CN112076297A - Pharmaceutical composition for preventing miscarriage and stopping vomiting and preparation method and application thereof - Google Patents
Pharmaceutical composition for preventing miscarriage and stopping vomiting and preparation method and application thereof Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A61K36/88—Liliopsida (monocotyledons)
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- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
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- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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Abstract
The invention provides a pharmaceutical composition for preventing miscarriage and stopping vomiting and a preparation method and application thereof, belonging to the field of traditional Chinese medicines. The pharmaceutical composition is a preparation prepared from the following raw materials in parts by weight: 8-12 parts of costustoot, 8-12 parts of fructus amomi, 8-12 parts of ginger processed pinellia, 8-12 parts of dried orange peel, 16-24 parts of adenophora tetraphylla, 8-12 parts of poria cocos, 16-24 parts of bighead atractylodes rhizome, 8-12 parts of perilla leaves, 1-10 parts of coptis chinensis, 8-12 parts of wrinkled gianthyssop herb, 8-12 parts of bamboo shavings and 10-20 parts of loquat leaves. The traditional Chinese medicine composition is prepared into the miscarriage prevention and vomiting stopping patch, and can effectively treat hyperemesis gravidarum by combining with the traditional Chinese medicine acupoint application. Meanwhile, the external application mode can avoid the toxic and side effects of the oral traditional Chinese medicine gastrointestinal administration mode on pregnancy. In addition, the miscarriage prevention and vomiting stopping patch is beneficial to the quick transdermal absorption of the effective components of the medicine, has no pain in peeling, improves the use comfort, avoids the sensitization and stimulation of common acupoint application on the skin, has the advantages of safety, economy, no toxic or side effect and has good application prospect.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for preventing miscarriage and stopping vomiting, and a preparation method and application thereof.
Background
The hyperemesis gravidarum is the hyperemesis gravidarum in western medicine, which means that the early pregnancy of the pregnant women has symptoms of nausea and vomiting, dizziness and anorexia, bad taste and even vomiting after eating, and if the intervention is not performed in time, the slow growth and development of embryos can be caused, the morbidity of pregnancy hypertension syndrome and the unbalance of potassium, sodium, chlorine, calcium and acid and alkali are increased, even the pregnancy is terminated, and the life safety of the pregnant women is threatened even in more serious cases.
At present, no treatment method with safety and obvious curative effect exists in Western medicine aiming at the disease. The western medicine treatment method mainly comprises supportive therapy and drug treatment. The supportive therapy is fluid resuscitation with a bolus of saline or lactate hormone solution, followed by improvement of nausea with a solution containing 5% glucose, in addition, serum electrolytes magnesium, phosphate, potassium should be supplemented, and sodium levels should be monitored and 100 mg of thymine should be given as necessary to prevent Wernicke's encephalopathy. The medication is medication with drugs such as Diclegis, promethazine, clonidine, metoclopramide, Zofran, mirtazapine, corticosteroids and the like. Although the western medicines can treat hyperemesis gravidarum, the western medicines have certain side effects on pregnant women and fetuses, such as: diclegis can cause adverse reactions such as lethargy and the like; zofran may cause significant allergic reactions and may be associated with fetal heart malformations; promethazine has an effect on the nervous system of the fetus; metoclopramide may cause tardive dyskinesia and pre-existing psychotic exacerbations; mirtazapine may increase birth defects, etc.
The traditional Chinese medicine has rich experience in treating hyperemesis gravidarum. "pregnancy" is first seen in "jin Kui Yao & Me Bing Mai Zheng Zhan Bing (treatise on syndrome of pregnancy diseases)": "Furen is in the normal pulse, the pulse of yin is small and weak, the woman is thirsty, unable to eat, and has no chills and fever, so it is named as pregnancy. The term "vomiting" is first described in the treatise on the etiology of various diseases: the aversion to obstruction, oppression in the heart, dizziness, restlessness and pain in the limbs, lassitude, no desire to do it and bad smell of food. The traditional Chinese medicine holds that the main pathogenesis of hyperemesis gravidarum is weakness of spleen and stomach of pregnant women, stomach disorder and descending of the stomach, and upward reversal of pulse qi. Because of weakness of spleen and stomach, blood accumulates to nourish fetus after conception, menstruation does not discharge, qi of pulse is strong, pulse is attached to yangming, qi of pulse goes up and down to attack stomach, stomach is disharmony and descending, nausea and vomiting; phlegm-dampness is generated internally due to spleen deficiency or yin and blood are gathered to nourish fetus, liver blood is insufficient, liver qi is vigorous, and liver qi transversely flows to invade stomach to cause disharmony between liver and stomach; also, vomiting cannot be stopped, and a poor appetite may lead to qi and yin deficiency. Therefore, the disease is mainly caused by weakness of the spleen and stomach, incoordination between the liver and stomach, and stomach-qi failing to descend. At present, the hyperemesis gravidarum is treated by various means such as decoction, acupuncture and moxibustion, acupoint application and the like in the traditional Chinese medicine, and the specific means is as follows:
(1) treatment with a traditional Chinese medicine decoction: the spleen-invigorating and stomach-benefiting method, which is represented by the modified Xiangsha Liujunzi decoction and Zhongzhong decoction, treats the syndrome of weakness of spleen and stomach due to pernicious vomiting of pregnancy. Regulating stomach and lowering adverse qi the syndrome of adverse rising of stomach qi is treated with light-weight coptis root, perilla leaf, ginger and the like. The recipe for nourishing liver and regulating stomach is to calm liver, regulate stomach and check adverse rise of qi, such as the decoction for harmonizing stomach and checking adverse rise of qi, the decoction for harmonizing liver and checking adverse rise of qi. Liver soothing and stomach harmonizing methods: modified Xiaochaihu decoction is used for treatment. The liver-and stomach-regulating method is to treat liver-and stomach-disharmony syndrome with liver-and stomach-regulating herbs (Su Ye, Huang Lian, Chen Pi, Zhu Ru, Gou Teng, Huang Qin, Sheng Jiang, etc.).
(2) And (3) acupuncture treatment: xiyu, etc. selects Cuanzhu, Neiguan, Zusanli, Yinlingquan, Zhongwan, Guanyuan, Tianshu, etc. to treat pernicious vomiting, and the total effective rate is 96%. The Hades and the like select a filiform needle to prick the acupuncture points of Zhongwan, Shangwan, Xiawan, Zusanli, Shangjuxue, Fenglong, Taichong, Neiguan, Baihui, Sishencleng and the like to combine with the conventional fluid infusion treatment of the western medicine, the total effective rate is obviously higher than that of a pure western medicine treatment group, and the treatment time is short and the recurrence rate is low.
(3) Acupoint injection: the acupoint injection is carried out by selecting Neiguan, Zusanli, Fenglong and other acupoints. Vitamin B6 is injected into acupoint Neiguan of Populus and Margarita, and combined with potassium chloride, vitamin C, and vitamin B6 for treatment, and has effects of improving urine ketone body and reducing hyperemesis gravidarum. Research on Cao Zheng Xiang shows that the cure rate of Zusanli or Fenglong acupoint for acupoint injection and Shenmen acupoint for ear acupoint can be up to 81.8%.
(4) The Chinese medicine acupoint application method comprises the following steps: according to the aged observation, 3g of fructus evodiae and 5ml of sesame oil are mixed and externally applied to the Yongquan acupoint to treat hyperemesis gravidarum, and the curative effect of an observed group is obviously superior to that of a control group. The prunus cerasifera is used for treating hyperemesis gravidarum by applying the Ding Jiang Hewei plaster to the Shenque acupoint in combination with the intravenous infusion, the cure rate of the treatment group after 4 and 7 days is better than that of the control group, and the disappearance rates of dizziness, lassitude and vomit after the treatment are better than that of the control group. Xudilong adopts clove, dried orange peel and pinellia tuber, each 3g of the mixing paste is externally applied to the Shenque point to improve nausea and vomiting symptoms and uretone body results.
In addition, the method for treating hyperemesis gravidarum also comprises an ear point bean pressing method, an acupuncture point ginger-separated moxibustion method, an acupuncture point ultrasonic therapy, a traditional Chinese medicine under-nose fumigation therapy and a combined therapy method, and a large number of clinical trial observations show that the traditional Chinese medicine can relieve the symptoms of patients and can effectively improve indexes such as urine ketone bodies, and the traditional Chinese medicine means has the advantages of safety, economy, low or no toxic and side effects compared with western medicine, and is worthy of vigorous popularization.
However, the use of the pharmaceutical composition of the present invention for treating hyperemesis gravidarum has not been known.
Disclosure of Invention
In order to solve the problems, the invention provides a pharmaceutical composition for preventing miscarriage and stopping vomit, a preparation method and application thereof.
The invention provides a pharmaceutical composition for preventing miscarriage and stopping vomiting, which is a preparation prepared from the following raw material medicines in parts by weight: 8-12 parts of costustoot, 8-12 parts of fructus amomi, 8-12 parts of ginger processed pinellia, 8-12 parts of dried orange peel, 16-24 parts of adenophora tetraphylla, 8-12 parts of poria cocos, 16-24 parts of bighead atractylodes rhizome, 8-12 parts of perilla leaves, 1-10 parts of coptis chinensis, 8-12 parts of wrinkled gianthyssop herb, 8-12 parts of bamboo shavings and 10-20 parts of loquat leaves.
Further, the pharmaceutical composition is a preparation prepared from the following raw material medicines in parts by weight: 10 parts of costustoot, 10 parts of fructus amomi, 10 parts of ginger processed pinellia tuber, 10 parts of dried orange peel, 20 parts of adenophora tetraphylla, 10 parts of poria cocos, 20 parts of bighead atractylodes rhizome, 10 parts of perilla leaf, 5 parts of coptis chinensis, 10 parts of wrinkled gianthyssop herb, 10 parts of bamboo shavings and 15 parts of loquat leaf.
Furthermore, the pharmaceutical composition is a preparation prepared by adding pharmaceutically acceptable auxiliary materials or auxiliary components into crude drug powder, or water or organic solvent extract of the raw drug materials according to the weight ratio;
preferably, the formulation is an external formulation;
more preferably, the external preparation is a patch or a cataplasm.
The invention also provides a method for preparing the pharmaceutical composition, which comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
The invention also provides a patch for preventing miscarriage and stopping vomit, which is prepared from the following raw and auxiliary materials in parts by weight: 8-12 parts of elecampane, 8-12 parts of fructus amomi, 8-12 parts of ginger processed pinellia, 8-12 parts of dried orange peel, 16-24 parts of adenophora tetraphylla, 8-12 parts of poria cocos, 16-24 parts of bighead atractylodes rhizome, 8-12 parts of perilla leaves, 1-10 parts of coptis chinensis, 8-12 parts of wrinkled gianthyssop herb, 8-12 parts of bamboo shavings, 10-20 parts of loquat leaves, 1-10 parts of carbomer, 2-10 parts of polyvinyl alcohol, 2-15 parts of gelatin and 3-10 parts of polyacrylic acid;
preferably, the medicament is prepared from the following raw and auxiliary materials in parts by weight: 10 parts of costustoot, 10 parts of fructus amomi, 10 parts of ginger processed pinellia tuber, 10 parts of dried orange peel, 20 parts of adenophora tetraphylla, 10 parts of poria cocos, 20 parts of bighead atractylodes rhizome, 10 parts of perilla leaf, 5 parts of coptis chinensis, 10 parts of wrinkled gianthyssop herb, 10 parts of bamboo shavings, 15 parts of loquat leaf, 1-10 parts of carbomer, 2-10 parts of polyvinyl alcohol, 2-15 parts of gelatin and 3-10 parts of polyacrylic acid.
Further, the patch is used for acupoint application;
preferably, the acupoints are Zhongwan, bilateral Neiguan and bilateral Zusanli.
The invention also provides a preparation method of the patch, which comprises the following steps:
(1) taking raw and auxiliary materials in each weight ratio;
(2) mixing adjuvants including carbomer, polyvinyl alcohol, gelatin and polyacrylic acid, and heating to obtain glue solution mixture;
(3) weighing raw materials including costustoot, fructus amomi, ginger processed pinellia tuber, dried orange peel, adenophora tetraphylla, poria cocos, bighead atractylodes rhizome, perilla leaf, coptis chinensis, agastache rugosus, bamboo shavings and loquat leaf, adding water for decoction, and filtering to obtain a liquid medicine mixture;
(4) uniformly stirring the liquid medicine mixture and the glue solution mixture to remove air bubbles, and uniformly mixing to prepare a patch;
preferably, in the step (3), the water is added for decoction for 1-1.5 hours, wherein the amount of the water is 8-10 times that of the water.
The invention also provides a combined medicament for preventing miscarriage and stopping vomit, which comprises the medicinal composition or the patch and the rehydration medicament which are simultaneously or respectively administered and have the same or different specifications, and a pharmaceutically acceptable carrier;
preferably, the fluid replacement drug is vitamin and 5% glucose injection or 0.9% normal saline injection;
more preferably, the vitamins are vitamin C and vitamin B6;
further preferably, the fluid replacement drug is 500-1000mL of 5% glucose injection or 0.9% physiological saline injection containing 2-3g of vitamin C and 0.1-0.2g of vitamin B6;
still more preferably, the rehydration drug is administered intravenously.
The invention also provides the application of the pharmaceutical composition, the patch or the combined medicament in preparing a medicament for preventing miscarriage and stopping vomit;
preferably, the medicament is a medicament for the treatment of hyperemesis gravidarum;
more preferably, the medicament is a medicament for treating liver-stomach disharmony type pernicious vomiting.
The invention also provides application of the pharmaceutical composition, the patch or the combined medicine in preparing medicines for soothing liver, strengthening spleen, calming adverse-rising energy, preventing vomiting and treating weakness of spleen and stomach, incoordination between liver and stomach depression.
In the present invention, Perilla leaf is Perilla leaf, which is a dried leaf (or with tender branches) of Perilla frutescens (L.) britt. Agastache rugosa is an above-ground part of Pogostemmincablin (blanco) Benth, or Agastache rugosa Agastache Herugosus (Fisch. etMey) O.Ktze.
In the invention: the largehead atractylodes rhizome has the effects of tonifying spleen and stomach, and tonifying qi and preventing miscarriage; coptis root, rhizoma Coptidis, with the action of clearing damp-heat, bitter in flavor and reducing uprush fire, folium Perillae, sweet in flavor and pungent in flavor, and dredging the descending and regulating qi, is used for treating pre-fetal pernicious vomiting, and can make healthy qi distribute and pathogenic qi disappear; ginger processed pinellia tuber and dried orange peel can resolve phlegm and stop vomiting, costustoot and villous amomum fruit can resolve dampness and promote qi circulation, ageratum can activate spleen and remove dirt and regulate the middle warmer, and poria cocos wolf can invigorate spleen to remove dampness; the caulis Bambusae in Taenia can not only resolve phlegm and stop vomiting, clear heart and relieve restlessness, but also prevent various medicines from strengthening spleen and promoting qi circulation and warming and tonifying excessive stomach and yin, and the radix adenophorae can clear stomach heat, nourish stomach and yin and strengthen spleen and qi; pi Pa Ye enters stomach meridian, excels in clearing stomach heat and descending stomach qi to arrest vomiting, and is combined with ban Xia to strengthen the action of arresting vomiting. The medicines are used together to play the roles of strengthening the spleen, soothing the liver, regulating qi, reducing phlegm, calming the adverse-rising energy, preventing vomiting and protecting the stomach, and treat both principal and secondary aspects of diseases.
The acupoint application is the combination of meridian and acupoint treatment and traditional Chinese medicine treatment, can regulate qi, blood, yin and yang of internal organs and communicate meridians, and effectively plays the dual functions of the two. The acupoint application is not similar to the gastrointestinal administration of traditional Chinese medicine decoction, and avoids the toxic and side effects of oral medicines on pregnancy. The traditional Chinese medicine composition is innovatively prepared into a liquid medicine mixture, and is uniformly mixed with a colloid mixture and then is applied to treat hyperemesis gravidarum in a transdermal administration acupoint application mode.
The invention creatively selects carbomer, polyvinyl alcohol, gelatin and polyacrylic acid as matrix materials, and the medicinal composition for preventing miscarriage and stopping vomiting is added to prepare the plaster for preventing miscarriage and stopping vomiting. Carbomer is a high molecular copolymer, has extremely strong water-coating property and excellent biological adhesion with skin, is beneficial to transdermal absorption of active ingredients of the medicine, and has no pain during peeling so as to improve the use comfort. The patch has the advantages of no pollution to the ecological environment, large drug loading capacity, high water content, contribution to the release of drugs from the patch to the skin, taking away the local heat of the skin while evaporating water, cool and comfortable use feeling, no sensitization and stimulation to the skin, no pain and residue during stripping and the like, and is easy to popularize and apply.
According to the application, carbomer, polyvinyl alcohol, gelatin and polyacrylic acid are selected as matrix materials, and the miscarriage prevention and vomiting stopping medicinal composition is added to prepare the miscarriage prevention and vomiting stopping patch. Compared with the traditional plaster and application, the plaster has the following advantages:
(1) the miscarriage prevention and vomiting prevention patch has high comfort: because the miscarriage prevention and vomiting stopping patch is composed of a substance with a water-soluble polymer frame structure, the patch is more moist than the traditional patch, the position can be microscopically adjusted at any time after the patch is attached, the viscosity is better, and the adhesive force cannot be influenced by the re-attachment. It will not form a firm state on the skin, and will not cause sweaty hair, pain, and local red swelling when torn off.
(2) The miscarriage prevention and vomiting prevention patch has strong ductility: the preparation adopts non-woven fabrics, has good extensibility, and the ointment can stretch along with the extension of skin.
(3) The miscarriage prevention and vomit prevention patch has strong permeability: the medicine in the patch can rapidly permeate into the skin of a human body in a short time and rapidly reach local tissues.
(4) The miscarriage prevention and vomit prevention patch has high reliability: the preparation can not cause adverse reaction such as allergy. The medicine has small molecular weight, and the reliability is obviously improved compared with a plaster with larger molecules and low water content.
In conclusion, the traditional Chinese medicine composition is prepared into the miscarriage prevention and vomiting stopping patch, and the traditional Chinese medicine acupoint pasting is combined to regulate qi, blood, yin and yang of internal organs and channels and collaterals of the whole body, so that the pernicious vomiting can be effectively treated, and particularly the liver-stomach disharmony type pernicious vomiting can be effectively treated. Meanwhile, the miscarriage prevention and vomiting stopping patch adopts an external application mode, so that the toxic and side effects of an oral traditional Chinese medicine gastrointestinal administration mode on pregnancy are avoided. In addition, the matrix material used by the miscarriage prevention and vomiting stopping patch has good biocompatibility, no pollution to the ecological environment and larger drug-loading rate, is beneficial to the quick transdermal absorption of the active ingredients of the drug, has no pain in stripping, improves the use comfort, avoids the sensitization and stimulation of common acupoint application to the skin, has the advantages of safety, economy and no toxic or side effect, and has good application prospect.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products.
Example 1 preparation of a pharmaceutical composition of the invention
1. The formula of the raw material medicine is as follows: 10g of costustoot, 10g of fructus amomi, 10g of ginger processed pinellia tuber, 10g of dried orange peel, 20g of adenophora tetraphylla, 10g of poria cocos, 20g of bighead atractylodes rhizome, 10g of perilla leaf, 5g of coptis chinensis, 10g of wrinkled gianthyssop herb, 10g of bamboo shavings and 15g of loquat leaf.
2. The preparation method comprises the following steps: weighing the raw materials, adding 8 times of water, decocting for 1 hour, and filtering to obtain filtrate, namely a liquid medicine mixture.
Example 2 preparation of a pharmaceutical composition of the invention
1. The formula of the raw material medicine is as follows: 8g of costustoot, 8g of fructus amomi, 8g of ginger processed pinellia tuber, 8g of dried orange peel, 16g of adenophora tetraphylla, 8g of poria cocos, 16g of bighead atractylodes rhizome, 8g of perilla leaf, 1g of coptis chinensis, 8g of wrinkled gianthyssop herb, 8g of bamboo shavings and 10g of loquat leaf.
2. The preparation method comprises the following steps: the same as in example 1.
Example 3 preparation of a pharmaceutical composition of the invention
1. The formula of the raw material medicine is as follows: 12g of costustoot, 12g of fructus amomi, 12g of ginger processed pinellia tuber, 12g of dried orange peel, 24g of adenophora tetraphylla, 12g of poria cocos, 24g of bighead atractylodes rhizome, 12g of perilla leaf, 10g of coptis chinensis, 12g of wrinkled gianthyssop herb, 12g of bamboo shavings and 20g of loquat leaf.
2. The preparation method comprises the following steps: the same as in example 1.
Example 4 preparation of the Patch of the invention
1. The formula of the raw materials and the auxiliary materials is as follows: 1-10 g of carbomer, 2-10 g of polyvinyl alcohol, 2-15 g of gelatin, 3-10 g of polyacrylic acid, 10g of elecampane, 10g of fructus amomi, 10g of ginger processed pinellia tuber, 10g of dried orange peel, 20g of adenophora tetraphylla, 10g of poria cocos, 20g of bighead atractylodes rhizome, 10g of perilla leaf, 5g of coptis chinensis, 10g of agastache rugosus, 10g of bamboo shavings and 15g of loquat leaf.
2. The preparation method comprises the following steps:
(1) mixing adjuvants including carbomer, polyvinyl alcohol, gelatin and polyacrylic acid, and heating to obtain glue solution mixture;
(2) weighing raw material medicines of costustoot, fructus amomi, ginger processed pinellia tuber, dried orange peel, adenophora tetraphylla, poria cocos, bighead atractylodes rhizome, perilla leaf, coptis chinensis, agastache rugosus, bamboo shavings and loquat leaf, adding 8 times of water, decocting for 1 hour, and filtering to obtain filtrate, namely a liquid medicine mixture.
(3) Uniformly stirring the liquid medicine mixture and the glue solution mixture to remove bubbles, uniformly mixing the liquid medicine mixture and the glue solution mixture in a dynamic and static combination mode by adopting a conventional preparation method, pouring the mixture into a vacuum device, forming, then pasting a cloth and cutting a die to obtain the adhesive tape.
Example 5 preparation of the pharmaceutical composition of the invention into other formulations
The bulk drugs of examples 2 and 3 can also be prepared into patches as described in example 4. Meanwhile, the raw material medicines are weighed according to the raw material medicine proportion in the embodiment 1-3, and the traditional external preparation can be prepared into other traditional external preparation forms according to the conventional technical means in the field.
The advantageous effects of the present invention are demonstrated by specific test examples below.
Test example 1 clinical therapeutic Effect of the pharmaceutical composition of the present invention
1. Clinical data
1.1 sources of data
Collecting 60 patients with liver-stomach disharmony type pernicious vomiting (60 patients with liver-stomach disharmony type of gynecological diagnosis in traditional Chinese medicine institute, Guangan, 01-2020-06-30-days), and grouping according to random number table, wherein the treatment group and the control group are 30 patients with age of 20-35 years and gestational week of 5-13+6Week (13)+6Week 13 plus 6 days).
1.2 diagnostic criteria
(1) Western diagnostic criteria: reference is made to the diagnostic criteria of hyperemesis gravidarum in gynaecology and obstetrics (national institutes of health, Xie Happy Master) to make: the medical history: the patient has a history of menopause, has early pregnancy reaction, and the nausea and vomiting are gradually aggravated along with the progress of pregnancy; ② symptoms: frequent vomiting, only eating a little liquid diet, even no food, resulting in dehydration, and sleepiness and vague consciousness in severe cases; ③ physical signs: mental fatigue, emaciation, dry skin of the lips, reduced urine volume, etc.; laboratory examination: positive urine pregnancy, type-B ultrasonic determination of intrauterine pregnancy, mild or even moderate electrolyte disorder, positive uretone body, etc.
(2) The traditional Chinese medicine diagnosis standard is as follows: reference is made to "traditional Chinese medicine gynecology" (published by Zhang Yuzhen Master, China) chapter of pregnancy pernicious vomiting: nausea and vomiting occur in the early stages of pregnancy, and even vomiting occurs when food is taken. Pregnancy pernicious vomiting of liver-stomach disharmony: nausea, vomiting of sour water or bitter water, bad smell of oil, polydipsia, dry mouth, bitter taste, fullness in the head, dizziness, fullness in the chest, hypochondriac pain, eructation, sighing, pale red tongue with yellowish fur, and wiry and slippery pulse in the early gestation period.
1.3 inclusion criteria
The compound preparation meets the diagnosis standard of hyperemesis gravidarum (hyperemesis gravidarum), and is classified as a liver-stomach disharmony syndrome, no serious electrolyte disorder, no serious acid-base balance disorder and no Wernicke encephalopathy; the subjects agreed to receive treatment from either the placebo or treatment groups and voluntarily signed an informed consent form to the subject group.
1.4 exclusion and rejection criteria
Gastroenteritis, nervous system diseases, endocrine system diseases, cardiovascular system diseases and cerebrovascular system diseases, such as neurosis, nervous system functional emesis, brain tumor and infectious diseases. ② the positive HCG in blood or urine but not proved by color Doppler ultrasound intrauterine pregnancy, ectopic pregnancy, hydatidiform mole and gestational trophoblastic disease. ③ those with pregnancy complications such as threatened abortion, gestational diabetes, gestational hypertension, etc. Fourthly, the skin disease exists at the position where the acupuncture points are pasted. Fifthly, the history of treating drug allergy is existed. Sixthly, the patients with mental diseases or mental state abnormalities. Seventhly, the pregnancy is terminated due to incomplete or halfway data. The patients with serious anaphylaxis or serious adverse events caused by treatment. Ninthly, withdrawing voluntarily and requiring the test termination.
2. Method of producing a composite material
2.1 methods of investigation
The patients are sequentially numbered according to the treatment order by Arabic numerals and divided into a control group and a treatment group by a random number table method. Treatment groups used the miscarriage prevention and antiemetic patch prepared in example 4 of the present invention; the control group used placebo patches that were identical in appearance, color, and texture to the anti-emetic patch of example 4 of the present invention. All patches are sealed and stored in a cool and dry place uniformly, and a drug specialist is responsible for receiving, processing and distributing the drug. Both groups of patients were treated after the cessation of antiemetic or sedative drugs.
Control group: basal therapy (fluid replacement therapy) plus placebo patch therapy was administered. The intravenous fluid infusion adopts 1000mL of 500-plus-one of 5% glucose injection or 0.9% normal saline injection, and 2-3g of vitamin C and 0.1-0.2g of vitamin B6 are added for intravenous infusion; according to the electrolyte result, 3-4g of potassium is supplemented every day, 10-20mL of 10% potassium chloride injection is added into 500mL of 10% glucose injection for slow drip infusion; if the patient is complicated with metabolic acidosis, the analysis of blood gas suggests CO2When the binding force is less than 18mmol/L, the sodium bicarbonate injection with the concentration of 5 percent can be properly supplemented; the amount of fluid infusion is adjusted as appropriate according to the weight, vomiting, eating and urine of the patient. Adding placebo patch (prepared by mixing edible pigment solution with the glue solution mixture of example 4 by using a mixing kettle, a kneader and the like), selecting Zhongwan, Neiguan on both sides and Zusanli on both sides, and carrying out acupoint application for 1 time every day, wherein each application is carried out for 4h, and 5 days is a treatment course, and two treatment courses are treated.
Treatment groups: the basic treatment (fluid replacement treatment) is added with the miscarriage prevention and vomiting stopping patch for treatment. Namely, on the basis of the fluid infusion treatment of a control group, a placebo patch is changed into the patch prepared in the embodiment 4 of the invention, acupuncture points of Zhongwan, Neiguan on both sides and Zusanli on both sides are applied for 1 time every day for 4 hours every time, 5 days are taken as a treatment course, two treatment courses are treated, and whether the skin is uncomfortable with pruritus, redness and the like during application is observed and recorded.
2.2 Observation index and therapeutic effect determining method
The symptoms and signs before and after the two groups of treatments are graded according to degrees, including nausea and vomiting, acid water vomiting or bitter water vomiting even after eating, dizziness and lassitude, abdominal fullness and distention, bitter taste and dry throat and other symptom improvement conditions, the degrees are graded into 3 according to the light degree, the middle degree and the heavy degree, and the grades are respectively marked as 1, 2 and 3, and the clinical curative effect is calculated.
Urinary ketone body level change: the levels of uroketone (-), (+ + + + and higher) were scored as 0, 1, 2, 3 points before observation, and after observation for 7 and 14 days, and their scores were statistically analyzed.
③ pre-and post-treatment scores of two groups are evaluated by a pregnancy-unique qualification of emergencies and nausea scale (PUQE);
fourthly, the evaluation standard of the curative effect is as follows: the method is drawn up according to the clinical research guiding principle of the new traditional Chinese medicine:
and (3) healing: nausea and vomiting are stopped, normal eating can be realized, various symptoms disappear, the urine ketone examination is negative for 3 times continuously, and all examinations are recovered to be normal.
The effect is shown: nausea and vomiting are stopped or occasionally, food intake is improved, all examinations are obviously improved, and the negative examination of the urine ketone examination is reduced by more than 2 '+'.
The method has the following advantages: the nausea and vomiting are reduced, the degree is reduced, the patient can eat the medicine, and various examinations are improved.
And (4) invalidation: no improvement in symptoms, and a positive and lasting test for uretone.
The effective rate is (the number of cure cases + the number of obvious cases + the number of effective cases)/the total number of cases is multiplied by 100%.
3. Therapeutic results
(1) The clinical efficacy results of the pharmaceutical composition of the present invention are shown in table 1.
TABLE 1 clinical efficacy results of the pharmaceutical compositions of the present invention
| Group of | Number of examples | Recovery (case) | Obvious effect (example) | Improvement (example) | Invalid (example) | Effective rate (%) |
| Experimental group | 30 | 21 | 5 | 2 | 2 | 93.33％ |
| Control group | 30 | 12 | 8 | 5 | 5 | 83.33％ |
The test results show that: the number of cure cases and the total effective rate of the treatment group are obviously higher than those of the control group, which shows that the miscarriage prevention and vomiting prevention patch can effectively treat liver-stomach disharmony type pernicious vomiting.
In conclusion, the traditional Chinese medicine composition is prepared into the miscarriage prevention and vomiting stopping patch, and the traditional Chinese medicine acupoint pasting is combined to regulate qi, blood, yin and yang of internal organs and channels and collaterals of the whole body, so that the pernicious vomiting can be effectively treated, and particularly the liver-stomach disharmony type pernicious vomiting can be effectively treated. Meanwhile, the miscarriage prevention and vomiting stopping patch adopts an external application mode, so that the toxic and side effects of an oral traditional Chinese medicine gastrointestinal administration mode on pregnancy are avoided. In addition, the matrix material used by the miscarriage prevention and vomiting stopping patch has good biocompatibility, no pollution to the ecological environment and larger drug-loading rate, is beneficial to the quick transdermal absorption of the active ingredients of the drug, has no pain in stripping, improves the use comfort, avoids the sensitization and stimulation of common acupoint application to the skin, has the advantages of safety, economy and no toxic or side effect, and has good application prospect.
Claims (10)
1. A pharmaceutical composition for preventing miscarriage and stopping vomit is characterized in that: the preparation is prepared from the following raw material medicines in parts by weight: 8-12 parts of costustoot, 8-12 parts of fructus amomi, 8-12 parts of ginger processed pinellia, 8-12 parts of dried orange peel, 16-24 parts of adenophora tetraphylla, 8-12 parts of poria cocos, 16-24 parts of bighead atractylodes rhizome, 8-12 parts of perilla leaves, 1-10 parts of coptis chinensis, 8-12 parts of wrinkled gianthyssop herb, 8-12 parts of bamboo shavings and 10-20 parts of loquat leaves.
2. The pharmaceutical composition of claim 1, wherein: the preparation is prepared from the following raw material medicines in parts by weight: 10 parts of costustoot, 10 parts of fructus amomi, 10 parts of ginger processed pinellia tuber, 10 parts of dried orange peel, 20 parts of adenophora tetraphylla, 10 parts of poria cocos, 20 parts of bighead atractylodes rhizome, 10 parts of perilla leaf, 5 parts of coptis chinensis, 10 parts of wrinkled gianthyssop herb, 10 parts of bamboo shavings and 15 parts of loquat leaf.
3. The pharmaceutical composition of claim 2, wherein: the preparation is prepared by adding pharmaceutically acceptable auxiliary materials or auxiliary components into crude drug powder, or water or organic solvent extracts of raw drug materials in weight ratio;
preferably, the formulation is an external formulation;
more preferably, the external preparation is a patch or a cataplasm.
4. A process for preparing a pharmaceutical composition according to any one of claims 1 to 3, characterized in that: it comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
5. A patch for preventing miscarriage and stopping vomit, which is characterized in that: the medicament is prepared from the following raw and auxiliary materials in parts by weight: 8-12 parts of elecampane, 8-12 parts of fructus amomi, 8-12 parts of ginger processed pinellia, 8-12 parts of dried orange peel, 16-24 parts of adenophora tetraphylla, 8-12 parts of poria cocos, 16-24 parts of bighead atractylodes rhizome, 8-12 parts of perilla leaves, 1-10 parts of coptis chinensis, 8-12 parts of wrinkled gianthyssop herb, 8-12 parts of bamboo shavings, 10-20 parts of loquat leaves, 1-10 parts of carbomer, 2-10 parts of polyvinyl alcohol, 2-15 parts of gelatin and 3-10 parts of polyacrylic acid;
preferably, the medicament is prepared from the following raw and auxiliary materials in parts by weight: 10 parts of costustoot, 10 parts of fructus amomi, 10 parts of ginger processed pinellia tuber, 10 parts of dried orange peel, 20 parts of adenophora tetraphylla, 10 parts of poria cocos, 20 parts of bighead atractylodes rhizome, 10 parts of perilla leaf, 5 parts of coptis chinensis, 10 parts of wrinkled gianthyssop herb, 10 parts of bamboo shavings, 15 parts of loquat leaf, 1-10 parts of carbomer, 2-10 parts of polyvinyl alcohol, 2-15 parts of gelatin and 3-10 parts of polyacrylic acid.
6. The patch according to claim 5, characterized in that: the patch is used for acupoint application;
preferably, the acupoints are Zhongwan, bilateral Neiguan and bilateral Zusanli.
7. A method of manufacturing a patch according to claim 5 or 6, characterized in that: it comprises the following steps:
(1) taking raw and auxiliary materials in each weight ratio;
(2) mixing adjuvants including carbomer, polyvinyl alcohol, gelatin and polyacrylic acid, and heating to obtain glue solution mixture;
(3) weighing raw materials including costustoot, fructus amomi, ginger processed pinellia tuber, dried orange peel, adenophora tetraphylla, poria cocos, bighead atractylodes rhizome, perilla leaf, coptis chinensis, agastache rugosus, bamboo shavings and loquat leaf, adding water for decoction, and filtering to obtain a liquid medicine mixture;
(4) uniformly stirring the liquid medicine mixture and the glue solution mixture to remove air bubbles, and uniformly mixing to prepare a patch;
preferably, in the step (3), the water is added for decoction for 1-1.5 hours, wherein the amount of the water is 8-10 times that of the water.
8. A combined medicine for preventing miscarriage and stopping vomit is characterized in that: the composition comprises the pharmaceutical composition of any one of claims 1 to 3 or the patch and the rehydration drug of claim 5, which are administered simultaneously or separately, and pharmaceutically acceptable carriers, wherein the pharmaceutical composition or the patch and the rehydration drug are of the same or different specifications;
preferably, the fluid replacement drug is vitamin and 5% glucose injection or 0.9% normal saline injection;
more preferably, the vitamins are vitamin C and vitamin B6;
further preferably, the fluid replacement drug is 500-1000mL of 5% glucose injection or 0.9% physiological saline injection containing 2-3g of vitamin C and 0.1-0.2g of vitamin B6;
still more preferably, the rehydration drug is administered intravenously.
9. Use of a pharmaceutical composition according to any one of claims 1 to 3, a patch according to claim 5 or 6, or a combination according to claim 8 for the manufacture of a medicament for preventing miscarriage and arresting vomiting;
preferably, the medicament is a medicament for the treatment of hyperemesis gravidarum;
more preferably, the medicament is a medicament for treating liver-stomach disharmony type pernicious vomiting.
10. Use of the pharmaceutical composition of any one of claims 1 to 3, the patch of claim 5 or 6, or the combination of claim 8 for the preparation of a medicament for soothing the liver, strengthening the spleen, calming the adverse-rising energy, arresting vomiting, and treating weakness of the spleen and stomach, incoordination between the liver and stomach, and loss of the stomach.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116850258A (en) * | 2023-06-18 | 2023-10-10 | 河南中医药大学 | Chinese medicinal composition with antiemetic effect and preparation method thereof |
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2020
- 2020-09-25 CN CN202011023280.XA patent/CN112076297A/en active Pending
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| 张春艳: "加味苏叶黄连汤治疗妊娠呕吐80例", 《河南中医学院学报》 * |
| 林振宇等: "穴位敷贴中脘、内关、足三里穴治疗妊娠剧吐的效果观察", 《当代护士》 * |
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| CN116850258A (en) * | 2023-06-18 | 2023-10-10 | 河南中医药大学 | Chinese medicinal composition with antiemetic effect and preparation method thereof |
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