CN101073603A - Huahong mixed suspended granule and its production - Google Patents

Huahong mixed suspended granule and its production Download PDF

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Publication number
CN101073603A
CN101073603A CN 200610050799 CN200610050799A CN101073603A CN 101073603 A CN101073603 A CN 101073603A CN 200610050799 CN200610050799 CN 200610050799 CN 200610050799 A CN200610050799 A CN 200610050799A CN 101073603 A CN101073603 A CN 101073603A
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China
Prior art keywords
herba
agent
premium
water
mix suspension
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CN 200610050799
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Chinese (zh)
Inventor
谢元德
苏春胜
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NANYANG PHARMACEUTICAL CO Ltd ZHEJAING
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NANYANG PHARMACEUTICAL CO Ltd ZHEJAING
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Priority to CN 200610050799 priority Critical patent/CN101073603A/en
Publication of CN101073603A publication Critical patent/CN101073603A/en
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Abstract

The invention is concerned with the method of preparation of the Bonuses suspension granule. It contents with sow thistle tasselflower, tongue of the long-noded viper, ground peach blossom, white Beitong, Simi, leatherleaf milletia and the mother Peach add with other necessary supplementary materials.

Description

A kind of premium mix suspension grain agent and preparation method thereof
Technical field
The present invention relates to a kind of medicine for the treatment of gynaecopathia, relate in particular to a kind of premium mix suspension grain agent and preparation method thereof.
Background technology
Gynecological inflammation such as pelvic inflammatory disease, adnexitis is commonly encountered diseases, the frequently-occurring disease of gynecological, brings serious harm for numerous women patient, primary disease sickness rate height, and sickness rate is still raising year by year.Though this sick types of drugs of treatment is quite a lot at present, the dosage form that has falls behind, and the price that has is too high, and the curative effect that yet has is not good enough, and therefore this sick medicine of treatment far can not satisfy the needs in market at present.According to the requirement of in the national modernization of Chinese medicine Tenth Five-year plan the famous and precious Chinese patent medicine of determined curative effect being carried out secondary development, we have chosen determined curative effect, the wide HUAHONG JIAONANG of market prospect has been carried out the improved research of novel form.This side now records in the 16th in " ministry standard " Chinese medicine.This side has clearing away heat-damp and promoting diuresis, and the effect of stasis-dispelling and pain-killing has significantly antibiotic, antiinflammation, and gynecological inflammations such as pelvic inflammatory disease, adnexitis are had unique curative effect.This prescription is once taken extractum, and to add crude drug powder amount be 1.4 grams, wherein contains 45% crude drug powder, for making capsule or tablet, added more adjuvant in the preparation, and the each dose of patient big (4-5 grain) causes and takes difficulty, makes patient's poor compliance.
Summary of the invention
The object of the present invention is to provide a kind of taking convenience, good patient compliance, the premium mix suspension grain agent of absorption easily.
Another object of the present invention is to provide the preparation method of a kind of premium mix suspension grain agent.
The agent of a kind of premium mix suspension grain, the agent of described premium mix suspension grain is made by the medicine of following weight parts:
Herba Duchesneae Indicae 1500~2500 Herba Hedyotidis Diffusaes 1000~1500 Radix Urenae Lobataes 1500~2500 Folium Malloti Apeltae 1000~1500 Herba Thlaspiss 1000~1500 Caulis Spatholobis 1200~1800
Fructus Rhodomyrti 1500~2500 carboxymethyl starch sodium 250~300 lactose 70~110
30 POVIDONE K 30 BP/USP-30 20~35 sodium alginate 30~40 mannitol 40~50
Protein sugar 50~100
The agent of described premium mix suspension grain is preferably made by the medicine of following weight parts:
Herba Duchesneae Indicae 2025 Herba Hedyotidis Diffusaes 1215 Radix Urenae Lobataes 2025
Folium Malloti Apeltae 1215 Herba Thlaspiss 1215 Caulis Spatholobis 1620
Fructus Rhodomyrti 2025 carboxymethyl starch sodium 272.7 lactose 90.9
30 POVIDONE K 30 BP/USP-30 27.3 sodium alginate 36.4 mannitol 45.5
Protein sugar 72.7
The present invention also discloses the preparation method of a kind of premium mix suspension grain agent, get the part Herba Duchesneae Indicae and be ground into fine powder, the residue Herba Duchesneae Indicae and and Herba Hedyotidis Diffusae, Radix Urenae Lobatae, Folium Malloti Apeltae Herba Thlaspis, Six-elements such as Caulis Spatholobi 1620 and Fructus Rhodomyrti decoct with water twice, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.18-1.23, adds ethanol and makes and contain alcohol amount and reach 65%, stirs evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25-1.30, drying, pulverize, add above-mentioned Herba Duchesneae Indicae fine powder and the abundant mixing of adjuvant, be mixed with 1.5% 30 POVIDONE K 30 BP/USP-30 solution with 50% ethanol and granulate, promptly.
The amount of water that water is carried is 18 times, adds 10 times in water for the first time, decocts 2 hours; Add 8 times of amounts of water for the 2nd time, decocted 1.5 hours.
Drying condition is 60 ℃ of dryings 48 hours.
According to the characteristics that contain 45% crude drug powder in this prescription, determine to make the mix suspension grain agent.Make patient's taking convenience, improved compliance.It is bigger than common granule, tablet, capsule dispersion to have brought into play mix suspension grain simultaneously, easier being absorbed, and absorb soon, the characteristics that bioavailability is high can be brought into play drug effect better.Make granule, can give prominence to the characteristics that Chinese medicine decoction fully absorbs fast again.Develop the agent of premium mix suspension grain, can remedy the deficiency of other dosage forms.
Preparation method of the present invention is according to 2002 following HUAHONG JIAONANG of the WS-10179 of State Drug Administration (ZD-1-0179), respectively the distinguish the flavor of optimum extracting method (see 3.2 extracting method determine) of pharmaceutically active ingredient of the design consideration of process route is concluded combination, and is simple and direct in the hope of obtaining, easily capable and guarantee the technological process that various active component are fully extracted.Though preparing institute's employing method with original capsule, the extraction process of design do not have difference basically, but the exsiccant process conditions of amount of water in the technology of original capsule and extract are unclear, existing mix suspension grain agent technology will be investigated: 1. the amount of water of Ti Quing, 2. the drying process condition of extract.Determine the optimised process operating condition, consistent in order to the curative effect of guaranteeing the mix suspension grain agent with the capsule of corresponding dosage.Extraction process by water is investigated test
Because the amount of water in the former extraction process is indeterminate,, water carries out the screening of optimum process condition so being put forward part.
Former technology extraction time (3.5h) and extraction time (2 times) are constant, and amount of water is investigated for 16,18,20 times.Active ingredient of meletin with monarch drug Herba Duchesneae Indicae and Herba Hedyotidis Diffusae in the prescription is investigated index as extraction effect, preferably draws optimum extraction condition by testing.Result of the test sees Table 1.
Table 1 extraction process by water test card
The experiment number Inventory (g) Amount of water (doubly) Fry in shallow oil the time of carrying (h) Extraction time (inferior) Investigate index
A B C Content (μ g/g Dry extract) Extraction ratio (%) Dry extract (%)
1 429.5 20(12,8) 3.5(2,1.5) 2 654.7 71.29 10.13
2 429.5 18(10,8) 3.5(2,1.5) 2 726.4 78.55 10.06
3 429.5 16(8,8) 3.5(2,1.5) 2 695.0 67.34 9.01
Result of the test shows that when being 18 times with amount of water, the content of extract Quercetin is 726.4 (μ g/g Dry extract) the highest, the extraction ratio 78.55% of Quercetin is the highest, and its yield in extractum is lower, the factor of comprehensive three aspects, determining this technology to extract water consumption is 18 times.Promptly extract 2 times, add 10 times of amounts of water, decocted 2 hours for the 1st time; Add 8 times of amounts of water for the 2nd time, decocted 1.5 hours, be optimum extraction process.
The investigation of baking temperature and time
Feed intake by prescription (former HUAHONG JIAONANG agent standard), the material 1718g that offers medicine altogether serves as to investigate index with quercetin content in the monarch drug Herba Duchesneae Indicae in the prescription, the Herba Hedyotidis Diffusae, investigates the influence to active constituent content of baking temperature and time.Herba Duchesneae Indicae, Herba Hedyotidis Diffusae medical material amount are 468g in the side, and quercetin content is 340 μ g/g in the used Herba Duchesneae Indicae medical material Herba Duchesneae Indicae, quercetin content is 350 μ g/g in the Herba Hedyotidis Diffusae medical material Herba Hedyotidis DiffusaeQuercetin content is 971 μ g/g in the dry preceding extractum ExtractumThe results are shown in Table 3.
Table 3 baking temperature and time are investigated table as a result
Temperature 60℃ 80℃
Time (h) 0 8 16 24 36 48 8 16 24 36 48
Quercetin content (μ g/g Extractum) 971 1035 1136 1190 1172 1154 1132 1213 1209 1184 1172
Extraction ratio (%) 43.8 1 42.2 2 41.9 3 41.2 4 40.1 0 39.1 2 42.0 6 41.5 8 40.9 9 39.6 2 38.7 8
Extraction ratio decline (%) 1.59 1.88 2.57 3.71 4.69 1.21 2.23 2.82 4.19 5.03
From last table as seen, 60 ℃ of vacuum dryings, 48 hours, extraction ratio descended 4.69%; 80 ℃ of vacuum dryings, 48 hours, content descended 5.03%; Investigate by test, adopted vacuum drying 60 ℃ of dry 16-24 hours, can reach needed degree of drying.Big production substantially also can reach dry, if big production do not reach degree of drying in 60 ℃ of dry 16-24 of vacuum drying hours, is increased to 48 hours, is can reach needed degree of drying fully.Being defined as 60 ℃ of dryings 48 hours so produce drying condition greatly, effective ingredient is reached the requirement of technology, is feasible fully.
80 ℃ of dryings 48 hours, also can reach the requirement of technology to the effective ingredient of Herba Duchesneae Indicae, Herba Hedyotidis Diffusae.
The specific embodiment
The present invention will be further described below by specific embodiment.
Embodiment 1: present embodiment adopts the medicine of following weight:
Herba Duchesneae Indicae 2025 Herba Hedyotidis Diffusaes 1400 Radix Urenae Lobataes 2300
Folium Malloti Apeltae 1215 Herba Thlaspiss 1215 Caulis Spatholobis 1620
Fructus Rhodomyrti 2025 carboxymethyl starch sodium 272.7 lactose 90.9
30 POVIDONE K 30 BP/USP-30 27.3 sodium alginate 36.4 mannitol 45.5
Protein sugar 72.7
At first get Herba Duchesneae Indicae 207g, be ground into fine powder, Six-elements such as residue Herba Duchesneae Indicae and all the other Herba Hedyotidis Diffusaes, decoct with water twice, for the first time add 10 times in water, fried in shallow oil 2 hours, add 8 times in water for the second time, fried in shallow oil 1.5 hours, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.18-1.23 (80 ℃), adding ethanol makes and contains alcohol amount and reach 65%, stir evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25-1.30 (80 ℃), dry (60 ℃) are pulverized, and add fully mixing of above-mentioned fine powder and adjuvant (1.2 times), be mixed with 1.5% 30 POVIDONE K 30 BP/USP-30 solution with 50% ethanol and granulate, promptly.
Embodiment 2: present embodiment adopts the medicine of following weight:
Herba Duchesneae Indicae 1800g Herba Hedyotidis Diffusae 1215g Radix Urenae Lobatae 2025g
Folium Malloti Apeltae 1100g Herba Thlaspis 1100g Caulis Spatholobi 1800g
Fructus Rhodomyrti 2000g carboxymethyl starch sodium 250g lactose 100g
30 POVIDONE K 30 BP/USP-30 25g sodium alginate 30g mannitol 50g
Protein sugar 80g
Preparation method is identical with embodiment 1.

Claims (5)

1, a kind of premium mix suspension grain agent is characterized in that the agent of described premium mix suspension grain made by the medicine of following weight parts:
Herba Duchesneae Indicae 1500~2500 Herba Hedyotidis Diffusaes 1000~1500 Radix Urenae Lobataes 1500~2500 Folium Malloti Apeltae 1000~1500 Herba Thlaspiss 1000~1500 Caulis Spatholobis 1200~1800
Fructus Rhodomyrti 1500~2500 carboxymethyl starch sodium 250~300 lactose 70~110
30 POVIDONE K 30 BP/USP-30 20~35 sodium alginate 30~40 mannitol 40~50
Protein sugar 50~100
2, a kind of premium mix suspension grain according to claim 1 agent is characterized in that the agent of described premium mix suspension grain made by the medicine of following weight parts:
Herba Duchesneae Indicae 2025 Herba Hedyotidis Diffusaes 1215 Radix Urenae Lobataes 2025
Folium Malloti Apeltae 1215 Herba Thlaspiss 1215 Caulis Spatholobis 1620
Fructus Rhodomyrti 2025 carboxymethyl starch sodium 272.7 lactose 90.9
30 POVIDONE K 30 BP/USP-30 27.3 sodium alginate 36.4 mannitol 45.5
Protein sugar 72.7
3, the preparation method of a kind of premium mix suspension grain according to claim 1 and 2 agent, it is characterized in that getting the part Herba Duchesneae Indicae and be ground into fine powder, the residue Herba Duchesneae Indicae and and Herba Hedyotidis Diffusae, Radix Urenae Lobatae, Folium Malloti Apeltae Herba Thlaspis, Six-elements such as Caulis Spatholobi 1620 and Fructus Rhodomyrti decoct with water twice, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.18-1.23, adding ethanol makes and contains alcohol amount and reach 65%, stir evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25-1.30, drying, pulverize, add above-mentioned Herba Duchesneae Indicae fine powder and the abundant mixing of adjuvant, be mixed with 1.5% 30 POVIDONE K 30 BP/USP-30 solution with 50% ethanol and granulate, promptly.
4, the preparation method of a kind of premium mix suspension grain according to claim 3 agent is characterized in that the amount of water that water is carried is 18 times, adds 10 times in water for the first time, decocts 2 hours; Add 8 times of amounts of water for the 2nd time, decocted 1.5 hours.
5, the preparation method of a kind of premium mix suspension grain according to claim 3 agent is characterized in that drying condition is 60 ℃ of dryings 48 hours.
CN 200610050799 2006-05-18 2006-05-18 Huahong mixed suspended granule and its production Pending CN101073603A (en)

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Application Number Priority Date Filing Date Title
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784546A (en) * 2012-10-31 2014-05-14 广西壮族自治区花红药业股份有限公司 Preparation process for Chinese herbal granule used for treating chronic pelvic inflammation
CN105412474A (en) * 2015-12-06 2016-03-23 济南新时代医药科技有限公司 Application of Huahong capsule in preparing medicine for treating epididymal cyst
CN106344804A (en) * 2016-10-14 2017-01-25 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for treating bone fracture, and preparation method thereof
CN106362032A (en) * 2016-11-24 2017-02-01 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for treating nervous vomiting and preparation method and application thereof
CN106421187A (en) * 2016-11-24 2017-02-22 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for curing prostatitis and preparation method and application thereof
CN106421490A (en) * 2016-11-24 2017-02-22 全椒先奇医药科技有限公司 Traditional Chinese medicinal composition for treating diarrhea, and preparation method and application thereof
CN113491728A (en) * 2021-08-09 2021-10-12 广西壮族自治区花红药业集团股份公司 Application of carthamus tinctorius composition in preparation of medicine for treating polycystic ovarian syndrome

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784546A (en) * 2012-10-31 2014-05-14 广西壮族自治区花红药业股份有限公司 Preparation process for Chinese herbal granule used for treating chronic pelvic inflammation
CN105412474A (en) * 2015-12-06 2016-03-23 济南新时代医药科技有限公司 Application of Huahong capsule in preparing medicine for treating epididymal cyst
CN106344804A (en) * 2016-10-14 2017-01-25 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for treating bone fracture, and preparation method thereof
CN106362032A (en) * 2016-11-24 2017-02-01 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for treating nervous vomiting and preparation method and application thereof
CN106421187A (en) * 2016-11-24 2017-02-22 全椒先奇医药科技有限公司 Traditional Chinese medicine composition for curing prostatitis and preparation method and application thereof
CN106421490A (en) * 2016-11-24 2017-02-22 全椒先奇医药科技有限公司 Traditional Chinese medicinal composition for treating diarrhea, and preparation method and application thereof
CN113491728A (en) * 2021-08-09 2021-10-12 广西壮族自治区花红药业集团股份公司 Application of carthamus tinctorius composition in preparation of medicine for treating polycystic ovarian syndrome

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Application publication date: 20071121