CN1251763A - Process for preparing Chinese medicine 'Qianjin tablets' for treating gynopathy - Google Patents
Process for preparing Chinese medicine 'Qianjin tablets' for treating gynopathy Download PDFInfo
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Abstract
A Chinese medicine "Qianjin tablets" for treating gynopathy is prepared from 8 Chinese-medicinal materials including Chinese angilica root, pilose asiabell root, green chiretta, spatholobus stem, mahonia, etc. It can remove moisture, regulate menstruation, relieve inflammation, relax pain and detoxicate.
Description
The present invention relates to a kind of compound method of compound Chinese medicinal preparation FUKE QIANJIN PIAN.
The treatment women is because of the FUKE QIANJIN PIAN of diseases such as urgent chronic pelvic inflammatory disease, endometritis, cervicitis and menoxenia, stomachache, leucorrhea be many, and its Main Ingredients and Appearance is a Radix Rosae Laevigatae, Radix Flemingiae Philippinensis, Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis etc.
Purpose of the present invention: be intended on the basis of the existing research application of forefathers, press the specification requirement of provisions for new drugs approval and research guideline, work out the Chinese patent medicine of the effect that prescription is precise and appropriate, evident in efficacy, safe and reliable, the suitability is wide with heat-clearing and toxic substances removing, strong waist collateral dredging, blood yiqi.
The compound Chinese medicinal preparation FUKE QIANJIN PIAN is made up of Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, Fructus Zanthoxyli Dissiti, Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and Radix Flemingiae Philippinensis, it is characterized in that:
The incorporation of Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, Fructus Zanthoxyli Dissiti respectively is 9% of a medical material total amount in A, this tablet composition; It is 16% of medical material gross weight that the incorporation of Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and Radix Flemingiae Philippinensis is equipped with.
The making step of B, this tablet is:
1, gets Radix Angelicae Sinensis, Radix Codonopsis, the Herba Andrographis of 9 weight portions, in pulverizer, be ground into the fine powder more than 100 orders, leave and take standby by at least 93.3% the powder rate that gets;
2, choose the Fructus Zanthoxyli Dissiti of 9 weight portions and Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and the Radix Flemingiae Philippinensis Chinese medicine of the five flavours material of each 16 weight portion, they are placed the multipotency extraction pot, add hot water and extract twice, cross leaching liquid by extractions in per 2 hours method once; The extractum that simultaneously this extracting solution is condensed into proportion and is 1.08/80 ℃ of F in the triple effect concentrator is standby;
3, the fine powder that will produce and extractum mixed pelletization, and be made into granule by boiling drier, after tabletting, bag sheet operation, make the FUKE QIANJIN PIAN of coated tablet type or Film coated tablets type.
With above-mentioned prescription and technology gained ' Qianjin tablets ' for treating gynopathy, Radix Rosae Laevigatae clearing away heat and eliminating dampness leukorrhagia stopping is a principal agent in the side, Radix Flemingiae Philippinensis clearing away heat-damp and promoting diuresis, detoxifcation, Caulis Mahoniae clearing away heat and cooling blood, the Herba Andrographis heat-clearing and toxic substances removing, Fructus Zanthoxyli Dissiti promoting blood circulation and detoxication, reducing swelling and alleviating pain, Chinese Angelica blood replonishing are invigorated blood circulation, channels sootheing and network vessel quickening, accent dash to appoint and end stomachache and be accessory drugs altogether, the Caulis Spatholobi promoting the circulation of blood of enriching blood, Radix Codonopsis invigorating the spleen and replenishing QI, invigorating the spleen to clear away damp pathogen, be adjuvant drug altogether, all medicines are harmonious, and play the effect of damp-clearing pain-relieving, menstruction regulating and pain relieving altogether.We's medication QI and blood is ruled together, and clear benefit combination, detoxification and removing stasis are executed together, thereby stasis of blood poison is gone, and clearing moist heat, all diseases are from removing.
Further set forth the present invention below in conjunction with embodiment.
One, pharmacodynamic study:
FUKE QIANJIN PIAN has the effect of blood yiqi, clearing heat and removing internal wetness, strong waist collateral dredging by the tablet of kinds of traditional Chinese medicines through being processed into such as Radix Rosae Laevigatae, Radix Flemingiae Philippinensis, Radix Angelicae Sinensis.Be widely used in diseases such as women's chronic pelvic inflammatory disease, endometritis, cervicitis, leucorrhea are many for many years, received good and clinical curative effect, be subjected to medical worker and Hui person's welcome deeply.With reference to the relevant requirements of " study of tcm new drug guide ", it is carried out pharmacodynamic study, what it adopted:
FUKE QIANJIN PIAN (950411), the 0.32g/ sheet contains crude drug 3.4g, is provided by Zhuzhou Qianjin Pharmacy Co., Ltd; JINJI PIAN (940314), the 0.4g/ sheet is produced by the Hunan * * pharmaceutical factory of traditional Chinese medicine; Oleum Tiglii, institute of internal medicine provides by Nanjing; Chondrus ocellatus Holmes (58F-0604), Sigma company produces, cyclophosphamide (Cy, 890415), Shanghai No.12 Pharmaceutical Factory produces; Nutrient broth medium (940406), factory provides by Yiyang biochemical reagents; Mould medium is provided by Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
The cleaning level Kunming mouse that it adopted, the SD rat provides by the institute for drug control, Hunan Province; Escherichia coli ATCC25922, staphylococcus aureus ATCC25923, hemolytic chain bacterium ATCC32172 provides by province health and epidemic prevention station, and Candida albicans by clinical separation, is provided by Annex III institute of Hunan Medical University clinical laboratory Bacteriology Room.The laboratory animal quality certification number; No. (1991) 02, the real moving accurate word of Hunan doctor.
1, to the extracorporeal bacteria inhibitor test (seeing Table 1,2) of standard bacterium
Table 1, FUKE QIANJIN PIAN bacteriostatic test result (fluid test tube method)
Bacterial concentration thing concentration (%) medicine bacterial strain
Antibacterial
(GFu/ml) 5.0 25.0 12.5 6.25 3.13 contrast contrast escherichia coli
10
5======++ ++ ++-+++staphylococcus aureus
10
6========++-+++beta hemolytic streptococcus
10
5======++ ++ ++-+++Candida albicans 10
6======++ +++-+++
Table 2, JINJI PIAN bacteriostatic test result (liquid tube method)
Bacterial concentration thing concentration (%) medicine bacterial strain
Antibacterial
(GFu/ml) 50.0 25.0 12.5 6.25 3.13 contrast contrast escherichia coli 10
5==++ +++++ ++ ++-+++staphylococcus aureus 10
6======++ ++-+++beta hemolytic streptococcus 10
5==++ +++++ ++ ++-+++Candida albicans 10
6====++ ++ ++ ++-+++
==two groups of repeated trials all do not have bacterial growth ,+, ++, +++cell enlargement degree
Experimental result shows: the minimal inhibitory concentration of escherichia coli, staphylococcus aureus, beta hemolytic streptococcus and Candida albicans FUKE QIANJIN PIAN is respectively 12.5,6.25,25.0 and 12.5g crude drug/100ml, and the minimal inhibitory concentration of JINJI PIAN is respectively 25.0,12.5,25.0g crude drug/100ml.Both Mlc basically identicals.
2, to the extracorporeal bacteria inhibitor tests (seeing Table 3,4) of clinical separation pathogenic bacterium
Escherichia coli, staphylococcus aureus, beta hemolytic streptococcus, Candida albicans separate acquisition by clinical patient, and differentiate through the bacteriology, are provided by attached institute of Hunan Medical University three institute's clinical laboratory Bacteriology Rooms.The same 2.2.1 of culture medium and experimental technique, drug level is assignment system on demand, the results are shown in Table 3,4
Table 3, FUKE QIANJIN PIAN to clinical isolating bacteriostatic test result (liquid tube method) bacterial strain strain count the bacterial concentration minimal inhibitory concentration
(strain) be (%) escherichia coli 32 10 (GFu/ml)
5-10
650.0-25.0 staphylococcus aureus 23 10
5-10
612.5-3.13 beta hemolytic streptococcus 20 10
5-10
650.0-25.0 Candida albicans 27 10
5-10
612.5-3.13
Table 4, JINJI PIAN are counted the bacterial concentration minimal inhibitory concentration to bacteriostatic test result (liquid tube method) the bacterial strain strain of clinical isolates
(strain) be (%) escherichia coli 32 10 (GFu/ml)
5-10
6100-50.0 staphylococcus aureus 23 10
5-10
625.0-6.25 beta hemolytic streptococcus 20 10
5-10
650.0-6.25 Candida albicans 27 10
5-10
625.0-3.13
Experimental result shows: FUKE QIANJIN PIAN and JINJI PIAN all have certain bacteriostasis to clinical isolating four kinds of antibacterials, and the two effect basically identical.
3, bacteriostatic test (seeing Table 5) in the body
To the colibacillary protective effect of mouse infection: get 70 of Kunming mouses; the male and female dual-purpose; body weight 20-22g; be divided into 7 groups (n=10); five groups are used for FUKE QIANJIN PIAN; dosage is 17.3; 24.7; 3; 5.3; 50.4 and 72.0g crude drug/kg; two groups are used for JINJI PIAN, and dosage is 40 and 80g crude drug/kg, irritate stomach and are 0.5ml/20g to volume; each group all after administration one hour; every ip in mice 0.5ml escherichia coli (106FGu/ml) are held the soup culture fluid, and behind the mouse infection antibacterial 12 hours and 24 hours, administration secondary again; observed record animal dead number then seven days.The animal dead peak after 24 hours to 48 hours between.
Table 5. FUKE QIANJIN PIAN is to the protective effect group dosage number of animals death toll protective rate of coli-infection mice
(g/kg) FUKE QIANJIN PIAN 72.0 10 4 60 FUKE QIANJIN PIANs 50.4 10 6 40 FUKE QIANJIN PIANs 35.3 10 8 20 FUKE QIANJIN PIANs 24.7 10 9 10 FUKE QIANJIN PIANs 17.3 10 10 0 JINJI PIANs 40 10 10 0 JINJI PIANs 80 10 9 10
Experimental result shows: FUKE QIANJIN PIAN all has certain protective role to coli-infection mice high dose group.
Antiinflammatory action
4. to the influence (seeing Table 6) of Oleum Tiglii induced mice swelling
50 of mices, male, body weight 24-26g, be divided into five groups (n=10), connect 2.1 method administrations, once a day, totally seven days, last administration 1 hour, every Mus auris dextra is coated with 2% Oleum Tiglii (2% Oleum Tiglii, 20% dehydrated alcohol, 5% distilled water and 73% ether) 0.1ml, and mice is put to death in the cervical vertebra dislocation after 4 hours, cuts ears, punching is weighed, and calculates every group of mice swelling degree.
Table 6, FUKE QIANJIN PIAN are to impact (X ± SD, n=10) group dosage (g/kg) swelling (mg) inhibiting rate (%) control group equal-volume water 9.7 ± 1.0 JINJI PIANs 80.0 6.9 ± 0.9*** 28.9 FUKE QIANJIN PIANs 18.2 5.9 ± 0.7*** 39.2 FUKE QIANJIN PIANs 9.1 6.5 ± 0.5*** 33.0 FUKE QIANJIN PIANs 3.6 6.8 ± 0.8*** 29.9 of mouse ear swelling due to the croton oil
Compare * * * p＜0.05 with matched group
The result shows: FUKE QIANJIN PIAN and JINJI PIAN compare with matched group respectively, all can obviously suppress Oleum Tiglii induced mice ear swelling.
5, to the influence (seeing Table 7) of rat paw edema due to the chondrus ocellatus Holmes
50 of SD rats, male, be divided into five groups (n=10), by 2.1 method administrations, once a day, and totally seven days, last administration 1 hour, bottom scl% chondrus ocellatus Holmes 0.1ml/ only causes inflammation in the right sufficient sole of the foot of rat.Cause scorching back 2 hours and be administered once again, except that measurement causes scorching preceding normal foot sole of the foot size, cause scorching back and surveyed sufficient sole of the foot size, totally 6 times, calculate the swelling degree every 1 hour.
(X ± cm, n=10) group dosage experiments front foot causes scorching back swelling degree to the influence of the swollen usefulness of the sufficient sole of the foot due to the rat chondrus ocellatus Holmes for table 7, FUKE QIANJIN PIAN
(g/kg) 1 hour 2 hours 3 hours 4 hours 5 hours 6 hours control group equal-volume water 2.00 ± 0.10 0.35 ± 0.09 0.74 ± 0.17 0.81 ± 0.14 0.68 ± 0.11 0.58 ± 0.18 0.68 ± 0.18 JINJI PIANs 55.5 2.03 ± 0.11 0.18 ± 0.10***, 0.45 ± 0.18** 0.53 ± 0.13*** 0.52 ± 0.09** 0.45 ± 0.08* 0.44 ± 0.07 FUKE QIANJIN PIAN 12.6 2.05 ± 0.08 0.27 ± 0.05**, 0.38 ± 0.09*** 0.46 ± 0.09*** 0.47 ± 0.09** 0.44 ± 0.11* 0.42 ± 0.09 woman of sole of the foot size expect a thousand pieces of gold sheet 6.32 2.10 ± 0.07 0.39 ± 0.07***, 0.48 ± 0.10***, 0.53 ± 0.08***, 0.56 ± 0.07*, 0.49 ± 0.13* 0.44 ± 0.08
The result shows: FUKE QIANJIN PIAN and JINJI PIAN respectively with matched group relatively, all can obviously suppress rat paw edema due to the chondrus ocellatus Holmes.
6, Dichlorodiphenyl Acetate causes the influence (seeing Table 8) of pain mice
Get 50 of mices, male and female are equipped with half, and body weight 20-22g is divided into 5 groups (n=10) at random, and by the dosed administration of 2.1 FAXIA once, after administration one hour, every mice iP0.6% acetic acid 0.2ml/ only.Write down mouse writhing number of times in 10 minutes.
Table 8, FUKE QIANJIN PIAN Dichlorodiphenyl Acetate cause the pain mice influence (X ± SD, n=10) group dosage (g/kg) is turned round body number of times (inferior) suppression ratio (%) matched group equal-volume water 22.2 ± 3.9 JINJI PIAN 80.0 14.0 ± 4.9*** 36.9 FUKE QIANJIN PIAN 18.2 10.2 ± 3.2*** 54.1 FUKE QIANJIN PIAN 9.1 11.7 ± 4.6*** 47.3 FUKE QIANJIN PIAN 3.6 13.8 ± 3.9*** 37.8
* compare * * * P＜0.01 with matched group
The result shows, FUKE QIANJIN PIAN and JINJI PIAN respectively with compare, all can significantly reduce vinegar and cause pain mouse writhing number of times.
7, hot plate method is caused the influence (seeing Table 9) of the pain mice threshold of pain
Get the threshold of pain less than 50 of 30 seconds female mices, body weight 20-22g is divided into 5 groups (n=10), by the disposable gastric infusion of dosage under 2.1, press literature method before 55 ± 0.5 ℃ are down measured administration with administration after 30,60 and 90 minutes pain thresholds, the results are shown in Table 9.
Table 9, FUKE QIANJIN PIAN cause influence (X ± SD, n=10) threshold of pain (threshold of pain raising percentage rate) after the preceding sick threshold administration of group dosed administration of the pain mice threshold of pain to hot plate method
(g/kg) (s) (s) (％)
30min 60min 90min matched group equal-volume water 18.8 ± 6.5 25.4 ± 5.9 28.1 ± 8.9 24.7 ± 7.6
(26.0) (49.5) (31.4) JINJI PIAN 80.0 18.2 ± 7.3* 38.2 ± 19.1** 49.5 ± 9.5*** 39.8 ± 10.8**
(37.0) (172.0) (118.7) FUKE QIANJIN PIAN 18.2 18.0 ± 5.8* 50.6 ± 18.8*** 47.3 ± 12.6*** 44.1 ± 12.6***
(181.1) (162.8) (145.0) FUKE QIANJIN PIAN 9.1 18.0 ± 4.8* 48.4 ± 13.7*** 43.2 ± 10.8** 41.5 ± 11.9**
(168.9) (140.0) (130.6) FUKE QIANJIN PIAN 3.6 17.3 ± 5.6* 49.6 ± 21.8** 54.7 ± 12.9*** 49.3 ± 9.7***
(186.7) (216.2) (1855.0)
* matched group compares, * P＜0.05, * * P＜0.01, P＜0.01
The result shows that FUKE QIANJIN PIAN and JINJI PIAN compare with matched group respectively, all can obviously improve the threshold of pain that the hot plate excitement causes the pain mice.
Compare * P＜0.05, * * P＜0.01 with matched group
8, to effect of immunologic function (seeing Table 10)
The influence that immunologic hypofunction Mus serum hemolytic antibody formed due to the ring phosphinylidyne pressed
Get 60 of BALB/C mice, male and female half and half, body weight 20-22g, be divided into 6 groups (n=10), by 2.1 following method administrations, after administration the 4th day, every only immunity of ip in mice 5%CRBC suspension 0.2ml/, continue administration, except that the normal control group, other each treated animal was in the 6th, seven, eight day difference ip cyclophosphamide 20mg/kg, administration is three days again, got blood from the mouse orbit venous plexus in 1 hour after the last administration, separation of serum is pressed the method for document [2] and is being surveyed hemolytic antibody in its serum in the 540nm place on 3210 ultraviolet spectrophotometers.The results are shown in Table 10.Table 10, FUKE QIANJIN PIAN are to influence (X ± SD, n=10) group dosage (g/kg) optical density * 100 normal control group equal-volume water, 45.5 ± 14.0*** model control group equal-volume water, 16.2 ± 4.9 JINJI PIAN, 80.0 44.9 ± 9.1*** FUKE QIANJIN PIAN, 18.2 53.2 ± 106*** FUKE QIANJIN PIAN, 9.1 53.1 ± 5.7*** FUKE QIANJIN PIAN, the 3.6 52.5 ± 6.8*** of immunologic hypofunction mice hemolytic antibody due to the Cy
Compare * * * P＜0.01 with model group
The result shows, cyclophosphamide type group and matched group relatively, Cy can obviously suppress the generation of mice hemolytic antibody, FUKE QIANJIN PIAN and JINJI PIAN respectively with model control group relatively, the effect that the immune function of mice that all can anti-cyclophosphamide causes suppresses.
9, to the influence (seeing Table 11) of the type blood group blood deficiency mice that loses blood
Table 11, FUKE QIANJIN PIAN are to influence (X ± SD, n=10) the group dosage RBC (* 10 of the type blood group blood deficiency mice that loses blood
12/ L) HB (g/L)
(g/kg) Normal group equal-volume water 6.89 ± 0.37* 6.20 ± 0.58*** 6.55 ± 0.37*** 129.8 ± 8.1* 128.7 ± 6.7*** 133.6 ± 7.0*** model control group equal-volume water 6.63 ± 0.41 3.69 ± 0.40 5.00 ± 0.22 130.5 ± 8.4 75.6 ± 6.3 95.3 ± 5.7 JINJI PIAN 80.0 6.99 ± 0.25* 3.72 ± 0.39* 5.18 ± 0.23* 127.9 ± 7.2 80.2 ± 7.5* 101.0 ± 8.4* FUKE QIANJIN PIAN 18.2 7.00 ± 0.21* 3.65 ± 0.35* 5.89 ± 0.17*** 129.7 ± 5.9* 75.0 ± 9.9* 110.8 ± 6.0*** FUKE QIANJIN PIAN 9.1 7.03 ± 0.26* 3.91 ± 0.36* 5.84 ± 0.14*** 127.9 ± 7.4* 79.3 ± 6.6* 112.2 ± 5.6*** FUKE QIANJIN PIAN 3.6 7.06 ± 0.29* 3.93 ± 0.37* 6.10 ± 0.31*** 128.9 ± 7.4* 77.2 ± 9.3* 111.8 ± 5.6*** after the rear treatment that loses blood before losing blood after the rear treatment that loses blood before losing blood
With model group through relatively, * P＞0.05, * *＜0.05, * * * P＜0.01
Take a broad view of above-mentioned experimental result as seen, FUKE QIANJIN PIAN is respectively 12.5,6.25,25.0 and 12.5g crude drug/100ml to escherichia coli, yellow staphylococcus, beta hemolytic streptococcus and the external minimal inhibitory concentration of Candida albicans, and clinical isolating above-mentioned four kinds of antibacterial minimal inhibitory concentrations are respectively 50.0-25.0,12.5-3.13,25.0-6.25 and 12.5-3.13g crude drug/kg.High dose group mouse infection escherichia coli protective rate is 60%.FUKE QIANJIN PIAN can obviously suppress rat paw edema due to Oleum Tiglii induced mice ear swelling and the chondrus ocellatus Holmes; Reduce the acetic acid induced mice and turn round the body number of times, improve the threshold of pain that hot plate method causes the pain mice.Can also resist the effect that the caused by cyclophosphamide immune function of mice descends, losing blood property blood deficiency mice is had tangible blood tonification effect.
Two, toxicity test
1, acute toxicity test:
The FUKE QIANJIN PIAN that employing is provided by zhuzhou,hunan a thousand pieces of gold Pharmaceutical limited company, lot number 950411,0.32g/ sheet, 3.40 gram crude drug/grams face the time spent to be made into the suspension that concentration is 1.60g crude drug/ml with distilled water, and this concentration is Cmax.
Adopt a cleaning level Kunming mouse, 20-22g, 30, male and female half and half, institute for drug control, Hunan Province Animal House provides, the laboratory animal quality certification number: No. the 02nd, the real moving accurate word (1991) of Hunan doctor, 25 ℃ of laboratory temperatures, self-control full nutrition pellet is fed.
2, long term toxicity test
Summary: FUKE QIANJIN PIAN is treatment gynecological urgent chronic pelvic inflammatory disease, endometritis, the pure compound Chinese medicinal preparation of cervicitis, through rat oral gavage FUKE QIANJIN PIAN (16 tablets of 32g crude drugs/kg), continuous two months, the behavioral activity, diet, two of observing rat just, body weight, blood and biochemical indexes, and main organs coefficient and histopathologic examination, the result shows, two administration groups and matched group are relatively, every index difference of examining does not have the significance meaning, and indication this product is safe under the dosage of clinical recommendation.
Toxicity test shows:
1, the oral 192g crude drug/kg of FUKE QIANJIN PIAN mice, toxic reaction is seen at the end, and prompting this product toxicity is little, and it is safe using under the dosage of clinical recommendation.
2, rat ig FUKE QIANJIN PIAN 16 and 32g crude drug/kg (suitable respectively 50kg be grown up a consumption per day 40 and 80 times), in continuous eight weeks, all equal ends of index inspection see that unusually prompting this product is safe under clinical recommended drug dosage.
Three, clinical use result:
In order to explore the clinical use curative effect of " FUKE QIANJIN PIAN ", in the past few years in tens hospitals on ground such as Hunan, Beijing, Shanghai, Hubei, carry out clinical application research respectively.The centralized and unified requirement according to the relevant new drug research of Ministry of Public Health bureau of drug administration in each testing site has been drafted the clinical research principle, has established diagnostic criteria, has been included standard in, dumps standard, and as criterion, collects and observe case.The method of administration of simultaneously in use abiding by the appended description of medicine begins during prescription on individual diagnosis to take medicine, and 7 days is a course of treatment, two courses of treatment of continuous use, and collect clinical symptoms and Signs changes by the clinical observation form of drafting.
1, table 1 is that Annex II institute of Hunan College of Traditional Chinese Medicine, the Hunan Province academy of traditional Chinese medicine, an attached hospital of Hunan Medical University etc. use this medicine, and 67 routine patients are taken the clinical change of FUKE QIANJIN PIAN after two courses of treatment.See Table 1
Before the lower abdominal pain soreness of waist menoxenia leucorrhoea grow in quantity title treatment that table 1 treatment takes a turn for the better and the tired lassitude of proportion table symptom low grade fever whole body discomfort is had a sleepless night
8 35 33 21 16 55 43 23 40 numbers treatment back improvement, 7 28 27 17 8 50 36 19 39 number improvement percentage rate 87.5 80 81.82 80.89 50 90.9 83.72 82.6 97.5 (%)
Model case is introduced:
A, patient * * *, the woman, 30 years old, the nurse of the province academy of traditional Chinese medicine showed effect 10 years repeatedly because of suffering from the bilateral adnexitis, told hot tired, lassitude, companion's hypogastralgia, soreness of waist discomfort, light red, the white and thin fur of body of the tongue when going to a doctor on July 13rd, 91.The woman checks that the bilateral adnexa thickens, tenderness is obvious, and scores accumulated are 16.After clothes gynecological a thousand pieces of gold rose for two courses of treatment, subjective symptoms was obviously alleviated, gynecologial examination, and two attached (one) scores accumulated are 0, clinical recovery is not found any untoward reaction after taking medicine.
B, patient * * *, the woman, 24 years old, Liuyang County Yongan township peasant, because of suffering from chronic pelvic inflammatory disease, menoxenia was gone to a doctor in gynecological of Annex II institute of Hunan institute of traditional Chinese medicine on July 24th, 1991.Tear menoxenia before taking medicine open, the leucorrhea amount is many, and the clothes western medicines in treatment does not have obvious curative effects.Gynecologial examination, the right side inflammatory masses of ovarian appendages, tenderness is obvious, ultrasound diagnosis, bilateral adnexa place finds that 41 * 21mm form owes rule, and the edge is lump clearly still, and echo is low slightly in the piece, distributes to owe evenly to be diagnosed as the right side inflammatory masses of pelvic cavity.Through treating two courses of treatment with FUKE QIANJIN PIAN, aforementioned symptom is all alleviated.B ultrasonic check on August 21, lump (38 * 21mm) with last time relatively took a favorable turn.It is remarkable that scores accumulated drop to 4 fens clinical efficacies by 12.
2, to go out be Beijing Obstetrical and Gynecological Hospital uses FUKE QIANJIN PIAN to 50 row chronic adnexitis patients in outpatient service statistical effect to table 2 example, its invading the exterior 2-1 is 50 routine people's gynecologial examination situations, table 2-2 curative effect statistics, and table 2-3 is the change situation of taking FUKE QIANJIN PIAN front and back symptom.
Table 2-1 gynecologial examination situation position example number tenderness ++ tenderness+light tenderness one side adnexitis 18 6 11 1 bilateral adnexitis 32 14 15 3 add up to 50 20 26 4
The one-sided adnexitis total effects of the FUKE QIANJIN PIAN curative effect position bilateral adnexitis curative effect produce effects of taking table 2-2 invalid produce effects invalid produce effects several 13 15 4882 21 23 6 % 40.6 46.9 12.5 44.4 44.4 11.2 42 46 12 of invalid example that take a turn for the better that take a turn for the better that take a turn for the better
After table 2-3 takes the preceding treatment of change treatment of FUKE QIANJIN PIAN front and back symptom
Example number symptom obviously alleviates the invalid soreness of waist that takes a turn for the better 38 28 10 0 inferior belly gas pains, 46 26 20 0 pains in the back, 22 10 84 leucorrhea increasings, 29 10 16 5 dysmenorrhoeas, 17 854 irregular menstrual periods 12 453 that drop
Model case is introduced:
The old * * of patient *, 36 years old, because of leucorrhoea grow in quantity, itching of vulva 1 wheat harvesting period is gone to a doctor, normal sense in menstrual period hypogastric region distending pain at ordinary times, the soreness of waist 1 year is surplus, the eumenorrhea, pregnant 3 produce 1, woman's inspection: pudendum nympha and vaginal mucosa hyperemia, light yellow secretions, rotten in the cervix uteri, retroposition of uterus normal size, activity can, it is obvious that the bilateral adnexa thickens tenderness.Infusorian, mycete feminine gender.
Give oral FUKE QIANJIN PIAN, every day 3 times, each 6, the conscious inferior belly gas pain of check, the soreness of waist obviously alleviate after totally 16 days, and leucorrhea reduces, and pudendum is not itched.The woman examines the vulvovaginal mucous hyperemia disappears, and leucorrhea becomes milky, and cervix uteri is gently rotten, and bilateral adnexa tenderness is not obvious.
Chronic adnexitis is a common gynecological disease, and the course of disease is longer, state of an illness stubbornness, and easily outbreak repeatedly influences patient's physically and mentally healthy and work.Many because of incoordination between the liver and spleen, Chong and Ren channel disorder or experience cold and cool, exopathogen or because of cold-evil's heat-transformation intoxicating heat according to the morbidity of theory of Chinese medical science adnexitis, the turbid damp stasis of blood collaterals of the uterus that stagnates influence QI-blood circulation and causes that QI and blood stagnates, phlegm-damp is coalescent.Differential diagnosis in tcm belongs to that the QI and blood stasis of blood is long-pending, phlegm-damp stagnant or qi depression to blood stasis more, and the Main Ingredients and Appearance of FUKE QIANJIN PIAN is formed the effect that can play symptomatic treatment according to pharmacological research by medicines such as Radix Codonopsis, Radix Rosae Laevigatae, Radix Flemingiae Philippinensis, Mahonia fortunei (Lindl.) Fedde, Radix Angelicae Sinensis, Caulis Spatholobi, Herba Andrographis, Radix Flemingiae Philippinensis, Radix Rosae Laevigatae, Herba Andrographis have heat-clearing and toxic substances removing, Fructus Zanthoxyli Dissiti dampness removing collateral dredging, but Mahonia fortunei (Lindl.) Fedde clearing away heat and cooling blood, the effect of nourishing blood, invigorate blood circulation of Radix Codonopsis replenishing QI to invigorate the spleen, Radix Angelicae Sinensis, Caulis Spatholobi.Therefore FUKE QIANJIN PIAN plays the effect of heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, inrigorating qi and promoting blood circulation, strong waist collateral dredging at the pathogeny of adnexitis, thereby reaches therapeutic purposes.Symptom such as inferior belly gas pain, soreness of waist tenesmus is eased more significantly in this group case, and the causes of disease such as lumbago, dysmenorrhea, irregular menstrual period, leucorrhoea grow in quantity also are affected by other factors.
This group patient is in drug administration process, and none example produces toxic and side effects, and take easy, the bitter taste of no Chinese medicine pill and decoction, moderate cost, the patient is acceptant.
3, Zhong Bei hospital in Shanghai City adopts diseases such as FUKE QIANJIN PIAN treatment woman uterus inflammation, anxious slow pelvic inflammatory disease, endometritis, menoxenia, leucorrhoea grow in quantity.
The morbidity in the women of gynecological pain is high, though Therapeutic Method is how not ideal enough, this institute is observed through 2 years by FUKE QIANJIN PIAN treatment gynaecopathia 330 examples, its result's report as:
Collect the out-patient of gynecological 330 examples, oral FUKE QIANJIN PIAN every day 3 times, each 6, warm water delivery service after meal, 30 days is a course of treatment, stage of two courses of treatment, medication partner treatment in addition during the treatment.The out-patient of gynecological selects 152 examples to organize in contrast with random packet, with FULE CHONGJI oral every day 2 times, and each 12g, drink back warm boiled water 30 days was a course of treatment, be a stage two courses of treatment.Minimum 16 years old of this group age, maximum 45 years old, 31.2 years old mean age.Occupation: workman's 208 examples, in portion's 92 examples, peasant's 21 examples, shop assistant's 9 examples.Curative effect judging standard [1] 1, recovery from illness: subjective symptoms and sign disappear or the overwhelming majority disappears, the healing of cervical erosion face.2, effective: subjective symptoms alleviates, and the sign uterine activity improves, and adnexa attenuation focus is dwindled or office's the moon, and tenderness alleviates, and the cervical erosion reduction of area is little by 1/2.3, invalid: subjective symptoms and sign do not have significant change, cervical erosion face no change.
Its result such as following table:
Sign and symptom situation before and after the table 3-1 treatment
Adnexa thickens the leucorrhoea grow in quantity inferior belly gas pain lumbosacral pain menoxenia hemorrhage preceding 96 152 26 4 42 10 330 treatment backs of the treatment 13 83062 32 effective percentage % 86.46 94.74 88.46 100 85.71 80 89.22 that add up in menstrual period more
Taking FUKE QIANJIN PIAN shown in the 3-1 from table all has obvious curative effects on symptom and sign after stage treatment, effective percentage is 89.22%, and to leucorrhoea grow in quantity, it is particularly evident that lumbosacral pain, inferior belly gas pain, adnexa thicken etc.
Each sick sick efficient % Uterine Cervix inflammation 159 122 27 10 93.71 chronic pelvic inflammatory diseases of routine number recovery from illness enabledisable 102 87 69 91.18 endometritises 17 10 34 76.47 irregular menstruation 52 45 34 92.31 of planting of efficacy result of planting of table 3-2 add up to 330 264 39 27 91.82
Shown in the table 3-2: 330 routine patients are recovery from illness 264 examples after the FUKE QIANJIN PIAN treatment, cure rate 80%, effective 39 routine effective percentage 11.82%, invalid 27 examples, inefficiency 8.18%.Total effective rate 91.82%.
Two groups of curative effects of table 3-3 relatively
The I II course of treatment adds up to group example number effective percentage % the course of treatment
Example number effective percentage % example number effective percentage % example number FUKE QIANJIN PIAN group 330 143 43.33 160 48.49 303 91.82 FULE CHONGJI groups 152 68 31.58 49 32.24 117 6.3.82
Shown in the table 3-3: FUKE QIANJIN PIAN group effective percentage 91.82% matched group FULE CHONGJI group effective percentage 63.82%, learning processing p＜0.01 by statistics has significant difference, and the treatment group is apparently higher than matched group.
The above results shows:
1, the multiple chronic disease effective percentage of FUKE QIANJIN PIAN treatment gynecological reaches 91.82%, and the leucorrhea negative conversion rate is 94.74%, and waist sacrum disease is 100%, and the pelvic inflammatory disease adnexa thickens, and urinary tract infection is all effective.
2, FUKE QIANJIN PIAN adopt pure Chinese medicine and bring into play that Chinese medicine is enriched blood, effect that QI invigorating, antiinflammatory damp eliminating, strong waist are stimulated the menstrual flow, side effect is little, and taking convenience more is better than tradition and uses a large amount of antibiotics for main Therapeutic Method, can avoid producing double infection, time is long, the shortcoming that dosage is big.Therefore clinical practice is welcome by the patient deeply in a word, and patient Le Yi receives treatment, and is more suitable for mass prevention and mass treatment, is worthy to be popularized and uses.
3, on treatment time, observe generally to finish and just take effect 1 course of treatment, effective 143 routine effective percentage 43.33% after 1 course of treatment, finish till the stage but still will adhere to taking medicine, through 2 the course of treatment total effective rate can reach 91.82%, and through clinical follow-up study the recidivist is arranged seldom afterwards, so FUKE QIANJIN PIAN is worth our further to study and discussion as very promising on the gynecopathy therapeutic.
4, Shanghai Medical Univ adopts the effect in the treatment of FUKE QIANJIN PIAN treatment female pelvic inflammation
Adopt the Zhompson point system to judge the order of severity that infects in the pelvic cavity, wherein 8 indexs are: 1. hypogastric region weighs down pain and tenderness; 2. lifting pain; 3. official's body tenderness; 4. left adnexa tenderness; 5. right adnexa tenderness; 6. left adnexa thickens; 7. right adnexa thickens; 8. a side or bilateral adnexa enclosed mass.Every item rating: 0 minute=recovery from illness; 1 minute=slight; 2 minutes=moderate; 3 minutes=severe.Efficacy determination compares with the scoring before and after the treatment.
The result shows 150 routine patients after 3 course of therapy, and hypogastric region weigh down to expand, pain, menostaxis does not reach uterus adnexa tenderness complete obiteration person only that 128 examples are arranged, and wherein 5 routine enclosed mass disappear, and 6 routine enclosed mass obviously dwindle, and symptom is obviously alleviated.Treatment back 22 customary HSG (hysterosalpingography), prompting: pelvic adhesion, fallopian tube is logical and not smooth, 3 routine umbrella end adhesions can not, 7 examples merge chlamydia trachomatis infections, behind the azithromycin combined treatment, 1 example gestation.The cure rate of its 1 course of treatment is that the cure rate of 52%, 2 course of treatment is that the cure rate of 67%, 3 course of treatment is 85.3% (seeing attached list)
Scoring relatively before and after the subordinate list treatment
Above smelting in 21 fens in 16～20 fens in 11～15 fens in 6～10 fens in 1～5 fen in 0 fen heals after rate (%) treatment front 28 44 55 231 courses for the treatment of after 78 23 19 22 8 522 courses for the treatment of after 101 26 14 9 673 courses for the treatment of 128 15 34 85.3
The Main Ingredients and Appearance of FUKE QIANJIN PIAN has Radix Flemingiae Philippinensis, Radix Rosae Laevigatae, Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, Caulis Spatholobi etc.This medicine is set upright with eliminating evil and is taken into account, the patient of about 1/3 placement of intrauterine devices, take FUKE QIANJIN PIAN continuously after, the endometrium of infection comes off, and forms FFI inner membrance under the effect of medicine, the clean symptom of menostaxis is also disappeared.Recover normal menstrual cycle, make the favour person of part placement of intrauterine devices avoid diagnostic curettage, get ring etc., make intrauterine device continue to play good contraceptive efficacy.
We are to continuous 3 course of therapy of inflammatory masses of pelvic cavity, and menstrual period are treatment continuously also, and this moment, capillary filling was expanded because of pelvic congestion, thus help drug osmotic, thus make drug effect continue performance.Therapeutic outcome shows: 5 routine enclosed mass disappear, and 6 examples are obviously dwindled.
In recent years, the antibacterials development rapidly, the patient repeatedly goes to a doctor and uses multiple antibiotic, often produces drug resistance and superinfection, and we have used pure Chinese medicine FUKE QIANJIN PIAN, the consumption foot, time is longer, has obtained excellent curative, is combined the patient of other pathogenic infection simultaneously, in time treatment can obviously improve cure rate.Therefrom we realize, and FUKE QIANJIN PIAN has the good curing effect for pelvic inflammatory disease, and these product are pure Chinese medicine, and side effect is little, and medicine is inexpensive, and taking convenience is worthy to be popularized clinically.
Claims (1)
1, the compound Chinese medicinal preparation FUKE QIANJIN PIAN is made up of Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, Fructus Zanthoxyli Dissiti, Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and Radix Flemingiae Philippinensis, it is characterized in that:
The incorporation of Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis and Fructus Zanthoxyli Dissiti respectively is 9% of a medical material gross weight in A, this tablet composition; The incorporation of Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and Radix Flemingiae Philippinensis respectively is 16% of a medical material gross weight;
The making step of B, this tablet is: 1. choose Radix Angelicae Sinensis, Radix Codonopsis, the Herba Andrographis of 9 weight portions, be ground into the fine powder more than 100 orders in pulverizer, leave and take standby by at least 93.3% the powder rate that gets; 2. choose the Fructus Zanthoxyli Dissiti of 9 weight portions and Radix Rosae Laevigatae, Caulis Spatholobi, Mahonia fortunei (Lindl.) Fedde and the Radix Flemingiae Philippinensis Chinese medicine of the five flavours material of 16 weight portions, they are placed the multipotency extraction pot, add hot water and extract twice, cross leaching liquid by extractions in per 2 hours method once; The extractum that simultaneously this extracting solution is condensed into proportion and is 1.08/80 ℃ of CF in the triple effect concentrator is standby; 3. the fine powder that will produce and extractum mixed pelletization, and be made into dried granule by boiling drier, after tabletting, bag sheet operation, make coated tablet type or film-coat type a thousand pieces of gold tablet.
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| CN98112696A CN1078079C (en) | 1998-10-21 | 1998-10-21 | Process for preparing Chinese medicine 'Qianjin tablets' for treating gynopathy |
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