CN110179893B - Enema liquid of ten ingredients with ginseng and angelica and preparation process thereof - Google Patents
Enema liquid of ten ingredients with ginseng and angelica and preparation process thereof Download PDFInfo
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- CN110179893B CN110179893B CN201910528050.XA CN201910528050A CN110179893B CN 110179893 B CN110179893 B CN 110179893B CN 201910528050 A CN201910528050 A CN 201910528050A CN 110179893 B CN110179893 B CN 110179893B
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Abstract
The invention discloses a compound traditional Chinese medicine which is mainly prepared from the following medicinal materials: radix salviae miltiorrhizae, angelica, rhizoma corydalis, plantain, peach kernel, houttuynia cordata, artemisia anomala, dandelion, red paeony root and patrinia. Accordingly, the inventor develops the ten-ingredient ginseng-angelica enema liquid and the preparation process thereof. The product has effects of clearing away heat and toxic materials, promoting blood circulation, removing blood stasis, activating qi-flowing, relieving pain, softening hard mass, and resolving hard mass, and is suitable for treating acute and chronic pelvic inflammatory disease due to stagnation of qi and blood stasis, damp-heat accumulation, and damp-heat accumulation. Clinical practices prove that the prescription of the shiwei Shengui enema liquid disclosed by the invention is effective on various types of pelvic inflammatory disease symptoms, the symptoms of patients are obviously relieved after the prescription is used, the tolerance of the patients is good, the cure rate is high, the recurrence rate is low, and adverse reactions are rarely caused, so that the prescription is safe and reliable in clinical use, exact in curative effect and free of toxic and side effects.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a ten-ingredient ginseng and angelica enema liquid and a preparation process thereof.
Background
Pelvic Inflammatory Disease (PID) refers to a group of infectious diseases of the upper genital tract of women of childbearing age, mainly including endometritis, salpingitis, salpingo-ovarian abscess, pelvic peritonitis. Pelvic inflammatory disease, if not treated in a timely and thorough manner, may result in a series of sequelae, namely pelvic inflammatory disease Sequelae (SPID), whose major pathologies are altered to tissue destruction, extensive adhesions, hyperplasia and scarring; and then a series of corresponding clinical symptoms are caused, such as chronic pelvic pain, infertility and the like. SPID is a common and frequently encountered disease of gynecology, is a chronic inflammatory state continuously existing in pelvic inflammatory diseases, and is characterized by fibrous connective tissue hyperplasia, adhesion of oviduct ovary and peripheral tissues and organs, scar contracture, unsmooth blood circulation, or formation of masses and hydrops, which cause poor absorption in focal areas. Therefore, more effective treatment methods for treating pelvic inflammation need to be found.
According to Western medicine, chronic pelvic inflammation is an inflammatory reaction which is continuously generated after female lower genital tract pathogens reversely infect a pelvic cavity, and can cause congestion, edema, exudation and extensive adhesion of visceral organs and surrounding tissues in the pelvic cavity. Western medicine adopts oral or intravenous drip antibiotic anti-inflammatory therapy, and auxiliary measures such as physical therapy, local medication and the like, and performs operative treatment if necessary. However, due to the complex anatomical structure of the pelvic cavity, inflammation can be clustered, various bacterial infections can be caused, the inflammation fading time is long, liver and kidney damage is easily caused by long-term use of antibiotics, flora imbalance is caused, and even antibiotic resistance is caused. In addition, after some patients take antibiotics, the symptoms of the patients are relieved and the patients stop taking the antibiotics blindly, so that the diseases are easy to repeat and linger.
The traditional Chinese medicine considers that pelvic inflammation takes abdominal pain, lumbosacral pain, dyspareunia and vaginal drainage as main clinical manifestations, pelvic inflammatory mass in severe cases, and traditional Chinese medicine should belong to the categories of abdominal pain, leukorrhagia, body mass retention and the like. The traditional Chinese medicine considers that the pathogenesis of the uterine cavity is mostly caused by improper regulation and control in menstrual period, sexual overstrain, postpartum or uterine cavity operation, when the uterine vessels are empty, damp heat, cold evil or heat toxin enter the uterine vessels due to deficiency, congeals and descends, accumulates in the uterine collaterals, causes stagnation of qi and blood, cold-damp stagnation, cold-damp heat toxin and blood to be combined, causes unsmooth operation, damages Chong and conception vessels and stasis to cause the disease. At present, the traditional Chinese medicine methods commonly used for treating pelvic inflammation comprise the following syndrome oral administration of traditional Chinese medicines, hot ironing of traditional Chinese medicines, acupoint injection of traditional Chinese medicines, retention enema of traditional Chinese medicines and the like. At present, the enema for treating pelvic inflammation in China has fewer varieties and higher price, and can not meet the requirements of clinical patients.
Disclosure of Invention
The invention aims to solve the technical problem of providing a ten-ingredient ginseng-angelica enema liquid which has novel dosage form, convenient use and high stability and a preparation process thereof, and the product has definite curative effect and good clinical effect on treating pelvic inflammation (acute/chronic), and is easy to popularize and use in clinic.
In order to solve the technical problems, the invention adopts the following technical scheme:
the compound traditional Chinese medicine is mainly prepared from the following medicinal materials: radix salviae miltiorrhizae, angelica, rhizoma corydalis, plantain, peach kernel, houttuynia cordata, artemisia anomala, dandelion, red paeony root and patrinia.
The compound traditional Chinese medicine is applied to the preparation of the medicine for treating pelvic inflammation.
The medicine for treating pelvic inflammation is a ten-ingredient ginseng-Chinese enema.
The enema liquid is mainly prepared from the following medicinal materials in parts by weight: 50 parts of salvia miltiorrhiza, 75 parts of angelica, 50 parts of corydalis tuber, 75 parts of plantain, 75 parts of peach kernel, 75 parts of houttuynia cordata, 50 parts of artemisia anomala, 75 parts of dandelion, 50 parts of red paeony root and 75 parts of dahurian patrinia herb.
The preparation process of the enema liquid of the ten ingredients of the ginseng and the angelica comprises the steps of extracting the two ingredients of the salvia miltiorrhiza and the corydalis tuber by ethanol to obtain ethanol extract, extracting the remaining eight ingredients of the salvia miltiorrhiza and the corydalis tuber by water and precipitating the eight ingredients of the corydalis tuber by ethanol to obtain water extraction and ethanol precipitation filtrate, respectively recovering ethanol from the ethanol extract and the water extraction and ethanol precipitation filtrate, concentrating and combining the ethanol extract and the water extraction and ethanol precipitation filtrate.
The ethanol extraction was performed as follows: reflux-extracting 50g of radix salviae miltiorrhizae and 50g of rhizoma corydalis with 70% ethanol for 2 times, each time for 1.5 hours, mixing the extracting solutions, filtering, recovering ethanol from the filtrate, and concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃) for later use.
Extracting with 70% ethanol under reflux for 2 times, wherein the amount of 70% ethanol added is 6 times of the amount of the medicinal materials for the first time and 5 times of the amount of the medicinal materials for the second time.
The water extraction and alcohol precipitation are carried out according to the following steps: taking 550g of the rest 8 medicinal materials, adding water, decocting for 2 times, decocting for 2 hours for the first time and 1.5 hours for the second time, combining decoction, filtering, concentrating to 550ml, keeping stand at 80 ℃, adding 1100ml of 2 times of ethanol, stirring uniformly, keeping stand for 24 hours, filtering, recovering ethanol from filtrate, and concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃).
Decocting in water for 2 times, the first time adding water 13 times of the medicinal materials, and the second time adding water 10 times of the medicinal materials.
The merging was performed as follows: concentrating the ethanol extractive solution and the filtrate, respectively, mixing the two fluid extracts, adding water to adjust total volume to 1000ml, stirring, packaging into 100ml per bottle, and sterilizing under hot pressure to obtain the final product
Aiming at the problem that the gynecological pelvic inflammatory disease is lack of economical and effective medicines, under the guidance of the theory of traditional Chinese medicine, the inventor summarizes according to clinical treatment experience and optimizes and develops a compound traditional Chinese medicine through long-term clinical verification, and the compound traditional Chinese medicine is mainly prepared from the following medicinal materials: radix salviae miltiorrhizae, angelica, rhizoma corydalis, plantain, peach kernel, houttuynia cordata, artemisia anomala, dandelion, red paeony root and patrinia. Accordingly, the inventor develops the ten-ingredient ginseng-angelica enema liquid and the preparation process thereof. The product has effects of clearing away heat and toxic materials, promoting blood circulation, removing blood stasis, activating qi-flowing, relieving pain, softening hard mass, and resolving hard mass, and is suitable for treating acute and chronic pelvic inflammatory disease due to stagnation of qi and blood stasis, damp-heat accumulation, and damp-heat accumulation. Clinical practices prove that the prescription of the shiwei Shengui enema liquid disclosed by the invention is effective on various types of pelvic inflammatory disease symptoms, the symptoms of patients are obviously relieved after the prescription is used, the tolerance of the patients is good, the cure rate is high, the recurrence rate is low, and adverse reactions are rarely caused, so that the prescription is safe and reliable in clinical use, exact in curative effect and free of toxic and side effects.
Drawings
FIG. 1 is a preparation process diagram of the SHIWEISHENGUIZHUYE of the invention.
Detailed Description
Development of ten-ingredient ginseng-angelica enema liquid
First, the theoretical basis of prescription
The ten-ingredient ginseng-angelica enema liquid is composed of ten Chinese medicines such as salvia miltiorrhiza, angelica, dandelion and the like, wherein the salvia miltiorrhiza in the prescription activates blood circulation and removes blood stasis, calms nerves and calms heart, discharges pus and relieves pain; chinese angelica has the functions of nourishing blood, promoting blood circulation and removing blood stasis; herba Patriniae, herba Taraxaci, and herba Houttuyniae have effects in clearing away heat and toxic materials, cooling blood, relieving swelling, softening and resolving hard mass; the plantain herb clears heat and promotes diuresis; rhizoma corydalis promotes qi circulation to relieve pain; the herba artemisiae anomala has the effects of warming and dispersing, activating blood and dissolving stasis, assisting the rhizoma corydalis to promote qi circulation and relieve pain on one hand, and preventing the dandelion, the patrinia and the houttuynia from being too bitter and cold to play a role in countermeasures on the other hand. The traditional Chinese medicine composition has the effects of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, promoting qi circulation to relieve pain, softening hardness and dissipating stagnation, and exactly hits the pathogenesis of heat, dampness and stasis of pelvic inflammation, so that a better curative effect can be obtained. Is suitable for treating clinical common acute and chronic pelvic inflammatory diseases caused by stasis-toxin internal accumulation, damp-heat accumulation and qi stagnation and blood stasis.
Second, use background conditions
The applicant is used in the unit for many years in the form of decoction, and is used for treating common acute and chronic pelvic inflammatory diseases of stasis and toxin internal accumulation type, damp and heat accumulation type, qi stagnation and blood stasis type, wherein the total clinical treatment cases exceed 10000 cases, and the curative effect is approved by clinicians and patients. In recent years, 100 cases are observed and recorded, and the effective rates of the traditional Chinese medicine for treating the pelvic inflammation of type 4 of stasis toxin internal accumulation, damp-heat stasis and qi stagnation and blood stasis are 92.3%, 95.7%, 92.6% and 91.7% in sequence. Safe and reliable clinical use, definite curative effect, no toxic or side effect and good tolerance of patients.
Preparation process
Prescription composition
50g of salvia miltiorrhiza, 75g of angelica, 50g of corydalis tuber, 75g of plantain, 75g of peach kernel, 75g of houttuynia cordata, 50g of artemisia anomala, 75g of dandelion, 50g of red paeony root and 75g of patrinia; making into enema 1000ml
Method for producing
Reflux-extracting Saviae Miltiorrhizae radix and rhizoma corydalis with 70% ethanol for 2 times (1.5 hr each time), mixing extractive solutions, filtering, recovering ethanol from filtrate, and concentrating to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C). Decocting the rest 8 medicinal materials with water for 2 times, the first time lasts for 2 hours, the second time lasts for 1.5 hours, combining the decoctions, filtering, concentrating to 550ml, the relative density is 1.10-1.20 (80 ℃), standing, cooling, adding 1100ml of 2 times of ethanol, stirring, standing for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃). Mixing the above two fluid extracts, adding water to adjust total amount to 1000ml, stirring, packaging into 100ml per bottle, and sterilizing under hot pressure.
Fourthly, research on process rationality
Selection of dosage forms
The 'retention enema' method is to directly inject the decocted liquid medicine into the rectum through the anus by a catheter, so that the method is not influenced by a plurality of factors such as gastrointestinal tract enzymes, digestive juice, liver first pass effect and the like. Is suitable for patients who are inconvenient to take orally. The special physiological anatomical characteristics of women, after the rectal mucosa absorbs the liquid medicine, the medicine can quickly disperse in the pelvic cavity, and the purposes of promoting blood circulation, improving tissue nutrition, reducing capillary permeability, reducing inflammatory exudation, and being beneficial to inhibiting connective tissue hyperplasia and promoting inflammatory mass absorption are achieved. And the local administration concentration is high, the absorption is good, the patient has no pain, and the cost is low. The action mechanism of the traditional Chinese medicine composition not only reduces the content of Smad3 protein in fibroblasts, thereby controlling the formation of the fibrosis and hyperplasia of the pelvic cavity part. Wherein, the angelica, the plantain, the houttuynia, the dandelion and other components can also directly kill various pathogenic microorganisms causing pelvic inflammation. The method can overcome the defects that the systemic medication methods such as oral administration, injection and the like are difficult to reach the focus due to the hyperplasia of fibrous connective tissue of chronic inflammation and poor blood circulation of pelvic cavity.
Due to the large amount of the medicinal materials in the prescription, if the medicinal materials are prepared into oral preparations such as tablets, capsules and the like, the finished products have large quantity, so that the dosage is large, the oral preparation is not easy to take, and the defects of low concentration and poor curative effect of oral medicines at local inflammation parts cannot be overcome. In addition, the enema can avoid the unpleasant odor and taste of oral drugs, the active ingredients of the drugs are absorbed by rectal mucosa and directly act on pelvic cavities, the local drug concentration is high, the enema has obvious improvement effect on states of blood stasis, inflammation and the like, and the curative effect is good. The retention enema of the traditional Chinese medicine has the unique advantages over the common oral and intravenous administration methods, and has the advantages of low price, good patient compliance and no obvious adverse reaction.
(II) Process study
1 study on extraction process of Salvia miltiorrhiza and corydalis tuber
1.1 the main ingredients of the selected salvia miltiorrhiza bunge in the extraction method comprise two groups, namely water-soluble ingredients such as tanshinol, protocatechualdehyde, salvianolic acid B and the like and fat-soluble ingredients such as tanshinone IIA, iso-tanshinone, cryptotanshinone and the like, and corydalis tuber mainly comprises tetrahydropalmatine which is easy to dissolve in water or ethanol. The alcohol solution with a certain concentration can effectively extract water-soluble and fat-soluble components at the same time, the permeability is strong, and the solvent is convenient to recover, so that the ethanol reflux extraction method is considered for extracting the salvia miltiorrhiza and the corydalis tuber. By an orthogonal test method, main factors such as the breakage degree of medicinal materials, the concentration of ethanol, the amount of ethanol, the reflux frequency, the reflux time and the like are inspected, and the optimal process conditions influencing the main factors of ethanol reflux extraction are determined by taking the content of salvianolic acid B and the content of tetrahydropalmatine as assessment indexes.
1.2 study of ethanol reflux extraction conditions
1.2.1 Experimental design
1.2.1.1 preparation of test solutions selection L8(27) Orthogonal table for examining crushing degree, ethanol concentration, ethanol amount and reflux frequency of medicinal materialsAnd the reflux time, two levels of each factor are taken for testing, and the factor levels are shown in the table 1. The test method of the extracting solution comprises the following steps: pulverizing rhizoma corydalis into coarse powder (5 mesh or 10 mesh), cutting Saviae Miltiorrhizae radix into slices (2mm or 4mm) thick, weighing 3/10 prescriptions, reflux-extracting according to the conditions of ten ingredient radix Ginseng and radix Angelicae sinensis enema liquid extraction process flow chart and each experimental arrangement in Table 1, mixing, filtering, adding ethanol with corresponding concentration to constant volume of 50ml, and shaking to obtain ethanol reflux-extraction orthogonal test sample solution.
TABLE 1 factor levels for ethanol reflux extraction
Note: the rhizoma corydalis in the factor A is coarse powder, the horizontal unit is mesh, the radix salviae miltiorrhizae is slice, and the horizontal unit is mm.
1.2.1.2 preparation of reference solution A proper amount of tetrahydropalmatine is taken, and methanol is added to prepare reference solution with tetrahydropalmatine content of 65.8 μ g/ml; taking appropriate amount of salvianolic acid B reference substance, and adding 75% methanol to obtain reference substance solution with salvianolic acid B content of 0.162 mg/ml.
1.2.1.3 preparation of sample test solutions
Preparing a salvianolic acid B sample test solution: precisely measuring 1.5ml of sample solution, placing in a 10ml measuring flask, adding ethanol with corresponding concentration to scale, shaking, and collecting the filtrate.
Preparing a tetrahydropalmatine sample test solution: the sample solution is directly used as a sample test solution.
1.2.1.4 chromatographic conditions
A chromatographic column: philomo Gemini C18(4.6 mm. times.250 mm, 5 μm); mobile phase: salvianolic acid B is methanol: acetonitrile: formic acid: water (30:10:1: 59); tetrahydropalmatine is methanol: 0.1% phosphoric acid solution (60: 40); flow rate: 1.0 ml/min; the detection wavelengths are respectively: salvianolic acid B286 nm; tetrahydropalmatine 280 nm; column temperature: 30.0 ℃.
1.2.1.5 assay method
Taking 10 mul of salvianolic acid B reference solution and salvianolic acid B sample test solution respectively for determination, and calculating the content of salvianolic acid B in the orthogonal sample. Taking 20 μ l of tetrahydropalmatine reference solution and tetrahydropalmatine sample test solution respectively, determining, and calculating the content of tetrahydropalmatine in orthogonal sample. The results show that:
firstly, salvianolic acid B: the main and secondary influencing factors are as follows: d is more than E and more than C is more than A and more than B, A, B, C, D, E, and the five influencing factors have no significant difference, so the process conditions can be combined arbitrarily.
② tetrahydropalmatine: the main and secondary influencing factors are as follows: a is more than B and more than C is more than E and more than D, except for the factor D, other factors have significant difference on the ethanol reflux extraction process, and the optimal combination condition is as follows: a. the2B1C2D1(or D)2)E2。
And thirdly, through comprehensive analysis, the ethanol reflux extraction condition only influences the yield of tetrahydropalmatine (except reflux times), but does not obviously influence the yield of salvianolic acid B. Therefore, the optimal extraction process condition is determined as A2B1C2D1E2The corydalis tuber is crushed and sieved by a sieve of 10 meshes, and the salvia miltiorrhiza is sliced to be 2 mm; the ethanol concentration is 70%; adding ethanol for the first time 6 times of the amount of the medicinal materials, and for the second time 5 times of the amount of the medicinal materials; reflux extraction was performed 2 times for 1.5 hours each. See table 2.
TABLE 2 ethanol reflux extraction orthogonal test table and test results of Salvia miltiorrhiza and corydalis
F0.05(1.1)＝161.4，F0.01(1.1)＝4052
1.2.1.6 optimization of Process conditions
A is preferred from the above analysis results2B1C2D1E2The optimum ethanol extraction process condition of the salvia miltiorrhiza and the corydalis tuber is that the ethanol concentration is 70 percent; the reflux extraction times are 2 times, and each time is 1.5 hours; adding ethanol: the first time is 6 times of the amount of the medicinal materials, and the second time is 5 times of the amount of the medicinal materials; pulverizing rhizoma corydalis, sieving with 10 mesh sieve, and cutting Saviae Miltiorrhizae radix into slices of 2mm。
2 Process research of water extraction and alcohol precipitation part of 8 medicinal materials such as angelica and the like
2.1 selection of extraction method
The angelica mainly contains ferulic acid, volatile oil and other components; the plantain herb mainly contains flavonoid components and phenylethanoid glycosides: such as plantaginin, luteolin, etc.; semen Persicae mainly contains amygdalin; the houttuynia cordata mainly contains volatile oil and flavonoid substances: such as houttuynin, quercetin, etc.; the diverse wormwood herb mainly contains hemiterpene lactones, flavonoids and coumarin components: such as artemisia flavone, coumarin, artemisia lactone, volatile oil and the like; the herba Taraxaci mainly contains taraxasterol, taraxacin, flavonoid, saponin, choline, inulin, pectin, etc.; radix Paeoniae Rubra mainly contains paeoniflorin; patrinia mainly contains patrinia villosa juss glycoside, morroniside, loganin and the like. It can be seen that most of the main active ingredients of the above drugs are soluble in water. The water is used as the coal dissolving agent, is economical and easy to obtain, has high safety, is suitable for industrial production, can keep the traditional medication habit of the traditional Chinese medicine, and is extracted by a water decoction method.
2.2 study of Water extraction and alcohol precipitation extraction Process
2.2.1 test design
2.2.1.1 preparation of test solutions
Factors affecting the decoction and extraction of Chinese herbal medicines generally include the degree of crushing of the medicinal materials, the times of decoction and extraction, the time of decoction and extraction, the water addition amount and the alcohol precipitation concentration. Therefore, the 5 factors are selected for design when the water extraction and alcohol precipitation process is researched. Selection of L8(27) And (3) an orthogonal table, wherein five factors such as the crushing degree of the medicinal material, the boiling and extraction times, the boiling and extraction time, the water addition amount, the alcohol precipitation concentration and the like are examined, two levels are respectively taken for testing, and the factor levels are shown in a table 3. The test method of the extracting solution comprises the following steps: taking 2/5 prescription amounts of 8 medicinal materials (tablets, small segments or crushed) such as angelica, semen citri reticulatae, plantain herb, heartleaf houttuynia herb, diverse wormwood herb, dandelion, red paeony root, dahurian patrinia herb and the like, adding water for boiling extraction according to the extraction process flow chart of the enema liquid of the ten medicinal materials and the conditions of each experimental arrangement in the table 3, continuously adding water to maintain the water amount, combining the decoction, filtering, concentrating, cooling, adding ethanol, fully stirring, standing for 24 hours, filtering, taking the filtrate and adding a counterDissolving the mixture into 100ml of ethanol with a certain concentration, and shaking the mixture evenly to obtain the orthogonal test sample solution of the water extraction and alcohol precipitation process.
TABLE 3 Water extraction and alcohol precipitation factor level table
2.2.1.2 preparation of control solutions
Preparing a reference substance solution by adding 70% methanol into a proper amount of ferulic acid reference substance to obtain a reference substance solution with ferulic acid content of 0.010 mg/ml; taking appropriate amount of amygdalin reference substance, adding 70% methanol, and making into reference substance solution with amygdalin content of 0.1172 mg/ml.
2.2.1.3 preparation of sample test solutions
Preparing a ferulic acid sample test solution: sampling 5ml of the sample solution, putting the sample solution into a 10ml measuring flask, adding ethanol with corresponding concentration to the scale, shaking up, and taking the subsequent filtrate to obtain the product.
Preparing a amygdalin sample test solution: taking 1ml of sample solution, placing in a 5ml measuring flask, adding ethanol with corresponding concentration to scale, shaking up, and taking the subsequent filtrate to obtain the final product.
2.2.1.4 chromatographic conditions
A chromatographic column: philomo Gemini C18(4.6 mm. times.250 mm, 5 μm); mobile phase: ferulic acid is acetonitrile: 0.085% phosphoric acid solution (17: 83); amygdalin is methanol: water (20: 80); flow rate: 1.0 ml/min; the detection wavelengths are respectively: ferulic acid 316 nm; amygdalin is 210 nm; column temperature: ferulic acid 35.0 deg.C; amygdalin is 30 ℃.
2.2.1.5 assay method
Determination of ferulic acid 5ml of each test solution of the orthogonal test is respectively taken, and is respectively placed in a 10ml measuring flask, ethanol with corresponding concentration is added to the scale, the mixture is shaken up, and the determination is carried out according to the method under the item of ferulic acid of Chinese angelica in 2010 version. The results of the measurement calculation are shown in Table 4.
The determination of amygdalin takes 1ml of orthogonal test sample solution (No. 1-8) respectively, puts into a 5ml measuring flask, adds ethanol with corresponding concentration to the scale, shakes up, determines according to the method under the item of amygdalin of the first part of the sample of Chinese pharmacopoeia 2010 edition.
As a result: ferulic acid: the main and secondary influencing factors are as follows: a is more than E and more than B and more than C and more than D, A, B, C, D, E, the factors have no significant difference to the water boiling extraction process, and the optimal combination condition is as follows: a. the2B2C1D1E2；
② amygdalin: the main and secondary influencing factors are as follows: a is more than D is more than E is more than B is more than C, except for C, other factors have significant difference to the water boiling extraction process, so the process conditions can be combined at will.
Thirdly, through comprehensive analysis, the conditions of the water extraction and alcohol precipitation process only influence the yield of the amygdalin (except the extraction times), and the optimum extraction process of the water extraction and alcohol precipitation is A in combination with the actual conditions of industrial production2B1C1D2E1The whole herb plantain herb and other medicinal materials are cut into sections with the length of 2cm, the root medicinal material angelica and other medicinal materials are cut into slices with the thickness of 0.5cm, and the peach kernels are not crushed; decocting in water for 2 times; the water addition amount of the 1 st time is 13 times of the amount of the medicinal materials, and the water addition amount of the 2 nd time is 10 times; decocting for 2 hr at 1 st time and decocting for 1.5 hr at 2 nd time; the ethanol is added in an amount of 2 times of the medicinal liquid during ethanol precipitation. See table 4.
TABLE 4 orthogonal design table and experimental results of decoction and extraction of eight Chinese medicinal materials such as radix Angelicae sinensis
F0.05(1.1)＝161.4
2.2.1.6 optimization of Process conditions
Therefore, A is preferable from the above analysis results2B1C1D2E1The method is characterized in that the method is the optimal extraction process conditions of 8 medicines such as angelica and the like, namely, whole grass is cut into sections (2cm) or rhizome slices (0.50cm), and peach kernel is granulated; decocting in water for 2 times, the first time adding water 13 times of the medicinal materials, decocting for 2 hr; the water amount added for the second time is 10 times of the amount of the medicinal materials, and the decoction is carried out for 1.5 hours; the optimal extraction process is that 2 times of ethanol is added during alcohol precipitation.
3 trial production by amplification process
The preparation process is determined according to the research, 6 continuous batches of amplification process experimental researches with 8 times of the prescription amount are carried out according to the optimal alcohol extraction and water extraction process conditions, and the yield of 6 batches of laboratory trial-produced samples is 95.0-97.5 percent according to the experimental results, which shows that the production process is stable and meets the production requirements.
The ten-ingredient ginseng-angelica enema liquid prepared by the preparation process contains saponin, flavonoid compounds, alkaloid, organic acid and other ingredients through chemical component tests; the thin-layer identification can detect the medicinal materials such as salvia miltiorrhiza, corydalis tuber, red paeony root, peach kernel and the like, and the content of salvianolic acid B is more than 0.20 mg/ml. The product is tested for long-term stability and accelerated stability, and the result meets the quality standard and hygiene requirements of the product. The fact shows that the ten-ingredient ginseng-angelica enema liquid prepared by the preparation process can basically keep the active ingredients of the medicinal materials and the quality of the original decoction, and has stable quality, and the preparation process is reasonable and feasible
4 clinical curative effect observation of' Shiwei Shengui enema liquid
The clinical summary of the cases observed by using the system for many years of the ten-ingredient ginseng-angelica enema liquid is as follows:
4.1 study object
100 patients with acute and chronic pelvic inflammatory disease, which are diagnosed by the applicant in outpatient clinic from 4 months to 2015 5 months in 2014, are taken as study targets. The age is 21-42 years, and the average age is 31.25 years. All case diagnoses meet the Western diagnosis standard of pelvic inflammation. 68 cases of acute pelvic inflammatory disease have the course of disease of 2-3 weeks, 32 cases of chronic pelvic inflammatory disease have the course of disease of 4-6 weeks. All cases meet the syndrome differentiation and typing standard of the traditional Chinese medicine and are divided into 26 cases of toxin stasis accumulation, 23 cases of damp-heat accumulation, 27 cases of damp-heat accumulation and 24 cases of qi stagnation and blood stasis. The main clinical symptoms are: 92 cases of lower abdominal pain, 39 cases of lumbosacral pain, 91 cases of leukorrhagia, 80 cases of yellow leucorrhea, 36 cases of leucorrhea odor, 36 cases of low fever fluctuation, and 38 cases of aggravated abdominal pain during menstruation.
4.2 prescription and usage amount
Prescription: 5g of salvia miltiorrhiza, 7.5g of angelica, 5g of corydalis tuber, 7.5g of plantain herb, 7.5g of peach seed, 7.5g of houttuynia cordata, 5g of diverse wormwood herb, 7.5g of dandelion, 5g of red paeony root and 7.5g of dahurian patrinia herb.
The use method comprises the following steps: one dose is taken every day, the preparation is carried out according to the process, the water decoction is concentrated to 100ml, one dose is kept for enema every day, the retention time is 0.5-1 hour, 7 doses are taken as a treatment course, and 2-3 doses are added or subtracted according to prognosis conditions to correspondingly consolidate strengthening or burden reduction treatment. The menstrual period is not used, and the couple life is avoided during the treatment period. The medicine for treating acute pelvic inflammatory disease is recommended to be used for not less than 2 courses of treatment, and the medicine for treating chronic pelvic inflammatory disease is recommended to be used for not less than 4 courses of treatment. The efficacy was assessed after treatment was complete.
4.3 therapeutic efficacy determination
Before treatment, routine blood test, blood sedimentation, B-ultrasonic examination of uterine adnexa, smear examination or culture of vaginal and cervical secretion, etc. are performed for 1 time. The related symptoms, signs and syndromes of traditional Chinese medicine are observed 1 time before and after treatment. The symptoms, signs and symptoms are scored according to the degree of local lesions (lesion site and extent, tenderness degree, mass size, etc.). Score 0 for asymptomatic signs and symptoms, score 2, score 4, score 6 for symptomatic, sign and symptom with weight as low as the reset weight.
Acute pelvic inflammatory disease
(1) The lower abdominal pain and fever disappear after healing treatment, and general examination, gynecological examination and physical and chemical examination are normal. The integral and reduction of syndrome and sign is more than or equal to 95%. Relapse does not occur within 1 month after stopping taking the medicine.
(2) The lower abdominal pain and fever and other symptoms disappear after the effective treatment, and general inspection, gynecological inspection and physical and chemical inspection are obviously improved. The integral and reduction of the syndrome and the physical sign is more than or equal to 70 percent.
(3) Can effectively treat lower abdominal pain, fever and other symptoms, and improve general examination, gynecological examination and physical and chemical examination. The integral and reduction of symptoms and signs is more than or equal to 30 percent.
(4) The symptoms such as lower abdominal pain and fever after ineffective treatment are not relieved or aggravated, and general examination, gynecological examination and physical and chemical examination are improved or aggravated compared with those before treatment. The syndrome, sign integration and reduction is less than 30%.
(II) chronic pelvic inflammatory disease
(1) The lower abdominal pain and lumbosacral distending pain disappear after healing treatment, and the gynecological examination and the physicochemical examination are normal. The sum of syndromes, physical signs and the sum of the syndromes, physical signs and the signs is reduced by more than or equal to 95 percent. Relapse does not occur within 1 month after the medicine is stopped.
(2) Can effectively treat lower abdominal pain, lumbosacral distending pain and other symptoms, and improves gynecological examination and physical and chemical examination. The integral and reduction of symptoms and signs is more than or equal to 70 percent.
(3) Can be used for treating lower abdominal pain and lumbosacral distending pain, and improving gynecological examination and physical and chemical examination. The integral and reduction of symptoms and signs is more than or equal to 30 percent.
(4) The symptoms such as lower abdominal pain, lumbosacral distending pain and the like after ineffective treatment are not reduced or aggravated, and gynecological examination and physical and chemical examination are not improved or aggravated compared with those before treatment. The syndrome, sign integration and reduction is less than 30%.
(III) evaluation standard of curative effect of main indexes (local physical signs)
(1) After the healing treatment, the physical signs disappear, and the integral value is reduced by more than or equal to 95 percent or 2 levels.
(2) After the effective treatment, the physical signs are obviously reduced, and the integral value is reduced by more than or equal to 70 percent or reduced by 1 level.
(3) After effective treatment, the physical signs are reduced to some extent, and the integral value is reduced by more than or equal to 30 percent or reduced by less than 1 grade.
(4) After ineffective treatment, the physical signs are not improved or aggravated, and the syndrome integral value is reduced by less than 30 percent
(IV) evaluation criteria for therapeutic Effect of syndrome
(1) After healing treatment, each symptom is obviously relieved, and the syndrome integral is reduced by more than or equal to 95 percent
(2) After the obvious effect treatment, all symptoms are obviously relieved, and the integral value of the symptoms is obviously reduced by more than or equal to 70 percent
(3) The symptoms are relieved after the effective treatment, and the integral value of the symptoms is obviously reduced by more than or equal to 30 percent
(4) After ineffective treatment, symptoms are not reduced or are aggravated, and the syndrome integral value is reduced by less than 30 percent
4.4 results
(I) distribution of therapeutic effects of acute and chronic diseases in TCM syndrome
In 100 cases of pelvic inflammatory disease patients, the acute degree accounts for 68 percent, and the chronic degree accounts for 32 percent. According to the dialectical results, the proportion of the four syndrome types is as follows: stasis accumulation in 24 cases (92.3%) and chronic 2 cases (7.7%); damp-heat accumulation in 21 cases (91.3%) acutely, 2 cases chronically (8.7%); damp-heat stasis 22 cases (81.5%) and 5 cases (18.8%) of chronic disease; 1 case (4.2%) of qi stagnation and blood stasis type acute disease and 23 cases (95.8%) of chronic disease. See table 5.
TABLE 5 distribution of acute and chronic symptoms in TCM syndrome
(II) comparison of therapeutic effects of four groups of Chinese medicinal symptoms
26 cases with toxin stasis syndrome, wherein 13 cases (50.0%) are cured, 9 cases (34.6%) with obvious effect, 2 cases (7.7%) with no effect, and the total effective rate is 92.3%; 23 cases of damp-heat accumulation, wherein 12 cases (52.2%) are cured, 8 cases (34.8%) are obviously effective, 2 cases (8.7%) are effective, 1 case (4.3%) is ineffective, and the total effective rate is 95.7%; 27 cases of damp-heat stasis type, wherein 13 cases (48.1%) are cured, 9 cases (33.3%) are obviously effective, 3 cases (11.1%) are effective, 2 cases (7.4%) are ineffective, and the total effective rate is 92.6%; 24 cases with qi stagnation and blood stasis, wherein 10 cases (41.7%) are cured, 9 cases (37.5%) with obvious effect, 3 cases (12.5%) with effect, 2 cases (8.3%) with no effect, and the total effective rate is 91.7%; the total effective rate of each Chinese medicine symptom type has no statistical difference, and P is more than 0.05. See table 6.
TABLE 6 comparison of the four groups of Chinese medicine syndromes
Note: there was no difference in comparison between groups, P > 0.05.
4.5 discussion
In the enema formula of the ten-ingredient ginseng-angelica enema, dandelion, herba patriniae and houttuynia cordata have the functions of clearing away heat and toxic materials; saviae Miltiorrhizae radix, rhizoma corydalis and semen Persicae have effects of promoting blood circulation, removing blood stasis, activating qi-flowing and relieving pain; the angelica is a tonic drug, can strengthen healthy qi and enhance the immunity of the human body; radix Paeoniae Rubra has effects in clearing away heat and cooling blood; the plantain herb clears heat, promotes diuresis and removes dampness; liu Xin is used for breaking blood and stimulating the menstrual flow, healing sore and relieving swelling. The traditional Chinese medicine enema formula formed by the medicines integrates the characteristics of entering liver, spleen and heart channels as main parts, and comprehensively aims at all pathogenic factors of stasis, heat and dampness, thereby playing the efficacies of clearing away heat and toxic material, promoting blood circulation and removing stasis, promoting qi circulation and relieving pain, and softening and resolving hard mass.
The 'SHIWEISHENGGUICHANG liquid' retention enema provided by the invention enables the medicine to be absorbed through rectal mucosa venous plexus without being metabolized by the liver, reduces the burden of the liver and avoids the stimulation of bitter cold medicine to gastrointestinal tracts. In view of the harmfulness of the disease, no control group was used in this study. In addition, the clinical application of western medicines has fewer cases, and no control group is added. However, according to the clinical research of the yellow roaring livers, the western medicines use 250ml of 5% glucose injection and 640 million U of penicillin/day, 200ml of 0.5% metronidazole injection/day, and are infused intravenously for 1 time/day; for patients with gastrointestinal tract reaction, metoclopramide is taken orally at 10mg for 3 times per day; the Sipinuo is orally taken by a patient with mould infection for 0.1 time/day and 2 weeks continuously; josamycin or roxithromycin is administered orally to persons infected with mycoplasma and chlamydia. The total effective rate is 65.33%, and the obvious difference exists between the traditional Chinese medicine retention enema treatment group. Song Ling research shows that the total effective rate is only 60.0% by using conventional anti-infection and fluid infusion support treatment. The method is obviously different from the retention enema treatment group using the traditional Chinese medicine. The research of Wanghana and the like shows that western medicines use 250ml of 5% glucose saline and 2.01g of cefotaxime sodium; and 100ml of metronidazole injection with concentration of 0.5 percent is intravenously dripped, 2 times/d, 7d are 1 treatment course, and 2 treatment courses are total. The dose of fluconazole for patients with fungal infection is increased by 0.12g and 1 time/day, and the total effective rate is 77.5 percent after continuous administration for 6 days, which is obviously different from that of retention enema treatment groups using traditional Chinese medicines.
Statistical data indicate that patients with pelvic inflammatory disease have more acute morbidity. The acute attack stage is short in duration, and the physician needs to see the disease before the lower abdominal pain and abnormal leucorrhea. The main clinical symptoms are different from chronic symptoms in fever or aversion to cold, low heat persistence, and local signs of lower abdominal pain with or without rebound pain, cervical pain, uterine body tenderness and adnexal region tenderness. When acute pelvic inflammatory disease is not completely treated or patients have poor constitution and prolonged course of disease and finally turn into chronic inflammation, damp evil blocks qi movement to cause qi and blood stasis, so that chronic pelvic inflammatory disease is mostly caused by qi stagnation and blood stasis. The symptoms include lower abdominal pain and abnormal leucorrhea in acute stage, lumbosacral pain, listlessness, abdominal pain aggravation during menstruation, cold limbs, loose stool, etc., and the physical examination is limited in uterine activity or accompanied by tenderness due to adhesion and fixation; tenderness in the adnexal area.
According to the theory of traditional Chinese medicine, referring to the guiding principle of clinical research on new traditional Chinese medicine for treating pelvic inflammation, the observed pelvic inflammation patients are differentiated according to clinical features and have types of interior accumulation of stagnant toxin, accumulation of damp-heat, stagnation of qi and blood stasis 4. The medicine comprises 26 cases (26 percent) of stasis toxin with internal accumulation, 23 cases (23 percent) of damp-heat accumulation, 27 cases (27 percent) of damp-heat stasis accumulation and 24 cases (24 percent) of qi stagnation and blood stasis. Therefore, the pelvic inflammatory disease patients studied above are mostly acute with the types of interior accumulation of stagnant toxin, accumulation of damp-heat and accumulation of damp-heat. The effective rates of the types 4 of stasis-toxin internal accumulation, damp-heat stasis and qi stagnation and blood stasis are 92.3%, 95.7%, 92.6% and 91.7% in sequence, and the curative effects of 4 groups of traditional Chinese medicine symptoms have no statistical difference. The prescription of the SHIWEISHENGUICHANG liquid is proved to be effective for various types of pelvic inflammatory disease symptoms.
4.6 conclusion
The prescription of 'SHIWEISHENGZHUYE' is used for treating acute and chronic pelvic inflammatory disease, and has good effects on syndrome differentiation and classification of toxin stasis, damp-heat accumulation, damp-heat stasis and qi stagnation and blood stasis type 4 treatment according to the traditional Chinese medicine, namely obvious symptom relief, good patient tolerance, high cure rate, low recurrence rate and few adverse reactions, so the clinical use is safe and effective.
Claims (7)
1. A ten-ingredient ginseng-angelica enema liquid for treating pelvic inflammation is characterized by being prepared from the following medicinal materials by weight: 50g of salvia miltiorrhiza, 75g of angelica, 50g of corydalis tuber, 75g of plantain, 75g of peach kernel, 75g of houttuynia cordata, 50g of artemisia anomala, 75g of dandelion, 50g of red paeony root and 75g of patrinia; the enema liquid is prepared by the following method: extracting Saviae Miltiorrhizae radix and rhizoma corydalis with ethanol to obtain ethanol extractive solution, extracting the rest eight materials with water, precipitating with ethanol to obtain filtrate, recovering ethanol from the ethanol extractive solution and the filtrate, concentrating, and mixing.
2. The preparation process of the SHIWEISHENGUIZHUYE as claimed in claim 1, wherein the preparation process comprises extracting Saviae Miltiorrhizae radix and rhizoma corydalis with ethanol to obtain ethanol extractive solution, extracting the rest eight materials with water and precipitating with ethanol to obtain filtrate, recovering ethanol from the ethanol extractive solution and the filtrate, concentrating, and mixing.
3. The preparation process of the ten-flavor ginseng-angelica enema liquid as claimed in claim 2, wherein the ethanol extraction is performed according to the following steps: taking 50g of salvia miltiorrhiza and 50g of corydalis tuber, carrying out reflux extraction for 2 times by using 70% ethanol, wherein each time lasts for 1.5 hours, combining extracting solutions, filtering, recovering ethanol from filtrate, and concentrating to obtain clear paste with the relative density of 1.10-1.20 for later use.
4. The preparation process of the ten-ingredient ginseng and angelica enema liquid according to claim 3, wherein the 70% ethanol is added for the first time which is 6 times of the amount of the medicinal materials and for the second time which is 5 times of the amount of the medicinal materials in the 2 times of reflux extraction by the 70% ethanol.
5. The preparation process of the ten-ingredient ginseng-angelica enema liquid as claimed in claim 4, wherein the water extraction and alcohol precipitation are carried out according to the following steps: taking 550g of the rest 8 medicinal materials, adding water, decocting for 2 times, decocting for 2 hours for the first time and 1.5 hours for the second time, combining the decoctions, filtering, concentrating to 550ml, wherein the relative density is 1.10-1.20, standing, cooling, adding 1100ml of 2 times of ethanol, stirring uniformly, standing for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain a clear paste with the relative density of 1.10-1.20.
6. The preparation process of the ten-ingredient ginseng-angelica enema liquid according to claim 5, wherein in the 2 times of decoction with water, the first time of water addition is 13 times of the amount of the medicinal materials, and the second time of water addition is 10 times of the amount of the medicinal materials.
7. The preparation process of the ten-flavor ginseng-angelica enema liquid as claimed in claim 6, wherein the combination is operated according to the following steps: mixing the ethanol extractive solution and the filtrate, adding water to adjust total amount to 1000ml, stirring, packaging into 100ml per bottle, and sterilizing under hot pressure.
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| CN1772153A (en) * | 2005-09-29 | 2006-05-17 | 甘肃医药集团西峰制药厂 | Compound Chinese medicine prepn for treating pulvic infection and its prepn process |
| CN103417695A (en) * | 2012-05-18 | 2013-12-04 | 孙冰清 | Traditional Chinese medicine for treating chronic pelvic inflammation |
| CN108671186A (en) * | 2018-07-06 | 2018-10-19 | 涂世红 | A kind of Chinese medicinal enema for treating chronic pelvic inflammatory disease |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1772153A (en) * | 2005-09-29 | 2006-05-17 | 甘肃医药集团西峰制药厂 | Compound Chinese medicine prepn for treating pulvic infection and its prepn process |
| CN103417695A (en) * | 2012-05-18 | 2013-12-04 | 孙冰清 | Traditional Chinese medicine for treating chronic pelvic inflammation |
| CN108671186A (en) * | 2018-07-06 | 2018-10-19 | 涂世红 | A kind of Chinese medicinal enema for treating chronic pelvic inflammatory disease |
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| Title |
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| VLH-D盆腔治疗仪加中药灌肠治疗慢性盆腔炎的临床观察;徐红;《现代中西医结合杂志》;20060531;第15卷(第09期);第1158页 * |
| 红藤汤治疗慢性盆腔炎45例临床观察;赵慧琴;《河南中医》;20040410;第24卷(第4期);第41页右栏第1、5段，第42页左栏最后1段至右栏第2段 * |
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