CN105147774A - Method for preparing toxicity-removing oral solution - Google Patents

Abstract

The invention relates to a method for preparing a toxicity-removing oral solution. People know that the curative effect can be directly influenced by responses of toxic and side effects, and patient health is threatened by serious responses. According to the preparation method, specific biological substances having resistance on toxic and side effects due to radiotherapy and chemotherapy in traditional Chinese medicinal materials are prepared by utilizing a biological enzymolysis technology combined formula and adopting a layered and segmental enzymolysis process, and are used for treating responses of toxic and side effects. The toxicity-removing oral solution can be used for improving generation and development of immune cells, protecting re-balance of the immune system, eliminating toxic and side effects, improving effects of radiotherapy and chemotherapy and improving the living quality of patients.

Description

A kind of preparation method of Jiedu oral liquid

Technical field

In the therapeutic process of toxic and side effects, owing to being directly related to patient treatment quality and quality of life, patient will recover the immunocyte lost and the untoward reaction eliminating whole body each histoorgan poison pair in time.Because toxicity directly has influence on the quality of life of curative effect and patient, it is badly in need of toxin expelling, removing toxic substances.Recover physical function and could improve chemicotherapy effect.

Background technology

Chemotherapeutic agent all has toxic and side effects in various degree, and some serious toxicity is the immediate cause of limit drug dosage or use.They kill and wound again the cell of normal structure while treatment, especially kill and wound the hematolymphoid histiocyte etc. that growth promoter in human body is vigorous.And these cells and tissue are the immune defense systems that body weight for humans is wanted, if the immune system cancer destroying human body just may develop rapidly cause serious consequence.Toxicity divides recent toxic reaction and toxic reaction at a specified future date two kinds.Recent toxic reaction is divided into again local response (as local tissue necrosis angiitis obliterans etc.) and systemic reaction (to comprise digestive tract hemopoietic system immune system skin and mucosa reaction nervous system, liver function injury, cardiac response, pulmonary toxicity reacts, renal dysfunction and other reaction etc.).Toxic reaction at a specified future date mainly reproductive dysfunction and carcinogenesis teratogenesis etc.In addition chemotherapy common are infection because its toxic and side effects also can develop complications sometimes, hemorrhage, perforation, uric acid crystal etc.

Common toxic and side effects has:

(1) local response: the medicine that some zests are stronger can cause serious local response when intravenous injection.A, phlebitis: show as the rubescent visible venous thrombosis sometimes of intravenous site pain used and along quiet red arteries and veins cutaneous pigmentation etc.B, local tissue necrosis: histotopochemistry's property inflammation congestion and swelling pain even tissue necrosis and ulcer is prolonged does not heal can be caused when the medicine that zest is strong bleeds subcutaneous.

(2) bone marrow depression: most of chemotherapeutics all has bone marrow depression in various degree and bone marrow depression is often the dose-limiting toxicity of antitumor drug.When bone marrow depression shows as that especially granulocytopenia is serious in early days, platelets erythrocytes hemoglobin all can reduce, the fast curtain of the power of different medicines to bone marrow effect is different with length, so the extent of reaction is also different, patient also can have performance such as fatigue and weak resistance decline easy infection heating hemorrhage grade simultaneously.

(3) gastrointestinal toxicity: most drug can cause gastrointestinal reaction; Show as xerostomia, inappetence, nausea and vomiting, sometimes can occur oral mucositis or ulcer.Constipation, paralytic ileus, diarrhoea gastrointestinal hemorrhage and stomachache also show.

(4) immunosuppressant: chemotherapeutics is generally is mostly inhibitory action that the immunologic function of immunosuppressant to body has in various degree, body immune system residual tumor cell plays a part very important in elimination body, and when immunologic hypofunction, tumor is not easily controlled to accelerate recurrence or transfer process on the contrary.

(5) nephrotoxicity: part chemotherapeutics can cause kidney injury; Main manifestations is the degeneration of renal cells acute necrosis, and interstitial edema, tubular ectasia, occurs Delayed graft function time serious.Can there is lumbago in patient, hematuria, edema, and urine chemical examination is abnormal.

(6) hepatic injury; The liver response that chemotherapeutics causes can be acute and of short duration, and hepatic injury comprises downright bad inflammation, also can cause liver chronic injury due to long-term prescription, as fibrosis Steatosis, and Granuloma formation, eosinophilic granulocyte infiltration etc.Clinical to show as liver function test abnormal, hepatalgia, hepatomegaly, jaundice etc.

(7) cardiac toxicity; Clinically show as arrhythmia, heart failure, (patient shows as unable cardiomyopathy syndrome, activeness dyspnea, ictal nocturnal dyspnea, can have arteries and veins fast, breathe fast, hepatomegaly during heart failure, cardiac dilatation, pulmonary edema, edema and hydrothorax etc.) electrocardiographic abnormality.

(8) pulmonary toxicity: minority treats medicine can cause pulmonary toxicity, shows as interstitial lung inflammation and fibrosis.Clinically show as heating, dry cough, out of breath, many Acute onset are with grain of rice cytosis.

(9) neurotoxicity: some drugs can cause peripheral neuritis to show as; Refer to, toe is numb, and tendon reflex disappears, and paraesthesia, also constipation or paralytic ileus can occur sometimes.Some medicine can produce Central neurotoxicity; Main manifestations is paraesthesia, and vibration sense weakens, the not twinge of limbs fiber crops, ataxic gait, drowsiness psychological problem etc.

(10) alopecia: some medicine can cause alopecia in various degree, generally only says hair, other hair also can be influenced sometimes, and this is the result of chemotherapeutics damage hair follicle.Alopecia degree is usually relevant with dosage with the concentration of medicine.

(11) other: as auditory dysesthesia, erythra, face or erubescence, fingernail be out of shape, osteoporosis, bladder and urethral stimulation, infertility, amenorrhea, sexual function large, oblong sheet of silk with an appropriate message attached hinders, and male mammary gland increase etc., also can be caused by part chemotherapeutics.Radiotherapy toxic side effect symptom: have weak, poor appetite, feels sick, vomiting, diarrhoea, leukopenia, tissue edema, downright bad and fibrosis, the red class of skin, dry reaction, wet reaction, ulcer, radiation rectitis, pneumonia and cranial nerve palsy, paraplegia etc.Although human normal tissue cell's but ionizing radiation that lonizing radiation cause lower to radiation-sensitive has certain infringement after all to body normal structure thus side effect served by band.

Common radiation reaction and damage can have following several:

(1) General reactions: can inappetence be shown as, fatigue and weak, headache and dizzy, immunologic hypofunction etc.

(2) digestive tract reaction: can show as nausea and vomiting, dyspepsia, stomach alkane is uncomfortable, abdominal distention diarrhoea etc.

(3) hemogram reaction: leukocyte count in Peripheral blood can be shown as and reduce blood, the myelosuppression such as platelet minimizing.

(4) local response: because each tissue site of health is different and the type dose irradiation area of lonizing radiation is also different so the performance of each tissue site is also inconsistent to the toleration of lonizing radiation.

(5) skin exposure: the skin radiation reaction of range of exposures is generally divided into three degree: once radiation skin reaction is dry skin dermatitis, and in irradiation area, red class appears in skin, itches, and loses hair or feathers and has pigmentation, and hair follicle is expanded, and similar acne sample changes.Two degree of skin radiation reaction are moisture dermatitis, dermathemia edema, occur the transparent blister differed in size, can outwards sepage after ulceration, consciously burn severe pain.Three degree of skin radiation reaction are, radiation ulcer, and this is the most serious radiation skin injury, and darker ulcer and erosion appear in skin.Conscious severe pain, ulcer is difficult to healing, often need excise skin-grafting.Radiation injury of skin, because of irradiated site, radiation quality, range of exposures size and have difference, and also individual variation is very big.Perineum, the most easily there is dermoreaction in axillary fossa.

(6) mucosa: the radiation reaction that mucosa occurs is similar to skin, but not easily cause too macrolesion by force because of cell migration power.

(7) glandula: glandula is very responsive to lonizing radiation, destroys by body of gland after radiation exposure, and secretion reduces, and very easily dry mouth and tougue occurs, and xerostomia is difficult to eliminate sometimes.

(8) eyes: the crystal of eyes is very responsive to lonizing radiation, low dose of lonizing radiation can make lenticular opacity, and cataract occurs,

(9) skeleton: skeleton, after a certain amount of radiation exposure of acceptance, easily osteoporosis occurs, easily fractures by during external force.Just very responsive to lonizing radiation at the osseous tissue of growth and development stage, low dose of lonizing radiation will make growth be suppressed so that grow stopping to cause deformity.

(10) brain: can tolerate median dose to lonizing radiation, heavy dose of lonizing radiation then can cause brain atrophy, angry necrosis.Spinal cord has certain toleration to lonizing radiation, and surmounting tolerance dose radiation myelitis can occur, and sensation and the dyskinesia can appear in the lighter, and severe one can hemiplegia, paraplegia.

(11) damage of lung lung is in early days for radiation pneumonia is that radiation fibrosis of lung patient has sensation of oppression over the chest with shortness of breath cough and to cough up phlegm the performances such as pulmonary function reduction of even generating heat late period.

(12) abdominal part: when abdominal cavity and pelvic cavity radiation therapy, lonizing radiation exceed gastrointestinal tolerant dosage and can cause gastroenteritis due to radiation.Particularly radiation enteritis, make the downright bad Ji Narrow of small intestinal local mucous membrane generation ulcer narrow, severe patient need be performed an operation and could be alleviated.Radioactivity colitis makes patient suffer from diarrhoea, and has blood in stool.Radiocystitis then can show as hematuria, frequent micturition, severe patient contracture of bladder, and bladder urination is unable to be needed urethral catheterization or perform an operation.Radiation nephritis can secondary renal hypertension heart disease and heart failure.

Summary of the invention

The invention application Chinese medicine, theories of Chinese materia medica: Chinese medicine control toxic and side effects of chemoradiotherapy reaction, takes the method for determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, Applied Biotechnology produces heat-clearing and toxic substances removing in Chinese crude drug, promote the production of body fluid and moisturize, compensate qi and blood, the intrinsic material of natural biology of invigorating the spleen and regulating the stomach and nourishing the liver and kidney uniqueness, invention point kind of the process of preparing Chinese medicine, layering is fermented, and stepwise fermentation technique produces Chinese crude drug, and extract combination is oral liquid, its effect is, suppresses the toxic and side effects reaction produced in putting.This Chinese crude drug extracting solution not only can be eliminated the toxic and side effects of chemicotherapy but also can also improve chemicotherapy effect.Producing following Chinese crude drug by biotechnology is we's combination prescription: the Radix Astragali, warm in nature, is gas and diuresis in QI invigorating key medicine and elevate a turnable ladder.Radix Angelicae Sinensis: warm in nature, enriches blood and invigorates blood circulation that key medicine is double moisturizes laxation.The Radix Paeoniae Alba: slightly warm in nature, tonifying the spleen and stomach, dampness and weakness of the spleen and stomach, retention of water-damp in the body and the vomiting caused, dizzy, bipod edema.Radix Salviae Miltiorrhizae: cold in nature, removing damp-heat, removing toxic substances diuresis, doublely controls leprosy.The Radix Linderae: warm in nature, except cold pleasant analgesia, Caulis Spatholobi: warm in nature, enriches blood and invigorates blood circulation, and channels sootheing and network vessel quickening is held concurrently and eased pain, Radix Rehmanniae: warm in nature, YIN nourishing and the production of body fluid promoting, vital essence replenishing and marrow benifiting, nourishing the liver and kidney.Radix Scutellariae ， Yellow cypress, Rhizoma Coptidis, removing toxic substances, regulates cold and heat balance.Poria: property is put down, and promoting diuresis to eliminate damp pathogen, reduce phlegm saliva diuresis.Fructus Lycii: Gan Ping, the kidney invigorating and essence nourishing, nourishing the liver to improve visual acuity.Radix Notoginseng: stopping bleeding and removing blood stasis subduing swelling and relieving pain.Semen Coicis: cold in nature, promoting diuresis to eliminate damp pathogen, clearing away heat and discharging pus.Radix Codonopsis: Gan Ping, invigorating the spleen and replenishing QI, regulates Liver and kidney balance.Above medical material boils extraction through the soup of decocting of several thousand, and clinical verification effect of suiting the medicine to the illness is distinguished.

The novelty of the invention is; Use ancient prescription to concoct in conjunction with modern biotechnology layering enzymolysis, subsection enzymolysis is produced.Its creativeness is: use biotechnology to produce required effective ingredient, this technique saving of labor convenient operation, saves time, and rapid processing can produce, economize and take, biotechnology can be energy-conservation, and conservation, saving of labor's recruitment is few, perfectly can extract desired substance.The suitability of this technique is, toxic and side effects of chemoradiotherapy can be suppressed to react, and does not have side effects and cause secondary injury to patient.

Detailed description of the invention

In conjunction with the following examples, the present invention is further elaborated:

Embodiment one

Get the Radix Astragali, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae (three kinds of medical materials are cut into 1 centimeter long), Radix Notoginseng (being broken into bulk), each 50 grams of Semen Coicis etc., put into iron pan, separately get Rhizoma Zingiberis Recens juice by till medical material floods in pot, till the micro-Huang of slow fire parch, enter pulverizer and beat powder, add purifying waste water of 1:12 and be ground to 0 through grinder.1 millimeter, enter enzymatic vessel, add pectase, cellulase each 6%, enter constant temperature 45C enzymolysis after 48 hours, then can opening adds protease, saccharifying enzyme each 5%, carry out constant temperature 50C enzymolysis with 100 order filter cloth filter pressings after 72 hours, filtrate is vacuum concentration 1/2nd under 60C

Embodiment two

Take medicine, dried radix rehmanniae, radix paeoniae alba, caulis spatholobi, poria cocos each 50 grams of crusher block into the sand covered pot USES wine vinegar, yellowish, gently making out with a mill powder to join 1:15 purifying water into the grinding machine grinding of 0.1 millimeter, then enter enzymatic vessel and add cellulase, Aspergillus niger each 6%, carry out constant temperature 45C enzymolysis after 48 hours, open cover and add amylase again, protease each 5%, constant temperature 50C enzymolysis obtained filtrate through 100 order net filter pressings after 72 hours, and filtrate is vacuum concentration to three/mono-under 60C

Embodiment three

Get Rhizoma Coptidis ， Yellow a kind of reed mentioned in ancient books, Cortex Phellodendri, each 50 grams of Fructus Lycii is 0 by crusher in crushing.2 centimeters of size bulks are put into iron pan and are added till Mel (liquid) floods medical material, till slow fire parch drying, put into ethanol extraction tank and add 1:15 containing concentration be 85% ethanol, 45C soak 80 hours then release filtrate obtain liquid one, then repeat with filtrate soak once filtrate two.In secondary soaks the slag after filtering from newly add 1:10 concentration be 85% new ethanol to reflux among constant temperature 45C lixiviate 3 hours, lixiviate is being repeated in constant temperature 45C 2 hours with lixiviating solution, twice lixiviate filtrate is merged, and the distilled that reduces pressure reclaims ethanol, gained enters vacuum concentration without alcohol extract under 65C condition, is concentrated into till 1/2nd.By above three kinds of extracting solution concentrate mixing through sterilizing bottle 10 milliliters every bottle be finished product.

Claims (4)

1. the preparation method of a kind of Jiedu oral liquid of the invention: the Applied Biotechnology enzymolysis Chinese crude drug Radix Astragali, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Notoginseng, the peculiar biologically effective material in waiting, is characterized in that; By the Radix Astragali, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Radix Notoginseng, after stir-frying with ginger juice, add 1:12 through crushing grinding powder process to purify waste water and be ground to 0.1 millimeter, insert in enzymatic vessel and add pectase, cellulase each 6%, constant temperature 45C enzymolysis is after 48 hours, add saccharifying enzyme again, protease each 5%, constant temperature 50C enzymolysis is with 100 order filter cloth filter pressings after 72 hours, and filtrate is through 60C vacuum concentration to two/mono-.

2. the preparation method of a kind of Jiedu oral liquid of the invention: the Applied Biotechnology enzymolysis Chinese crude drug Radix Linderae, the Radix Paeoniae Alba, Radix Rehmanniae, Caulis Spatholobi, Poria, Semen Coicis, etc. producing wherein peculiar biologically effective material, it is characterized in that: above medical material uses the micro-Huang of vinegar parch after fragmentation, smash again and be ground to 0.1 millimeter for adding purifying waste water of 1:15 after powder through grinder, insert in enzymatic vessel and add cellulase again, Aspergillus niger each 6%, in 45C constant temperature, enzymolysis adds amylase after 48 hours again, protease each 5%, constant temperature 50C enzymolysis after 72 hours with 100 order filter cloth filter pressings, filtrate is through 60C vacuum concentration to three/mono-.

3. the preparation method of a kind of Jiedu oral liquid of the invention: application ethanol extraction method, produce peculiar biological substance in Chinese crude drug, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, active substance in Fructus Lycii etc., it is characterized in that: by medical material Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Fructus Lycii etc. are after Mel parch drying, through pulverize be 0.2 centimeter of bulk, add 1:15 concentration be 85% ethanol soak in 45C constant temperature and release filtrate after 80 hours after, be 85% new ethanol 45C constant temperature backflow lixiviate 3 hours by 1:10 concentration in filtering residue again, repeat to reflux in 45C lixiviate 2 hours with lixiviating solution again, twice lixiviating solution is merged, decompression distilled reclaims ethanol, vacuum concentration to two/mono-under 60C condition.

4. the extracting solution produced by above three kinds of preparation methods merges, and sterilizing bottling, often propping up 10 milliliters, bottle is finished product.