CN103127113B - Compound pseudoe-phedrine hydro-chloride dry suspension and preparation method thereof - Google Patents
Compound pseudoe-phedrine hydro-chloride dry suspension and preparation method thereof Download PDFInfo
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- CN103127113B CN103127113B CN201310053721.4A CN201310053721A CN103127113B CN 103127113 B CN103127113 B CN 103127113B CN 201310053721 A CN201310053721 A CN 201310053721A CN 103127113 B CN103127113 B CN 103127113B
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Abstract
The invention discloses a compound pseudoe-phedrine hydro-chloride dry suspension and a preparation method of the compound psedoe-phedrine hydro-chloride dry suspension. The compound psedoe-phedrine hydro-chloride dry suspension comprises 40-100 parts of active ingredients, 600-2200 parts of filler, 50-200 parts of flavoring agents, 40-100 parts of suspending agents and 10-40 parts of flocculating agents, wherein the active ingredients are composed of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate. The compound pseudoe-phedrine hydro-chloride dry suspension is even in particle distribution, good in stability, large in distribution area in a stomach and intestines, quick in absorption, high in bioavailability, quick in effect producing, and superior to a compound pseudoe-phedrine hydro-chloride premix in pharmaceutical effect.
Description
Technical field
The present invention relates to a kind of dry suspension, relate in particular to a kind of compound recipe acetaminophen compound dry suspension and preparation method thereof, belong to compound recipe acetaminophen compound formulation art.
Background technology
Dry suspension refers to that insoluble drug and proper auxiliary materials make powder or shot-like particle, faces the used time jolting that adds water and can be dispersed into suspension for oral liquid preparation.Dry suspension belongs to suspensoid, adds after aqueous dispersion, should meet the prescription of suspensoid, and the microgranule in suspension should be dispersed, should not call in the following text rapidly, should not form cake piece after sedimentation, redispersion rapidly after jolting.Desirable suspensoid be except having effectiveness and chemical stability (depending primarily on the character of principal agent), also should (1) sedimentation slow, jolting energy redispersion gently after sedimentation; (2) size of suspended particles in long-term storage, should remain unchanged (3) easily topple over.Above-mentioned is the physical stability of suspensoid.The feature of the existing solid preparation of dry suspension (granule), as be convenient for carrying, convenient transportation, good stabilities etc., have again the advantage (conveniently take, be suitable for swallowing inconvenient patient, as child, old man) of liquid preparation.
The effective ingredient of compound recipe Compound Pseudoephedrine Hydrochloride Capsule is acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate, be the flu symptomatic treatment medicine for child, be applicable to the symptoms such as heating, headache that treatment causes by flu, whole body extremities aching pain, sneeze, watery nasal discharge, nasal obstruction, cough.
There is the defect that disintegrate result of extraction is poor, bioavailability is low in existing compound recipe acetaminophen compound oral formulations, affects its therapeutic effect clinically, haves much room for improvement.
Summary of the invention
The present invention, in order to solve existing compound recipe acetaminophen compound poorly water-soluble, shortcoming that bioavailability is low, has invented compound recipe acetaminophen compound dry suspension.
Composition and the content weight proportion of compound recipe acetaminophen compound dry suspension of the present invention are as follows:
Active component: 40-100 part;
Filler: 600-2200 part;
Correctives: 50-200 part;
Suspending agent: 40-100 part;
Flocculating agent: 10-40 part.
Preferably, the content weight proportion of each composition is as follows:
Active component: 50 parts;
Filler: 700 parts;
Correctives: 50 parts;
Suspending agent: 50 parts;
Flocculating agent: 10 parts.
Described active component is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1;
Described filler is selected from mannitol, microcrystalline Cellulose or lactose; Described correctives is selected from aspartame and stevioside; Described suspending agent be selected from methylcellulose, carboxylic propyl methocel, hydroxypropyl cellulose, sodium alginate, agar, starch slurry, polyvidone or glucosan any one or multiple; Flocculating agent is selected from disodium hydrogen phosphate,anhydrous.
Applicant is surprised to find that selecting the compositions of methylcellulose and glucosan is suspending agent, and the two part by weight is while being 3:2, and the dry suspension settling volume preparing is than large, and redispersibility is good especially.
The preparation method of described compound recipe acetaminophen compound dry suspension, is characterized in that comprising the following steps:
(1) active component that takes recipe quantity is crossed 80-120 mesh sieve;
(2) take respectively filler, correctives, suspending agent and the flocculating agent of recipe quantity, cross after 80-120 mesh sieve respectively, equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively to mix homogeneously and must mix powder, cross 30-40 mesh sieve;
(4) intermediate detection qualified after, subpackage gets final product to obtain finished product.
Compared with prior art, the present invention has following beneficial effect:
(1) compound recipe acetaminophen compound dry suspension even particle distribution of the present invention, good stability, large at the distribution area of gastrointestinal, absorb soon, bioavailability is high, and drug effect is fast, and drug effect is better than compound recipe acetaminophen compound pre-mixing agent.
(2) compared with prior art, though the dry suspension the present invention relates to is solid preparation, adds water before use and can become liquid preparation, easy mix homogeneously and time saving and energy saving, has solved can not the drink water use restricted problem of administration of compound recipe acetaminophen compound
(3) the compound recipe acetaminophen compound dry suspension the present invention relates to, preparation technology is simple, is easy to preserve, and effect duration is not long, perishable and easily grasp dosage, is applicable to company's production of multiple scale.
Detailed description of the invention
Further explain the present invention below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
The preparation of embodiment 1 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is as follows:
(1) active component that precision takes recipe quantity is crossed 80 mesh sieves;
(2) accurate mannitol, aspartame, methylcellulose, glucosan, the disodium hydrogen phosphate,anhydrous that takes recipe quantity respectively, crosses after 80 mesh sieves respectively, and equivalent increases progressively mix homogeneously;
(3) step (1) and (2) equivalent are increased progressively to mix homogeneously and must mix powder, cross 40 mesh sieves;
(4) intermediate detection qualified after, subpackage gets final product to obtain finished product.
The preparation of embodiment 2 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 1:1) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 3 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 3:1) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 4 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 2:1) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 5 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 5:1) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 6 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 1:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 7 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 1:3) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 8 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 1:4) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 9 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan (weight ratio is 1:5) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 10 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: sodium alginate (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 11 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: starch slurry (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 12 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: polyvidone (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 13 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: agar (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 14 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Carboxylic propyl methocel: glucosan (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 15 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Hydroxypropyl cellulose: glucosan (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
The preparation of embodiment 16 compound recipe acetaminophen compound dry suspension
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Sodium alginate: glucosan (weight ratio is 3:2) 50g
Disodium hydrogen phosphate,anhydrous 10g
Described effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1.
Preparation method is with embodiment 1.
Test example 1 dry suspension settling property and suspendible performance test
Regulation according to one of Pharmacopoeia of the People's Republic of China version in 2005 about dry suspension settling volume ratio is tested, and the results are shown in Table 1.
Measure the suspendible performance of glycosides sugar ester dry suspension of the present invention about the quality evaluating method of dry suspension according to Chinese Pharmacopoeia (2000 editions).The results are shown in Table 1.
Table 1
| ? | Settling volume ratio | Redispersibility |
| Embodiment 1 | 0.98 | Very good |
?
| Embodiment 2 | 0.90 | Generally |
| Embodiment 3 | 0.91 | Poor |
| Embodiment 4 | 0.91 | Poor |
| Embodiment 5 | 0.90 | Poor |
| Embodiment 6 | 0.91 | Generally |
| Embodiment 7 | 0.90 | Poor |
| Embodiment 8 | 0.90 | Generally |
| Embodiment 9 | 0.91 | Poor |
| Embodiment 10 | 0.90 | Poor |
| Embodiment 11 | 0.91 | Generally |
| Embodiment 12 | 0.91 | Poor |
| Embodiment 13 | 0.91 | Generally |
| Embodiment 14 | 0.90 | Poor |
| Embodiment 15 | 0.90 | Generally |
| Embodiment 16 | 0.90 | Poor |
Pertinent regulations under annex of Pharmacopoeia of the People's Republic of China version in 2005 13 dry suspension item for oral administration, weight differential < 10%, loss on drying < 2%, judge that the leading indicator whether dry suspension is qualified is not less than 0.90 as settling volume ratio, therefore this product conforms with the regulations.
As seen from the data in Table 1, glycosides sugar ester dry suspension settling volume of the present invention is greater than 0.9 than all, meets pharmacopeia regulation.And select methylcellulose: the redispersibility of the embodiment 1 that the compositions of polyvidone (weight ratio is 3:2) is suspending agent is significantly better than other embodiment.
Claims (1)
1. a dry suspension, wherein effective ingredient is made up of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate; Meter by weight proportion, acetaminophen: pseudoephedrine hydrochloride: dextromethorphan hydrobromide: chlorphenamine maleate=16:1.5:0.5:0.1, each composition and content weight proportion are as follows:
Effective ingredient 50g
Mannitol 700g
Aspartame 50g
Methylcellulose: glucosan 50g
Disodium hydrogen phosphate,anhydrous 10g
Described methylcellulose and glucosan weight ratio are 3:2.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310053721.4A CN103127113B (en) | 2013-02-19 | 2013-02-19 | Compound pseudoe-phedrine hydro-chloride dry suspension and preparation method thereof |
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| CN201310053721.4A CN103127113B (en) | 2013-02-19 | 2013-02-19 | Compound pseudoe-phedrine hydro-chloride dry suspension and preparation method thereof |
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| CN103127113B true CN103127113B (en) | 2014-07-30 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1360892A (en) * | 2000-12-28 | 2002-07-31 | 营口奥达制药有限公司 | Dry mixed suspension of Meptin and pseudoephe and its prepn |
| CN1616102A (en) * | 2004-10-12 | 2005-05-18 | 李�杰 | Compound dry suspensoid agent for curing cold and its prescription and preparing method |
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- 2013-02-19 CN CN201310053721.4A patent/CN103127113B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1360892A (en) * | 2000-12-28 | 2002-07-31 | 营口奥达制药有限公司 | Dry mixed suspension of Meptin and pseudoephe and its prepn |
| CN1616102A (en) * | 2004-10-12 | 2005-05-18 | 李�杰 | Compound dry suspensoid agent for curing cold and its prescription and preparing method |
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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Address after: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee after: Zhengda Pharmaceutical (Qingdao) Co., Ltd. Address before: 266103 3601 Tuen Jie Road, Qingdao economic and Technological Development Zone, Shandong Patentee before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |