Radix Rehmanniae 10g, Radix Scrophulariae 10g, Radix Ophiopogonis 15g, Radix Adenophorae (Radix Glehniae) 10g, Rhizoma Anemarrhenae 15g, Herba Sarcandrae 6g.Its preparation method may further comprise the steps:
(1) Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), Herba Sarcandrae are mixed, add the water of 6 times of weight, collect distillate with steam distillation, distillate is carried out redistillation, it is standby to get rectification liquid;
(2) the crude drug medicinal residues after will distilling add the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), the Rhizoma Anemarrhenae, and the water boiling that adds 6 times of weight decocts 2 times, and each 2 hours, filter, merge filtrate twice;
(3) described filtrate is got supernatant with centrifuge centrifugal (600r/min) 5min, adds described rectification liquid, and mix homogeneously adds ultrafiltration after the injection water;
(4) ultrafiltrate fill sealing by fusing under the dust-free sterile condition, 100 ℃ of circulation steam sterilizations 30 minutes, packing.
Embodiment 3, the crude drug weight proportion: Radix Serissae 8g, Fructus Ligustri Lucidi 10g, Folium fici wightianae (Ficus wightiana Wall) 10g, Radix Rehmanniae 8g, Radix Scrophulariae 8g, Radix Ophiopogonis 10g, Radix Adenophorae (Radix Glehniae) 8g, Rhizoma Anemarrhenae 10g, Herba Sarcandrae 5g.Its preparation method may further comprise the steps:
(1) Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), Herba Sarcandrae are mixed, add the water of 5 times of weight, collect distillate with steam distillation, distillate is carried out redistillation, it is standby to get rectification liquid;
(2) the crude drug medicinal residues after will distilling add the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), the Rhizoma Anemarrhenae, and the water boiling that adds 5 times of weight decocts 2 times, and each 1.5 hours, filter, merge filtrate twice;
(3) described filtrate is got supernatant with centrifuge centrifugal (300r/min) 15min, adds described rectification liquid, and mix homogeneously adds ultrafiltration after the injection water;
(4) active carbon that adds step (3) gained ultrafiltrate weight 0.5% in step (3) gained ultrafiltrate is heated with stirring to and boils, and filters carbon removal to clear and bright, adds ultrafiltration after the injection water;
(5) step (4) gained ultrafiltrate, fill sealing by fusing under the dust-free sterile condition, 100 ℃ of circulation steam sterilizations 30 minutes, packing.
The decoct matched group adopts embodiment 3 formulation weight proportionings, Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), Herba Sarcandrae and the Rhizoma Anemarrhenae is decocted with water twice, merging filtrate.
Effective combination of said medicine is coordinated mutually, can effectively reach the purpose of oral mucositis due to the prevention chemotherapy, and side effect is less.The above results is that clinical data proves that fully interrelated data is as follows, wherein studies drug use and is the crude drug weight proportion among the embodiment 3.
1 object and method.
1.1 object in May, 2005 to 2006 year December, accepting fluorouracil is the chemotherapeutical patient of main cancer therapy drug totally 287 examples, male's 178 examples wherein, women's 109 examples, 25 ~ 81 years old age, 55 years old mean age.179 examples that wherein undergo surgery before the chemotherapy are accepted radiotherapy 11 examples, operation+radiotherapy 97 examples.The patient goes into set condition pathology and is diagnosed as malignant tumor; Contain fluorouracil drug in the chemotherapeutics; The patient first chemotherapy or once more the preceding oral cavity of chemotherapy all do not have ulcer and infection.
1.2 method.
1.2.1 grouping: be divided into two groups at random, decoct group 157 examples and conditioning liquid group 130 examples are observed contrast.Patient's age, sex, cancer do not constitute upward no significance difference between two groups.
1.2.2 Therapeutic Method: the decoct group is used weight proportion gained Chinese herbs decoction in the embodiment of the invention 3, and the conditioning liquid group adopts the embodiment of the invention 3 gained finished products.The decoct group is identical with conditioning liquid group rinsing the mouth method, i.e. 3 times/d, 20 ml/ time, rinsing the mouth 3 ~ 5 min, and the rinsing the mouth time is after three cold after the meal boiled water are gargled, to begin to end of chemotherapy from chemotherapy.
1.2.3 observation index.
1.2.3.1 the patient is to the toleration of medicine rinsing the mouth: with regard to character, the mouthfeel of decoct group and conditioning liquid group, have no adverse reaction behind the oral and rinsing the mouth, investigate as feel sick, vomiting etc.
1.2.3.2 oral mucositis diagnosis and classification: The World Health Organization (WHO) is divided into the 0-IV level with the oral ulcer mucositis: 0 grade: oral mucosa is no abnormal; The I level: oral mucosa has 1 ~ 2＜1. ulcer of 0 cm; The II level: oral mucosa has 1〉1. 0 several aphthas of cm ulcer; The III level: oral mucosa has 2〉1. 0 several aphthas of cm ulcer; IV level: have more than 2〉1. the ulcer of 0 cm is or/and merge ulcer.
1.2.4 statistical analysis carries out statistical analysis with SPSS 13.0, P＜0.05 expression has the significance meaning.
2. result.
2. 1 patient is to the operating position of medicine rinsing the mouth: the patient does not have bored, the psychology of fear to oral medicine and the gargarism that uses; The decoct group has 7 examples to occur significantly feeling sick, and vomiting appears in 1 example, and the conditioning liquid group has 1 example to occur significantly feeling sick, and does not have the vomiting case.The two relatively has notable difference (P＜0.01).
2.2 the comparison of two groups of patient's oral mucositis incidence rates, degree: oral mucositis incidence rate and oral mucositis degree after two groups of patient's chemotherapy, through single factor χ
2Check analysis, comparing difference not statistically significant between group.See the following form.
3. conclusion.
Oral mucositis definite effect due to the demonstration of this result of study, the oral nursing liquid prevention chemotherapy of the inventive method preparation, untoward reaction is little, and better tolerance is worthy of promotion and application.
Claims (2)
1. mouth care liquid and preparation method thereof that prevents oral mucositis due to the chemotherapy, described oral nursing liquid raw material comprises 6 ~ 10 parts of Radix Serissae, 8 ~ 15 parts of Fructus Ligustri Lucidi, 8 ~ 15 parts of Folium fici wightianae (Ficus wightiana Wall)s, 6 ~ 10 parts in the Radix Rehmanniae, 6 ~ 10 parts of Radix Scrophulariaes, 8 ~ 15 parts of Radix Ophiopogonis, 6 ~ 10 parts of Radix Adenophorae (Radix Glehniae), 8 ~ 15 parts of the Rhizoma Anemarrhenaes, 3 ~ 6 parts of Herba Sarcandraes is characterized in that its preparation method may further comprise the steps:
(1) Radix Serissae, Fructus Ligustri Lucidi, Folium fici wightianae (Ficus wightiana Wall), Herba Sarcandrae are mixed, add the water of 3 ~ 6 times of weight, collect distillate with steam distillation, distillate is carried out redistillation, it is standby to get rectification liquid;
(2) the crude drug medicinal residues after will distilling add the Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Adenophorae (Radix Glehniae), the Rhizoma Anemarrhenae, and the water boiling that adds 4 ~ 6 times of weight decocts 2 times, and each 1 ~ 2 hour, filter, merge filtrate twice;
(3) described filtrate is centrifugal with centrifuge, gets supernatant, adds described rectification liquid, and mix homogeneously adds ultrafiltration after the injection water;
(4) ultrafiltrate fill sealing by fusing under the dust-free sterile condition, 100 ℃ of flowing steam sterilizations 30 minutes, packing.
2. the mouth care liquid and preparation method thereof of oral mucositis due to the prevention chemotherapy according to claim 1, it is characterized in that: between step (3) and (4), the active carbon that adds step (3) gained ultrafiltrate weight 0.5% in step (3) gained ultrafiltrate is heated with stirring to and boils, filter carbon removal to clear and bright, add ultrafiltration after the injection water.
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| CN103768408B (en) * | 2014-01-30 | 2016-02-10 | 于守水 | A kind of medicine preventing and treating anal and intestinal disease postoperative pain |
| CN103751489B (en) * | 2014-01-30 | 2016-04-13 | 于宗光 | A kind of preparation method for the treatment of the postoperative pain medication of neurosurgery |
| CN103735868B (en) * | 2014-01-30 | 2016-01-13 | 李磊 | A kind of preparation method of anal and intestinal disease postoperative bag |
| CN105726884A (en) * | 2014-01-30 | 2016-07-06 | 许加屯 | Method for preparing decoction for relieving postoperative pain |
| CN103735866A (en) * | 2014-01-30 | 2014-04-23 | 威海市妇女儿童医院 | Capsules for preventing and treating exaggerative pain after anesthesia and preparation method thereof |
| CN108553508B (en) * | 2018-05-02 | 2021-09-03 | 杭州市第三人民医院 | Three-herb ulcer healing soup for preventing and treating oral mucositis after chemotherapy |
| CN108653081B (en) * | 2018-06-19 | 2020-11-06 | 广西中医药大学 | Compound golden camellia mouthwash and preparation method thereof |
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| CN101036741B (en) * | 2006-03-16 | 2010-11-17 | 赵红 | Medicine for treating cancer and preparing method therefor |
| CN101053602B (en) * | 2007-04-25 | 2010-12-01 | 昆明涞章医药科技有限公司 | Medicine for treating oral ulcer and its preparing method |
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