CN107050395B - Traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever and preparation method and application thereof - Google Patents

Traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever and preparation method and application thereof Download PDF

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CN107050395B
CN107050395B CN201710386049.9A CN201710386049A CN107050395B CN 107050395 B CN107050395 B CN 107050395B CN 201710386049 A CN201710386049 A CN 201710386049A CN 107050395 B CN107050395 B CN 107050395B
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王晓燕
刘宝琴
汤瑞莲
王芳
鲁斌
李晶
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Zhengzhou Hospital of Traditional Chinese Medicine
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Abstract

The invention relates to a traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever and a preparation method and application thereof. The preparation is prepared from the following raw materials in parts by weight: 4-8 parts of kudzu root, 4-8 parts of radix bupleuri, 8-12 parts of radix scutellariae, 12-18 parts of gypsum, 2-4 parts of rheum officinale, 4-8 parts of cape jasmine, 4-8 parts of curcuma zedoary, 8-12 parts of wintersweet leaf, 10-12 parts of fingered citron, 4-6 parts of cicada slough and 2-4 parts of liquorice. The traditional Chinese medicine sigmoid colon infusion preparation for treating infantile exogenous fever has the characteristics of quick response, good curative effect, difficult rebound at body temperature, obvious relief of accompanying symptoms, small adverse reaction and the like when being used for treating infantile exogenous fever, and has better effect on wind-heat clamping stagnation type.

Description

Traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever and preparation method and application thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever as well as a preparation method and application thereof.
Background
The infantile exogenous fever is equivalent to the upper respiratory tract infection and influenza category of western medicine, and the incidence rate accounts for the first pediatric diseases. The pathogens are mainly viruses and can account for more than 90 percent of the primary upper respiratory tract infection. The virus is the smallest of pathogenic microorganisms, the core of the virus is ribonucleic acid (RNA) or deoxyribonucleic acid (DNA), the outer shell of the virus is protein, the virus does not have a cellular structure, most of the virus lacks an enzyme system, the virus cannot live independently, and the virus can be propagated (replicated) only by being integrated into a host cell depending on the enzyme system of the host. Thus, antiviral agents are in a sense only viral inhibitors and are not able to kill viruses and destroy virions directly, or otherwise damage host cells. Therefore, the curative effect of the current antiviral western medicine cannot be determined, and the current antiviral western medicine has larger side effect. At present, the treatment of upper respiratory tract infection internationally mainly comprises rest, symptomatic treatment and complication prevention, and antipyretic analgesics are advocated when the fever exceeds 38.5 ℃, but because viruses are not effectively controlled, the body temperature is mostly repeatedly raised after a plurality of hours, great discomfort is caused to children patients, or convulsion is induced.
The traditional Chinese medicine has systematic theoretical research and abundant clinical experience for dialectically treating the exogenous fever of the children, emphasizes the difference between individuals and syndrome types, treats the exogenous fever according to differentiation of syndromes of local, time and people, has definite curative effect, and has low price and small toxic and side effect. However, the traditional Chinese medicine decoction is difficult to feed due to poor taste of the decoction and the phenomenon of vomiting and refusal of the medicine occurs when the sick children are young. Many Chinese patent medicines are also published, including oral and injection preparations, such as Shuanghuanglian oral liquid and injection, Xiao Chaigui defervesce oral liquid and the like, but the Chinese patent medicines cannot fully reflect the concept of treatment based on syndrome differentiation, and the clinical curative effect of the Chinese patent medicines is obviously inferior to that of the traditional Chinese medicine decoction pieces. The above varieties seriously hinder the clinical popularization and application of the traditional Chinese medicine. The traditional Chinese medicine external treatment method solves the problems that children are afraid of taking medicines and injection and are afraid of pain, has definite curative effect and is advocated by medical staff and parents. The traditional Chinese medicine external treatment methods commonly used in clinic include medicine application, massage and spinal kneading, enema, acupuncture and moxibustion and the like, and in recent years, the traditional Chinese medicines rectal instillation and sigmoid colonic instillation are increasingly popular as a novel administration way.
Sigmoid administration is therapeutic by infusing the drug into the sigmoid via the anus. The traditional transanal administration adopts a retention enema mode, most of the retention enema modes are random operations without normative requirements, the retention enema is generally finished by injecting into rectum, and the retention time is short or small, so the retention enema is generally only limited to treating anorectal diseases or pelvic cavity and lower abdominal diseases. Sigmoid colonic instillation is developed from retention enema and rectal instillation, can control the speed of liquid medicine instillation, has slow administration speed, does not accumulate too much in intestinal tract quickly to cause defecation and discharge, and has much less stimulation to anus and rectum than retention enema. The drip administration of the traditional Chinese medicine rectum can ensure that the liquid medicine is uniformly dispersed on the surface of the rectal mucosa and dissolved in secretions, and then is fully absorbed, most of the liquid medicine enters the major circulation through the middle and lower veins of the rectum and the anal canal vein, so the first pass effect of the liver is avoided, in addition, the rectal administration is faster than the oral administration and is similar to the intravenous administration, the difficulty of oral administration of children and the influence of the upper gastrointestinal enzymolysis and acidolysis on orally taken medicines are also avoided, and the bioavailability of the medicine is improved. Therefore, clinical research and experimental research aiming at rectal instillation administration are more, but with the continuous and deep research, many defects are exposed, such as obvious rectal administration convenience, sensitive liquid medicine temperature and administration speed, discomfort for sick children and reduced compliance of the sick children; the rectum section is short, the liquid medicine is easy to leak out, the drip tube is easy to slide out, and the operation difficulty is increased, so that the sick children and family members thereof feel boring; small rectal space, and the dosage and administration speed are not easy to master. The sigmoid colon is the intersection of the colon and the rectum, has the physiological function characteristics of the rectum and the colon, has mild pH condition and less metabolic enzyme, and can improve the stability of the medicine; the drug has large capacity, has lower requirements on the dosage, the administration speed and the temperature, has longer running time in the colon than in the rectum, can increase the absorption of the drug and improve the bioavailability of the drug; the deeper part can overcome the defects of easy exudation of the liquid medicine, easy sliding of the drip chamber, strong defecation sense of the sick children and the like. In addition, the exogenous febrile disease is in the lung defense, the lung and the large intestine are exterior and interior, and the traditional Chinese medicine sigmoid colon drip is adopted to ensure that the efficacy of the medicine reaches the lung defense along the channels to eliminate pathogenic factors and reduce fever, thereby achieving the purpose of treating the internal disease by external therapy. This is the specific embodiment of the treatment of pediatrics in TCM, namely "lower-lying upper diseases" and "six fu-organs are used for general purpose".
According to traditional Chinese medicine, the exogenous fever of children is mainly caused by wind evil, and is divided into wind cold and wind heat. Clinically, wind-heat syndrome is the most common syndrome because children are the body of shaoyang disease and are prone to heat transformation after being infected with pathogens. The frequent insufficiency of the spleen in children usually affects the transportation and transformation functions of children, and sometimes causes the retention of milk and food, the obstruction of the middle energizer, the abdominal distention and fullness, poor appetite and other symptoms of exogenous pathogenic factors with stagnation. The body of shaoyang children is easy to be transformed into heat after being attacked by pathogenic factors, and is quick to be transmitted and changed, so that the exogenous pathogenic factors of the children are often not characterized and the interior symptoms appear again, and most of the three symptoms of taiyang, yangming and shaoyang are complicated in treatment. The three-yang clearing and resolving liquid is derived from ChaoGe Jieji Tang from Shang Han six Books, and Dachaihu Tang and Baihu Tang from Shang Han miscellaneous diseases, based on the syndrome differentiation theory of six meridians from Zhongjing Shang Han Lun. Wherein the root of kudzu vine is pungent and cool to release exterior and enter the sun; the bupleurum root, radix bupleuri, the scutellaria root, the radix scutellariae, the radix bupleuri, the radix scutellariae, the radix; gypsum, Gypsum Fibrosum, radix et rhizoma Rhei, fructus Gardeniae, radix Et rhizoma Rhei, radix Glycyrrhizae, radix rehmanniae Preparata, fructus Gardeniae, radix Et rhizoma Rhei, fructus Gardeniae, radix Et rhizoma Rhei. The whole formula has the effects of pungent and cool for relieving exterior syndrome, regulating Shaoyang and clearing and purging yangming. According to modern researches, the radix bupleuri, the radix scutellariae, the cape jasmine and the rhubarb have the functions of inhibiting viruses and bacteria, relieving fever and resisting inflammation, and the radix puerariae and the gypsum have good relieving fever functions. The most wonderful formula is added with the zedoary, which has the following four: it can promote blood circulation to dissipate blood stasis and promote the absorption of the medicine; the dual-purpose of the utility model can eliminate food retention and promote qi circulation, thus enhancing the appetite of children patients; thirdly, taking the property of bitter, warm, pungent and dispersed herbs to assist the cold and cool nature of the herbs; and the volatile oil of the medicine is taken to inhibit viruses and bacteria and enhance immunity, thereby comprehensively improving the curative effect of the medicine.
At present, the three-yang clearing decoction sigmoid colon infusion is used for treating the best indication of the infantile exogenous fever, the best medicine compatibility, the best depth of the entering of an intestinal drip tube, the best temperature of liquid medicine, the best infusion speed and the like, but the experiences are mature, but the experiences on the aspects of the influence of the osmotic pressure, the pH value and the like of the liquid medicine on the human body and the like do not exist.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides a traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever and a preparation method and application thereof.
The technical scheme of the invention is as follows:
a traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 4-8 parts of kudzu root, 4-8 parts of radix bupleuri, 8-12 parts of radix scutellariae, 12-18 parts of gypsum, 2-4 parts of rheum officinale, 4-8 parts of gardenia, 4-8 parts of curcuma zedoary, 8-12 parts of wintersweet leaf, 8-12 parts of fingered citron, 4-6 parts of cicada slough and 2-4 parts of liquorice.
Preferably, the traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 5.5 to 6.5 parts of kudzuvine root, 5.5 to 6.5 parts of Chinese thorowax root, 9 to 11 parts of baical skullcap root, 13.5 to 16.5 parts of gypsum, 2.5 to 3.5 parts of rhubarb, 5.5 to 6.5 parts of cape jasmine fruit, 5.5 to 6.5 parts of zedoary, 9 to 11 parts of wintersweet leaf, 9 to 11 parts of finger citron, 4.5 to 5.5 parts of cicada slough and 2.5 to 3.5 parts of liquoric root.
Preferably, the traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 6 parts of kudzu root, 6 parts of radix bupleuri, 10 parts of radix scutellariae, 15 parts of gypsum, 3 parts of rhubarb, 6 parts of cape jasmine, 6 parts of curcuma zedoary, 10 parts of wintersweet leaf, 10 parts of fingered citron, 5 parts of cicada slough and 3 parts of liquorice.
Further, the preparation contains crude drug 0.06-0.1 g/mL, preferably 0.08 g/mL.
The traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever has the functions that: pungent and cool to relieve exterior syndrome, harmonize Shaoyang, clear and purge Yangming, promote digestion and resolve phlegm; the main treatment is as follows: fever caused by exogenous pathogens in children is manifested by severe fever, slight aversion to cold, tidal fever in the afternoon or alternating chills and fever, sweating, thick nasal discharge, cough, yellow phlegm, red and swollen throat, dry and thirst mouth, abdominal distention, anorexia, feverish sensation in the palms and soles, foul breath or vomiting, abdominal pain, constipation or diarrhea, red tongue, yellow and greasy coating, slippery and rapid pulse or purple stagnation of fingerprints. The use method comprises the following steps: decocted in water for sigmoid colonic instillation.
The invention relates to a traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever, which is prepared by improving a three-yang clearing decoction formula (6 g of kudzuvine root, 6g of Chinese thorowax root, 10g of baical skullcap root, 15g of gypsum, 3g of rhubarb, 6g of cape jasmine fruit, 6g of zedoary and 3g of liquoric root). In the original three-yang clearing and detoxifying decoction formula, the kudzuvine root is pungent and cool to relieve exterior syndrome and enters the sun; bupleurum root, radix bupleuri; gypsum, Gypsum Fibrosum, radix et rhizoma Rhei, is sweet and cold in nature and can clear heat evil in the yang-qi system; the combination of the kudzuvine root, the Chinese thorowax root and the gypsum is a monarch drug which can clear excess heat of three yang; the scutellaria baicalensis clears away the ministerial fire and relieves shaoyang disease; rhubarb, radix et rhizoma Rhei purges heat, relieves constipation and washes yang-heat in the open bowel; gardenia is bitter and cold and can clear damp-heat in triple energizer; the pungent and warm zedoary can promote qi circulation, remove food retention, break blood and alleviate pain; licorice root, radix Glycyrrhizae coordinates the effects of the other drugs in the recipe. According to modern researches, radix bupleuri, scutellaria baicalensis, gardenia and rheum officinale have the effects of inhibiting viruses and bacteria, relieving fever and resisting inflammation, and radix puerariae and gypsum have good antipyretic effects. The most wonderful formula is added with the zedoary, which has the following four: it can promote blood circulation to dissipate blood stasis and promote the absorption of the medicine; the dual-purpose of the utility model can eliminate food retention and promote qi circulation, thus enhancing the appetite of children patients; thirdly, taking the property of bitter, warm, pungent and dispersed herbs to assist the cold and cool nature of the herbs; and the volatile oil of the medicine is taken to inhibit viruses and bacteria and enhance immunity, thereby comprehensively improving the curative effect of the medicine.
The wintersweet leaf, the fingered citron and the cicada slough are added on the basis of the original prescription; the wintersweet leaves are pungent and cool, relieve exterior syndrome, clear away heat and toxic materials, and have the effects of resisting bacteria, resisting viruses, relieving fever, easing pain, relieving cough, eliminating phlegm and increasing immunity according to research; the fingered citron enters the liver channel, the spleen channel and the stomach channel and has various medicinal functions of regulating qi, reducing phlegm, stopping vomiting, relieving flatulence, soothing the liver, strengthening the spleen, harmonizing the stomach and the like; cicada slough dissipates wind and removes heat, relieves sore throat, promotes eruption and relieves spasm; the whole formula has the effects of pungent and cool for relieving exterior syndrome, regulating Shaoyang and clearing and purging yangming. The phlegm, food and convulsion are often included in the exogenous fever of the children, and the three medicines are added, so that the antipyretic effect can be enhanced, and the phlegm, food and convulsion accompanied with the exogenous fever of the children can be considered.
Further, the invention also provides a preparation method of the traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever, which comprises the following steps: taking the traditional Chinese medicine raw materials according to the proportion, soaking, decocting, concentrating the liquid medicine, adding ethanol until the ethanol content is 50% (volume content), fully stirring, cooling (generally 0-4 ℃) and filtering, removing precipitates, recovering ethanol from the filtrate until no ethanol smell exists, adding a proper amount of distilled water until the crude medicine raw materials are contained in each mL of the liquid medicine, adjusting the pH value to 6.5-7.5, cooling (generally 0-4 ℃) and filtering, discarding the precipitates, filling and sterilizing to obtain the traditional Chinese medicine composition.
Preferably, the soaking is carried out for 20-40min (preferably 30min) by using cold water (generally 20-30 ℃).
Preferably, decocting for 1-3 times (1-3 hr each time), and adding 8-15 times of water.
Preferably, the drug solution is concentrated to a relative density of 1.10 (measured at 80 ℃).
Preferably, the sterilization is performed by using flowing steam (100 ℃) for 40 min.
Preferably, the traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever further comprises a proper amount of pharmaceutically acceptable preservative, such as sodium benzoate.
Specifically, the preparation method of the traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever comprises the following steps: taking the traditional Chinese medicine raw materials according to the proportion, adding cold water (generally 20-30 ℃) to soak for 0.5h, decocting and extracting for three times with 10 times of water each time, decocting for 1h each time, combining the decoctions, filtering, concentrating the filtrate to relative density of 1.10 (measured at 80 ℃); adding 95% ethanol until ethanol content is 50% (volume content), stirring, cooling (generally 0-4 deg.C) for 48 hr, filtering, removing precipitate, recovering ethanol from filtrate until no alcohol smell is produced, adding appropriate amount of antiseptic (such as sodium benzoate), adding appropriate amount of distilled water to make the solution contain crude drug 0.06-0.1 g/mL, adjusting pH to 6.5-7.5, cooling (generally 0-4 deg.C) for 48 hr, filtering, discarding precipitate, bottling, and sterilizing with flowing steam (100 deg.C) for 40min to obtain the final product.
Through a large number of clinical observations, the invention summarizes the instillation method, the entering depth of the dropper, the temperature of the liquid medicine, the dosage and the instillation speed: connecting a medicine bottle with a disposable transfusion leather strip, then connecting a catheter, ordering the patient to empty the bowels, lying on the left side, lubricating the front end of the catheter with paraffin oil, holding the catheter by a hand, slowly inserting the catheter into the anus through an anus rotating catheter, wherein the medicine temperature is 39-41 ℃, the depth is 20-30cm, the medicine amount is 10ml preparation/Kg body weight, the dripping speed is 1.5-2 ml preparation/min, the dripping speed of the medicine liquid can be properly adjusted according to the age and the tolerance of the patient, the patient feels warm, comfortable and inconvenient to feel in the lower abdomen, gently softening the abdomen for several minutes after dripping is finished, and ordering the patient to continue to keep the lying on the left side for 10 minutes.
The invention also comprises the application of the preparation or the preparation prepared by the method in preparing a medicine for treating infantile exogenous fever.
The traditional Chinese medicine sigmoid colon infusion preparation for treating infantile exogenous fever has the characteristics of quick response, good curative effect, difficult rebound at body temperature, obvious relief of accompanying symptoms, small adverse reaction and the like when being used for treating infantile exogenous fever, and has better effect on wind-heat clamping stagnation type.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention. The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products available from regular distributors, not indicated by the manufacturer.
Example 1
A traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 6 parts of kudzu root, 6 parts of radix bupleuri, 10 parts of radix scutellariae, 15 parts of gypsum, 3 parts of rhubarb, 6 parts of cape jasmine, 6 parts of curcuma zedoary, 10 parts of wintersweet leaf, 10 parts of fingered citron, 5 parts of cicada slough and 3 parts of liquorice.
The preparation method comprises the following steps: taking the traditional Chinese medicine raw materials according to the proportion, adding cold water (20-30 ℃) to soak for 0.5h, decocting and extracting for three times with 10 times of water each time, decocting for 1h each time, combining the decoctions, filtering, and concentrating the filtrate to relative density of 1.10 (measured at 80 ℃); adding 95% ethanol until ethanol content is 50% (volume content), stirring, cooling at 0-4 deg.C for 48 hr, filtering, removing precipitate, recovering ethanol from filtrate until ethanol smell disappears, adding sodium benzoate 3g, adding distilled water to 1000mL (equivalent to 0.08g of crude drug per mL of medicinal liquid), adjusting pH to 6.5-7.5, cooling at 0-4 deg.C for 48 hr, filtering, discarding precipitate, bottling, and sterilizing with flowing steam (100 deg.C) for 40 min.
Example 2
A traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 8 parts of kudzu root, 8 parts of radix bupleuri, 12 parts of radix scutellariae, 18 parts of gypsum, 4 parts of rhubarb, 8 parts of cape jasmine, 8 parts of curcuma zedoary, 12 parts of wintersweet leaf, 12 parts of fingered citron, 6 parts of cicada slough and 4 parts of liquorice.
The preparation method is the same as example 1.
Example 3
A traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is prepared from the following raw materials in parts by weight: 4 parts of kudzu root, 4 parts of radix bupleuri, 8 parts of radix scutellariae, 12 parts of gypsum, 2 parts of rhubarb, 4 parts of cape jasmine, 4 parts of curcuma zedoary, 8 parts of wintersweet leaf, 8 parts of fingered citron, 4 parts of cicada slough and 2 parts of liquorice.
The preparation method is the same as example 1.
Comparative example 1
A traditional Chinese medicine sigmoid colon instillation preparation comprises the following formula: 6g of kudzuvine root, 6g of Chinese thorowax root, 10g of baical skullcap root, 15g of gypsum, 3g of rhubarb, 6g of cape jasmine fruit, 6g of zedoary and 3g of liquoric root.
The preparation method is the same as example 1.
Comparative example 2
A traditional Chinese medicine sigmoid colon instillation preparation comprises the following formula: 10g of wintersweet leaf, 10g of finger citron and 5g of cicada slough.
The preparation method is the same as example 1.
Examples of the experiments
30 cases (wind-heat clamping stagnation type) of exogenous febrile children with fever time within 6 hours, body temperature not more than 38.5 ℃ and blood conventional white blood cell count within normal range are observed to be randomly divided into three groups, each group is respectively added with 1 sigmoid colon instillation daily for 1 time and 10ml preparation/Kg body weight on the basis of conventional treatment, and the results of 2 continuous experiments are shown in the following table:
Figure BDA0001306388330000071
note: in effective cases, A means that the endosome temperature of the infant patient is normal within 36 hours, no rebound occurs within 72 hours, and no obvious adverse reaction occurs; b means that the endosome temperature of the infant patient is normal within 40 hours, no rebound occurs within 72 hours, and no obvious adverse reaction occurs; c means that the body temperature of the infant patient is normal within 48 hours, no rebound occurs within 72 hours, and no obvious adverse reaction occurs.
The experimental results show that: example 1 sigmoid colon instillation preparation for treating infantile exogenous fever has quick response, good curative effect, difficult rebound of body temperature, obvious relief of accompanying symptoms, small adverse reaction and obviously better treatment effect than comparative examples 1 and 2.
Although the invention has been described in detail hereinabove with respect to a general description and specific embodiments thereof, it will be apparent to those skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims (11)

1. A traditional Chinese medicine sigmoid colon instillation preparation for treating infantile exogenous fever is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 5.5 to 6.5 parts of kudzuvine root, 5.5 to 6.5 parts of Chinese thorowax root, 9 to 11 parts of baical skullcap root, 13.5 to 16.5 parts of gypsum, 2.5 to 3.5 parts of rhubarb, 5.5 to 6.5 parts of cape jasmine fruit, 5.5 to 6.5 parts of zedoary, 9 to 11 parts of wintersweet leaf, 9 to 11 parts of finger citron, 4.5 to 5.5 parts of cicada slough and 2.5 to 3.5 parts of liquoric root;
the preparation method of the preparation comprises the following steps: taking the traditional Chinese medicine raw materials according to the proportion, soaking, decocting, concentrating the liquid medicine, adding ethanol until the ethanol content is 50%, fully stirring, cooling, filtering, removing precipitate, recovering ethanol from the filtrate until no alcohol smell exists, adding a proper amount of distilled water until the content of the raw medicine raw materials is 0.06-0.1g per mL of the liquid medicine, adjusting the pH value to 6.5-7.5, cooling, filtering, removing the precipitate, filling and sterilizing to obtain the traditional Chinese medicine composition.
2. The preparation according to claim 1, which is prepared from the following Chinese medicinal raw materials in parts by weight: 6 parts of kudzu root, 6 parts of radix bupleuri, 10 parts of radix scutellariae, 15 parts of gypsum, 3 parts of rhubarb, 6 parts of cape jasmine, 6 parts of curcuma zedoary, 10 parts of wintersweet leaf, 10 parts of fingered citron, 5 parts of cicada slough and 3 parts of liquorice.
3. The preparation according to claim 1 or 2, wherein the crude drug raw material is contained in an amount of 0.06 to 0.1g per mL of the preparation.
4. The preparation according to claim 3, wherein the crude drug raw material is contained in an amount of 0.08 g/mL of the preparation.
5. The formulation according to claim 1 or 2, further comprising a suitable amount of a pharmaceutically acceptable preservative.
6. The formulation of claim 5, wherein the preservative is sodium benzoate.
7. A method of preparing a formulation as claimed in any one of claims 1 to 6, comprising: taking the traditional Chinese medicine raw materials according to the proportion, soaking, decocting, concentrating the liquid medicine, adding ethanol until the ethanol content is 50%, fully stirring, cooling, filtering, removing precipitate, recovering ethanol from the filtrate until no alcohol smell exists, adding a proper amount of distilled water until the content of the raw medicine raw materials is 0.06-0.1g per mL of the liquid medicine, adjusting the pH value to 6.5-7.5, cooling, filtering, removing the precipitate, filling and sterilizing to obtain the traditional Chinese medicine composition.
8. The preparation method of the preparation according to claim 7, wherein the preparation is soaked in cold water for 20-40 min;
and or, decocting for 1-3 times (1-3 h each time), and adding water 8-15 times of the Chinese medicinal materials each time;
and/or, the liquid medicine is concentrated to the relative density of 1.10;
andor, the sterilization is by flowing steam; sterilizing for 40 min.
9. The method for preparing the formulation according to claim 8, wherein the soaking is performed with cold water for 30 min.
10. The method of preparing the formulation of claim 7, comprising: taking the traditional Chinese medicine raw materials according to the proportion, adding cold water to soak for 0.5h, decocting and extracting for three times with 10 times of water each time, decocting for 1h each time, combining the decoctions, filtering, and concentrating the filtrate to the relative density of 1.10; adding 95% ethanol until ethanol content is 50%, stirring, cooling for 48 hr, filtering, removing precipitate, recovering ethanol from filtrate until no ethanol smell exists, adding appropriate amount of antiseptic, adding appropriate amount of distilled water to make the solution contain crude drug 0.06-0.1g per mL, adjusting pH to 6.5-7.5, cooling for 48 hr, filtering, removing precipitate, bottling, and sterilizing with flowing steam for 40 min.
11. Use of a formulation according to any one of claims 1 to 6 or a formulation prepared by a method according to any one of claims 7 to 10 in the manufacture of a medicament for the treatment of fever from exogenous childhood.
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