CN100586466C - Film coating tablet for treating gynaecologic disease and method for preparing the same - Google Patents
Film coating tablet for treating gynaecologic disease and method for preparing the same Download PDFInfo
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- CN100586466C CN100586466C CN200710092498A CN200710092498A CN100586466C CN 100586466 C CN100586466 C CN 100586466C CN 200710092498 A CN200710092498 A CN 200710092498A CN 200710092498 A CN200710092498 A CN 200710092498A CN 100586466 C CN100586466 C CN 100586466C
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Abstract
The present invention relates to a film-coated tablet for treating gynecological diseases, which is prepared by the raw materials with the following mix ratio by weight: 0.35 to 0.85 part of dahurianpatrinia herb, 0.15 to 0.55 part of coix seed, 0.12 to 0.45 part of Szechwan Chinaberry fruit, 0.12 to 0.45 part of Chinese thorowax root, 0.12 to 0.45 part of baical skullcap root, 0.12 to 0.45 partof red paeony root and 0.08 to 0.35 part of tangerine peel. The preparation method of the present invention is that: the medicines are taken, except part of the coix seed is smashed into coarse powder, others are respectively boiled and extracted for three times by taking the water as the solvent, and finally the film-coated tablet is prepared by filtration, concentration, granulation and compression. Compared with the congeneric gynecological products, the present invention has good efficacy, small dosage, no sugar or other excipients and broad application scope. The present invention can beused by the women with obesity and diabetes, as well as the patients with saccharocoria; the present invention has special and novel appearance, easy carry and storage, which can reach the leading domestic level.
Description
Technical field
The present invention relates to the Chinese herbal medicine is the Chinese patent medicine of feedstock production, treats the Film coated tablets of gynaecopathia specifically, the invention still further relates to the preparation method of this medicine.
Background technology
Gynaecopathia, incomplete statistics according to World Health Organization (WHO), various gynaecopathia sickness rate are more than 65% among the women, China's interrelated data investigation shows, women of child-bearing age's disease incidence is more than 70%, the women is 100% vaginitis of suffering from various degree almost in life, and wherein having more than 5% due to illness, feelings have had a strong impact on normal work and life.
Gynaecopathia belongs to the traditional Chinese medical science " stomachache ", " leukorrheal diseases ", “ mass in the abdomen ", sick category such as " infertile "; how by artificial abortion, wear intrauterine device, puerperal wound etc. and cause blood stasis numbness resistance network road and form; or by menstrual period, the childbirth hematozemia of losing blood; nutrition loss; stagnated heat of liver channel accumulates the deep-sited part of the chong channel and appoints, and stagnation of blood stasis and heat forms; Or by sexual intercourse in menstrual period or operation, exopathogen is invaded, and fighting mutually with QI and blood forms.Its pathogenesis is a deficiency in origin and excess in superficiality.The deficiency in origin person is positive QI-insufficiency, caused by liver and kidney deficiency; Marking real person, is that the stasis of blood, heat, wet three accumulate among the born of the same parents, and QI-blood circulation is not smooth, and collaterals of the uterus is obstructed, stagnation of QI and blood may bring about pain.So should be in the treatment based on blood circulation promoting and blood stasis dispelling, clearing away heat and eliminating dampness.Treat this type of disease, need to select preparation easy to carry and use, alternative preparation has granule, tablet and capsule etc., though the more approaching traditional decoction of granule, still owe convenient but take, must have water to brew, the capsule shells of capsule is grown spleen and is hindered stomach often for animal's leather boils.
At present, the Western medicine that is used for gynaecopathia is all more, and Western medicine mostly has effect preferably aspect controlling inflammation, but is easy to recurrence after studies show that this class drug use clinically, and Western medicine all exists certain side effect or drug resistance.At present, the Chinese patent medicine of available treatment gynaecopathia is quite a few, but therapeutic effect is undesirable, and does not have the film coating dosage form.
Summary of the invention
At the prior art above shortcomings, the object of the present invention is to provide a kind of good effect, consumption is little, does not contain the Film coated tablets of the treatment gynaecopathia of sugar and other excipient.
Another object of the present invention provides the preparation method of the Film coated tablets of this gynaecopathia.
The object of the present invention is achieved like this: a kind of Film coated tablets for the treatment of gynaecopathia, and medicine is made by the following weight proportion raw material:
Herba Patriniae 0.35～0.85 Semen Coicis 0.15～0.55 Fructus Toosendan 0.12～0.45 Radix Bupleuri 0.12～0.45 Radix Scutellariae 0.12～0.45 Radix Paeoniae Rubra 0.12～0.45 Pericarpium Citri Reticulatae 0.08～0.35.
The preferred specification ratio range of medicine of the present invention is: substrate is heavy: 0.3～0.9 gram; Every weight: 0.35～1.2 gram.
The optimum ratio scope of medicine of the present invention is:
Herba Patriniae 0.5～0.8 Semen Coicis 0.25～0.4 Fructus Toosendan 0.2～0.3 Radix Bupleuri 0.2～0.3 Radix Scutellariae 0.2～0.3 Radix Paeoniae Rubra 0.2～0.3 Pericarpium Citri Reticulatae 0.12～0.15.
The optimum weight proportioning of medicine of the present invention is:
Herba Patriniae 0.7 Semen Coicis 0.35 Fructus Toosendan 0.26 Radix Bupleuri 0.26 Radix Scutellariae 0.26 Radix Paeoniae Rubra 0.26 Pericarpium Citri Reticulatae 0.13.
A kind of preparation method for the treatment of the Film coated tablets of gynaecopathia is:
1. get Herba Patriniae, Semen Coicis, Fructus Toosendan, Radix Bupleuri, Radix Scutellariae, Radix Paeoniae Rubra, Pericarpium Citri Reticulatae by prescription, except that half of Semen Coicis is ground into the coarse powder, all the other are respectively solvent with water, decoct and extract three times, first and second time solvent consumption is 8～10 times of medical material weight, first and second time respectively extracted 60 minutes, and the solvent consumption is 6～8 times of medical material weight for the third time, extracts for the third time 40 minutes.Filter, merge medicinal liquid, be condensed into thick paste, standby.
2. above-mentioned thick paste mixes with the Semen Coicis coarse powder, in dry below 80 ℃, is ground into fine powder, and mixing is granulated, and adds appropriate amount of auxiliary materials, tabletting, and the bag film-coat, promptly.
Dosage form selection: the function of this product is a clearing away heat-damp and promoting diuresis, blood-activating analgetic.Be used for women's leukorrhagia due to the dampness and heat stasis, yellow skin matter thickness or as the bean dregs shape, gas is smelly, few abdomen, lumbus sacrum pain, diseases such as the dark yellow and greasy fur of tongue, and chronic pelvic inflammatory disease is seen above-mentioned patient.The present invention selects film-coat to replace sugar-coat especially, promptly can reduce dose, can be applicable to women's obesity and diabetes again, patients such as saccharocoria, and efficacy stability, mature production technology.
The present invention is complete, and the side is made up of medicines such as Herba Patriniae, Fructus Toosendan, Radix Bupleuri, Radix Scutellariae, Radix Paeoniae Rubra, Pericarpium Citri Reticulataes.Herba Patriniae, Fructus Toosendan, Radix Scutellariae, Radix Paeoniae Rubra heat-clearing and toxic substances removing in the side can also promoting blood circulation, removing blood stasis and relieving pains, are aided with spleen invigorating, soothing liver-QI simultaneously, regulate the flow of vital energy; Treating both the principal and secondary aspects of a disease such as medical material Semen Coicis, Radix Bupleuri, Pericarpium Citri Reticulatae.Modern pharmacological research confirms that it has bacteriostasis preferably to staphylococcus aureus, staphylococcus epidermidis, Hemolytic streptococcus, escherichia coli, pseudomonas aeruginosa, proteus mirabilis, Candida albicans.Golden Portugal bacterium is caused that mouse infection has very strong endogenous protective effect, and have stronger clinical value.
The present invention is based on understanding and the Therapeutic Principle of motherland's medical science to gynaecopathia, forms in conjunction with modern pharmacological research achievement and scientific research, clinical practice experience prescription.On it falls ill clinical syndrome Epidemiological study basis, be foundation with ancient literature research, prompting gynaecopathia deficiency in origin and excess in superficiality.The deficiency in origin person is positive QI-insufficiency, caused by liver and kidney deficiency; Marking real person, is that the stasis of blood, heat, wet three accumulate among the born of the same parents, and QI-blood circulation is not smooth, and collaterals of the uterus is obstructed, stagnation of QI and blood may bring about pain.The present invention just is being based on this, and the Chinese medicine compound Film coated tablets of the gynaecopathia of development treatment targetedly is used for the treatment of various gynecological diseases.
The present invention shows that through the modern pharmacology drug efficacy study modern pharmacological research confirms that it has bacteriostasis preferably to staphylococcus aureus, staphylococcus epidermidis, Hemolytic streptococcus, escherichia coli, pseudomonas aeruginosa, proteus mirabilis, Candida albicans.Golden Portugal bacterium is caused that mouse infection has very strong endogenous protective effect.
This technology advanced person, steady quality are reliable, safe and effective, are the effective Chinese traditional compound medicines that is mainly used in the treatment gynaecopathia.
Description of drawings:
Accompanying drawing is Film coated tablets technological process of production figure of the present invention.
The specific embodiment
Embodiment 1: take by weighing Herba Patriniae 695.6g, Semen Coicis 347.8g, Fructus Toosendan 260.8g, Radix Bupleuri 260.8g, Radix Scutellariae 260.8g, Radix Paeoniae Rubra 260.8g, Pericarpium Citri Reticulatae 130.4g, make Film coated tablets as follows:
Get Herba Patriniae, Semen Coicis, Fructus Toosendan, Radix Bupleuri, Radix Scutellariae, Radix Paeoniae Rubra and Pericarpium Citri Reticulatae by prescription, except that half of Semen Coicis is ground into 20～40 purpose coarse powder, all the other are respectively solvent with water, decoct and extract three times, first and second time solvent consumption is 8～10 times of medical material weight, first and second time respectively extracted 60 minutes, and the solvent consumption is 6～8 times of medical material weight for the third time, extracts for the third time 40 minutes.Filter, merge medicinal liquid, be condensed into thick paste, thick paste mixes with the Semen Coicis coarse powder, dry under 60 ℃ of-80 ℃ of conditions, be ground into 80～100 purpose fine powders, mixing is granulated, add appropriate amount of auxiliary materials such as carboxymethylstach sodium 7.2%, citric acid 4.5%, sodium bicarbonate 6.75% and film coating agent 0.27%, be pressed into 1000, the bag film-coat, promptly.
Its technological process is referring to accompanying drawing.
Other reference example: (unit: kilogram)
| Herba Patriniae | Semen Coicis | Fructus Toosendan | Radix Bupleuri | Radix Scutellariae | Radix Paeoniae Rubra | Pericarpium Citri Reticulatae | |
| Prescription 1 | 35 | 15 | 12 | 12 | 12 | 12 | 8 |
| Prescription 2 | 69.5 | 34.7 | 26 | 26 | 26 | 26 | 13 |
| Prescription 3 | 50 | 25 | 20 | 20 | 20 | 20 | 12 |
| Prescription 4 | 70 | 35 | 26 | 26 | 26 | 26 | 13 |
In like manner, prescription 1～4 all promptly can be made into FUYANKANGFU sheet of the present invention with reference to embodiment 1 preparation method.
The side separates: we are principal agent with the Herba Patriniae, put down in writing according to " herbal classic ": " remove carbuncle, edema, stagnation of pathogenic heat, migratory arthralgia deficiency, puerperal abdonimal pain." " not Lu " record: ... broken blood for many years, can suppurate is water, puerperal all diseases, surplus rash excessive thirst." Zhen Quan " record: control the vim and vigour trusted subordinate, broken Disorder knot expedites the emergence of born of the same parents ... red and white leukorrhea not ... fistula is mended in evacuation of pus.Clinically breast abdomen pain that are used for stasis, this product has the effect of stasis-dispelling and pain-killing more.Radix Bupleuri, Radix Paeoniae Rubra are aided with principal agent, and the former is usually used in depression of liver-QI, distending pain over the hypochondrium, and menoxenia, cards such as dysmenorrhea, this product can reach irritability and dispersing the stagnated live-QI to relieve the stagnation of QI by bar; And Radix Paeoniae Rubra function clearing away heat and cooling blood, stasis-dispelling and pain-killing is usually used in amenorrhea due to stagnation of blood, dysmenorrhea card, for blood-heat syndromes such as pyretic stranguria, stranguria with blood and hematodiarrhoea band blood curative effect is preferably arranged; Fructus Toosendan, Semen Coicis, Pericarpium Citri Reticulatae, Radix Scutellariae are the double medicine of controlling, and Fructus Toosendan mainly is to go up lower abdominal pain; The Semen Coicis promoting diuresis with drugs of tasteless flavour, the energy spleen invigorating of holding concurrently, merit is like Poria; During Pericarpium Citri Reticulatae is regulated the flow of vital energy and is transferred, according to " not record " record: except that bladder stays heat, cuts off the water, five types of stranguria, diuresis ...Radix Scutellariae function clearing away heat-damp and promoting diuresis, eliminating fire and detoxication, hemostasis, antiabortive.Multiple disease due to this product is used for wetting is as hygropyrexia, dysentery, pyretic stranguria etc.Major-minorly doublely draw mutual combination and play clearing away heat-damp and promoting diuresis altogether, the merit of blood-activating analgetic.Be mainly used in women's leukorrhagia due to the dampness and heat stasis, yellow skin matter thickness or as the bean dregs shape, gas is smelly, few abdomen, lumbus sacrum pain, diseases such as the dark yellow and greasy fur of tongue, and chronic pelvic inflammatory disease is seen above-mentioned patient.
Acute toxicity test: observe the FUYANKANGFU sheet to chmice acute toxicity, the result fails to detect mice median lethal dose(LD 50) (LD
50), record the maximum tolerance of one day and be 26.4g/kg/ day, 31 times of the usual amounts that is equivalent to be grown up.
Long term toxicity test: by observing continuous 4 weeks of FUYANKANGFU sheet of the present invention, to rat body weight, organ coefficient, the morphologic influence of vital tissue organ pathology and the recovery situation after 2 weeks of drug withdrawal.Animal does not have death as a result, and ordinary circumstance is no abnormal, the no abnormal change of indexs such as the weight of animals, organ coefficient, and 15 main organs gross examination of skeletal muscle and mirror are checked no toxic pathology change down.Each administration treated animal outward appearance, body weight, appetite, blood parameters, hepatic and renal function and each organ coefficient and matched group relatively do not have obvious change, the main organs pathological examination there is no pathological change, illustrates that this medicine that is put to the test does not have the target organ of overt toxicity in vivo, points out FUYANKANGFU sheet clinical oral administration drug safety of the present invention.The long-term oral growth promoter and the normal tissue morphology that can not influence the weight of animals and each main histoorgan.
Main pharmacodynamics research: antiinflammatory experimental results show that the FUYANKANGFU sheet has obvious suppression mice ear and rat paw edema effect (P＜0.01); The mouse writhing test confirms that the FUYANKANGFU sheet has the obvious suppression mice and produces the effect (P＜0.01) of turning round body; Paper disk method antibacterial tests confirmation FUYANKANGFU sheet and FUYANKANG PIAN bacteriostasis do not have significant difference; the double dilution method of test tube confirms that the FUYANKANGFU sheet is respectively 125mg/ml to staphylococcus aureus, staphylococcus epidermidis, streptococcus faecalis, colibacillary MIC; 150mg/ml; 125mg/ml; 125mg/ml, endogenous protective test confirms that its survival rate heavy dose reaches 60%, middle dosage reaches 50%, low dose reaches 40% and is the dose-effect dependence.Blood circulation promoting and blood stasis dispelling test confirm the large and small dosage of FUYANKANGFU sheet to whole blood high, medium and low cut viscosity and blood stasis model group mutually specific viscosity obvious reduction is arranged, plasma viscosity, whole blood reduced viscosity, packed cell volume and blood stasis model group are compared also tangible reduction.
Medicine of the present invention can be made into different shape " special-shaped tablets " as bar shaped, rhombus etc., and is heavy as substrate: 0.875 gram, every weight behind the coating: 0.9 gram.Compare with similar gynecological product, good effect, consumption is little.This product does not contain sugar and other excipient, wide accommodation, and as women's obesity and diabetes, patients such as saccharocoria also can take, its outward appearance uniqueness, novelty, the storage that is easy to carry, this product reaches the top standard at home.
Claims (1)
1. Film coated tablets for the treatment of gynaecopathia, it is characterized in that it is to be made by the following weight proportion raw material: Herba Patriniae 0.35～0.85 Semen Coicis 0.15～0.55 Fructus Toosendan 0.12～0.45 Radix Bupleuri 0.12～0.45 Radix Scutellariae 0.12～0.45 Radix Paeoniae Rubra 0.12～0.45 Pericarpium Citri Reticulatae 0.08～0.35;
Described Film coated tablets specification is: substrate is heavy: 0.3～0.9 gram; Every weight: 0.35～1.2 gram;
The preparation method of described Film coated tablets comprises the steps:
1) gets Herba Patriniae, Semen Coicis, Fructus Toosendan, Radix Bupleuri, Radix Scutellariae, Radix Paeoniae Rubra and Pericarpium Citri Reticulatae by prescription, except that half of Semen Coicis is ground into 20～40 purpose coarse powder, all the other are respectively solvent with water, decoct and extract three times, first and second time solvent consumption is 8～10 times of medical material weight, first and second time respectively extracted 60 minutes, and the solvent consumption is 6～8 times of medical material weight for the third time, extracts for the third time 40 minutes; Filter, merging filtrate is condensed into thick paste, and is standby;
2) above-mentioned thick paste mixes with the Semen Coicis coarse powder, in dry below 80 ℃, is ground into 80～100 purpose fine powders, and mixing is granulated, and adds appropriate amount of auxiliary materials, tabletting, and the bag film-coat, promptly;
Described adjuvant is carboxymethylstach sodium 7.2%, citric acid 4.5%, sodium bicarbonate 6.75% and film coating agent 0.27%.
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| CN200710092498A CN100586466C (en) | 2007-07-30 | 2007-07-30 | Film coating tablet for treating gynaecologic disease and method for preparing the same |
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| CN200710092498A CN100586466C (en) | 2007-07-30 | 2007-07-30 | Film coating tablet for treating gynaecologic disease and method for preparing the same |
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| CN100586466C true CN100586466C (en) | 2010-02-03 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101380434B (en) * | 2008-10-21 | 2012-12-12 | 沈阳盛达科医药科技有限公司 | Yisheng granules and preparation method thereof |
| CN101658647B (en) * | 2009-09-25 | 2011-12-14 | 西安碑林药业股份有限公司 | Preparation method of traditional Chinese medicine women inflammation recovery preparation and detection method thereof |
| CN103055192B (en) * | 2011-10-19 | 2014-09-10 | 杨文龙 | Women inflammation recovery chewable tablet |
| CN104800432A (en) * | 2015-04-15 | 2015-07-29 | 刘卓韬 | Application of traditional Chinese medicine composition and acupoint combination acupuncture for treating chronic pelvic inflammation |
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